Single and Multiple Dose Escalation Study to Assess the Safety and Tolerability of CJM112 in Psoriasis
Status: | Completed |
---|---|
Conditions: | Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 4/4/2019 |
Start Date: | June 2013 |
End Date: | October 2015 |
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
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.
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.
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
We found this trial at
19
sites
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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