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NCT03517722 · ClinicalTrials.gov registry record · Phase 3
A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus
A Phase 3 study, sponsored by Janssen Research & Development.
- Terminated
- Registry status
- Phase 3
- Development phase
- 516
- Enrollment target
NCT03517722: Clinical Trial Phase 3 study, sponsored by Janssen Research & Development.
NCT03517722 is a Phase 3 study that was terminated before completion, run by Janssen Research & Development. The registered enrollment target is 516 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03517722, a Phase 3 study, was terminated before completion, sponsored by Janssen Research & Development.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 516 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy of ustekinumab in participants with active systemic lupus erythematosus (SLE) who have not adequately responded to one or more standard of care treatments.
Primary Outcome
SRI-4 response:\>=4-point reduction in SLEDAI-2K total score, no British Isles Lupus Assessment Group (BILAG) A (severe disease) and no more than 1 new BILAG B (moderate disease) domain score and no worsening (\<10 % increase)from baseline in Physician's Global Assessment(PGA).SLEDAI measures disease activity in 9 organ systems,higher scores=more severe disease activity.Each organ system measured as either absent/present within last 30 days and weighted score across systems was utilized to calcu
Interventions
- DRUG Placebo
- DRUG Ustekinumab 90 mg
- DRUG Ustekinumab (approximately 6 mg/kg)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 516 participants |
| Start Date | 2018-04-16 |
| Est. Completion | 2020-11-05 |
| Phase | Phase 3 |
Why NCT03517722 stopped before completion
NCT03517722 is an interventional study that assigns participants to a tested intervention. The registered 516 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03517722 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03517722 about?
NCT03517722 is a clinical study titled "A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus". The purpose of this study is to evaluate the efficacy of ustekinumab in participants with active systemic lupus erythematosus (SLE) who have not adequately responded to one or more standard of care treatments.
What is the current status of trial NCT03517722?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 516 participants. The study started on 2018-04-16. Estimated completion is 2020-11-05.
What interventions are being tested in trial NCT03517722?
The interventions under investigation include: Placebo (DRUG), Ustekinumab 90 mg (DRUG), Ustekinumab (approximately 6 mg/kg) (DRUG).
Who is sponsoring clinical trial NCT03517722?
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 NCT03517722's enrollment target sits among peer trials
516 724th of 2000 higher than 1,277 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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