Apremilast as a Direct Treatment for Mild-to-moderate Plaque Psoriasis Versus Placebo: an Analysis of Clinical Safety and Efficacy

NCT ID: NCT03721172

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 595 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-11
• Study Completion Date: 2020-07-24

Brief Summary

This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with mild to moderate plaque psoriasis.

Approximately 574 subjects with mild to moderate plaque psoriasis will be randomized 1:1 to receive either apremilast 30 mg BID or placebo for the first 16 weeks.

Detailed Description

The study will consist of four phases:

• Screening Phase - up to 35 days
• Double-blind Placebo-controlled Phase - Weeks 0 to 16

• Subjects will be randomly assigned to either apremilast 30 mg tablets orally BID or placebo tablets (identical in appearance to apremilast 30 mg tablets) orally BID.
• Apremilast Extension Phase - Weeks 16 to 32

• All subjects will be switched to (or continue with) apremilast 30 mg BID. All subjects will maintain this dosing through Week 32.
• Observational Follow-up Phase - 4 weeks - Four-week Post-Treatment Observational Follow-up Phase for all subjects who complete the study or discontinue the study early.

Conditions

Psoriasis

Study Design

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

Study Groups

Placebo-controlled Phase:

Participants received placebo as oral tablets twice daily (BID) for up to 16 weeks (Week 0 to Week 16).

Group Type: EXPERIMENTAL

Placebo

Intervention Type: OTHER

Placebo, oral, twice daily

Placebo-controlled Phase: Apremilast 30 mg

Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).

Group Type: EXPERIMENTAL

Apremilast

Intervention Type: DRUG

Apremilast, oral, twice daily

Extension Phase: Apremilast 30 mg

Eligible participants who completed the placebocontrolled phase entered the extension phase and received apremilast 30 mg as oral tablets BID for up to an additional 16 weeks (Week 16 to Week 32).

Group Type: EXPERIMENTAL

Apremilast

Intervention Type: DRUG

Apremilast, oral, twice daily

Interventions

Apremilast

Apremilast, oral, twice daily

Intervention Type: DRUG

Placebo

Placebo, oral, twice daily

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Subjects must satisfy the following criteria to be enrolled in the study:

1. Subject must be male or female, ≥18 years of age at the time of signing the informed consent form (ICF).

2. Subject must have a diagnosis of chronic plaque psoriasis for at least 6 months prior to signing the ICF.

3. Subject must have a diagnosis of mild to moderate plaque psoriasis at both Screening and Baseline.

4. Subject must be inadequately controlled with or intolerant of at least one topical therapy at both Screening and Baseline.

5. Subject must be in good health (except for psoriasis) as judged by the investigator, based on medical history, physical examination, clinical laboratories, and urinalysis.

6. Subject must meet laboratory criteria.

7. Subject has not had prior exposure to biologics for the treatment of psoriatic arthritis or psoriasis, or any other condition that could impact the assessment of psoriasis.

Exclusion Criteria

The presence of any of the following will exclude a subject from enrollment:

1. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.

2. Subjects has 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.

2. Subject has hepatitis B surface antigen positive at Screening. 3. Subject has active tuberculosis (TB) or a history of incompletely treated TB.

4. Subject has history of positive human immunodeficiency virus (HIV), or has congenital or acquired immunodeficiency (eg, common variable immunodeficiency disease).

5. Subject has hepatitis B surface antigen or anti-hepatitis C antibody positive at Screening.

6. Subject has prior history of suicide attempt at any time in the subject's life time or major psychiatric illness requiring hospitalization within the last 3 years prior to signing the informed consent. 7. Subject has current or planned concurrent use of therapies that may have a possible effect on psoriasis during the course of the treatment phase of the trial.

