Status:
COMPLETED
Single and Multiple Dose Escalation Study to Assess the Safety and Tolerability of CJM112 in Psoriasis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Plaque-type Psoriasis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT01828086
Start Date
June 1 2013
End Date
October 1 2015
Last Update
December 11 2020
Active Locations (18)
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1
Novartis Investigative Site
Anniston, Alabama, United States, 36207
2
Novartis Investigative Site
Anaheim, California, United States, 92801
3
Novartis Investigative Site
Encino, California, United States, 91436
4
Novartis Investigative Site
North Hollywood, California, United States, 91606