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

NCT03721172 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: CC-10004-PSOR-022U1111-1218-8372
• Study Type: interventional
• Target: 595
• Locations: 2 countries
• Sites: 64

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.

Conditions

Psoriasis

Keywords

Phase 3; Double-Blind; Efficacy; Safety; Apremilast; Otezla; CC-10004; Plaque Psoriasis; Mild; Moderate; Scalp; Nail; Itch

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16 During the Placebo-Controlled Phase

  The sPGA is a 5-point scale where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 =severe. Scores incorporate an assessment by the Investigator of the severity of the 3 primary signs of the disease: erythema, scaling and plaque elevation. An sPGA response is defined as sPGA score of clear (0) or almost clear (1) and with at least a 2-point reduction from baseline at Week 16.

  Baseline and Week 16 of the placebo-controlled phase

Secondary Outcomes (8)

• Percentage of Participants With a ≥ 75 Percent (%) Improvement From Baseline in Affected Body Surface Area (BSA) at Week 16

  Baseline and Week 16 of the placebo-controlled phase

• Change From Baseline in Percentage of Affected BSA at Week 16

  Baseline and Week 16 of the placebo-controlled phase

• Change From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 16

  Baseline and Week 16 of the placebo-controlled phase

• Percentage of Participants Who Achieved BSA ≤ 3% for Participants With Baseline Affected BSA > 3% at Week 16

  Baseline and Week 16 of the placebo-controlled phase

• Percentage of Participants With ≥ 4-point Reduction From Baseline in Whole Body Itch Numeric Rating Scale (NRS) Score at Week 16 Who Had Baseline Whole Body Itch NRS ≥ 4

  Baseline and Week 16 of the placebo-controlled phase

Study Arms (3)

Placebo-controlled Phase:

EXPERIMENTAL

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

Other: Placebo

Placebo-controlled Phase: Apremilast 30 mg

EXPERIMENTAL

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

Drug: Apremilast

Extension Phase: Apremilast 30 mg

EXPERIMENTAL

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).

Drug: Apremilast

Interventions

Apremilast DRUG

Apremilast, oral, twice daily

Extension Phase: Apremilast 30 mg; Placebo-controlled Phase: Apremilast 30 mg

Placebo OTHER

Placebo, oral, twice daily

Placebo-controlled Phase:

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must satisfy the following criteria to be enrolled in the study:
• Subject must be male or female, ≥18 years of age at the time of signing the informed consent form (ICF).
• Subject must have a diagnosis of chronic plaque psoriasis for at least 6 months prior to signing the ICF.
• Subject must have a diagnosis of mild to moderate plaque psoriasis at both Screening and Baseline.
• Subject must be inadequately controlled with or intolerant of at least one topical therapy at both Screening and Baseline.
• Subject must be in good health (except for psoriasis) as judged by the investigator, based on medical history, physical examination, clinical laboratories, and urinalysis.
• Subject must meet laboratory criteria.
• 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.

You may not qualify if:

• The presence of any of the following will exclude a subject from enrollment:
• Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
• 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.
• \. Subject has hepatitis B surface antigen positive at Screening. 3. Subject has active tuberculosis (TB) or a history of incompletely treated TB.
• \. Subject has history of positive human immunodeficiency virus (HIV), or has congenital or acquired immunodeficiency (eg, common variable immunodeficiency disease).
• \. Subject has hepatitis B surface antigen or anti-hepatitis C antibody positive at Screening.
• \. 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.
• \. Use of any investigational drug beginning 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
• \. Subject had prior treatment with apremilast.

Sponsors & Collaborators

• Amgen: lead

Study Sites (64)

Total Skin & Beauty Dermatology Center

Birmingham, Alabama, 35205, United States

Location

Johnson Dermatology Clinic

Fort Smith, Arkansas, 72916, United States

Location

Northwest Arkansas Clinical Trials Center, PLLC / Hull Dermatology

Rogers, Arkansas, 72758, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

TCR Medical Corporation

San Diego, California, 92123, United States

Location

University of California San Francisco Psoriasis and Skin Treatment Center

San Francisco, California, 94118, United States

Location

Clinical Science Institute

Santa Monica, California, 90404, United States

Location

University of Colorado Hospital - Dermatology Clinic

Aurora, Colorado, 80045, United States

Location

Total Vein and Skin, LLC

Boynton Beach, Florida, 33437, United States

Location

Florida Academic Centers Research and Education

Coral Gables, Florida, 33134, United States

Location

International Dermatology Research

Miami, Florida, 33144, United States

Location

Center for Clinical and Cosmetic Research

Miami, Florida, 33180, United States

Location

Renstar Medical Research

Ocala, Florida, 34470, United States

Location

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

Tampa, Florida, 33612, United States

Location

Atlanta Dermatology, Vein and Research Center, PC

Alpharetta, Georgia, 30022, United States

Location

Medical Dermatology Specialists, Inc. - Advanced Medical Research

Atlanta, Georgia, 30328, United States

Location

MedaPhase INC

Newnan, Georgia, 30263, United States

Location

Gwinnett Clinical Research Center, Inc.

