A randomized, double-blind, placebo controlled, multicenter regimen finding study of subcutaneously administered AIN457, assessing Psoriasis Area and Severity Index (PASI) response in patients with moderate to severe chronic plaque-type psoriasis. - A2211
- Conditions
- Moderate to severe plaque-type psoriasisMedDRA version: 9.1Level: LLTClassification code 10050576Term: Psoriasis vulgaris
- Registration Number
- EUCTR2008-007525-39-IS
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 459
Key inclusion criteria:
• Males or females at least 18 years of age at time of entry
• Diagnosis of chronic plaque-type psoriasis for at least 6 months at time of randomization
• At randomization, moderate to severe psoriasis (PASI = 12, IGA = 3, and BSA = 10%)
• At screening and randomization, psoriasis considered inadequately controlled by topical treatment and / or phototherapy and / or previous systemic therapy
• Male patients must consent to practice reliable contraception during the study and for 16 weeks after the last dose of study drug administration.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Key exclusion criteria:
• Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at screening or randomization
• Drug-induced psoriasis at randomization (i.e., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium)
• Ongoing use of prohibited psoriasis treatments / medications (e.g., topical or systemic corticosteroids, UV therapy) at randomization
• Ongoing use of other prohibited treatments at randomization. All concomitant medication must be on a stable dose for at least four weeks before first study drug administration.
• Known immunosuppression (e.g., AIDS) at screening and / or randomization
• History or evidence to suggest active TB at screening. All patients will be tested for TB status using a blood test (QuantiFERON®-TB Gold In-Tube). Patients with evidence of latent TB may enter the trial after sufficient treatment has been initiated according to local regulations.
• Active systemic infections during the last two weeks before randomization (exception: common cold)
• At screening, history or symptoms of malignancy of any organ system (other than history of basal cell carcinoma and / or up to three squamous cell carcinomas of the skin, if successful treatment has been performed, with no signs of recurrence; actinic keratoses, if present at screening, should be treated according to standard therapy before randomization), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of three induction regimens of AIN457 administered s.c. in patients with moderate to severe chronic plaque-type psoriasis with respect to PASI 75 achievement after 12 weeks of treatment, compared to placebo.;Secondary Objective: Key Secondary objectives:<br><br>To compare the efficacy of two maintenance regimens of AIN457 with respect to PASI 75 achievement at least once from week 21 to 29<br><br>To evaluate the efficacy of three induction regimens of AIN457 administered s.c. with respect to IGA 0 or 1 achievement after 12 weeks of treatment, compared to placebo.;Primary end point(s): The primary endpoint, achievement of PASI 75 at week 13, will be analyzed by Dunnett’s test procedure for proportions in a sequential manner.
- Secondary Outcome Measures
Name Time Method