Phase 3
Completed N=110
A Study of the Safety and Efficacy of Ustekinumab in Adolescent Patients With Psoriasis (CADMUS)
Source: ClinicalTrials.gov NCT01090427 ↗Enrolled (actual)
110
Serious AEs
3.2%
Results posted
Dec 2014
Primary outcomePrimary: The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12 — 5.4; 67.6; 69.4 Percentage of Participants — p=<0.001
Summary
This is a study of the safety and efficacy of ustekinumab (CNTO 1275) in adolescent patients with moderate to severe psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12 |
5.4; 67.6; 69.4 | <0.001 sig |
| SECONDARY The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 75 Response at Week 12 |
10.8; 78.4; 80.6 | <0.001 sig |
| SECONDARY Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups |
-1.5; -5.6; -6.7 | 0.003 sig |
| SECONDARY The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups |
5.4; 54.1; 61.1 | <0.001 sig |
| SECONDARY The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) and PGA Score of Mild or Better (<=2) at Week 12 |
2.7; 32.4; 47.2; 32.4; 81.1; 83.3 | <0.001 sig |
| SECONDARY The Percentage of Participants Who Were PASI 50 Responders and the Percentage of Participants With a PASI Score of 0 at Week 12 |
29.7; 81.1; 88.9; 2.7; 21.6; 38.9 | <0.001 sig |
| SECONDARY The Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Total Scale Score, Psychosocial Health Summary Score, and Physical Health Summary Score at Week 12 |
3.35; 10.81; 8.03; 3.66; 12.13; 8.43 | 0.003 sig |
| SECONDARY The Percentage of Participants With CDLQI Scores of 0 or 1 at Week 12 for Randomized Participants With a Baseline CDLQI Score > 1 |
13.3; 38.7; 56.7 | 0.027 sig |
Eligibility Criteria
Inclusion Criteria
- Have a diagnosis of plaque-type psoriasis with or without psoriatic arthritis (PsA) for at least 6 months
- Are candidates for phototherapy or systemic treatment of psoriasis
- Have screening laboratory test results within the study parameters
Exclusion Criteria
- Currently have nonplaque forms of psoriasis
- Have used any therapeutic agent targeted at reducing interleukin-12 (IL-12) or interleukin-23 (IL-23), including but not limited to ustekinumab and briakinumab
- Received conventional systemic therapies or phototherapy within the last 4 weeks
- Received biologic therapies within the last 3 months
Data sourced from ClinicalTrials.gov (NCT01090427). 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.