Chronic Plaque-type Psoriasis
Conditions
Keywords
Psoriasis, chronic plaque-type psoriasis, IL17, monoclonal antibody
Brief summary
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.
Interventions
BIOLOGICALCJM112
Monoclonal antibody
BIOLOGICALSecukinumab
Monoclonal antibody
OTHERPlacebo
Liquid for subcutaneous injection without active drug.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events as a measure of safety | 19 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Psoriasis Area and Severity Index (PASI) | 19 weeks | — |
| Total CJM112 Concentrations in Serum | 19 weeks | Measurement of drug levels in the blood of treated patients. |
| Concentration of anti-CJM112 Antibodies in Serum | 19 weeks | Assessment of the ability of the compound to evoke an immune response. Assessed in blood of treated patients. |
Countries
United States
Outcome results
None listed