Phase 2
Completed N=125
A Dose Ranging Study of AIN457 in Patients With Moderate to Severe Chronic Plaque-type Psoriasis
Chronic Plaque-type Psoriasis
Source: ClinicalTrials.gov NCT01071252 ↗
Enrolled (actual)
125
Serious AEs
4.0%
Results posted
Feb 2015
Primary outcomePrimary: Percentage of Participants of Reponders of Psoriasis Area and Severity Index (PASI) 75 Achievement at Week 13 — 3.4; 19.2; 57.1; 81.5 percentage of participants
Summary
The purpose of the study is to determine whether, in patients with moderate to severe plaque-type psoriasis, AIN457 administered subcutaneously reduces the severity of psoriasis symptoms and the extent to which the patient's body area is affected by the disease (compared to placebo).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants of Reponders of Psoriasis Area and Severity Index (PASI) 75 Achievement at Week 13 |
3.4; 19.2; 57.1; 81.5; 9.1 | — |
| SECONDARY Percentage of Participants With Investigator's Global Assessment (IGA) Response |
0; 0; 0; 3.7; 0; 0 | — |
| SECONDARY Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) |
3.4; 7.7; 4.8; 11.1; 0; 0 | — |
| SECONDARY To Assess the Time to Relapse |
NA; NA; NA; 203 | — |
Eligibility Criteria
Inclusion Criteria
Chronic plaque-type psoriasis diagnosed for at least 6 months at time of randomization
At randomization, moderate to severe psoriasis as defined by:
- PASI score of 12 or greater and,
- IGA score of 3 or greater and,
- Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater At screening and randomization, chronic plaque-type psoriasis considered inadequately controlled by topical treatment.
Exclusion Criteria
- Forms of psoriasis other than chronic plaque-type
- Drug-induced psoriasis (e.g., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) at randomization
- Previous exposure to AIN457
- Ongoing use of prohibited psoriasis treatments / medications and other prohibited medication at randomization. Washout periods detailed in the protocol have to be adhered to
- Known immunosuppression (e.g., AIDS) at screening and / or randomization
- History or evidence of active tuberculosis at screening
- Active systemic infections (other than common cold)
- History or symptoms of malignancy of any organ system, treated or untreated, within the past 5 years.
- Any severe, progressive or uncontrolled medical condition at randomization that in the judgment of the investigator prevents the patient from participating in the study
- Any clinically significant abnormal laboratory tests at randomization, that in the judgment of the investigator prevents the patient from participating in the study
- Inability or unwillingness to undergo repeated venipuntures
- History or evidence of drug or alcohol abuse
- Pregnant or nursing (lactating) women
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01071252). 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.