[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-spontaneous-urticaria-csu\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-spontaneous-urticaria-csu":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,42,73,96,120,141,173,194,215,244],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100644221","phase-1-a-phase-ibiia-study-assessing-the-rapid-onset-characteristics-of-tll-018-for-moderate-to-severe-csu-with-inadequate-response-to-second-generation-h1-antihistamines-100644221",false,"NCT07665996","A Phase Ib\u002FIIa Study Assessing the Rapid Onset Characteristics of TLL-018 for Moderate-to-Severe CSU With Inadequate Response to Second-Generation H1 Antihistamines","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ib\u002FIIa Clinical Trial Assessing the Rapid Onset Characteristics of TLL-018 in Subjects With Moderate-to-Severe Chronic Spontaneous Urticaria Who Fail to Achieve Adequate Control With Second-Generation H1 Antihistamines","Inclusion Criteria:\n\n* Aged between 18 and 75.\n* Diagnosis of CSU refractory to second-generation H1-AH.\n* CSU diagnosis for ≥ 6 months.\n* The presence of itch and hives despite current use of an approved dose of H1-AH for ≥ 6 weeks prior to screening visit.\n* UAS7 score (range 0-42) ≥ 16 and itch component of UAS7 (ISS range 0-21) ≥ 8 during 7 days prior to randomization (Day 1), and ISS ≥2 on the day of randomization.\n* Participants are required to take a stable standard dose of a second generation H1-AH concomitantly according to local guidelines.\n* Willing and able to to comply with the study protocol and complete the participant diary throughout the study period. Participants shall have no more than one missing urticaria symptom score (morning or evening HSS score and ISS score) within 7 days prior to randomization, and no missing HSS score or ISS score on the day immediately before randomization..\n* Women of Child Bearing Potential (WOCBP) should not be pregnant or breastfeeding and the pregnancy test should be negative before randomization.\n* Participants (whether male or female) should have adequate barrier contraception during the whole treatment period and at least 90 days after treatment; subjects should avoid the sperm or ovum donation for at least six months after treatment.\n\nExclusion Criteria:\n\n1. Participants who meet the diagnostic criteria for chronic spontaneous urticaria (CSU) shall be excluded if they present with any of the following conditions:\n\n   * Progressive or uncontrolled symptoms of renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiovascular, neurological, psychiatric or cerebral disorders that, in the investigator's judgment, would expose the patient to unacceptable risk from study participation.\n   * A well-defined underlying etiology of chronic urticaria other than CSU, such as inducible urticaria, including but not limited to dermatographism, cold contact urticaria, heat contact urticaria, delayed pressure urticaria, solar urticaria, vibratory angioedema, cholinergic urticaria, aquagenic urticaria, and contact urticaria.\n   * Other diseases presenting with urticaria or angioedema symptoms, including but not limited to urticarial vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary urticaria, drug-induced urticaria, and hereditary or acquired angioedema.\n   * Other chronic pruritic diseases that may interfere with efficacy outcome assessment, such as psoriasis, atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, and senile pruritus.\n   * History of any malignant neoplasm prior to screening, with the exception of non-melanoma skin cancer (NMSC) or basal cell carcinoma that has been adequately treated and deemed cured, cervical carcinoma in situ, or ductal carcinoma in situ of the breast.\n   * History of lymphoproliferative disorders (including but not limited to Epstein-Barr virus-related lymphoproliferative disorders, lymphoma, leukemia, etc.); or signs or symptoms suggestive of active lymphoproliferative disorder.\n   * History of cardiovascular or cerebrovascular events or related surgical procedures within 12 months prior to screening, including but not limited to myocardial infarction, unstable angina pectoris, acute coronary syndrome, cerebral hemorrhage, stroke, coronary artery stent implantation, percutaneous transluminal coronary angioplasty, and coronary artery bypass graft surgery.\n   * History of thromboembolic events within 12 months prior to screening (e.g., pulmonary thromboembolism, deep vein thrombosis, mesenteric artery embolism); or current high-risk factors for thromboembolic diseases (e.g., immobilization within 12 weeks prior to screening, congenital or hereditary thrombophilia, antiphospholipid antibody syndrome, etc.).\n   * History of gastrointestinal perforation, except for cases caused by appendicitis or trauma.\n   * History of herpes zoster within 1 year prior to randomization; history of disseminated herpes zoster or recurrent herpes zoster at any time prior to randomization; history of disseminated herpes simplex at any time prior to randomization.\n   * Positive HBsAg prior to randomization (or negative HBsAg with positive HBcAb and abnormal HBV-DNA test results), positive HCV antibody (with abnormal HCV-RNA test results), positive HIV antibody, or positive syphilis serological antibody; or known HIV infection or known immunodeficiency status.\n   * Any severe or systemic infection (bacterial, fungal, viral, parasitic, etc.) requiring intravenous antimicrobial therapy or resulting in hospitalization within 4 weeks prior to randomization; or any other active or recent infection that, in the investigator's judgment, would expose the participating patient to unacceptable risk.\n   * Tuberculosis-related exclusion: Medical history, symptoms and relevant test results (e.g., tuberculosis screening test, chest X-ray) at screening suggest active tuberculosis.\n   * History of severe hematologic disorders (e.g., aplastic anemia, myelodysplastic syndrome) or any disease that may cause hemolysis or erythrocyte instability, such as malaria and hemolytic anemia.