Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-29 @ 11:49 PM
Study NCT ID:
NCT07406204
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-12
First Post:
2026-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tofacitinib vs Methotrexate for Severe Alopecia Areata (TOFA-MTX-AA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000506', 'term': 'Alopecia Areata'}, {'id': 'C537055', 'term': 'Alopecia universalis'}], 'ancestors': [{'id': 'D000505', 'term': 'Alopecia'}, {'id': 'D007039', 'term': 'Hypotrichosis'}, {'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C479163', 'term': 'tofacitinib'}, {'id': 'D008727', 'term': 'Methotrexate'}], 'ancestors': [{'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This is an open-label trial. Due to different dosing schedules and monitoring requirements for the two interventions, blinding of participants, treating clinicians, investigators, and outcome assessors will not be feasible.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized in a 1:1 ratio to two parallel treatment arms (tofacitinib vs methotrexate) and followed for 12 weeks. Efficacy will be assessed by change in SALT score from baseline to week 12.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 78}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-05', 'studyFirstSubmitDate': '2026-02-05', 'studyFirstSubmitQcDate': '2026-02-05', 'lastUpdatePostDateStruct': {'date': '2026-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Severity of Alopecia Tool (SALT) Score', 'timeFrame': 'Week 12', 'description': 'SALT score ranges from 0 to 100, with higher scores indicating greater scalp hair loss. The primary outcome is the change in SALT score from baseline to week 12, compared between the tofacitinib and methotrexate groups.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tofacitinib', 'Methotrexate', 'Janus Kinase Inhibitor', 'Severe Alopecia Areata', 'Autoimmune Hair Loss'], 'conditions': ['Alopecia Areata', 'Alopecia Totalis (AT)', 'Alopecia Universalis']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Abe DT, Tashima LM, Basilio FMA, Mulinari-Brenner F. Clinical experience with oral tofacitinib in a patient with alopecia areata universalis and rheumatoid arthritis. Int J Trichology. 2020;12(4):188-90.'}, {'type': 'RESULT', 'citation': 'Asma JK, Huma AS, Urooj M. A study on the role of tofacitinib among patients treated with alopecia areata. Pak J Med Health Sc. 2022;16(12):801-3.'}, {'type': 'RESULT', 'citation': 'Iorizzo M, Tosti A. Emerging drugs for alopecia areata: JAK inhibitors. Expert Opin Emerg Drugs. 2018;23(1):77-81.'}, {'type': 'RESULT', 'citation': 'Cervantes J, Jimenez JJ, DelCanto GM, Tosti A. Treatment of alopecia areata with simvastatin/ezetimibe. J Investig Dermatol Symp Proc. 2018;19(1):S25-S31.'}, {'type': 'RESULT', 'citation': 'Strazzulla LC, Avila L, Lo Sicco K, Shapiro J. an overview of the biology of platelet-rich plasma and microneedling as potential treatments for alopecia areata. J Investig Dermatol Symp Proc. 2018;19(1):S21-S24.'}, {'type': 'RESULT', 'citation': 'Lee S, Kim BJ, Lee YB, Lee WS. Hair Regrowth outcomes of contact immunotherapy for patients with alopecia areata: a systematic review and meta-analysis. JAMA Dermatol. 2018;154(10):1145-51.'}, {'type': 'RESULT', 'citation': 'Ro BI. Alopecia areata in Korea (1982-1994). J Dermatol. 1995;22(11):858-64.'}, {'type': 'RESULT', 'citation': 'Melo DF, Dutra TBS, Baggieri VMAC, Tortelly VD. Intralesional betamethasone as a therapeutic option for alopecia areata. an Bras Dermatol. 2018;93(2):311-12'}, {'type': 'RESULT', 'citation': 'Chu TW, AlJasser M, Alharbi A, Abahussein O, McElwee K, Shapiro J, et al. Benefit of different concentrations of intralesional triamcinolone acetonide in alopecia areata: an intrasubject pilot study. J Am Acad Dermatol. 2015;73(2):338-40.'