[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"alopecia-areataaa\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:alopecia-areataaa":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":34,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100622279","phase-4-cyclosporine-or-methotrexate-for-pediatric-alopecia-areata-routine-clinical-care-effectiveness-study-100622279",false,"NCT07381556","Cyclosporine Or Methotrexate for Pediatric Alopecia Areata: Routine Clinical Care Effectiveness Study","The Effectiveness of Cyclosporine Versus Methotrexate in the Treatment of Pediatric Alopecia Areata in Routine Clinical Care: a Patient Preference Trial","COMPARE","Inclusion criteria\n\nIn order to be eligible to participate in this study, a subject must meet all of the following criteria:\n\n* Age 2-17 years\n* Clinical diagnosis of AA by a certified dermatologist\n* Willingness of participant (in case 12-17 years) and parents to provide informed consent for participation in the study.\n\nExclusion criteria\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study:\n\n* Inability to adhere to the study protocol, including medication intake, clinic visits, and questionnaire completion.\n* Patients who are ineligible for the CsA arm (due to contraindications), are automatically included in the MTX arm.\n* Contra-indications CsA:\n\nImpaired kidney function. Poorly controlled hypertension Active infections. Presence of a malignancy. Nephrotic syndrome combined with poorly controlled hypertension, infection or malignancy.\n\nKidney disorders, except in cases of nephrotic syndrome with mild to moderate renal impairment.\n\n* Patients who are ineligible for the MTX arm (due to contraindications), are automatically included in the CsA arm.\n* Contraindications MTX:\n\nConception (both male and female) and lactation Severe kidney or liver dysfunction (fibrosis, cirrhosis) or alcohol abuse Bone marrow hypoplasia, immunodeficiency Anemia, leukopenia, or thrombocytopenia Poor nutritional status (low albumin) Hypersensitivity or allergy to MTX Lung toxicity due to MTX or significant reduction in lung function.","ALL","2 Years","17 Years",{"count":21,"type":22},50,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","Rationale: Since the introduction of Janus kinase (JAK) inhibitors, there has been a significant advancement in the treatment of pediatric alopecia areata. Eligibility for this treatment, in the Netherlands, requires prior failure of systemic therapies such as cyclosporin or methotrexate. However, the choice between methotrexate and cyclosporin as first-line systemic treatment is not supported by robust comparative studies.\n\nTherefore, the investigators conduct a patient preference trial with a long-term follow-up provided in the Pediatric Systemic Alopecia Areata Registry (STA2R-Pediatric). This study will evaluate the effectiveness of Cyclosporin (CsA) and Methotrexate (MTX) in children and adolescents with moderate-to-severe AA.\n\nObjective(s): To investigate the effectiveness of CsA and MTX in the treatment of children and adolescents with alopecia areata in routine clinical care.\n\nStudy type: This is a prospective, patient preference clinical trial with a duration up to 36 weeks in accordance with the routine clinical care guidelines.\n\nStudy population: This study will include children and adolescents (2-17 years old) diagnosed with AA who start first-line systemic treatment.\n\nMethods: Patients and their parents will choose between CsA and MTX treatment as in routine clinical care, receiving follow-up in accordance with standard clinical practices. The participants will not be randomized. The primary endpoint is the measurement of the Severity of Alopecia Tool (SALT) at 9-months with a secondary endpoint at 24 weeks. SALT scores will be measured by a blinded assessor. The (Children) - Dermatology Life Quality Index ((C)-DLQI) questionnaire will be conducted at each visit (0, 3, 6, 9 months), allowing evaluation of the impact on patients' quality of life.",[28,29,30,31,32,33],"Alopecia Areata(AA)","Alopecia Areata (AA)","Alopecia Totalis\u002FUniversalis","Alopecia Universalis (AU)","Alopecia Totalis (AT)","Alopecia Areata (& Ophiasis)",[35,36,37],"Pediatric","Alopecia areata","systemic treatment alopecia areata","RECRUITING","2026-01-26",{"date":41,"type":42},"2026-02-02","ACTUAL",{"date":44,"type":42},"2025-11-01",{"date":46,"type":22},"2027-11-01",{"name":48,"class":49},"Erasmus Medical Center","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":23,"phases":63,"briefSummary":65,"conditions":66,"keywords":67,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":5},"100596734","phase-1-hcw9302-interleukin-2-fusion-protein-for-alopecia-areata-100596734","NCT07049328","HCW9302 (Interleukin-2 Fusion Protein) for Alopecia Areata","A Phase 1 Study of HCW9302, an IL-2 Fusion Protein, for Alopecia Areata","IL-2","Inclusion Criteria:\n\n1. Adult women who are 18 to 70 years of age, or adult males who are 18 to 60 years of age at the time of informed consent.\n2. Clinical diagnosis of Alopecia Areata (AA) (including ophiasis, totalis or universalis forms) at Screening.