[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hangzhou Highlightll Pharmaceutical Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":84},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,63],{"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":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":62,"locationsCount":41},"100640796","phase-1-hl-300-ointment-in-patients-with-mild-to-moderate-atopic-dermatitis-100640796","NCT07629778","HL-300 Ointment in Patients With Mild-to-Moderate Atopic Dermatitis","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ib\u002FII Clinical Study to Evaluate the Safety and Efficacy of HL-300 Ointment in Patients With Mild-to-Moderate Atopic Dermatitis","Inclusion Criteria:\n\n1. Age ≥18 years and ≤75 years at the time of ICF signing, with no gender restriction\n2. Meeting the Hanifin \\& Rajka diagnostic criteria for atopic dermatitis (AD) at screening, with a history of AD ≥ 6 months before screening, and the AD condition judged by the investigator to be stable within 4 weeks prior to ICF signing,.\n3. vIGA-AD score of 2-3 at screening and baseline visits;\n4. EASI score within the range of 5-21 at screening and baseline;\n5. \"Body Surface Area (BSA) affected by AD skin lesions meeting one of the following requirements at screening and baseline visits, with skin lesions suitable for topical treatment:\n\n   * Cohort 1: BSA of 5% to 20%;\n   * Cohort 2: BSA of 15% to 25%. \"\n6. Women of childbearing potential and men willing to use at least one highly effective method of contraception or practice abstinence from the time of informed consent signing until 3 months after the last dose of the investigational product\n7. Those who voluntarily participate in the study and sign the informed consent form\n\nExclusion Criteria:\n\n1. \"Trial participants with any of the following medical histories or abnormal conditions at screening: (1) Skin lesions or abnormalities that may affect the assessment of the investigational product application site; (2) Clinically relevant skin diseases that are contraindicated for the study or affect the assessment of the application site, including but not limited to: psoriasis, acne, skin cancer; (3) Other autoimmune diseases besides AD, such as inflammatory bowel disease, rheumatoid arthritis, where the investigator believes the disease would unfavorably impact the assessment of this study; (4) Current or history of lymphoproliferative disorders, or signs or symptoms suggestive of possible lymphoproliferative disorders, including lymphadenopathy or splenomegaly; (5) Any malignancy, or any history of malignancy within 5 years prior to screening (except for completely resected cervical carcinoma in situ or non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma, or papillary thyroid carcinoma); (6) History of herpes virus infection within the past 6 months, or recurrent herpes zoster (≥2 episodes), disseminated herpes zoster, disseminated herpes simplex, or current inability to rule out herpes zoster or herpes simplex infection; (7) Systemic infection requiring hospitalization within 12 weeks prior to screening to baseline, or active bacterial, viral, fungal, parasitic, or other infections requiring anti-infective treatment within 4 weeks prior to screening to baseline; (8) Local active infection within 1 week prior to screening to baseline, such as active infected AD, or any superficial skin infection requiring oral or intravenous antibiotic, antifungal, or antiviral medication; (9) History of thrombotic events, including deep vein thrombosis and pulmonary embolism, or high-risk factors for thromboembolism (e.g., immobilization or prolonged bed rest), which is judged by the investigator's comprehensive clinical assessment to be unsuitable for participation in this study; (10) History of significant cardiovascular, neurological, respiratory, hematological, digestive, urinary, immune, or psychiatric diseases that the investigator believes may confound study results or affect drug absorption, distribution, metabolism, and excretion, or place the trial participant at undue risk; (11) History of drug abuse or substance abuse.\"\n2. \"Trial participants who have received any of the following treatments: (1) Use of topical skin products for AD or AD-related skin infections at the study application site within 2 weeks prior to baseline, including but not limited to: topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), topical phosphodiesterase 4 (PDE-4) inhibitor ointments, topical antimicrobials, etc.; (2) Use of topical skin products containing chemically active ingredients (including but not limited to vitamin E cream, functional products containing niacinamide\u002Furea\u002Fceramide, excluding emollients without any chemically active ingredients) at the study application site within 1 week prior to baseline; (3) Use of systemic therapeutic drugs for AD within 4 weeks or 5 half-lives (whichever is longer) prior to baseline, including but not limited to systemic anti-infectives, PDE-4 inhibitors, and systemic traditional Chinese medicine or herbal medicines for AD; (4) Use of systemic or topical JAK inhibitors (such as ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib, pacritinib, delgocitinib, upadacitinib, abrocitinib, etc.) within 12 weeks prior to baseline; (5) Use of sedating antihistamines within 2 weeks prior to baseline (Stable use of non-sedating antihistamines is permitted \\[dose stable for 2 weeks or 5 half-lives (whichever is longer) before the first study medication\\]); (6) Use of systemic immunosuppressants or immunomodulators (such as oral or injectable corticosteroids, methotrexate, cyclosporine, mycophenolate mofetil, and azathioprine) within 4 weeks or 5 half-lives (whichever is longer) prior to baseline; (7) Use of biologics (such as dupilumab) within 12 weeks or 5 half-lives (whichever is longer) prior to baseline; (8) Use of strong CYP450 inhibitors or inducers within 2 weeks prior to baseline, including but not limited to: nelfinavir, ritonavir, clarithromycin, itraconazole, nevirapine, and barbiturates; (9) Vaccination with live\u002Fattenuated live vaccines within 4 weeks prior to baseline, or planning to receive vaccination during the study period; (10) Sunbathing or phototherapy (including ultraviolet therapy, photochemotherapy, etc.) with AD therapeutic effects within 4 weeks prior to baseline;\"\n3. \"Trial participants with any of the following laboratory and instrumental examination results:\n\n(1) Any significant clinical and laboratory abnormalities that the investigator believes may affect trial participant safety, including but not limited to:\n\n1. White blood cell count (WBC) \\\u003C 3×109\u002FL, absolute neutrophil count (ANC) \\\u003C 1.5×109\u002FL, absolute lymphocyte count (ALC) \\\u003C 0.8×109\u002FL, platelet count (PLT) \\\u003C 100×109\u002FL, hemoglobin (Hb) \\\u003C 100 g\u002FL;\n2. