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 |
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
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.
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