Study of the Efficacy and Safety Of Apremilast (CC-10004), in Subjects With Moderate Plaque Psoriasis



Status:Recruiting
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:March 2015
Contact:Krista Bohnert
Email:kbohnert@sadickdermatology.com
Phone:212 772 7242

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A PHASE 4, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, STUDY OF THE EFFICACY AND SAFETY OF APREMILAST (CC-10004), IN SUBJECTS WITH MODERATE PLAQUE PSORIASIS

A Phase 4, Multicenter, Randomized, Placebo-controlled, Double-blind, Study of the Efficacy
and Safety of Apremilast (CC-10004), in Subjects with Moderate Plaque Psoriasis


Inclusion Criteria:

- Males or females, ≥ 18 years of age

- Able to adhere to the study visit schedule and other protocol requirements.

- Diagnosis of chronic plaque psoriasis for at least 6 months prior to signing the
informed consent.

- Have moderate plaque psoriasis at screening and baseline as defined by

- Must be in general good health (except for psoriasis) as judged by the investigator,
based

- No prior systemic treatments or biologics for the treatment of psoriatic arthritis,
psoriasis

- Females must have a negative pregnancy test at screening and baseline. Participants
must agree to use contraception during the course of the study

Exclusion Criteria:

- Other than psoriasis, any clinically significant (as determined by the Investigator)
major disease that is currently uncontrolled.

- Any condition, including the presence of laboratory abnormalities, which would place
the subject at unacceptable risk if he/she were to participate in the study.

- Pregnant or breast feeding.

- Active substance abuse or a history of substance abuse within 6 months prior to
signing the informed consent.

- Malignancy or history of malignancy

- Topical therapy within 2 weeks of starting trial

- Use of phototherapy within 4 weeks prior to starting trial

- Use of any investigational drug within 4 weeks prior to starting trial

- Prolonged sun exposure or use of tanning booths, which may confound the ability to
interpret data from the study.

- Prior treatment with apremilast.
We found this trial at
1
site
911 Park Avenue
New York, New York 10075
212-710-9855
Phone: 212-772-7242
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New York, NY
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