Phase 2
Completed N=198
Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis
Source: ClinicalTrials.gov NCT00975637 ↗Enrolled (actual)
198
Serious AEs
0.5%
Results posted
Dec 2016
Primary outcomePrimary: Dose-response Efficacy Profile of AMG 827 Compared With Placebo as Measured by the Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 — 86.3; 85.9; 76; 16 percentage of psoriasis improvement
Summary
The study evaluated the efficacy of AMG 827 compared with placebo as measured by the percent of improvement in PASI score at week 12.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dose-response Efficacy Profile of AMG 827 Compared With Placebo as Measured by the Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 |
86.3; 85.9; 76; 16; 45 | — |
| SECONDARY Change in Percent of Body Surface Area (BSA) Affected by Psoriasis |
22.1; 21.1; 16.1; 0.9; 9.2 | — |
Eligibility Criteria
Inclusion Criteria
- Subject has had stable moderate to severe plaque psoriasis for at least 6 months
- Subject has received at least one previous phototherapy or systemic psoriasis therapy or has been a candidate to receive phototherapy or systemic psoriasis therapy in the opinion of the investigator.
- Subject has involved BSA ≥ 10% and PASI ≥ 12 at screening and at baseline.
Exclusion Criteria
- Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, medication-induced, or medication-exacerbated psoriasis.
- Evidence of skin conditions at the time of the screening visit (eg, eczema, guttate psoriasis) that would interfere with evaluations of the effect of IP on psoriasis.
- Subject has any active CTCAE grade 2 or higher infection
- Subject has a significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol.
- Subject has used the following therapies within 14 days of the first dose: UVB therapy or topical psoriasis therapies other than Class I or II topical steroids
- Subject has used the following therapies within 28 days of the first dose: Class I or II topical steroids, UVA therapy (with or without psoralen), or systemic psoriasis therapies
- Subject has used the following therapies within 3 months of the first dose: adalimumab, alefacept, etanercept, infliximab, certolizumab, or live vaccines
- Subject has used an anti-IL12/IL23 inhibitor within 6 months of the first dose
- Subject has previously used an anti-IL17 biologic therapy, efalizumab, or rituximab
Data sourced from ClinicalTrials.gov (NCT00975637). 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.