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NCT01550744 · ClinicalTrials.gov registry record · Phase 3
A Study of Ustekinumab to Evaluate a "Subject-tailored" Maintenance Dosing Approach in Subjects With Moderate-to-Severe Plaque Psoriasis
A Phase 3 study, sponsored by Janssen Biotech.
- Completed
- Registry status
- Phase 3
- Development phase
- 478
- Enrollment target
NCT01550744: Completed Phase 3 study, sponsored by Janssen Biotech.
NCT01550744 is a Phase 3 study that has completed, run by Janssen Biotech. The registered enrollment target is 478 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01550744, a Phase 3 study, has completed, sponsored by Janssen Biotech.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 478 participants
- Enrollment target
Study Summary
The purpose of the study is to assess the effect of extending maintenance dosing intervals beyond 12 weeks on the clinical efficacy and safety of ustekinumab in subjects with moderate-to-severe plaque psoriasis.
Primary Outcome
Clinical responses for week (wk)28 sPGA responders randomized to every 12 weeks (q12wk) fixed-interval dosing (Group 1) vs. patient-tailored fixed-interval dosing (Group 2) were assessed using the static PGA (sPGA) measure. Investigators graded psoriasis lesions for induration (0=no plaque elevation to 5=severe plaque elevation), erythema (0=no evidence of erythema to 5=dusky to deep red coloration), and scaling (0=no evidence of scaling to 5=severe scaling). The sum of the 3 scales is divided b
Interventions
- DRUG Placebo
- DRUG Ustekinumab 45 mg
- DRUG Ustekinumab 90 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 478 participants |
| Start Date | 2012-03 |
| Est. Completion | 2015-07 |
| Phase | Phase 3 |
What the finished NCT01550744 record still lists
NCT01550744 is an interventional study that assigns participants to a tested intervention. The registered 478 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 (38% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01550744 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01550744 about?
NCT01550744 is a clinical study titled "A Study of Ustekinumab to Evaluate a "Subject-tailored" Maintenance Dosing Approach in Subjects With Moderate-to-Severe Plaque Psoriasis". The purpose of the study is to assess the effect of extending maintenance dosing intervals beyond 12 weeks on the clinical efficacy and safety of ustekinumab in subjects with moderate-to-severe plaque psoriasis.
What is the current status of trial NCT01550744?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 478 participants. The study started on 2012-03. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01550744?
The interventions under investigation include: Placebo (DRUG), Ustekinumab 45 mg (DRUG), Ustekinumab 90 mg (DRUG).
Who is sponsoring clinical trial NCT01550744?
This trial is sponsored by Janssen Biotech, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01550744's enrollment target sits among peer trials
478 805th of 2000 higher than 1,194 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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