A randomized, double-blind, placebo controlled, multicenter dose ranging study of subcutaneously administered AIN457, assessing Psoriasis Area and Severity Index (PASI) response in patients with moderate to severe chronic plaque-type psoriasis
- Conditions
- moderate to severe chronic plaque-type psoriasisMedDRA version: 12.0Level: LLTClassification code 10050576Term: Psoriasis vulgaris
- Registration Number
- EUCTR2009-016807-42-EE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
1. Patient must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed.
2. Men or women at least 18 years of age at time of consent. Where relevant, parents will also sign the informed consent according to local laws and regulations.
3. Chronic plaque-type psoriasis diagnosed for at least 6 months at time of randomization
4. 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
5. At screening and randomization, chronic plaque-type psoriasis considered inadequately controlled by topical treatment.
In addition, patients may have failed to respond to:
- phototherapy and/or
- previous systemic therapy
6. Male patients must consent to practice reliable contraception during the study and for 16 weeks after the last dose of study drug administration.
Reliable contraception is defined as using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as condoms, implants (by the partner), injectables (by the partner), combined oral contraceptives (by the partner), and some intrauterine devices ( (by the partner)). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not considered acceptable forms of birth control within this study.
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
1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at screening or randomization
2. Drug-induced psoriasis (i.e. new onset or current exacerbation from beta-blockers,
calcium channel inhibitors or lithium) at randomization
3. Previous participation in AIN457 studies
4. Ongoing use of prohibited psoriasis treatments / medications (e.g., topical or systemic corticosteroids, UV therapy) and other prohibited medication at randomization. Washout periods detailed in the protocol have to be adhered to. All prior concomitant medications must be on a stable dose for at least four weeks before first study drug administration
5. Known immunosuppression (e.g., AIDS) at screening and / or randomization.
6. History or evidence of tuberculosis at screening. All patients will be tested for
tuberculosis status using a blood test (QuantiFERON®-TB Gold In-Tube). Patients with evidence of tuberculosis may enter the trial after sufficient treatment has been initiated according to local regulations.
7. Active systemic infections (other than common cold) during the two weeks before
randomization (e.g., hepatitis)
8. At screening, history or symptoms of malignancy of any organ system (other than history of basal cell carcinomas 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 assess the efficacy of three different doses of AIN457 s.c. administered monthly (25 mg, 75 mg and 150 mg) or as a single administration (25 mg) in patients with moderate to severe chronic plaque-type psoriasis with respect to PASI 75 achievement 12 weeks after start of treatment, compared to placebo.;Secondary Objective: Key secondary objective:<br>To evaluate treatment success as assessed by the Investigator’s Global<br>Assessment (static IGA) 12 weeks after start of treatment;Primary end point(s): achievement of PASI 75, 12 weeks after start of treatment, compared to placebo
- Secondary Outcome Measures
Name Time Method