Phase 2
Completed N=355
A Study to Determine the Optimal Dose of Tildrakizumab (SCH 900222/MK-3222) for the Treatment of Moderate-to-severe Chronic Plaque Psoriasis (P05495) (MK-3222-003)
Source: ClinicalTrials.gov NCT01225731 ↗Enrolled (actual)
355
Serious AEs
2.4%
Results posted
Mar 2015
Primary outcomePrimary: Percentage of Participants With a Psoriasis Area and Severity Index (PASI)75 Response at Week 16 — 33.33; 64.44; 66.29; 74.42 Percentage of participants — p=0.001
Summary
This is a response-driven study of tildrakuzumab for the treatment of moderate to severe chronic plaque psoriasis. The primary study hypothesis is that one or more doses of tildrakizumab will be superior to placebo for the treatment of psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Psoriasis Area and Severity Index (PASI)75 Response at Week 16 |
33.33; 64.44; 66.29; 74.42; 4.44 | 0.001 sig |
| PRIMARY Number of Participants Experiencing Adverse Events |
30; 56; 58; 54; 31; 7 | — |
| PRIMARY Number of Particpants Discontinuing Study Treatment Due to Adverse Events |
1; 2; 1; 1; 1; 0 | — |
| SECONDARY Percentage of Participants With a PASI 75 Response at Week 12 |
23.81; 58.89; 60.67; 72.09; 4.44 | 0.009 sig |
| SECONDARY Percentage of Participants With Physician's Global Assessment (PGA) of "Cleared" or "Minimal" at Week 16 |
33.33; 57.78; 61.80; 74.42; 2.22 | <0.001 sig |
| SECONDARY Percentage of Participants With PASI 90 Response at Week 16 |
12.50; 25.29; 38.64; 52.38; 2.44 | — |
| SECONDARY Percentage of Participants With PASI 100 Response at Week 16 |
5.0; 9.20; 14.77; 16.67; 0.00 | — |
| SECONDARY PASI 75 Response Rate by Time |
0.00; 1.12; 1.12; 0.00; 0.00; 0.00 | — |
| SECONDARY Mean Change From Baseline in PASI Score at Weeks 12 and 16 |
-10.2; -14.4; -14.1; -14.9; -2.2; -10.0 | — |
| SECONDARY Percentage of Participants With PASI 50 Response at Week 16 |
57.14; 82.22; 82.02; 91.86; 8.89 | — |
| SECONDARY Mean Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16 |
-4.9; -9.2; -8.5; -8.8; 1.0 | — |
| SECONDARY Percentage of Participants Achieving DLQI Score of 0 or 1 at Week 16 |
32.5; 57.47; 52.27; 57.83 | — |
| SECONDARY Percentage of Participants Achieving a >=5 Point Reduction in DLQI at Week 16 |
52.50; 70.11; 64.77; 73.49; 19.05 | — |
Eligibility Criteria
Inclusion Criteria
- Adult participants (≥18 years of age) with a diagnosis of moderate-to-severe chronic plaque psoriasis (defined by ≥10% body surface area [BSA] involvement, "moderate" or greater score on the Physician's Global Assessment [PGA] scale, and PASI score ≥12 at Baseline)
- Participants must have a diagnosis of predominantly plaque psoriasis for ≥6 months (as determined by interview and confirmation of diagnosis through physical examination by investigator) and be considered candidates for phototherapy or systemic therapy. Participants with psoriatic arthritis may be included in the study
Exclusion Criteria
- Nonplaque forms of psoriasis specifically erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis
- Participants who will require oral or injectable corticosteroids during the trial
- Presence of any infection requiring treatment with systemic antibiotics within 2 weeks prior to Screening, or serious infection (eg, pneumonia, cellulitis, bone or joint infections) requiring hospitalization or treatment with intravenous antibiotics within 8 weeks prior to Screening
- Participants with evidence of active or untreated latent tuberculosis (TB) according to Screening criteria specified in the protocol. (Prophylactic treatment for latent TB as per local guidelines must be initiated at least 4 weeks prior to treatment with study medication)
- Previous exposure to any agents targeting interleukin-12 (IL-12) and/or Interleukin-23 (IL-23)
- Participants with prior exposure to two or more tumor necrosis factor (TNF) antagonists with discontinuation due to lack of efficacy.
Data sourced from ClinicalTrials.gov (NCT01225731). 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.