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NCT03288324 · ClinicalTrials.gov registry record · Phase 1
Open-label Study of Tofacitinib for Moderate to Severe Skin Involvement in Young Adults With Lupus
A Phase 1 study of Systemic Lupus Erythematosus and Cutaneous Lupus, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
- 2
- Study locations
NCT03288324: Completed Phase 1 study of Systemic Lupus Erythematosus and Cutaneous Lupus, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT03288324 is a Phase 1 study of Systemic Lupus Erythematosus and Cutaneous Lupus that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 13 participants, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03288324, a Phase 1 study of Systemic Lupus Erythematosus and Cutaneous Lupus, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
Apparent total clearance of the drug from plasma after oral administration
Conditions Studied
Interventions
- DRUG Tofacitinib
Study Locations (2)
Ohio
- Cincinnati Childrens Hospital Medical Center - Cincinnati
- MetroHealth Medical Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2017-08-23 |
| Est. Completion | 2023-12-01 |
| Phase | Phase 1 |
What the finished NCT03288324 record still lists
NCT03288324 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 1 intervention - of which Tofacitinib is the first listed.
NCT03288324 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT03288324 about?
NCT03288324 is a clinical study titled "Open-label Study of Tofacitinib for Moderate to Severe Skin Involvement in Young Adults With Lupus". 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 stu...
What is the current status of trial NCT03288324?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2017-08-23. Estimated completion is 2023-12-01.
What conditions does trial NCT03288324 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus, Cutaneous Lupus.
What interventions are being tested in trial NCT03288324?
The interventions under investigation include: Tofacitinib (DRUG).
Who is sponsoring clinical trial NCT03288324?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03288324 being conducted?
This trial has 2 study locations across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03288324's enrollment target sits among peer trials
13 95th of 99 higher than 5 of 99 other Systemic Lupus Erythematosus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Systemic Lupus Erythematosus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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