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

9. Subject had 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

Total Skin & Beauty Dermatology Center

Birmingham, Alabama, United States

Johnson Dermatology Clinic

Fort Smith, Arkansas, United States

Northwest Arkansas Clinical Trials Center, PLLC / Hull Dermatology

Rogers, Arkansas, United States

Dermatology Research Associates

Los Angeles, California, United States

TCR Medical Corporation

San Diego, California, United States

University of California San Francisco Psoriasis and Skin Treatment Center

San Francisco, California, United States

Clinical Science Institute

Santa Monica, California, United States

University of Colorado Hospital - Dermatology Clinic

Aurora, Colorado, United States

Total Vein and Skin, LLC

Boynton Beach, Florida, United States

Florida Academic Centers Research and Education

Coral Gables, Florida, United States

International Dermatology Research

Miami, Florida, United States

Center for Clinical and Cosmetic Research

Miami, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

University of South Florida - Carol and Frank Morsani Center for Advanced Health Care

Tampa, Florida, United States

Atlanta Dermatology, Vein and Research Center, PC

Alpharetta, Georgia, United States

Medical Dermatology Specialists, Inc. - Advanced Medical Research

Atlanta, Georgia, United States

MedaPhase INC

Newnan, Georgia, United States

Gwinnett Clinical Research Center, Inc.

Snellville, Georgia, United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States

Clinical Trials Management LLC

Metairie, Louisiana, United States

Derm Associates

Rockville, Maryland, United States

Lawrence Green, MD, LLC

Rockville, Maryland, United States

ActivMed Practices & Research Inc

Beverly, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Henry Ford Medical Center - New Center One

Detroit, Michigan, United States

Minnesota Clinical Study Center

Fridley, Minnesota, United States

Central Dermatology

St Louis, Missouri, United States

JDR Dermatology Research, LLC

Las Vegas, Nevada, United States

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Albert Einstein College of Medicine - Montefiore Medical Center

The Bronx, New York, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Wright State Physicians

Fairborn, Ohio, United States

Temple University - Lewis Katz School of Medicine

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Clinical Partners, LLC

Johnston, Rhode Island, United States

Clinical Research Center of the Carolinas

Charleston, South Carolina, United States

Austin Institute for Clinical Research

Pflugerville, Texas, United States

Center for Clinical Studies

Webster, Texas, United States

University of Utah MidValley Dermatology

Murray, Utah, United States

Virginia Clinical Research Inc

Norfolk, Virginia, United States

Dermatology Center for Skin Health

Morgantown, West Virginia, United States

Institute for Skin Advancement

Calgary, Alberta, Canada

Stratica Medical

Edmonton, Alberta, Canada

Chih-Ho Hong Medical, Inc.

Surrey, British Columbia, Canada

Enverus Medical Research

Surrey, British Columbia, Canada

Winnipeg Clinic Dermatology Research

Winnipeg, Manitoba, Canada

SkinWise Dermatology

Winnipeg, Manitoba, Canada

Brunswick Dermatology Centre

Fredericton, New Brunswick, Canada

Karma Clinical Trials

St. John's, Newfoundland and Labrador, Canada

SimcoDerm Medical and Surgical Dermatology Center

Barrie, Ontario, Canada

Guelph Dermatology Research

Guelph, Ontario, Canada

DermEffects

London, Ontario, Canada

Lynderm Research

Markham, Ontario, Canada

North Bay Dermatology Centre

North Bay, Ontario, Canada

Skin Center for Dermatology

Peterborough, Ontario, Canada

Toronto Research Centre

Toronto, Ontario, Canada

Sameh Hanna Medicine Professional Corporation DBA Dermatology on Bloor

Toronto, Ontario, Canada

K. Papp Clinical Research

Waterloo, Ontario, Canada

Windsor Clinical Research Inc.

Windsor, Ontario, Canada

Dr Isabelle Delorme inc

Drummondville, Quebec, Canada

Dre Angelique Gagne-Henley M.D. Inc.

Saint-Jérôme, Quebec, Canada

Skinsense Medical Research

Saskatoon, Saskatchewan, Canada

Countries

United States; Canada

References

Stein Gold L, Papp K, Pariser D, Green L, Bhatia N, Sofen H, Albrecht L, Gooderham M, Chen M, Paris M, Wang Y, Callis Duffin K. Efficacy and safety of apremilast in patients with mild-to-moderate plaque psoriasis: Results of a phase 3, multicenter, randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol. 2022 Jan;86(1):77-85. doi: 10.1016/j.jaad.2021.07.040. Epub 2021 Jul 31.

Reference Type: BACKGROUND

PMID: 34343599 (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: BACKGROUND

PMID: 37316690 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

U1111-1218-8372

Identifier Type: REGISTRY

Identifier Source: secondary_id

CC-10004-PSOR-022

Identifier Type: -

Identifier Source: org_study_id