\n2. Participants with any of the following prior therapies or concomitant medications cannot be enrolled:\n\n   * Receipt of treatment with JAK inhibitors (e.g., tofacitinib, baricitinib, ruxolitinib, etc.) or BTK inhibitors (e.g., remibrutinib) within 4 weeks prior to randomization.\n   * Receipt of any investigational medicinal product within 4 weeks or 5 elimination half-lives prior to randomization, whichever is longer.\n   * Prior exposure to omalizumab or omalizumab biosimilars.\n   * Use of biologic agents with potential therapeutic effect on chronic spontaneous urticaria (CSU) (e.g., dupilumab, GR1802, SYB507, etc.) within 3 months or 5 elimination half-lives prior to randomization, whichever is longer.\n   * Receipt of immunosuppressive or immunomodulatory agents within 4 weeks prior to randomization, including but not limited to systemic corticosteroids, ciclosporin, Tripterygium wilfordii tablets, Tripterygium glycosides tablets, methotrexate, mycophenolate mofetil, azathioprine, tacrolimus, dapsone, sulfasalazine and hydroxychloroquine.\n   * Receipt of Traditional Chinese Medicine (TCM) or Chinese patent medicine explicitly indicated for urticaria per the package insert, clinical practice guidelines or prescription, within 4 weeks prior to randomization.\n   * Receipt of topical therapy or phototherapy for CSU within 2 weeks prior to randomization.\n   * Underwent major surgery within 4 weeks prior to randomization, or is scheduled to undergo major surgery after study enrollment.\n   * Received any live vaccine within 2 months prior to screening, or plans to receive any live vaccine during the study period.\n   * Donated a total of ≥400 mL of blood, or received blood transfusion, within 3 months prior to randomization.\n   * History of drug or alcohol abuse within 6 months prior to screening (defined as 14 units of alcohol per week; 1 unit = 17.7 mL of pure ethanol, equivalent to 357 mL of 5% ABV beer, 43 mL of 40% ABV liquor, or 147 mL of 12% ABV wine).\n3. History of allergy to any component of the investigational medicinal product or H1-antihistamines, or history of anaphylactic shock.\n4. Abnormal findings at screening that meet any of the following criteria:\n\n   * Complete blood count (CBC): hemoglobin (Hb) \\\u003C 90 g\u002FL; or white blood cell (WBC) count \\\u003C 2.5 × 10⁹\u002FL; or absolute neutrophil count (ANC) \\\u003C 1.5 × 10⁹\u002FL; or absolute lymphocyte count (ALC) \\\u003C 0.8 × 10⁹\u002FL; or platelet (PLT) count \\\u003C 100 × 10⁹\u002FL.\n   * Liver function: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 2 × upper limit of normal (ULN), or total bilirubin (TBIL) \\> 2 × ULN.\n   * nSerum creatinine ≥ 1.2 × ULN.\n   * Coagulation function: either prothrombin time (PT) or activated partial thromboplastin time (APTT) exceeds the ULN and is clinically significant.\n   * Uncontrolled hypertension (systolic blood pressure \\[SBP\\] ≥ 160 mmHg and\u002For diastolic blood pressure \\[DBP\\] ≥ 100 mmHg). One repeat measurement shall be performed for confirmation: if the initial blood pressure reading exceeds the above threshold, a repeat test will be conducted after the participant has rested for at least 10 minutes; if the repeat result is below the threshold, the second measurement value shall be adopted.\n   * Uncontrolled hyperlipidemia (fasting total cholesterol ≥ 7.2 mmol\u002FL, or fasting low-density lipoprotein cholesterol \\[LDL-C\\] ≥ 4.9 mmol\u002FL, or fasting triglycerides \\[TG\\] \\> 5.6 mmol\u002FL).\n   * Abnormal cardiac function, or clinically significant abnormal electrocardiogram (ECG) findings that are assessed by the investigator to pose unpredictable risks, such as severe arrhythmia.\n   * Other abnormal examination findings that, in the investigator's judgment, may impair the participant's ability to complete the study or interfere with study outcomes.\n5. Any other condition or circumstance that, in the investigator's judgment, renders the participant unsuitable for participation in this study.","ALL","18 Years","75 Years",{"count":20,"type":21},36,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The goal of this clinical trial is to evaluate the rapid onset characteristics of TLL-018 in moderate-to-severe CSU with inadequate response to second-generation H1 antihistamines.\n\nThe main objectives are:\n\nTo evaluate the rapid onset characteristics of TLL-018 in participants with moderate-to-severe chronic spontaneous urticaria.\n\nTo evaluate the safety profile of TLL-018 in participants with moderate-to-severe chronic spontaneous urticaria.\n\nTo evaluate the pharmacokinetic (PK) profile of TLL-018 in participants with moderate-to-severe chronic spontaneous urticaria.\n\nParticipants will be randomly allocated at a 1:1:1 ratio to receive TLL-018 10 mg, TLL-018 20 mg, or placebo orally after meals.",[28],"Chronic Spontaneous Urticaria (CSU)","NOT_YET_RECRUITING","2026-06-29",{"date":32,"type":33},"2026-07-01","ACTUAL",{"date":35,"type":21},"2026-07-15",{"date":37,"type":21},"2027-12-31",{"name":39,"class":40},"Hangzhou Highlightll Pharmaceutical Co., Ltd","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100582815","phase-3-a-study-to-evaluate-efficacy-of-remibrutinib-compared-to-dupilumab-at-early-timepoints-in-adults-with-chronic-spontaneous-urticaria-inadequately-controlled-by-second-generation-h1-antihistamines-100582815","NCT06868212","A Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-antihistamines","A US Phase 3b, Multi-center, Randomized, Double-blind, Double-Dummy Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-Antihistamines","RECLAIM","Inclusion Criteria:\n\n* Adults ≥ 18 years of age at the time of signing the informed consent\n* CSU duration for ≥ 6 months prior to screening (defined as the onset of CSU determined by the Investigator based on all available supporting documentation)\n* Diagnosis of CSU inadequately controlled by sgH1-AH at the time of randomization, defined as:\n* The