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NCT01972568 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus
A Phase 2 study, sponsored by EMD Serono.
- Completed
- Registry status
- Phase 2
- Development phase
- 306
- Enrollment target
NCT01972568: Completed Phase 2 study, sponsored by EMD Serono.
NCT01972568 is a Phase 2 study that has completed, run by EMD Serono. The registered enrollment target is 306 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (130% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01972568, a Phase 2 study, has completed, sponsored by EMD Serono.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 306 participants
- Enrollment target
Study Summary
This is a multi-center, double-blind, randomized, Phase 2b trial to evaluate the efficacy of atacicept in subjects with systemic lupus erythematosus (SLE).
Primary Outcome
SRI response, a composite measure of reduced SLE disease activity, was defined as a reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (\>=) 4 points; no significant worsening in Physician's Global Assessment (PGA) score (\<10 % increase, defined as \<0.3 point increase for statistical analyses); no new British Isles Lupus Assessment Group (BILAG) A organ domain scores and \<=1 (defined as no more than one) new BIL
Interventions
- DRUG Placebo
- DRUG Atacicept 150 mg
- DRUG Atacicept 75 milligram (mg)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 306 participants |
| Start Date | 2013-12 |
| Est. Completion | 2016-09 |
| Phase | Phase 2 |
What the finished NCT01972568 record still lists
NCT01972568 is an interventional study that assigns participants to a tested intervention. The registered 306 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 (130% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01972568 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01972568 about?
NCT01972568 is a clinical study titled "Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus". This is a multi-center, double-blind, randomized, Phase 2b trial to evaluate the efficacy of atacicept in subjects with systemic lupus erythematosus (SLE).
What is the current status of trial NCT01972568?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 306 participants. The study started on 2013-12. Estimated completion is 2016-09.
What interventions are being tested in trial NCT01972568?
The interventions under investigation include: Placebo (DRUG), Atacicept 150 mg (DRUG), Atacicept 75 milligram (mg) (DRUG).
Who is sponsoring clinical trial NCT01972568?
This trial is sponsored by EMD Serono, which has 71 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01972568's enrollment target sits among peer trials
306 165th of 2000 higher than 1,835 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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