CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 13 enrolled
Drug / intervention
Tofacitinibdrug
Likely dose
Tofacitinib 5 mg twice dailyAI-extracted
Key inclusion· 7
  • ✓Age 18–45 years, body weight >40 kg
  • ✓Fulfilled at least 4 of 11 SLE Classification Criteria
  • ✓CLASI activity score ≥8 at screening and baseline despite standard of care
  • ✓Prednisone dose ≤20 mg/day, stable for ≥2 weeks before enrollment
Key exclusion· 17
  • ✕Mild cutaneous lupus (CLASI score ≤7)
  • ✕Increase in corticosteroid dose within 2 weeks before study start or expected during first 4 weeks
  • ✕IV corticosteroids within 4 weeks before study start
  • ✕Prior treatment with tofacitinib or known intolerability

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03288324
NCT03288324Phase 2Completed
CompareCT.gov

A 3-part Open-label Study Assessing Safety, Tolerability, Pharmacokinetic and -Dynamic Profiles, and Efficacy of Tofacitinib in Young Adults From Age 18 to 45 With Moderate to Severe Skin Involvement Due to Lupus

Children's Hospital Medical Center, Cincinnati·interventional·Posted Sep 20, 2017·Updated Mar 3, 2026

In Brief

A Phase 2 clinical trial evaluating Tofacitinib for Cutaneous Lupus and Systemic Lupus Erythematosus. Completed, enrolled 13 participants across 2 sites.

Detailed Summary

This 76-week, 3-part Phase 1b/2 study is intended to evaluate the pharmacological properties (pharmacokinetics and pharmacodynamics), safety, tolerability and preliminary effectiveness of TOFA administrated to young adults (18-45 years) with moderately to severely active SLE-CL. Subjects will be studied at the Cincinnati Children's Hospital Medical Center (CCHMC) and in Cleveland at MetroHealth Medical Center.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCutaneous Lupus, Systemic Lupus Erythematosus
CountriesUnited States
CollaboratorsPfizer

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedSep 20, 2017
Enrollment StartAug 23, 2017
Primary CompletionNov 1, 2022
Study CompletionDec 1, 2023
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 8.8 years ago

Interventions

Tofacitinibdrug

Tofacitinib 5 mg twice daily