Open-label Study of Tofacitinib for Moderate to Severe Skin Involvement in Young Adults With Lupus (NCT03288324) | Clinical Trial Compass
CompletedPhase 1/2
Open-label Study of Tofacitinib for Moderate to Severe Skin Involvement in Young Adults With Lupus
United States13 participantsStarted 2017-08-23
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion criteria
✓. Male or female \> 18 years of age and \< 45 years of age and \> 40 kg body weight.
✓. Fulfilled at least 4 out of the 11 Classification Criteria for SLE by the time of screening.
✓. Willing to give written informed consent, must fully understand the requirements of the trial, and must be willing to comply with all trial visits and assessments.
✓. CLASI activity score of 8 or higher at screening and baseline despite standard of care therapy.
✓. Stable dose of prednisone of ≤ 20 mg/day within 2 weeks of enrollment.
✓. Female subjects of childbearing potential must use a highly effective method of contraception to prevent pregnancy (abstinence is considered highly effective) and must agree to continue to practice adequate contraception for the duration of their participation in the trial and for 28 days after their last dose of TOFA.
✓. Female subjects of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at Trial Day 1 before dosing.
✓. For subjects receiving leflunomide treatment, total daily dose does not exceed 20 mg.
Exclusion criteria
✕. Mild SLE-CL defined as a CLASI activity score of 7 or lower at screening and baseline.
✕. Increase in CS dosing within 2 weeks prior to Trial Day 1, or expected to require an increase in CS dosing during the first 4 weeks of the study.
What they're measuring
1
Oral Clearance (CL/F) (Cohort 1 Only)
Timeframe: Day 5
Trial details
NCT IDNCT03288324
SponsorChildren's Hospital Medical Center, Cincinnati
. Use of i.v. corticosteroids within 4 weeks prior to Trial Day 1.
✕. Increase in dosing of methotrexate, leflunomide, within 4 weeks before Trial Day 1 or expected to require an increase during the first 8-weeks of the study.
✕. Increase in dosing of hydroxychloroquine, or chloroquine within 4 weeks before Trial Day 1 or expected to require an increase during the first 8-weeks of the study.
✕. Rituximab within 1 year of Trial Day 1.
✕. Increase in dosing of any medication or herbal treatment considered to have immunosuppressive properties with 4 weeks before Trial Day 1.
✕. Prior treatment with or known intolerability of TOFA.