Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis - Full Text View

Sponsor:	Celgene Corporation
Information provided by (Responsible Party):	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT01194219

Purpose

This study will evaluate the effects of an experimental (being tested) study drug called apremilast. Apremilast works by lowering some of the chemicals that affect psoriasis and therefore improves the symptoms of psoriasis. The purpose of this study is to test apremilast and compare its effects to placebo (an inactive substance which contains no medicine but is in the same form as the drug). This study will test efficacy (improvement of signs and symptoms) and safety of apremilast in patients with moderate to severe psoriasis.

Condition	Intervention	Phase
Plaque Psoriasis	Drug: Apremilast Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis

Resource links provided by NLM:

Genetics Home Reference related topics: psoriatic arthritis

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:

Proportion of subjects achieving at least a 75% improvement in Psoriasis Area Severity Index (PASI) score. [ Time Frame: From Baseline (pre-dose) to Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of subjects treated with either apremilast 30 mg BID or placebo with a static Physician Global Assessment (sPGA) score of clear (0) or almost clear (1) with at least 2 points reduction. [ Time Frame: From Baseline (pre-dose) to Week 16 ] [ Designated as safety issue: No ]
Percent change in percent of affected body surface area. [ Time Frame: From Baseline (pre-dose) to Week 16 ] [ Designated as safety issue: No ]
Percent change in the PASI score. [ Time Frame: From Baseline (pre-dose) to Week 16 ] [ Designated as safety issue: No ]
Proportion of subjects who achieve PASI-50. [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Percent change in Pruritus VAS. [ Time Frame: From Baseline (pre-dose) to Week 16 ] [ Designated as safety issue: No ]
Change in DLQI total score. [ Time Frame: From baseline (pre-dose) to Week 16 ] [ Designated as safety issue: No ]
Change in Mental Component Summary (MCS) score of SF-36. [ Time Frame: From Baseline (pre-dose) to Week 16 ] [ Designated as safety issue: No ]
Proportion of subjects who achieve both PASI-75 and sPGA score of clear (0) or almost clear (1) with at least 2 points reduction. [ Time Frame: From Baseline (pre-dose) to Week 16 ] [ Designated as safety issue: No ]
Time to loss of PASI-75 response (loss of effect) during the Randomized Treatment Withdrawal Phase [ Time Frame: Week 32 until approximately Week 52 ] [ Designated as safety issue: No ]
Type, frequency, severity, seriousness, and relationship of adverse events to apremilast [ Time Frame: From the time of Informed Consent, through dosing, and for 28 days after the last dose of study medication. ] [ Designated as safety issue: Yes ]
Number of subjects who prematurely discontinue Investigational Product due to an adverse event [ Time Frame: From the time of Informed Consent, through dosing, and for 28 days after the last dose of study medication. ] [ Designated as safety issue: Yes ]
Frequency of clinically significant changes in physical examination, vital signs, electrocardiogram, and/or laboratory findings [ Time Frame: From the time of Informed Consent, through dosing, and for 28 days after the last dose of study medication. ] [ Designated as safety issue: Yes ]
Psoriasis flare or rebound [ Time Frame: From the time of Informed Consent, through dosing, and for 28 days after the last dose of study medication. ] [ Designated as safety issue: Yes ]
Population-based pharmacokinetic estimate of systemic exposure of apremilast [ Time Frame: Sparse sampling will be collected at Weeks 24, Week 32, Week 36, Week 40, Week 44, and Week 48. ] [ Designated as safety issue: No ]
Explore the relationship of apremilast exposure with efficacy and safety endpoints. [ Time Frame: Sparse sampling will be collected at Weeks 24, Week 32, Week 36, Week 40, Week 44, and Week 48. ] [ Designated as safety issue: No ]

Enrollment:	844
Study Start Date:	August 2010
Estimated Study Completion Date:	November 2016
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Apremilast Subjects are randomized to either a) placebo or b) apremilast 30 mg twice a day. Subjects initially randomized to placebo, are assigned to apremilast 30 mg twice a day beginning at Week 16 for the duration of the subject's participation in the study. Subjects initially randomized to apremilast 30 mg twice a day, and who demonstrate a PASI 75 response at Week 32 will be randomized (1 to 1) to either continue to receive apremilast 30 mg ) BID or to receive placebo (until effect is lost). At the time effect is lost, subjects will be treated with apremilast 30 mg twice a day for the duration of their participation in the study. Non-responders or partial responders (PASI response <75) in both arms may receive additional topical or phototherapy beginning at Week 32.	Drug: Apremilast Apremilast 30 mg twice a day Other Name: CC-10004
Placebo Comparator: Placebo Subjects are randomized to either a) placebo or b) apremilast 30 mg twice a day. Subjects initially randomized to placebo, are assigned to apremilast 30 mg twice a day beginning at Week 16 for the duration of the subject's participation in the study. Non-responders or partial responders (PASI response <75) in both arms may receive additional topical or phototherapy beginning at Week 32.	Drug: Placebo Placebo

Arms

Assigned Interventions

Active Comparator: Apremilast

Subjects are randomized to either a) placebo or b) apremilast 30 mg twice a day.

