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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02555826
• Other study ID #: CC-10004-PSOR-012
• Status: Recruiting
• Phase: Phase 4
• First received: September 18, 2015
• Last updated: November 17, 2015
• Start date: March 2015

Study information

• Verified date: November 2015
• Source: Sadick Research Group
• Contact: Krista Bohnert
• Phone: 212 772 7242
• Email: kbohnert[@]sadickdermatology.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Apremilast

Locations

Country	Name	City	State
United States	Sadick Research Group	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Sadick Research Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PASI		One Year	No