AIN457 Regimen Finding Study in Patients With Moderate to Severe Psoriasis

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Chronic Plaque-type Psoriasis

Intervention / Treatment
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* Drug: AIN457
* Drug: AIN457A
* Drug: AIN457A
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women at least 18 years of age at time of consent Chronic plaque-type psoriasis diagnosed for at least 6 months at time of randomization At time of 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 and/or phototherapy and/or previous systemic therapy Exclusion Criteria: Patients meeting any of the following criteria will be excluded from entry into the study: Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at screening or randomization Drug-induced psoriasis (i.e. new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) and randomization Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids, UV therapy) at randomization. Washout periods detailed in the study protocol have to be adhered to Ongoing use of other prohibited treatments at randomization. Washout periods detailed in the study protocol have to be adhered to. All prior concomitant medications must be on a stable dose for at least four weeks before study drug administration Known immunosuppression (e.g., AIDS) at screening and / or randomization History or evidence of active tuberculosis at screening. All patients will be tested for tuberculosis status using a blood test (QuantiFERON®-TB Gold In-Tube). Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment has been initiated according to local regulations. Active systemic infections (other than common cold) during the two weeks before randomization (e.g., hepatitis) 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 History of congestive heart failure (NYHA functional classification ≥III) at screening and / or randomization History of severe hypersensitivity to any human or humanized biological agents (antibody or soluble receptor) at screening and / or randomization Any severe, progressive or uncontrolled medical condition at randomization that in the judgment of the investigator prevents the patient from participating in the study Pregnant or nursing (lactating) women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Induction Single Dose<br>Induction with single injection - Single: secukinumab (AIN457) 150 mg s.c. administered at Week 1, Baseline through Week 12 | Drug: AIN457<br> <br> * Other names: Secukinumab;|
| Experimental: Induction Monthly Dose<br>Induction with monthly injections - Monthly: secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9, Baseline through Week 12 | Drug: AIN457A<br>* Induction with monthly injections - Monthly: secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9<br>* Other names: Secukinumab;|
| Experimental: Induction Early Loading Dose<br>Early loading induction - Early: secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5, Baseline through Week 12 | Drug: AIN457A<br>* Early loading induction - Early: secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5<br>* Other names: Secukinumab;|
| Placebo Comparator: Placebo Dose<br>Placebo administered at weeks 1, 2, 3, 5, 9, Baseline through Week 12 | Drug: Placebo<br>* Placebo - Placebo: Placebo administered at weeks 1, 2, 3, 5, 9<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously in Patients With Moderate to Severe Chronic Plaque-type Psoriasis With Respect to PASI 75 Achievement After 12 Weeks of Treatment, Compared to Placebo. | Number (%) of patients achieving PASI 50, PASI 75, PASI 90, by visit and induction treatment | 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Efficacy of Two Maintenance Regimens of AIN457 With Respect to PASI 75 Achievement at Least Once From Week 21 to 29 |  | week 21 to 29 | 
| The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously With Respect Participants Who Reported Either an IGA 0 or 1 After 12 Weeks of Treatment, Compared to Placebo | The investigator's global assessment (IGA) was used to evaluate overall psoriatic disease, with scores ranging from 0 (clear) to 5 (very severe disease). Treatment success was defined as patients who achieved IGA 0 or 1 and improvement of at least 2 points on the IGA scale compared to baseline. The IGA rating score for involvement of hands and feet ranged from 0 (clear) to 4 (severe). | 13 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Moderate to severe chronic plaque-type psoriasis, AIN457, dermatology