presence of itch and hives for ≥ 6 consecutive weeks prior to screening despite the use of sgH1-AH during the 7 days prior to randomization (Day 1):\n* UAS7 score (range, 0-42) ≥ 16, and\n* ISS7 score (range, 0-21) ≥ 6, and\n* HSS7 score (range, 0-21) ≥ 6\n* Documentation of hives within 3 months before randomization (either at screening and\u002For at randomization); or documented in the participants medical history\n* Willing and able to complete an Urticaria Patient Daily Diary (UPDD) for the duration of the study and adhere to the study protocol\n* Participants must not have had more than one missing UPDD entry (either morning or evening) in the 7 days prior to randomization (Day 1)\n\nExclusion Criteria:\n\n* Previous use of remibrutinib or other bruton's tyrosine kinase (BTK) inhibitors\n* Previous use of dupilumab\n* Evidence of clinically significant cardiovascular (such as but not limited to myocardial infarction, unstable ischemic heart disease, NYHA Class III\u002FIV left ventricular failure, arrhythmia and uncontrolled hypertension within 12 months prior to Visit 1), neurological, psychiatric, pulmonary, renal, hepatic (past history or current), endocrine or metabolic disorder, or immunodeficiency that, in the investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant.\n* Evidence of hematological disorders (including coagulation disorders or significant bleeding risk)\n* History or evidence of gastrointestinal disease (including gastrointestinal bleeding, e.g., in association with use of nonsteroidal anti-inflammatory drugs (NSAID), that was clinically relevant (e.g., where intervention was indicated or requiring hospitalization or blood transfusion)\n* Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100 mg\u002Fd or clopidogrel up to 75 mg\u002Fd. The use of dual anti-platelet therapy (e.g., acetylsalicylic acid + clopidogrel) is prohibited.\n* Requirement for anticoagulant medication (for example, warfarin or Novel Oral Anti-Coagulants \\[NOAC\\])\n* History or current hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis or hepatic failure or hepatic parameters at screening: Aspartate Aminotransferase (AST)\u002F Alanine Aminotransferase (ALT) levels more than 1.5x ULN or International Normalized Ratio (INR) \\> 1.5 at screening",{"count":51,"type":21},400,[53],"PHASE3","This is a US, multi-center, randomized, double-blind, double-dummy, Phase 3b study to evaluate efficacy of remibrutinib (25 mg twice daily \\[b.i.d.\\] by mouth \\[p.o.\\]) compared to dupilumab (600 mg loading dose administered subcutaneously (s.c.) followed by 300 mg every 2 weeks s.c.) at early timepoints (4 weeks and earlier), when administered as an add-on treatment to second generation H1-antihistamines (sgH1-AH) (standard label dose as background therapy) in adult US participants with moderate to severe chronic spontaneous urticaria (CSU) inadequately controlled by sgH1-AHs.",[28],[57,58,59,60,61],"BTK inhibitor","chronic spontaneous urticaria","Urticaria activity score","Hives severity score","Itch severity score","RECRUITING","2026-06-04",{"date":65,"type":33},"2026-06-05",{"date":67,"type":33},"2025-07-11",{"date":69,"type":21},"2027-05-17",{"name":71,"class":40},"Novartis Pharmaceuticals",128,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":41},"100635838","a-prospective-single-centre-observational-cohort-study-on-the-efficacy-and-safety-of-bacterial-lysate-om-85-in-combination-with-antihistamines-for-the-treatment-of-chronic-spontaneous-urticaria-csu-100635838","NCT07557888","A Prospective, Single-centre, Observational Cohort Study on the Efficacy and Safety of Bacterial Lysate (OM-85) in Combination With Antihistamines for the Treatment of Chronic Spontaneous Urticaria (CSU)","A Prospective Clinical Study on the Efficacy and Safety of Bacterial Lysate (OM-85) Combined With Antihistamines in the Treatment of Chronic Spontaneous Urticaria (CSU): A Single-Centre, Observational, Cohort Study","Inclusion Criteria:\n\n1. The participants were fully informed of the purpose, procedure and risks of the study and voluntarily signed the informed consent form.\n2. Aged 18 to 65 (inclusive), no gender restrictions.\n3. Meets the CSU diagnostic criteria, with a disease duration of ≥6 weeks.\n4. Antihistamine resistance: Regular use of a standard dose (as recommended in the package leaflet) of a second-generation H1 antihistamine (e.g. desloratadine 5 mg, levocetirizine 5 mg, etc.) for at least 2 weeks prior to screening, but with symptoms still not effectively controlled. Defined as: a UAS7 score of ≥7 within 7 days prior to the screening visit (V1) and baseline visit (V2).\n5. Agree to maintain the type and dose of the baseline antihistamine throughout the trial.\n6. Agree not to consume any products that may significantly affect the gut microbiota during the trial (such as yoghurt containing probiotics, or probiotic\u002Fprebiotic supplements).\n7. At the baseline visit, the treatment regimen was clearly defined, and exposure status (OM-85 exposure group or non-exposure group) could be determined based on actual prescriptions and medication records.\n\nExclusion Criteria:\n\n1. Special types of urticaria: These primarily include physical urticaria (such as artificial urticaria, cold contact urticaria and cholinergic urticaria), urticarial vasculitis, and angioedema caused by hereditary or acquired C1 esterase inhibitor deficiency;\n2. Systemic use of glucocorticoids (oral or injectable) within the four weeks prior to screening;\n3. Exclude patients who have used immunosuppressants (such as cyclosporine, methotrexate, or Tripterygium wilfordii) within the previous four weeks;\n4. Exclude patients who have used biologics (such as omazulimab, dupilumab, etc.) within the previous three months;\n5. Exclude those who have used bacterial lysates (such as Panfuxu or Pidomod) or received vaccinations within the past three months;\n6. Key exclusion criteria for the microbiome study: use of oral or intravenous antibiotics within the four weeks prior to screening, or continuous use of probiotic supplements for more than one week.