\n3. Negative serum pregnancy test within 14 days of treatment start if female and of childbearing potential (non-childbearing is defined as greater than one year postmenopausal or surgically sterilized).\n4. Female subjects of childbearing potential must adhere to using a highly effective medically accepted method of birth control (defined as those with failure less than 1%; see Appendix 2) prior to screening and agree to continue its use for at least 28 days after the last dose of HCW9302 or be surgically sterilized (e.g., hysterectomy or tubal ligation) and males must agree to use a barrier method of birth control and agree to continue its use for at least 28 days after the last dose of HCW9302.\n5. Laboratory tests performed within 28 days of treatment start:\n\n   1. Absolute neutrophil count (AGC\u002FANC) ≥ 1,500\u002FμL (≥1.5 × 109\u002FL)\n   2. Platelets ≥ 100,000\u002FμL (≥ 100 × 109\u002FL)\n   3. Hemoglobin ≥ 10 g\u002FdL (\\>100g\u002FL)\n   4. Calculated glomerular filtration rate (GFR)\\* \\>40 mL\u002Fmin OR serum creatinine ≤ 1.5 × ULN\n   5. Total bilirubin ≤ 2.0 × ULN or ≤ 3.0 × ULN for subjects with Gilbert's syndrome\n   6. AST, ALT, ALP ≤ 2.0 × ULN\n6. Able and willing to comply with requested study visits and procedures.\n7. Able and willing to provide written informed consent and HIPAA authorization\n\nExclusion Criteria:\n\n1. Men and women (of reproductive potential) unwilling to use birth control and women who are pregnant or breastfeeding\n2. Patient has primarily \"diffuse\" type AA (characterized by diffuse hair shedding)\n3. Presence of another form of alopecia\n4. Prior use of any of the following treatments: a. Aldesleukin b. Investigational IL-2 analog\n5. Concurrent use of oral or topical treatments targeting hair growth or hair restoration (including but not limited to finasteride, dutasteride, topical minoxidil or oral minoxidil) if discontinuation or dosage change is planned during the study period.\n6. Prior use of phototherapy and any systemic immunosuppressant (systemic steroids, cyclosporin, methotrexate or any other immunosuppressive therapy) or immunomodulating biologic therapy (including but not limited to dupilumab, tralokinumab, lebrikizumab, nemolizumab, rocatinlimab, or daxdilimab, whether marketed or investigational) within 3 months prior to Screening.\n7. Prior use of any B-cell depleting agents, whether marketed or investigational, including but not limited to rituximab, ocrelizumab, ofatumumab, or belimumab, within 6 months prior to Screening.\n8. Known hypersensitivity or history of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in the study.\n9. History of diabetes mellitus, regardless of whether it is controlled or not.\n10. History of myocardial infarction, congestive heart failure, uncontrolled arrhythmias, cardiac revascularization, stroke, uncontrolled hypertension, or uncontrolled diabetes within 6 months prior to Screening.\n11. Significant organ dysfunction that is unstable or inadequately treated within 6 months prior to Screening.\n12. History of cancer or lymphoproliferative disease, except for the following: adequately treated basal cell or squamous cell skin cancer without current evidence of disease.\n13. Currently receiving any chronic systemic (oral or intravenous) anti-infective therapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes zoster, or atypical mycobacteria).\n14. Active tuberculosis (TB) (based on TB blood test or a TB skin test) or a history of inadequately treated TB.\n15. Herpes zoster or cytomegalovirus (CMV) that resolved less than 2 months prior to Screening. Subjects with a history of frequent outbreaks of Herpes Simplex Virus (defined as 4 or more outbreaks a year).\n16. Major surgery within 3 months prior to Screening visit or has a major surgery planned during the study.\n17. Active systemic infection requiring parenteral antibiotic\u002Fantiviral therapy. All prior infections must have resolved following optimal therapy.\n18. Prior organ allograft or allogeneic transplantation.\n19. Positive based on serological screening for human immunodeficiency virus (HIV), hepatitis B or hepatitis C at screening.\n20. Any ongoing toxicity from prior therapies that, in the judgment of the Investigator, may interfere with study treatment. All toxicities attributed to prior therapy must resolve to grade 1 or baseline before administration of the study treatment.\n21. Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n22. Other skin conditions that would interfere with study assessments of AA.\n23. Other illness or a medical issue that in the opinion of the Investigator would exclude the subject from participating in this study.","18 Years","70 Years",{"count":62,"type":22},30,[64],"PHASE1","This is a Phase 1, open-label, multi-center, competitive enrollment, and dose-escalation study of HCW9302 in subjects with Alopecia Areata (AA)",[28],[68,69,70],"Alopecia","Interleukin-2 (IL-2)","T-Reg","2025-10-16",{"date":73,"type":42},"2025-10-20",{"date":75,"type":42},"2025-08-16",{"date":77,"type":22},"2026-12-15",{"name":79,"class":80},"HCW Biologics","INDUSTRY"]