A Phase 4 Study of Efficacy and Safety of Apremilast in Subjects With Moderate Plaque Psoriasis.

NCT ID: NCT02425826

Last Updated: 2023-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 221 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-20
• Study Completion Date: 2016-11-22

Brief Summary

This study will evaluate the clinical efficacy, the patients quality of life, and safety of oral apremilast 30 mg twice daily (BID) compared to placebo, in adult patients with moderate plaque psoriasis during the 16 week Placebo controlled Phase and then upto 1 year in the Extension Phase of the trial.

Detailed Description

This is a Phase 4, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast in subjects with moderate plaque psoriasis. 221 participants were randomized 2 (apremilast):1 (placebo) at approximately 25 sites in the United States. Those randomized to the apremilast treatment group received apremilast 30 mg tablets orally twice daily for 52 weeks. Those randomized to the placebo treatment group received placebo tablets (identical in appearance to the apremilast 30 mg tablets) orally twice daily (BID) for 16 weeks. Beginning Week 16, those initially randomized to placebo were switched to receive apremilast 30 mg BID for an additional 36 weeks (52 weeks total).

Study enrolled adult patients with stable moderate plaque psoriasis, who are naïve to systemic psoriasis treatments.

Conditions

Parapsoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Apremilast

Apremilast 30 mg tablets orally twice daily (BID) weeks 0 to 52.

Group Type: EXPERIMENTAL

Apremilast

Intervention Type: DRUG

Apremilast 30 mg tablets orally twice daily (BID) weeks 0 to 52.

Placebo

Intervention Type: DRUG

Participants randomized to the placebo treatment group received placebo tablets (identical in appearance to the apremilast 30 mg tablets) orally BID for from weeks 0-16.

Placebo-Apremilast

Intervention Type: DRUG

At Week 16, those randomized to placebo were switched to apremilast 30mg BID for an additional 36 weeks (52 weeks total)

Placebo

Placebo tablets BID during Weeks 0 to 16; at week 16, placebo participants were switched to apremilast 30 mg tablets BID for 36 weeks (from week 16 to week 52)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Participants randomized to the placebo treatment group received placebo tablets (identical in appearance to the apremilast 30 mg tablets) orally BID for from weeks 0-16.

Placebo-Apremilast

Intervention Type: DRUG

At Week 16, those randomized to placebo were switched to apremilast 30mg BID for an additional 36 weeks (52 weeks total)

Interventions

Apremilast

Apremilast 30 mg tablets orally twice daily (BID) weeks 0 to 52.

Intervention Type: DRUG

Placebo

Participants randomized to the placebo treatment group received placebo tablets (identical in appearance to the apremilast 30 mg tablets) orally BID for from weeks 0-16.

Intervention Type: DRUG

Placebo-Apremilast

At Week 16, those randomized to placebo were switched to apremilast 30mg BID for an additional 36 weeks (52 weeks total)

Intervention Type: DRUG

Other Intervention Names

CC-10004, Otzela; Otezla; CC-10004

Eligibility Criteria

Inclusion Criteria

1. Males or females, ≥ 18 years of age at the time of signing the informed consent document.

2. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.

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

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

5. Have moderate plaque psoriasis at screening and baseline as defined by

1. BSA (Body Surface Area)5% to 10% and

2. sPGA (Physician's Global Assessment) 3 (moderate) based on a 0 to 5 point scale

6. Must be in general good health (except for psoriasis) as judged by the investigator, based on medical history, physical examination, and clinical laboratories.

7. No prior exposure to systemic treatments or biologics for the treatment of psoriatic arthritis, psoriasis, or any other indication that could impact the assessment of psoriasis.

8. Females of childbearing potential (FCBP)must have a negative pregnancy test at Screening and Baseline. While on investigational product and for at least 28 days after taking the last dose of investigational product, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive§ options described below: Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy; OR Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]) PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.

9. Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (male latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]) while on investigational product and for at least 28 days after the last dose of investigational product

Exclusion Criteria

1. Other than psoriasis, any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic,immunologic disease, or other major disease that is currently uncontrolled.

2. 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.

3. Any condition, including other inflammatory diseases or dermatologic conditions, which confounds the ability to interpret data from the study, including other types of psoriasis (ie, erythrodermic, guttate, inverse, or pustular psoriasis), other than plaque psoriasis.