\n7. Patients with severe systemic autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc.) may interfere with the assessment of immune mechanisms;\n8. A history of serious liver, kidney, heart, lung or blood disorders, or malignant tumours;\n9. Individuals known to be allergic to bacterial lysates and their excipients.\n10. Special populations: pregnant or breastfeeding women, or participants of childbearing age who do not intend to use contraception during the trial.\n11. Other: Participants who have taken part in other clinical trials involving medicinal products within the past 30 days; or where the investigator considers that there is poor compliance, a mental health condition, or any other circumstance rendering the participant unsuitable for the trial.","65 Years",{"count":82,"type":21},132,"OBSERVATIONAL","A Prospective Clinical Study on the Efficacy and Safety of Bacterial Lysate (OM-85) Combined with Antihistamines in the Treatment of Chronic Spontaneous Urticaria (CSU): A Single-Centre, Observational, Cohort Study",[28],"2026-05-04",{"date":88,"type":33},"2026-05-07",{"date":90,"type":21},"2026-05-01",{"date":92,"type":21},"2027-06-01",{"name":94,"class":95},"The Fourth Affiliated Hospital of Zhejiang University School of Medicine","OTHER",{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":103,"maxAge":18,"enrollmentInfo":104,"targetDuration":4,"studyType":22,"phases":106,"briefSummary":107,"conditions":108,"keywords":109,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":4},"100634961","phase-3-a-study-of-mg-k10-in-chronic-spontaneous-urticaria-100634961","NCT07546487","A Study of MG-K10 in Chronic Spontaneous Urticaria","A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study Evaluating the Efficacy and Safety of MG-K10 Humanized Monoclonal Antibody Injection in Patients With Chronic Spontaneous Urticaria","Inclusion Criteria:\n\n1. Aged ≥12 and ≤75 years, body weight ≥30 kg, voluntarily sign ICF.\n2. Diagnosed with CSU for ≥6 months, with pruritus and wheals for \\>6 weeks despite using second-generation H1 antihistamines.\n3. Within 7 days prior to randomization: UAS7 score ≥16, ISS7 score ≥8, and at least one UAS ≥4.\n\n3.Willing to maintain stable background antihistamine dose during the study (up to 4 times standard dose allowed).\n\n4.Agree to use effective contraception during the study and for 6 months after last dose.\n\nExclusion Criteria:\n\n1. Inducible urticaria (e.g., dermographism, cold, heat, cholinergic) or other chronic pruritic skin diseases (e.g., atopic dermatitis) affecting study assessment.\n2. Active tuberculosis, or untreated latent TB; serious active infections.\n3. Known or suspected immunodeficiency, or history of invasive opportunistic infections.\n4. Known allergy to study drug or excipients.\n5. Prior use of MG-K10 or other biologics (anti-IL-4Rα, anti-IgE, etc.) within 16 weeks or 5 half-lives.\n6. Use of immunosuppressants, systemic corticosteroids, phototherapy, or Chinese herbal medicine within 4 weeks prior to first UAS assessment.\n7. Clinically significant laboratory abnormalities at screening: ANC \\\u003C1.2×10⁹\u002FL, platelets \\\u003C90×10⁹\u002FL, ALT\u002FAST\u002Ftotal bilirubin \\>2×ULN, creatinine \\>1.5×ULN.\n8. Positive for HBsAg, or HBcAb positive with HBV-DNA ≥1×10³ copies\u002Fml; HCV-Ab positive with HCV-RNA positive; HIV antibody positive.\n9. QTcF \\>500 msec or other clinically significant ECG abnormalities.\n10. Pregnant, breastfeeding, or planning pregnancy during the study.\n11. History of malignant tumors within 5 years (except adequately treated non-melanoma skin cancer or cervical carcinoma in situ).\n12. Participated in another clinical study and used investigational drug within 12 weeks or 5 half-lives prior to first UAS assessment.","12 Years",{"count":105,"type":21},226,[53],"This study is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial aimed at evaluating the efficacy and safety of MG-K10 humanized monoclonal antibody injection in CSU trial participants with poor control of second-generation H1 antihistamines.",[28],[110],"MG-K10","2026-04-16",{"date":113,"type":33},"2026-04-22",{"date":115,"type":21},"2026-04-14",{"date":117,"type":21},"2028-03-31",{"name":119,"class":40},"Shanghai Mabgeek Biotech.Co.Ltd",{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":127,"targetDuration":4,"studyType":22,"phases":129,"briefSummary":130,"conditions":131,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":140},"100622046","phase-2-study-of-the-efficacy-and-safety-of-icp-332-in-participants-with-chronic-spontaneous-urticaria-100622046","NCT07378527","Study of the Efficacy and Safety of ICP-332 in Participants With Chronic Spontaneous Urticaria","A Phase II\u002FIII Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of ICP-332 in Moderate to Severe Chronic Spontaneous Urticaria Subjects Inadequately Controlled by Second Generation H1-antihistamines","Inclusion Criteria:\n\n* 1\\. Men and women aged 18 to 75 years.\n* 2\\. Diagnosis of CSU inadequately controlled by second generation H1-antihistamines.\n* 3\\. CSU duration for ≥ 6 months prior to randomization.\n* 4\\. Before initiating any screening or study-specific procedures, the subject must voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Having the other medical conditions related to CSU or other skin diseases\u002Fconditions.\n* 2\\. Potential medical conditions or issues.\n* 3\\. Pregnant female subjects or lactating female subjects.