}, {'type': 'RESULT', 'citation': "Messenger AG, McKillop J, Farrant P, McDonagh AJ, Sladden M. British Association of Dermatologists' guidelines for the management of alopecia areata 2012. Br J Dermatol. 2012;166(5):916-26."}, {'type': 'RESULT', 'citation': 'Rajabi F, Drake LA, Senna MM, Rezaei N. Alopecia areata: a review of disease pathogenesis. Br J Dermatol. 2018;179(5):1033-48.'}, {'type': 'RESULT', 'citation': 'Mirzoyev SA, Schrum AG, Davis MDP, Torgerson RR. Lifetime incidence risk of alopecia areata estimated at 2.1% by Rochester Epidemiology Project, 1990-2009. J Invest Dermatol. 2014;134(4):1141-2.'}, {'type': 'RESULT', 'citation': 'Safavi KH, Muller SA, Suman VJ, Moshell AN, Melton LJ. Incidence of alopecia areata in Olmsted County, Minnesota, 1975 through 1989. Mayo Clin Proc. 1995;70(7):628-33'}, {'type': 'RESULT', 'citation': 'Pratt CH, King LE, Messenger AG, Christiano AM, Sundberg JP. Alopecia areata. Nat Rev Dis Primers. 2017;3:17011.'}, {'type': 'RESULT', 'citation': 'Gilhar A, Etzioni A, Paus R. Alopecia areata. N Engl J Med. 2012;366(16):1515-5.'}]}, 'descriptionModule': {'briefSummary': 'This study will compare two oral medicines-tofacitinib and methotrexate-for treating severe alopecia areata, including alopecia totalis (loss of all scalp hair) and alopecia universalis (loss of scalp and body hair). Alopecia areata is an autoimmune condition that can cause significant hair loss and emotional distress.\n\nAdults aged 18 to 60 years with severe disease will be enrolled at the Department of Dermatology, MTI-Hayatabad Medical Complex, Peshawar, after ethical approval and written informed consent. Participants will be randomly assigned to receive either tofacitinib 10 mg twice daily or methotrexate 0.2-0.4 mg/kg once weekly for 12 weeks.\n\nThe main outcome will be improvement in hair loss measured by the Severity of Alopecia Tool (SALT) score. Treatment will be considered effective if there is more than 50% improvement in SALT score from baseline at the end of 12 weeks. Safety will be monitored during follow-up visits. The findings may help guide treatment decisions for severe alopecia areata in our local population.', 'detailedDescription': 'This is a single-center, parallel-group, randomized controlled trial to compare the clinical efficacy of oral tofacitinib versus methotrexate in adults with severe alopecia areata, including alopecia totalis and alopecia universalis, conducted at the Department of Dermatology, MTI-Hayatabad Medical Complex, Peshawar.\n\nAfter approvals from the Institutional Ethical Committee and CPSP-REU and after obtaining written informed consent, eligible participants aged 18-60 years with severe alopecia areata/totalis/universalis diagnosed by a consultant dermatologist will be enrolled using consecutive non-probability sampling. Patients already receiving systemic therapy for hair regrowth, pregnant women, and patients with renal, hepatic, or pulmonary disease (based on history and clinical assessment) will be excluded.\n\nBaseline demographic and clinical data will be recorded, and baseline disease severity will be assessed using the Severity of Alopecia Tool (SALT) score. Participants will be randomized using blocked randomization into two treatment arms:\n\nArm A: Oral tofacitinib 10 mg twice daily for 12 weeks.\n\nArm B: Oral methotrexate 0.2-0.4 mg/kg once weekly for 12 weeks, with scheduled follow-up and laboratory monitoring for potential adverse effects as per institutional protocol.\n\nParticipants will be reviewed every 4 weeks during treatment. At the end of 12 weeks, the SALT score will be reassessed. The primary endpoint is clinical efficacy defined a priori as \\>50% improvement in SALT score from baseline at week 12. Safety and tolerability will be assessed through clinical review and routine monitoring during follow-up visits.