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 2× ULN, or total bilirubin (TBIL) ≥ 1.5× ULN;\n3. Blood creatinine \\> 1.5× ULN; (2) Confirmed or suspected active tuberculosis, incompletely cured tuberculosis, or active Mycobacterium tuberculosis infection (except for trial participants with documented treatment proving adequate therapy, who may enter this study based on the medical judgment of the investigator and\u002For infectious disease specialist) judged by the investigator and\u002For infectious disease specialist (combining medical history, symptoms, signs, laboratory tests, tuberculosis screening tests, and imaging findings); (3) QT interval corrected by Fridericia formula (QTcF) ≥500 ms in 12-ECG results at screening; (4) Hepatitis B surface antigen (HBsAg) positive; HBsAg negative but hepatitis B core antibody (HBcAb) positive and HBV-DNA above detection limit, or human immunodeficiency virus antibody (HIV) positive, or anti-hepatitis C virus (HCV) antibody positive and HCV-RNA positive, or Treponema pallidum antibody positive (excluding trial participants with negative non-specific syphilis antibody results and judged by the investigator to have a past history of syphilis infection that has been cured);\" 4.Known or suspected allergy to the investigational product or excipients in the investigational product; 5.Female trial participants who are suspected or known to be pregnant, breastfeeding, or planning pregnancy during the trial period; 6.History of major surgery within 4 weeks prior to baseline or planned surgery during the study; 7.Significant blood loss, received blood transfusion, or donated blood (≥400 mL) within 3 months prior to baseline; 8.Participation in other clinical trials within 3 months prior to baseline; 9.Weekly alcohol consumption greater than 14 units within 3 months prior to screening (1 unit of alcohol ≈ 360 mL beer or 45 mL spirits with 40% alcohol content or 150 mL wine); 10.Other conditions judged by the investigator to be unsuitable for participation in the study.",{"count":50,"type":21},156,[24,25],"This study is a randomized, double-blind, placebo-controlled, multicenter Phase Ib\u002FII clinical study designed to evaluate the efficacy, safety, and PK characteristics of HL-300 ointment with different concentration regimens for mild-to-moderate AD.",[54],"Atopic Dermatitis","RECRUITING","2026-06-18",{"date":58,"type":33},"2026-06-23",{"date":60,"type":33},"2026-05-26",{"date":37,"type":21},{"name":39,"class":40},{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":70,"targetDuration":4,"studyType":22,"phases":72,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":83,"locationsCount":41},"100584268","phase-3-a-long-term-extension-clinical-study-of-tll-018-in-patients-with-rheumatoid-arthritis-100584268","NCT06887127","A Long-term Extension Clinical Study of TLL-018 in Patients With Rheumatoid Arthritis","An Open-label, Long-term Extension Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of TLL-018 in Patients With Rheumatoid Arthritis","Inclusion Criteria:\n\n* Subjects have completed TLL-018-301 study within 3 months;\n* Age (at the time of consent):\\>＝18 years of age, \\\u003C＝75 years of age;\n* Female subjects of childbearing potential (WOCBP), who should not be pregnant or breastfeeding, should not enter the study until after pregnancy testing (e.g., HCG beta subunit-based monitoring);\n* All subjects and their partners voluntarily use contraception as deemed effective by the investigator for at least 90 days from the first dose of the investigational drug to the last dose of the investigational drug (Appendix I); no sperm or egg donation is planned by the subject for at least 6 months from the screening period to the last dose of the investigational drug.\n* Subjects can understand the informed consent form, volunteer to participate in the study and sign the informed consent form.\n\nExclusion Criteria:\n\n* Subjects have had severe allergic reaction related to the investigational drug during the TLL-018-301 study;\n* Subjects have had herpes zoster, a major cardiovascular event (MACE), thromboembolism, or lymphoproliferative disorders from the time of TLL-018-301 study to the screening of OLE study;\n* Subjects have a clinically significant cardiovascular, respiratory, or any other serious and\u002For non-stable disease, and there is security risk for subjects to participate in this study judged by the investigator;\n* Subjects have abnormal and clinically significant laboratory test values at screening;\n* Subjects who have taken traditional Chinese medicines, csDMARDs, immunosuppressive drugs, potent opioids, and other JAK inhibitors (except the investigational drugs in TLL-018-301 study) within 1 week before taking the first dose of the investigational drug in OLE study;\n* Subjects have treated with flunomide, any bDMARDs, interferon, and other injected immunosuppressive drugs from TLL-018-301 study to the screening of OLE study;\n* Subjects who have received any live vaccine within 2 months prior to taking the first dose of the investigational drug or who plan to receive a live vaccine during the study;\n* Subjects have had active tuberculosis infection without evidence of clinical cure; have suspected tuberculosis symptoms judged by the investigator; have latent tuberculosis infection (LTBI) but not received preventive treatment regimens within 3 years prior to screening or not completed a course of therapy.",{"count":71,"type":21},350,[73],"PHASE3","The primary objective of the study is to evaluate the long-term safety, tolerability, and efficacy of TLL-018 in patients with rheumatoid arthritis (RA) who have completed a preceding randomized controlled trial with TLL-018.",[76],"Rheumatoid Arthritis","2026-05-18",{"date":79,"type":33},"2026-05-20",{"date":81,"type":33},"2025-03-10",{"date":37,"type":21},{"name":39,"class":40},""]