\n* 4\\. The investigator determines that the subject is unsuitable for participating in this study for any reason.",{"count":128,"type":21},344,[25,53],"The purpose of this study is to compare the efficacy and safety of ICP-332 in moderate to severe chronic spontaneous urticaria subjects inadequately controlled by second generation H1-antihistamines",[28],{"date":133,"type":33},"2026-04-21",{"date":135,"type":33},"2026-02-13",{"date":137,"type":21},"2028-09",{"name":139,"class":40},"Beijing InnoCare Pharma Tech Co., Ltd.",30,{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":149,"targetDuration":4,"studyType":22,"phases":151,"briefSummary":152,"conditions":153,"keywords":155,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":140},"100624893","phase-2-phase-2-study-of-lesigercept-in-adult-patients-with-chronic-spontaneous-urticaria-who-are-inadequately-controlled-by-h1-antihistamines-100624893","NCT07415551","Phase 2 Study of Lesigercept in Adult Patients With Chronic Spontaneous Urticaria Who Are Inadequately Controlled by H1-Antihistamines","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy, Safety and Tolerability of Lesigercept in Adult Patients With Chronic Spontaneous Urticaria Who Are Inadequately Controlled by H1-Antihistamines (CLEAR)","CLEAR","Inclusion Criteria:\n\n* Chronic spontaneous urticaria for ≥6 months, uncontrolled on 2nd-generation H1-antihistamines (UAS7≥16, ISS7≥8, HSS7≥8).\n* Stable dose of 2nd-generation H1-antihistamines for ≥7 days; symptom diary compliance ≥80%.\n* Adults 18-75 years; informed consent signed; contraception and pregnancy test requirements for both genders.\n* ≥80% adherence to antihistamines during screening.\n\nExclusion Criteria:\n\n* Any medical or lab findings suggesting risk of worsening co-existing conditions during the study.\n* Clinically significant cardiovascular, neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematologic, gastrointestinal, or immunodeficiency disorders that may compromise safety or study results.\n* History of malignancy within 5 years (except certain cured skin\u002Fcervical cancers) or chronic urticaria with known etiology other than CSU (e.g., inducible urticaria, autoimmune diseases).\n* Active or high-risk parasitic infections, chronic\u002Frecurrent infections (e.g., TB, HBV, HCV, HIV), or hypersensitivity\u002Fanaphylaxis to study drugs or related classes.\n* Skin diseases affecting assessments (e.g., atopic dermatitis, psoriasis) or history of drug\u002Falcohol abuse within 6 months.",{"count":150,"type":21},150,[25],"This study aims to evaluate the efficacy and safety of lesigercept in approximately 150 participants with CSU. By enrolling participants with an inadequate response to H1-antihistamines, including those previously treated with omalizumab, this study is expected to provide evidence for the clinical utility of lesigercept and to further characterize its benefit-risk profile in the target participant population.",[154,28],"Allergic Diseases",[156,157,158,159,160,161,162,163],"CSU","YH35324","Allergic disease","Chronic Spontaneous Urticaria","Yuhan","GI-301","Lesigercept","M9010","2026-04-12",{"date":166,"type":33},"2026-04-15",{"date":168,"type":33},"2026-03-26",{"date":170,"type":21},"2027-07-24",{"name":172,"class":40},"Yuhan Corporation",{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":180,"targetDuration":4,"studyType":22,"phases":182,"briefSummary":183,"conditions":184,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":41},"100605722","phase-2-study-of-cm512-injection-in-subjects-with-chronic-spontaneous-urticariacsu-100605722","NCT07166211","Study of CM512 Injection in Subjects With Chronic Spontaneous Urticaria(CSU)","A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of CM512 Injection in Subjects With CSU","Inclusion Criteria:\n\n* Voluntarily sign the Informed Consent Form.\n* Age ≥ 18 years old and ≤ 75 years old.\n* Patients with a diagnosis of CSU before screening visit, and the duration was ≥6 months.\n* Pruritus and wheals existed for more than 6 weeks before screening, despite regular H1-Antihistamines(AH) treatment during this period.\n* A stable dose of the second-generation H1-Antihistamines(AH) has been continuously used for at least 7 days before randomization, and the individual is willing to continue to use it stably as stipulated in the protocol during the study period.\n* Within 7 days before randomization, UAS7≥16 and ISS7 ≥8.\n\nExclusion Criteria:\n\n* Not enough washing-out period for previous therapy.\n* Planned major surgical procedure during the patient's participation in this study.\n* Has ever experienced a systemic allergic reaction or immediate allergic reaction to any biological product (including any excipients).\n* CM512 has been used before.\n* Women who are pregnant or breastfeeding. During the study period, subjects who had plans to have children, or did not agree to contraception.\n* With any medical or non-medical conditions that are not suitable for participation in this study by investigators.",{"count":181,"type":21},48,[25],"This study is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of CM512 in subjects with CSU.",[28],"2026-04-06",{"date":187,"type":33},"2026-04-09",{"date":189,"type":33},"2025-11-27",{"date":191,"type":21},"2027-01-14",{"name":193,"class":40},"Keymed Biosciences Co.Ltd",{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":200,"eligibilityCriteria":201,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":202,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":204,"conditions":205,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":213,"locationsCount":41},"100625669","rollyn-oma-an-observational-study-in-patients-treated-by-omlyclo-an-omalizumab-biosimilar-100625669","NCT07425639","ROLL'YN-OMA: an Observational Study in Patients Treated by Omlyclo®, an Omalizumab Biosimilar","ROLL'YN-OMA : Etude Observationnelle de Cohorte Pour la Prise en Charge Des Patients Atteints de Pathologies Inflammatoires Chroniques traités Par Omlyclo®, un Omalizumab Biosimilaire","ROLL'YN-OMA","Inclusion Criteria:\n\n* Be an adult (aged 18 years or older at the time of inclusion) receiving specialist care and diagnosed with one of the following conditions: Severe asthma, Chronic Spontaneous Urticaria\n* Have been treated for at least 6 months prior to inclusion with the reference omalizumab for the relevant condition (Severe asthma or Chronic Spontaneous Urticaria).