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

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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

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.


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
Cincinnati, Ohio 45229
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Anaheim, California 92801
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Anaheim, CA
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Anniston, Alabama 36207
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Anniston, AL
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Austin, Texas 78759
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Austin, TX
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Crowley, Louisiana 70526
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Crowley, LA
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Encino, California 91436
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Encino, CA
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Indianapolis, Indiana 46202
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Indianapolis, IN
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Miami, Florida 33136
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Miami, FL
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Miami, Florida 33136
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Miami, FL
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Normal, Illinois 61761
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Normal, IL
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North Hollywood, California 91605
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North Hollywood, CA
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Oklahoma City, Oklahoma 73104
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Oklahoma City, OK
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Orlando, Florida 32806
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Orlando, FL
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Overland Park, Kansas 66210
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Overland Park, KS
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Philadelphia, Pennsylvania 19102
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Philadelphia, PA
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Raleigh, North Carolina 27609
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Raleigh, NC
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San Antonio, Texas 78207
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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Tampa, Florida 33613
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Tampa, FL
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Tampa, Florida 33613
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Tampa, FL
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