Phase 3
Completed N=478
A Study of Ustekinumab to Evaluate a "Subject-tailored" Maintenance Dosing Approach in Subjects With Moderate-to-Severe Plaque Psoriasis
Source: ClinicalTrials.gov NCT01550744 ↗Enrolled (actual)
478
Serious AEs
4.9%
Results posted
Nov 2016
Primary outcomePrimary: The Number of Visits at Which Participants Achieved a Static Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) — 4.5; 4.1 number of visits
◆ Published Evidence
Established
71citations · ~9 / year
Longitudinal Study of the Psoriasis-Associated Skin Microbiome during Therapy with Ustekinumab in a Randomized Phase 3b Clinical Trial.
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.
Linked Publications (2)
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Longitudinal Study of the Psoriasis-Associated Skin Microbiome during Therapy with Ustekinumab in a Randomized Phase 3b Clinical Trial.
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Extension of ustekinumab maintenance dosing interval in moderate-to-severe psoriasis: results of a phase IIIb, randomized, double-blinded, active-controlled, multicentre study (PSTELLAR).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Visits at Which Participants Achieved a Static Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) |
4.5; 4.1 | — |
| SECONDARY The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time |
100; 100; 78.7; 71.0; 75.7; 59.0 | — |
| SECONDARY The Number of Visits for Which Participants Achieved a Psoriasis Area and Severity Index (PASI) 75 Response |
5.8; 5.4 | — |
| SECONDARY The Percentage of Participants With a PASI 75 Response Over Time |
96.1; 95.7; 92.0; 81.1; 93.2; 78.8 | — |
Eligibility Criteria
Key Eligibility Criteria
- Male or female
- Have had a diagnosis of plaque-type psoriasis at least 6 months prior to the first administration of study agent (subjects with concurrent psoriatic arthritis may be enrolled).
- Have plaque-type psoriasis covering at least 10% of their total BSA at screening and at the time of the first administration of study agent.
- Have a PGA score of ≥ 3 at screening and at the time of the first administration of study agent.
Data sourced from ClinicalTrials.gov (NCT01550744) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.