Single and Multiple Dose Escalation Study to Assess the Safety and Tolerability of CJM112 in Psoriasis

Study Overview
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Brief Summary
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A randomized, double-blind, placebo and positive controlled, single and multiple dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of CJM112 in chronic plaque-type psoriasis patients. This trial never made it to the Phase II part of this trial.

Official Title
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A Randomized, Double-blind, Placebo and Positive Controlled, Single and Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CJM112 in Chronic Plaque-type Psoriasis Patients

Conditions
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Chronic Plaque-type Psoriasis

Intervention / Treatment
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* Biological: CJM112
* Biological: Secukinumab
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women 18-65 years of age at time of consent 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. Female patients may be included according to the following: Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, using highly effective methods of contraception during dosing and for 5 times the terminal half-life of study treatment. • Male subjects must agree to comply with two highly effective contraceptive methods Exclusion Criteria: Forms of psoriasis other than chronic plaque-type (incl. drug induced psoriasis) Ongoing use of prohibited psoriasis treatments and other prohibited medication at randomization. Washout periods detailed in the protocol have to be adhered to Previous treatment with IL-17 or IL17R blocking agents, including secukinumab Any live vaccines (including nasal-spray flu vaccine) starting from 6 weeks before screening, during the study, and up to 24 weeks after the last dose of CJM112 or secukinumab Evidence of active tuberculosis at screening Active systemic infections (other than common cold) Pregnant or nursing (lactating) women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CJM112<br>CJM112 in different doses; single ascending and multiple ascending | Biological: CJM112<br>* Monoclonal antibody<br>|
| Placebo Comparator: Placebo<br>Placebo to match | Other: Placebo<br>* Liquid for subcutaneous injection without active drug.<br>|
| Active Comparator: Secukinumab<br>Active investigational drug. | Biological: Secukinumab<br>* Monoclonal antibody<br>* Other names: AIN475;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events as a measure of safety | Safety as assessed by the number of participants with adverse events as measured by laboratory parameters, vital signs, electrocardiogram and the collection of serious and non-serious adverse events. | 19 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psoriasis Area and Severity Index (PASI) |  | 19 weeks | 
| Total CJM112 Concentrations in Serum | Measurement of drug levels in the blood of treated patients. | 19 weeks | 
| Concentration of anti-CJM112 Antibodies in Serum | Assessment of the ability of the compound to evoke an immune response. Assessed in blood of treated patients. | 19 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis, chronic plaque-type psoriasis, IL17, monoclonal antibody