\n* Have been stable for at least 3 months according to the prescribing physician, with the disease controlled or in clinical remission based on the disease-specific activity score: Severe asthma: ≤ 1 course of oral corticosteroids per year related to disease worsening, without hospitalization, and ACQ \\\u003C 1.5 and FEV1 ≥ 80% of the patient's most recent values\u002F Chronic Spontaneous Urticaria : UCT ≥ 12\n* For whom the specialist physician has decided to switch to OMLYCLO® (biosimilar developed and marketed by Celltrion) on the day of patient inclusion (shared medical decision independent of the study).\n* Be able to start treatment within a maximum of 60 days following inclusion.\n* Have an email address.\n* Have a mobile phone number.\n* Be able to understand and complete questionnaires in French.\n* Not object to participating in the study.\n* Be affiliated with a French Social Security scheme or be a beneficiary of such a scheme\n\nExclusion Criteria:\n\n* Patients under guardianship or trusteeship, or otherwise deprived of liberty.\n* Pregnant women or women of childbearing potential with a desire to become pregnant during treatment with OMLYCLO®.\n* Patients who, at the time of inclusion, are participating in a clinical trial or another clinical study that prohibits simultaneous participation in other studies.\n* Contraindication to the study products.",{"count":203,"type":21},225,"ROLL'YN-OMA is a real-world study in patients receiving standard biologic therapies who have been in control and\u002For remission of their disease for at least 3 months and whose physician has independently decided, within the framework of a shared medical decision, to switch them to OMLYCLO®. The primary objective of this study is to evaluate the maintenance of this control and\u002For clinical remission 12 months after initiation of the biosimilar, and subsequently, patient satisfaction at 6 and 12 months.",[28,206],"Allergic Asthma","2026-02-16",{"date":209,"type":33},"2026-02-23",{"date":211,"type":33},"2025-10-02",{"date":137,"type":21},{"name":214,"class":40},"Celltrion HealthCare France",{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":219,"acronym":220,"eligibilityCriteria":221,"healthyVolunteers":222,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":225,"conditions":226,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":41},"100618173","analysis-of-the-role-of-ige-proteoforms-in-health-and-disease-100618173","NCT07328178","Analysis of the Role of IgE Proteoforms in Health and Disease","IgE-PhD","Inclusion Criteria:\n\n* CSU and type I allergic diseases (including anaphylaxis and desensitization), atopic dermatitis, mastocytosis, XLA and HaT (informed consent, age: any available adult subject, gender: any available subject, clinical phenotype and specific information about the allergy (e.g. severity, medication, medical history, laboratory testing)\n* Healthy controls (informed consent, age matched to the allergic patients, gender matched to the allergic patients, patient-reported symptoms related to allergy to aeroallergens, food, drugs, hymenoptera venom, CSU)\n\nExclusion Criteria:\n\n* Absence of informed consent\n* Age \\\u003C 18 years old",true,{"count":224,"type":21},200,"The goal of this observational study is to evaluate the role of IgE proteoforms in healthy volunteers and in patients with type I allergy, patients with chronic spontaneous urticaria, patients with a recent history of anaphylaxis, patients with mastocytosis, patients with hereditary alpha tryptasemia, patients with X-linked agammaglobulinemia (XLA), and patients undergoing desensitization for venom or medication allergy.",[227,228,229,230,28,231,232,233,234],"Anaphylaxis","Mastocytosis","X-linked Agammaglobulinaemia","Venom Allergy","Type I Allergy","Medication Allergy","Healthy Control","Hereditary Alpha-Tryptasemia","2025-12-26",{"date":237,"type":33},"2026-01-09",{"date":239,"type":33},"2025-01-01",{"date":241,"type":21},"2029-01-01",{"name":243,"class":95},"KU Leuven",{"id":245,"slug":246,"hasResults":11,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":250,"eligibilityCriteria":251,"healthyVolunteers":222,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":254,"conditions":255,"keywords":260,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":310},"100594595","skin-disease-profiling-by-an-exploratory-prospective-biomarker-study-in-dermatology-practice-skinergy-100594595","NCT07021495","SKIN Disease Profiling by an Exploratory, pRospective, Biomarker Study in dermatoloGY Practice (SKINERGY)","A Prospective, Multi-Center, Observational Biomarker Real-World Evidence Study for In-Depth Profiling of Patients With Chronic Immune-Mediated Inflammatory Skin Diseases in Daily Practice","SKINERGY","Inclusion Criteria:\n\nPatients:\n\n1. Able to understand and provide a written informed consent prior to any study procedures\n2. Male or non-pregnant female, ≥18 years of age\n3. Patient is willing to refrain from extensively washing (including bathing, swimming) the target lesional skin 12 hours before every study visit day.\n4. Patient is willing and able to comply with the study protocol\n5. Female participants are willing to not get pregnant between M0 until M12, from study entry to the last study visit\n6. The patient is willing to start the prescribed treatment.\n\nDisease-specific inclusion criteria\n\nFor patients with AD:\n\nTo be eligible to participate in this study, a subject must meet all of the following criteria:\n\n6\\. Diagnosis and history of chronic, moderate-to-severe AD (by the Eichenfield revised criteria of Hanifin and Rajka for at least 3 years before baseline visit.\n\n7\\. Documented recent history (last 6 months) of eligibility for (local or systemic) treatment with immunosuppressants, biologics or JAK-inhibitors.\n\n8\\. When applicable, documented recent history (last 6 months) of inadequate response to treatment with topical therapy, immunosuppressants, biologics or JAK-inhibitors.