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NCT02349061 · ClinicalTrials.gov registry record · Phase 2
A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus
A Phase 2 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 102
- Enrollment target
NCT02349061: Completed Phase 2 study, sponsored by Janssen Research & Development.
NCT02349061 is a Phase 2 study that has completed, run by Janssen Research & Development. The registered enrollment target is 102 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02349061, a Phase 2 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 102 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy of ustekinumab as measured by a reduction in disease activity for subjects with active Active Systemic Lupus Erythematosus (SLE - chronic disorder of connective tissue in which there can be skin rash, arthritis, kidney problems, and anemia, among other problems).
Primary Outcome
SRI-4 response was defined as greater than or equal to 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score and no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA). Composite response is defined as SRI-4 response in participants who do not meet treatment failure criteria. SLEDAI-2K ass
Interventions
- DRUG Placebo SC
- DRUG Ustekinumab IV
- DRUG Ustekinumab SC
- DRUG Placebo Infusion
- OTHER Concomitant Medication
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2015-10-15 |
| Est. Completion | 2019-03-13 |
| Phase | Phase 2 |
What the finished NCT02349061 record still lists
NCT02349061 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo SC is the first listed.
NCT02349061 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02349061 about?
NCT02349061 is a clinical study titled "A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus". The purpose of this study is to evaluate the efficacy of ustekinumab as measured by a reduction in disease activity for subjects with active Active Systemic Lupus Erythematosus (SLE - chronic disorder of connective tissue in which there can be skin rash, arthritis, kidney problems, and anemia, among...
What is the current status of trial NCT02349061?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 102 participants. The study started on 2015-10-15. Estimated completion is 2019-03-13.
What interventions are being tested in trial NCT02349061?
The interventions under investigation include: Placebo SC (DRUG), Ustekinumab IV (DRUG), Ustekinumab SC (DRUG), Placebo Infusion (DRUG), Concomitant Medication (OTHER).
Who is sponsoring clinical trial NCT02349061?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02349061's enrollment target sits among peer trials
102 668th of 2000 higher than 1,329 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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