Snellville, Georgia, 30078, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46256, United States

Location

Clinical Trials Management LLC

Metairie, Louisiana, 70006, United States

Location

Derm Associates

Rockville, Maryland, 20850, United States

Location

Lawrence Green, MD, LLC

Rockville, Maryland, 20850, United States

Location

ActivMed Practices & Research Inc

Beverly, Massachusetts, 01915, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114-2517, United States

Location

Henry Ford Medical Center - New Center One

Detroit, Michigan, 48202, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Central Dermatology

St Louis, Missouri, 63117, United States

Location

JDR Dermatology Research, LLC

Las Vegas, Nevada, 89148, United States

Location

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10003, United States

Location

Albert Einstein College of Medicine - Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27104, United States

Location

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Wright State Physicians

Fairborn, Ohio, 45324, United States

Location

Temple University - Lewis Katz School of Medicine

Philadelphia, Pennsylvania, 19140, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Clinical Partners, LLC

Johnston, Rhode Island, 02919, United States

Location

Clinical Research Center of the Carolinas

Charleston, South Carolina, 29407, United States

Location

Austin Institute for Clinical Research

Pflugerville, Texas, 78660, United States

Location

Center for Clinical Studies

Webster, Texas, 77598, United States

Location

University of Utah MidValley Dermatology

Murray, Utah, 84107, United States

Location

Virginia Clinical Research Inc

Norfolk, Virginia, 23502, United States

Location

Dermatology Center for Skin Health

Morgantown, West Virginia, 26505, United States

Location

Institute for Skin Advancement

Calgary, Alberta, T3A 2N1, Canada

Location

Stratica Medical

Edmonton, Alberta, T5K 1X3, Canada

Location

Chih-Ho Hong Medical, Inc.

Surrey, British Columbia, V3R 6A7, Canada

Location

Enverus Medical Research

Surrey, British Columbia, V3V 0C6, Canada

Location

Winnipeg Clinic Dermatology Research

Winnipeg, Manitoba, R3CON2, Canada

Location

SkinWise Dermatology

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

Brunswick Dermatology Centre

Fredericton, New Brunswick, E3B 1G9, Canada

Location

Karma Clinical Trials

St. John's, Newfoundland and Labrador, A1A 4Y3, Canada

Location

SimcoDerm Medical and Surgical Dermatology Center

Barrie, Ontario, L4M 7G1, Canada

Location

Guelph Dermatology Research

Guelph, Ontario, N1L 0B7, Canada

Location

DermEffects

London, Ontario, N6H 5L5, Canada

Location

Lynderm Research

Markham, Ontario, L3P 1X2, Canada

Location

North Bay Dermatology Centre

North Bay, Ontario, P1B 3Z7, Canada

Location

Skin Center for Dermatology

Peterborough, Ontario, K9J 5K2, Canada

Location

Toronto Research Centre

Toronto, Ontario, M3H 5Y8, Canada

Location

Sameh Hanna Medicine Professional Corporation DBA Dermatology on Bloor

Toronto, Ontario, M4W 2N2, Canada

Location

K. Papp Clinical Research

Waterloo, Ontario, N2J 1C4, Canada

Location

Windsor Clinical Research Inc.

Windsor, Ontario, N8W 5L7, Canada

Location

Dr Isabelle Delorme inc

Drummondville, Quebec, J2B 5L4, Canada

Location

Dre Angelique Gagne-Henley M.D. Inc.

Saint-Jérôme, Quebec, J7Z 7E2, Canada

Location

Skinsense Medical Research

Saskatoon, Saskatchewan, S7K 0H6, Canada

Location

Related Publications (2)

• 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.

  PMID: 34343599 BACKGROUND

• 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.

  PMID: 37316690 BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Psoriasis; Lymphoma, Follicular; Pruritus

Interventions

apremilast

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: October 26, 2018
• Study Start: March 11, 2019
• Primary Completion: March 6, 2020
• Study Completion: July 24, 2020
• Last Updated: May 29, 2024
• Results First Posted: May 17, 2021

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

CA (21); US (43)