\n\n9\\. Current treatment can include moisturizers, topical treatment and\u002For systemic treatments with preferable wash-out (see exclusion criterion #9). On-study treatment is at physician and patient discretion but must include eligibility to starting new systemic treatment.\n\n10\\. EASI≥7 (moderate-to-severe disease) 11. At least one suitable target lesion at the discretion of the investigator 12. Intention to start treatment with cyclosporine A, dupilumab, tralokinumab, lebrikizumab or a JAK1-inhibitor (abrocitinib or upadacitinib)\n\nFor patients with CLE:\n\nParticipants must have a diagnosis of CLE, including SCLE, CDLE or LET that fulfil the following:\n\n6\\. Confirmed CLE diagnosis by clinicopathological correlation. 7. An overall CLE Disease Area and Severity Index Activity (CLASI-A) Score ≥3 without counting any diffuse alopecia or oral ulcers.\n\n8\\. Intention to start treatment with TCS, hydroxychloroquine or methotrexate (combination or mono-treatment).\n\nIf participating in the exploratory study with the skin biopsy: location of the lesion(s) selected for biopsy preferably outside the facial area (possible are e.g., neck, chest, back, limbs, scalp, ear etc.).\n\nFor patients with CSU:\n\n6\\. Diagnosis of CSU (moderate to severe according to international guidelines (Zuberbier et al, 2022)) for ≥3 months and symptomatic disease despite treatment with second generation H1 antihistamines (up to fourfold the approved dose).\n\n7.Patients currently on an antihistamine (up to fourfold the approved dose) must be on a stable dose for at least 2 weeks prior to day 1 and must maintain the same stable dose throughout the treatment period.\n\n8\\. Intention to start (add-on to antihistamine) treatment of omalizumab, cyclosporine A or BTK inhibitor\\*. (\\*when approved and reimbursed in NL)\n\nFor patients with HS:\n\n6\\. Patient with a history of signs and symptoms consistent with moderate-to-severe HS, based on IHS4 score (Zouboulis et al., 2017), for at least 1 year prior to baseline 7. Current treatment can include topical treatment. On-study treatment is at physician and patient discretion but must include eligibility to starting systemic treatment 8. Intention to start treatment with anti-TNF or anti-IL17 (secukinumab, bimekizumab\\*) \\*when approved and reimbursed in NL.\n\nFor patients with MF:\n\n6\\. A confirmed diagnosis of CTCL MF type and stage classification via histology or clinicopathological correlation 7. For the stage IA-IIA CTCL patients: at least one patch and\u002For one plaque lesion is present 8. Intention to start treatment with topical chlormethine, topical corticosteroids or phototherapy (PUVA \u002F UV-B).\n\nFor patients with PSO:\n\n6\\. Diagnosed with chronic plaque psoriasis at least 6 months prior to study participation 7. PASI≥5 with at least one suitable target lesion at the discretion of the investigator 8. Current treatment can include moisturizers, topical treatment and\u002For systemic treatments with preferable wash-out. On-study treatment is at physician and patient discretion but must include eligibility to starting new systemic treatment 9. Intention to start treatment with biologics: anti-TNF, anti-IL23, anti-IL17 or anti-TYK2\n\nHealthy volunteers:\n\nAll healthy volunteers must meet all of the following inclusion criteria:\n\n1. Signed informed consent before any study-mandated procedure.\n2. Male or non-pregnant female volunteers, ≥18 years of age\n3. Subject is in stable good health as per judgement of the investigator based upon the results of medical history and assessments performed at baseline.\n4. No clinically significant skin disease as judged by the investigator.\n5. No history of hypertrophic scarring or keloid.\n6. Subject is willing to refrain from extensively washing (including bathing, swimming) the skin 12 hours before every study visit.\n7. Subject is willing and able to wash out and withhold any topical treatment (prescription and over-the-counter products) in the investigational area for 2 weeks prior to Day 1.\n8. Subject is willing to refrain from application of any topical product (e.g. ointments, cream, or washing lotions) on the skin 24 hours prior to every study visit day.\n9. Subject is willing and able to wash out any antibiotic therapy for 14 days prior to Day 1.\n10. Subject is willing and able to comply with the study protocol.\n11. Female participants are willing to not get pregnant from study entry to the last study visit\n\nExclusion Criteria:\n\nPatients:\n\n1. Have any other relevant skin infection\u002Fdisease in the treatment area other than the investigated skin disease.\n2. Subjects who have received treatment with any non-marketed drug substance (that is, an agent which has not yet been made available for clinical use following registration) within 4 weeks prior to the baseline visit.\n3. Any other condition, disease, or known factor that could interfere with the study conduct or the study objectives as per judgement of the investigator. 4. Having received treatments for the investigated skin disease within the following intervals prior to the start of the study is not a strict exclusion criterion since this is a real-world study. However, preferred intervals for washout are as follows:\n\n   * 1 week for topical treatment, e.g. corticosteroids, retinoids, vitamin D analogs, calcineurin inhibitors\n   * 4 weeks for phototherapy, e.g. UVB, PUVA, PDT\n   * 4 weeks for non-biologic systemic treatment, e.g. retinoids, methotrexate, cyclosporine, JAK inhibitors\n   * 8 weeks for radiotherapy or surgery in the treatment area\n   * 8 weeks for biologics\n   * 3 months for any systemic chemotherapeutical treatment\n\nDisease specific exclusion criteria for patients with CLE:\n\n5\\. Diagnosed with SLE\n\nDisease specific exclusion criteria for patients with CSU:\n\n5\\. Treatment with omalizumab within 8 weeks prior to Day 1 6. Urticarial or angioedema symptoms such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary, acquired angioedema or drug-induced (e.g., due to C1 esterase inhibitor deficiency, ACE-inhibitor induced).