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

Completed · Phase 1 · Has a placebo group

Conditions studied: Chronic Plaque-type Psoriasis

In brief

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.

Key facts

Study ID

NCT01828086

Run by

Novartis Pharmaceuticals

People needed

95

Starts

2013-06-01

Expected to finish

2015-10-01

Last updated by the study team

2020-12-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Anniston, Alabama, United States
• Novartis Investigative Site — Anaheim, California, United States
• Novartis Investigative Site — Encino, California, United States
• Novartis Investigative Site — North Hollywood, California, United States
• Novartis Investigative Site — Miami, Florida, United States
• Novartis Investigative Site — Miami, Florida, United States
• Novartis Investigative Site — Orlando, Florida, United States
• Novartis Investigative Site — Tampa, Florida, United States
• Novartis Investigative Site — Normal, Illinois, United States
• Novartis Investigative Site — Indianapolis, Indiana, United States
• Novartis Investigative Site — Overland Park, Kansas, United States
• Novartis Investigative Site — Crowley, Louisiana, United States
• Novartis Investigative Site — Raleigh, North Carolina, United States
• Novartis Investigative Site — Cincinnati, Ohio, United States
• Novartis Investigative Site — Oklahoma City, Oklahoma, United States
• Novartis Investigative Site — Philadelphia, Pennsylvania, United States
• Novartis Investigative Site — Austin, Texas, United States
• Novartis Investigative Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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