At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 7 enrolled
Drug / intervention
Tofacitinibdrug
Likely dose
Tofacitinib 11 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of Tofacitinib in Prevention of Photosensitivity in Cutaneous Lupus Erythematosus (ALE11)
National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Sep 17, 2021·Updated Aug 22, 2025
In Brief
A Phase 1 clinical trial evaluating Tofacitinib for Cutaneous Lupus. Completed, enrolled 7 participants across 2 sites.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCutaneous Lupus
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20222023202420252026
First PostedSep 2021
Enrollment StartSep 2022
Primary CompletionFeb 2024
Study CompletionFeb 2024
TodayJul 2026
First PostedSep 17, 2021
Enrollment StartSep 30, 2022
Primary CompletionFeb 15, 2024
Study CompletionFeb 29, 2024
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 4.8 years ago
Interventions
Tofacitinibdrug
10 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