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NCT01708629 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects
A Phase 3 study, sponsored by Bausch Health Americas.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1,881
- Enrollment target
NCT01708629: Clinical Trial Phase 3 study, sponsored by Bausch Health Americas.
NCT01708629 is a Phase 3 study that was terminated before completion, run by Bausch Health Americas. The registered enrollment target is 1,881 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (144% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01708629, a Phase 3 study, was terminated before completion, sponsored by Bausch Health Americas.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1,881 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses compared with placebo in participants with moderate to severe plaque psoriasis. A second purpose of this study is to assess the safety and efficacy brodalumab at two different doses compared with ustekinumab in participants with moderate to severe plaque psoriasis. A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens of brodalumab.
Primary Outcome
The Psoriasis Area and Severity Index Score is used as a scale to show change from Baseline of study to a certain point. PASI Score ranges from (0) no disease to (72) maximal disease. The proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index, PASI75, was assessed.
Interventions
- DRUG placebo
- DRUG ustekinumab
- DRUG 210 mg brodalumab
- DRUG 140 mg brodalumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,881 participants |
| Start Date | 2012-09 |
| Est. Completion | 2015-10 |
| Phase | Phase 3 |
Why NCT01708629 stopped before completion
NCT01708629 is an interventional study that assigns participants to a tested intervention. Its 1,881 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (144% higher).
The record links to 0 conditions, and to 4 interventions - of which placebo is the first listed.
NCT01708629 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01708629 about?
NCT01708629 is a clinical study titled "Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects". The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses compared with placebo in participants with moderate to severe plaque psoriasis. A second purpose of this study is to assess the safety and efficacy brodalumab at two different doses compared with ust...
What is the current status of trial NCT01708629?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1,881 participants. The study started on 2012-09. Estimated completion is 2015-10.
What interventions are being tested in trial NCT01708629?
The interventions under investigation include: placebo (DRUG), ustekinumab (DRUG), 210 mg brodalumab (DRUG), 140 mg brodalumab (DRUG).
Who is sponsoring clinical trial NCT01708629?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01708629's enrollment target sits among peer trials
1,881 113th of 2000 higher than 1,888 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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