\n\nData will be analyzed using SPSS (version 23.0). Quantitative variables (e.g., age, duration of disease, baseline and post-treatment SALT scores) will be summarized as mean ± standard deviation, and categorical variables (e.g., gender, residence, efficacy) will be presented as frequency and percentage. Efficacy between groups will be compared using the chi-square test, and stratification will be performed for age group, gender, residence, and disease duration; post-stratification chi-square testing will be applied. A p-value \\<0.05 will be considered statistically significant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nAdults aged 18-60 years.\n\nClinical diagnosis of severe alopecia areata, alopecia totalis, or alopecia universalis (as per protocol/operational definition), confirmed by a consultant dermatologist.\n\nEither sex.\n\nAble and willing to provide written informed consent.\n\nExclusion Criteria:\n\nCurrently receiving or recently used any systemic treatment intended for hair regrowth for alopecia areata (e.g., systemic corticosteroids, immunosuppressants, JAK inhibitors).\n\nPregnant women.\n\nHistory or clinical evidence of renal, hepatic, or pulmonary disease.\n\nAny condition that, in the investigator's judgment, makes participation unsafe or interferes with adherence to the study protocol."}, 'identificationModule': {'nctId': 'NCT07406204', 'acronym': 'TOFA-MTX-AA', 'briefTitle': 'Tofacitinib vs Methotrexate for Severe Alopecia Areata (TOFA-MTX-AA)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hayat Abad Medical Complex, Peshawar'}, 'officialTitle': 'Comparative Clinical Efficacy of Tofacitinib Versus Methotrexate in Severe Alopecia Areata, Alopecia Totalis, and Alopecia Universalis: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'HMC-DERM-TOFA-MTX-AA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tofacitinib 10 mg Twice Daily', 'description': 'Participants will receive oral tofacitinib 10 mg twice daily for 12 weeks. Clinical response will be assessed using the SALT score at baseline and at week 12. Efficacy is defined as \\>50% improvement in SALT score from baseline.', 'interventionNames': ['Drug: Tofacitinib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Methotrexate 0.2-0.4 mg/kg Weekly', 'description': 'Participants will receive oral methotrexate 0.2-0.4 mg/kg once weekly for 12 weeks with routine follow-up and laboratory monitoring for adverse effects as per institutional protocol. Clinical response will be assessed using the SALT score at baseline and at week 12. Efficacy is defined as \\>50% improvement in SALT score from baseline.', 'interventionNames': ['Drug: Methotrexate']}], 'interventions': [{'name': 'Tofacitinib', 'type': 'DRUG', 'description': 'Oral tofacitinib 10 mg twice daily for 12 weeks.', 'armGroupLabels': ['Tofacitinib 10 mg Twice Daily']}, {'name': 'Methotrexate', 'type': 'DRUG', 'description': 'Oral methotrexate 0.2-0.4 mg/kg once weekly for 12 weeks, with routine monitoring for adverse effects as per institutional protocol.', 'armGroupLabels': ['Methotrexate 0.2-0.4 mg/kg Weekly']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hira Rehman, FCPS', 'role': 'CONTACT', 'email': 'khira420.hr@gmail.com', 'phone': '03359849292'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared because this is an investigator-initiated, single-center study and data sharing is not covered in the participant consent/IRB approvals. De-identified aggregate results will be reported in publications and presentations. De-identified data may be considered for sharing in the future upon reasonable request after publication, subject to additional ethical approvals and a data use agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hayat Abad Medical Complex, Peshawar', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PGR', 'investigatorFullName': 'Hira Rehman', 'investigatorAffiliation': 'Hayat Abad Medical Complex, Peshawar'}}}}