\n\nDisease specific exclusion criteria for patients with MF:\n\n5\\. Ongoing uncontrolled active skin infection, other than secondary impetiginized CTCL lesions as judged by the investigator\n\nDisease specific exclusion criteria for patients with PSO:\n\n5\\. Having primarily erythrodermic, pustular or guttate psoriasis; 6. Having drug-induced psoriasis;\n\nHealthy volunteers:\n\nAll healthy volunteers must meet none of the following exclusion criteria:\n\n1. History of immunological abnormality (e.g. immune suppression, severe allergy, or anaphylaxis) that may interfere with study objectives as per judgement of the investigator.\n2. History or symptoms of any uncontrolled, significant disease including (but not limited to), a neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder that may interfere with the study objectives as per judgement of the investigator.\n3. The use of systemic antibiotic therapy for \\>2 months in the past 12 months.\n4. The use of any immunosuppressive or immunomodulatory therapy within the past 30 days prior to Day 1.\n\n6\\. Loss or donation of blood over 500mL within three months prior to baseline. Participation in an investigational drug study within 3 months prior to baseline visit or more than 4 times a year.\n\n7\\. History of alcohol consumption exceeding 5 standard drinks per day on average within 3 months prior to baseline. Alcohol consumption will be prohibited for at least 24 hours preceding each study visit.\n\n8\\. Positive urine test for drugs or history of abuse at baseline. 9. Exposure to high doses of UV radiation is not permitted within 3 weeks of the first study visit until the end of the study 10. Extreme physical activities are not permitted within 48 hours before each study visit 11. Any other condition, disease, or known factor that could interfere with the study conduct or the study objectives as per judgement of the investigator.",{"count":253,"type":21},840,"The goal of this observational study is to comprehensively profile six immune-mediated inflammatory diseases, including atopic dermatitis (AD), plaque psoriasis (PSO), hidradenitis suppurativa (HS), cutaneous T-cell lymphoma subtype mycosis fungoides (MF), chronic spontaneous urticaria (CSU), and cutaneous lupus erythematosus (CLE) in daily practice. Data will be compared with data from healthy volunteers. This study is part of the larger NGID (Next Generation ImmunoDermatology) initiative, of which the main objective is to develop infrastructure that enables personalised patient care. The main questions the SKINERGY study aims to answer are:\n\n* Which biomarkers can discriminate between responders and non-responders to treatment in patients with AD, CLE, CSU, HS, MF, and PSO?\n* How do disease-related biomarkers in patients with AD, CLE, CSU, HS, MF, and PSO differ from those in healthy volunteers?\n* Which (multi-omics) biomarkers are associated with disease subtypes and predict response or non-response to (targeted) therapies in daily clinical practice?\n* How do biomarker profiles compare across different cohorts of patients with immune-mediated inflammatory skin diseases (AD, CLE, CSU, HS, MF, PSO)\n* How do biomarker levels change over time in response to treatment in these patient populations?\n* Which skin tissue biomarkers are associated with disease progression or treatment response?\n* How do the genomic profiles of patients differ across diseases or correlate with treatment outcomes?\n* Can additional imaging biomarkers enhance the characterization of disease profiles or treatment monitoring over time?\n\nResearchers will compare both differences beween patients within a disease group in different treatment arms, as well as patients within the same treatment arm. Additionally, biomarker profiles of patients with different diseases will be evaluated. These comparisons will be made to see if shared or distinct biomarker patterns exist across diseases and treatments, which could inform patient stratification, optimize therapeutic decision-making, and identify potential targets for future interventions.\n\nParticipants will start medication according to national guidelines for the treatment of their inflammatory skin disease (AD: Cyclosporin A, anti-IL4\u002F13, or anti-JAK; PSO: anti-TNF, anti-IL23, ani-IL17, anti-TYK2; HS: anti-TNF, anti-IL17; MF: CHLORM, TSC, PUVA-UV-B; CSU: anti-IgE, Cyclosporin A, anti-BTK\\*; CLE: TSC, HCQ, MTX)\n\n\\*once approved and reimbursed in the Netherlands\n\nParticipants will:\n\n* Take the prescribed medication for their skin disease (in line with standard care in the Netherlands).\n* Visit the clinic for a study visit combined with their standard care appointment 3 times (baseline, month 3, and month 6. An additional 4th visit at month 12 is optional).\n* Fill in an online set of questionnaires from home, 3 times during the study period (an additional 4th time is optional).\n* Patients with CSU fill in the UAS7 (and if applicable the AAS7) daily for the study period.",[28,256,257,258,259],"Hidradenitis Suppurativa (HS)","Psoriasis (PsO)","Atopic Dermatitis (AD)","CTCL\u002F Mycosis Fungoides",[261,262,263,264,265,266,267,268,269,270,271,272,273,274,275,276,277,278,279,280,281,282,283,284,285,286,287,288,289,290,291,292,293,294,295,296,297,298,299,300],"Urticaria","Hives","Mast cells","Autoimmune","Autoallergic","Wheals","Angioedema","Abscess","Nodules","Sweat glands","Acne inversa","Eczema","Itchy, dry skin","Mycosis Fungoides","Skin patches","Tumors","T-cells","Lupus","Skin rash","Photosensitivity","Plaques","Scaling","Erythema","Induration","Inflammatory skin diseases","Immune-mediated","Deep phenotyping","Multi-omics","Transcriptomics","Lipidomics","Metabolomics","Proteomics","Genomics","Microbiomics","Imaging mass cytometry (CyTOF)","Real-world practice","Standard care","NextGenerationImmunoDermatology","NGID","Biomarkers","2025-08-18",{"date":303,"type":33},"2025-08-19",{"date":305,"type":33},"2025-07-29",{"date":307,"type":21},"2029-12-31",{"name":309,"class":95},"Leiden University Medical Center",8]