Phase 2
N=100
Multiple-loading Dose Regimen Study in Patients With Chronic Plaque-type Psoriasis
Chronic Plaque Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT00805480 ↗Enrolled (actual)
100
Serious AEs
7.0%
Results posted
Feb 2015
Primary outcome: Primary: Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores — -12.46; -13.35; -18.02; -4.18 scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AIN457 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores |
-12.46; -13.35; -18.02; -4.18 | — |
| PRIMARY Percentage of Participants Who Had Not Relapsed at Any Time in the Trial |
100.0; 100.0; 100.0; 100.0; 100.0; 96.6 | — |
| SECONDARY Percentage of Participants With at Least 50% Improvement From Baseline in PASI |
56.7; 84.0; 89.7; 10.0; 73.3; 80.0 | — |
| SECONDARY Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI |
30.0; 56.0; 65.5; 0.0; 3.3; 28.0 | — |
| SECONDARY Percentage of Participants in Each Investigator Global Assessment (IGA) Category |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
Summary
Loading dose, four arm, double-blind, parallel group, placebo-controlled study comparing single and multiple doses of AIN457 to placebo in patients with a diagnosis of moderate to severe chronic plaque psoriasis.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of plaque psoriasis for at least 6 months prior to screening. The patients must meet all of the following criterion:
- Coverage of the body surface area (BSA) of 10% or more with plaques
- A score of 3 or more on the IGA scale
- A PASI score of at least 12 at baseline
Exclusion Criteria
- Have forms of psoriasis other than the required "plaque psoriasis"
- Women of childbearing potential
- Recent use of investigational drugs or treatment with other biological therapies (wash-out periods required)
- Previous treatment with this investigational drug
- Subjects with active or history of clinically significant cardiac, kidney or liver abnormalities;
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00805480). 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.