4. Prior history of suicide attempt at any time in the subject's life time prior to signing the informed consent and randomization, or major psychiatric illness requiring hospitalization within the last 3 years prior to signing the informed consent.

5. Pregnant or breast feeding.

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

7. Malignancy or history of malignancy, except for:

1. treated (ie, cured) basal cell or squamous cell in situ skin carcinomas;

2. treated (ie, cured) cervical intraepithelial neoplasia (CIN) or carcinoma in situ of the cervix with no evidence of recurrence within 5 years of signing the informed consent.

8. Topical therapy within 2 weeks of randomization (including, but not limited to, topical corticosteroids, retinoids or vitamin D analog preparations, tacrolimus, pimecrolimus, or anthralin/dithranol). Use of phototherapy within 4 weeks prior to randomization.

9. Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).

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

11. Prior treatment with apremilast.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

UAB at Birmingham - The Kirklin Clinic

Birmingham, Alabama, United States

Center For Dermatology

Fremont, California, United States

Dermatology Research Associates

Los Angeles, California, United States

Blue Harbor Dermatology

Newport Beach, California, United States

Center for Dermatology and Laser Surgery

Sacramento, California, United States

East Bay Rheumatology Medical

San Leandro, California, United States

Tien Q. Nguyen MD Inc

Tustin, California, United States

UConn Health Center

Farmington, Connecticut, United States

Dermatology Associates

Panama City, Florida, United States

USF Health Faculty Office Building-FOB

Tampa, Florida, United States

Forward Clinical Trials Inc

Tampa, Florida, United States

Dermatologic Surgery Specialists, P.C.

Macon, Georgia, United States

Shideler Clinical Research Center

Carmel, Indiana, United States

Dermatology Specialists, PSC

Louisville, Kentucky, United States

DermResearch, PLLC

Louisville, Kentucky, United States

Lawrence Green, MD, LLC

Rockville, Maryland, United States

Henry Ford Hospital

Detroit, Michigan, United States

Las Vegas Skin and Cancer Clinics

Las Vegas, Nevada, United States

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, United States

Garden City Dermatology

Garden City, New York, United States

Sadick Research Group

New York, New York, United States

Dermatology Associates of Rochester PC

Rochester, New York, United States

University of Cincinnati

Cincinnati, Ohio, United States

Dermatology and Laser Center of Charleston

Charleston, South Carolina, United States

University of Utah School of Medicine

Salt Lake City, Utah, United States

Dermatology Consultants, Inc.

Lynchburg, Virginia, United States

Countries

United States

References

Reich K, Mrowietz U, Menter A, Griffiths CEM, Bagel J, Strober B, Nunez Gomez N, Shi R, Guerette B, Lebwohl M. Effect of baseline disease severity on achievement of treatment target with apremilast: results from a pooled analysis. J Eur Acad Dermatol Venereol. 2021 Dec;35(12):2409-2414. doi: 10.1111/jdv.17520. Epub 2021 Aug 23.

Reference Type: BACKGROUND

PMID: 34255891 (View on PubMed)

Mease PJ, Hatemi G, Paris M, Cheng S, Maes P, Zhang W, Shi R, Flower A, Picard H, Stein Gold L. Apremilast Long-Term Safety Up to 5 Years from 15 Pooled Randomized, Placebo-Controlled Studies of Psoriasis, Psoriatic Arthritis, and Behcet's Syndrome. Am J Clin Dermatol. 2023 Sep;24(5):809-820. doi: 10.1007/s40257-023-00783-7. Epub 2023 Jun 14.

Reference Type: DERIVED

PMID: 37316690 (View on PubMed)

Stein Gold L, Bagel J, Lebwohl M, Jackson JM, Chen R, Goncalves J, Levi E, Duffin KC. Efficacy and Safety of Apremilast in Systemic- and Biologic-Naive Patients With Moderate Plaque Psoriasis: 52-Week Results of UNVEIL. J Drugs Dermatol. 2018 Feb 1;17(2):221-228.

Reference Type: DERIVED

PMID: 29462231 (View on PubMed)

Other Identifiers

CC-10004-PSOR-012

Identifier Type: -

Identifier Source: org_study_id

NCT02555826

Identifier Type: -

Identifier Source: nct_alias