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NCT03134222 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate Safety and Efficacy of Filgotinib and Lanraplenib in Females With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE)
A Phase 2 study of Cutaneous Lupus Erythematosus, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 47
- Enrollment target
- 16
- Study locations
NCT03134222: Completed Phase 2 study of Cutaneous Lupus Erythematosus, sponsored by Gilead Sciences.
NCT03134222 is a Phase 2 study of Cutaneous Lupus Erythematosus that has completed, run by Gilead Sciences. The registered enrollment target is 47 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). The trial reports 16 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03134222, a Phase 2 study of Cutaneous Lupus Erythematosus, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 47 participants
- Enrollment target
- 16
- Study locations
Study Summary
The primary objective of this study is to evaluate the efficacy of filgotinib and lanraplenib (formerly GS-9876) in females with moderately-to-severely active cutaneous lupus erythematosus (CLE).
Primary Outcome
CLASI Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and nonscarring alopecia. Evaluation of erythema and scale/hyperkeratosis is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area. The total score ranges from 0-70, with higher scores indicating more severe skin disease.
Conditions Studied
Interventions
- DRUG Filgotinib
- DRUG Lanraplenib
- DRUG Lanraplenib placebo
- DRUG Filgotinib placebo
Study Locations (16)
California
- Wallace Rheumatic Studies Center - Beverly Hills
- St. Jude Hospital Yorba Linda DBA Dr. Joseph Heritage Healthcare - Fullerton
- Dermatology Research Associates - Los Angeles
- Desert Medical Advances - Palm Desert
- Medderm Associates - San Diego
- Inland Rheumatology Clinical Trials - Upland
Other
- Dermatology Ottawa Research Centre - Ottawa
- University Health Network (UHN) - Toronto Western Hospital - Toronto
- K.Papp Clinical Research - Waterloo
Florida
- Clinical Research of West Florida, Inc. - Clearwater
- Omega Research Consultants LLC - DeBary
North Carolina
- DJL Clinical Research, PLLC - Charlotte
- Wake Forest University Health Sciences - Winston-Salem
Pennsylvania
- Penn State Hershey Medical Center - Hershey
- University of Pennsylvania - Philadelphia
Texas
- Metroplex Clinical Research Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2017-05-24 |
| Est. Completion | 2019-12-18 |
| Phase | Phase 2 |
What the finished NCT03134222 record still lists
NCT03134222 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).
The record links to 1 condition, with Cutaneous Lupus Erythematosus appearing as the primary indexed condition, and to 4 interventions - of which Filgotinib is the first listed.
NCT03134222 lists 16 locations in 6 states (California, Other, Florida).
Frequently Asked Questions
What is clinical trial NCT03134222 about?
NCT03134222 is a clinical study titled "Study to Evaluate Safety and Efficacy of Filgotinib and Lanraplenib in Females With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE)". The primary objective of this study is to evaluate the efficacy of filgotinib and lanraplenib (formerly GS-9876) in females with moderately-to-severely active cutaneous lupus erythematosus (CLE).
What is the current status of trial NCT03134222?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 47 participants. The study started on 2017-05-24. Estimated completion is 2019-12-18.
What conditions does trial NCT03134222 study?
This clinical trial studies the following conditions: Cutaneous Lupus Erythematosus.
What interventions are being tested in trial NCT03134222?
The interventions under investigation include: Filgotinib (DRUG), Lanraplenib (DRUG), Lanraplenib placebo (DRUG), Filgotinib placebo (DRUG).
Who is sponsoring clinical trial NCT03134222?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03134222 being conducted?
This trial has 16 study locations across California, Florida, North Carolina, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03134222's enrollment target sits among peer trials
47 1283rd of 2000 higher than 715 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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