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NCT03403036 · ClinicalTrials.gov registry record · Phase 4
Brodalumab in Subjects With Moderate to Severe Plaque Psoriasis Who Have Failed IL-17A Therapies
A Phase 4 study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- Phase 4
- Development phase
- 39
- Enrollment target
NCT03403036: Completed Phase 4 study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT03403036 is a Phase 4 study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 39 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03403036, a Phase 4 study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 39 participants
- Enrollment target
Study Summary
This study will evaluate the safety and efficacy of brodalumab in the treatment of moderate-to-severe psoriasis in patients who have previously failed treatment with interleukin (IL)-17A therapies. Forty patients will be enrolled in this 16-week open-label study. Patients will receive 210 mg of brodalumab subcutaneous injection at weeks 0, 1, and 2, followed by 210 mg every 2 weeks. The primary efficacy endpoint will be the proportion of patients achieving a score of "0-clear" or "1-almost clear" in the sPGA score after 16 weeks of treatment. After completion of the 16-week trial, patients may desire to continue treatment with brodalumab.
Primary Outcome
Number of patients achieving a score of "0-clear" or "1-almost clear" in the sPGA score after 16 weeks of treatment to measure efficacy. Static Physician Global Assessment (sPGA) - 3 categories induration, erythema, and scaling, scored 0-4, these 3 categories averaged giving total score from 0-4, with higher score indicating more symptoms.
Interventions
- DRUG Brodalumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2017-10-31 |
| Est. Completion | 2018-08-18 |
| Phase | Phase 4 |
What the finished NCT03403036 record still lists
NCT03403036 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Brodalumab is the first listed.
NCT03403036 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03403036 about?
NCT03403036 is a clinical study titled "Brodalumab in Subjects With Moderate to Severe Plaque Psoriasis Who Have Failed IL-17A Therapies". This study will evaluate the safety and efficacy of brodalumab in the treatment of moderate-to-severe psoriasis in patients who have previously failed treatment with interleukin (IL)-17A therapies. Forty patients will be enrolled in this 16-week open-label study. Patients will receive 210 mg of brod...
What is the current status of trial NCT03403036?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 39 participants. The study started on 2017-10-31. Estimated completion is 2018-08-18.
What interventions are being tested in trial NCT03403036?
The interventions under investigation include: Brodalumab (DRUG).
Who is sponsoring clinical trial NCT03403036?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03403036's enrollment target sits among peer trials
39 1468th of 2000 higher than 525 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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