Evaluation of Tofacitinib in Prevention of Photosensitivity in Lupus
Part of paid clinical trials in Worcester, Massachusetts.
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study ID
- NCT05048238
- Phase
- PHASE1
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- Tofacitinib — DRUG10 participants with Cutaneous lupus erythematosus (CLE). Consenting individuals meeting all entry criteria will undergo 25 days of treatment with tofacitinib (11 mg orally (PO) daily) with evaluation of UVB-mediated cutaneous apoptosis
Study Details
This is a single-arm, multi-site, proof-of-concept study that will evaluate the treatment of 10 participants with cutaneous lupus erythematosus (CLE) with Tofacitinib.
Key Dates
- Start date
- Sep 30, 2022
- Status verified
- Aug 2025
- Primary completion
- Feb 15, 2024
- Completion
- Feb 29, 2024
Study Design
- Enrollment
- 7 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Tofacinitib10 participants receiving 11 mg of Tofacitinib administered orally and daily, from Day 2 to Day 26
Primary Outcome Measure
Change in Percentage of UVB-induced Apoptotic Epidermal Cells [ Time Frame: Day 1 (pre-treatment) to Day 26 ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Massachusetts Medical School | Worcester | Massachusetts | 01605 | - |
| University of Michigan Health System: Department of Internal Medicine, Division of Rheumatology | Ann Arbor | Michigan | 48109 | - |
Related coverage on Hipa.ai
- Tofacitinib Phase 1 Trial for Cutaneous Lupus Shows Reduced Apoptotic CellsTofacitinib · Mar 21, 2025 · ClinicalTrials.gov
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