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NCT02908100 · ClinicalTrials.gov registry record · Phase 2
A Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
A Phase 2 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 2
- Development phase
- 260
- Enrollment target
NCT02908100: Completed Phase 2 study, sponsored by Genentech.
NCT02908100 is a Phase 2 study that has completed, run by Genentech. The registered enrollment target is 260 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02908100, a Phase 2 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 260 participants
- Enrollment target
Study Summary
This is a study to evaluate the safety and efficacy of GDC-0853 in combination with standard of care therapy in participants with moderate to severe active systemic lupus erythematosus (SLE).
Primary Outcome
The Systemic Lupus Erythematosus Responder Index (SRI)-4 measures reduction in SLE disease activity and is a composite measure that includes the SLE Disease Activity Index (SLEDAI-2K), British Isles Lupus Activity Group (BILAG) 2004 and Physician Global Assessment. It is defined as: 1) Reduction of ≥4 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease ac
Interventions
- DRUG Placebo
- DRUG GDC-0853
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2017-01-19 |
| Est. Completion | 2019-07-16 |
| Phase | Phase 2 |
What the finished NCT02908100 record still lists
NCT02908100 is an interventional study that assigns participants to a tested intervention. The registered 260 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02908100 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02908100 about?
NCT02908100 is a clinical study titled "A Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus". This is a study to evaluate the safety and efficacy of GDC-0853 in combination with standard of care therapy in participants with moderate to severe active systemic lupus erythematosus (SLE).
What is the current status of trial NCT02908100?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 260 participants. The study started on 2017-01-19. Estimated completion is 2019-07-16.
What interventions are being tested in trial NCT02908100?
The interventions under investigation include: Placebo (DRUG), GDC-0853 (DRUG).
Who is sponsoring clinical trial NCT02908100?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02908100's enrollment target sits among peer trials
260 210th of 2000 higher than 1,789 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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