Open-label Study of Tofacitinib for Moderate to Severe Skin Involvement in Young Adults With Lupus

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT03288324
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Aug 23, 2017
Status verified
Feb 2026
Primary completion
Nov 1, 2022
Completion
Dec 1, 2023

Study Design

Enrollment
13 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tofacitinib Arm
    open-label study

Primary Outcome Measure

Oral Clearance (CL/F) (Cohort 1 Only) [ Time Frame: Day 5 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Cincinnati Childrens Hospital Medical CenterCincinnatiOhio45229-
MetroHealth Medical CenterClevelandOhio44109-

Find similar trials in Cincinnati, OH

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
Cincinnati Childrens Hospital Medical Center· Cincinnati, OHMetroHealth Medical Center· Cleveland, OH

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