Subjects initially randomized to placebo, are assigned to apremilast 30 mg twice a day beginning at Week 16 for the duration of the subject's participation in the study.

Subjects initially randomized to apremilast 30 mg twice a day, and who demonstrate a PASI 75 response at Week 32 will be randomized (1 to 1) to either continue to receive apremilast 30 mg ) BID or to receive placebo (until effect is lost). At the time effect is lost, subjects will be treated with apremilast 30 mg twice a day for the duration of their participation in the study.

Non-responders or partial responders (PASI response <75) in both arms may receive additional topical or phototherapy beginning at Week 32.

Drug: Apremilast

Apremilast 30 mg twice a day

Other Name: CC-10004

Placebo Comparator: Placebo

Subjects are randomized to either a) placebo or b) apremilast 30 mg twice a day.

Subjects initially randomized to placebo, are assigned to apremilast 30 mg twice a day beginning at Week 16 for the duration of the subject's participation in the study.

Non-responders or partial responders (PASI response <75) in both arms may receive additional topical or phototherapy beginning at Week 32.

Drug: Placebo

Placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males or females, ≥ 18 years of age at the time of signing the informed consent document
Diagnosis of chronic plaque psoriasis for at least 12 months prior to Screening

a. Have moderate to severe plaque psoriasis at Screening and Baseline
Must meet all laboratory criteria
Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use 2 forms of contraception as described by the Study Doctor while on study medication and for at least 28 days after taking the last dose of study medication
Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (latex condom or any nonlatex condom NOT made out of natural [animal] membrane [eg, polyurethane]) while on study medication and for a least 28 days after the last dose of study medication.

Exclusion Criteria:

Other than psoriasis, history of any clinically significant (as determined by the Investigator) or other major uncontrolled disease.

.
Pregnant or breast feeding
History of allergy to any component of the study drug
Hepatitis B surface antigen positive at Screening
Anti-hepatitis C antibody positive at Screening
Active tuberculosis (TB) or a history of incompletely treated TB
Clinically significant abnormality on 12-Lead ECG at Screening
Clinically significant abnormal chest x-ray
History of positive human immunodeficiency virus (HIV), or have congenital or acquired immunodeficiency
Active substance abuse or a history of substance abuse within 6 months prior to Screening
Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening
Malignancy or history of malignancy (except for treated [ie, cured] basal cell or squamous cell in situ skin carcinomas and treated [ie, cured] cervical intraepithelial neoplasia [CIN] or carcinoma in situ of the cervix with no evidence of recurrence within the previous 5 years)
Psoriasis flare or rebound within 4 weeks prior to Screening
Evidence of skin conditions that would interfere with clinical assessments
Topical therapy within 2 weeks of randomization
Systemic therapy for psoriasis within 4 weeks prior to randomization
Use of phototherapy within 4 weeks prior to randomization (ie, UVB, PUVA)
Adalimumab, etanercept, infliximab, or certolizumab pegol within 12 weeks prior to randomization
Alefacept, briakinumab, or ustekinumab within 24 weeks prior to randomization
Use of any investigational drug within 4 weeks prior to randomization
Prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources
Prior treatment with apremilast

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01194219

Show 76 Study Locations

Sponsors and Collaborators

Celgene Corporation

Investigators

Study Director:

Irina Khanskaya, MD

Celgene Corporation

More Information

No publications provided

Responsible Party:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT01194219 History of Changes
Other Study ID Numbers:	CC-10004-PSOR-008
Study First Received:	August 31, 2010
Last Updated:	January 13, 2012
Health Authority:	Canada: Health Canada United States: Food and Drug Administration Australia: Department of Health and Ageing Therapeutic Goods Administration Belgium: Federal Agency for Medicinal Products and Health Products France: Afssaps - French Health Products Safety Agency Germany: Federal Institute for Drugs and Medical Devices Italy: National Monitoring Centre for Clinical Trials - Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Celgene Corporation:

Plaque Psoriasis

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Leprostatic Agents

Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 24, 2012