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

NCT02425826 | Completed Phase 4 Results

• 1 other identifier: CC-10004-PSOR-012
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 26

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.

Conditions

Parapsoriasis

Keywords

Parapsoriasis; Plaque Psoriasis; CC-10004; Apremilast; Moderate Plaque Psoriasis; Safety

Outcome Measures

Primary Outcomes (1)

• Mean Percentage Change From Baseline in the Product of BSA (%) and the sPGA Which is Considered as the Total Psoriasis Severity Index at Week 16

  BSA is a measurement of involved skin. The overall BSA affected by psoriasis is estimated based on the palm area of the participant's hand (entire palmar surface or "handprint" including the fingers), which equates to approximately 1% of total body surface area. The sPGA is a 6-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), 5 (very severe) incorporating a separate assessment of the severity of the three primary signs of the plaques of all involved areas: erythema, scaling and plaque elevation with an overall sPGA calculated as (E + I + D)/3. Scores for each assessment are rounded to the nearest whole number to result in the final score. The range of BSA\*sPGA mean percentage change from baseline to week 16 (end of phase) were -100 to 344.4 and -100 to 100 for the placebo and apremilast groups respectively. Higher scores represented worse outcomes.

  Baseline to Week 16 (end of phase)

Secondary Outcomes (14)

• Mean Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16

  Baseline to Week 16 (end of phase)

• Percentage of Participants Who Achieved a sPGA Score of Clear (0) or Almost Clear (1) at Week 16 From Baseline

  Baseline to Week 16 (end of phase)

• Percentage of Participants Who Achieved a Clear (0) or Very Mild (1) on Patient Global Assessment (PtGA) Scale at Week 16 From Baseline

  Baseline to Week 16 (end of phase)

• Mean Change From Baseline in Pruritus Visual Analog Scale (VAS)

  Baseline to Weeks 1 and 16 (end of phase)

• Percentage of Participants With Scalp Psoriasis Who Achieved a Clear (0) or Minimal (1) on Scalp Physician's Global Assessment (ScPGA) Scale at Week 16.

  Baseline to Week 16 (end of phase)

Study Arms (2)

Apremilast

EXPERIMENTAL

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

Drug: Apremilast; Drug: Placebo; Drug: Placebo-Apremilast

Placebo

PLACEBO COMPARATOR

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)

Drug: Placebo; Drug: Placebo-Apremilast

Interventions

Apremilast DRUG

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

Also known as: CC-10004, Otzela

Apremilast

Placebo 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.

Apremilast; Placebo

Placebo-Apremilast DRUG

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

Also known as: Otezla, CC-10004

Apremilast; Placebo

Eligibility Criteria

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

You may qualify if:

• Males or females, ≥ 18 years of age at the time of signing the informed consent document.
• Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.
• 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
• BSA (Body Surface Area)5% to 10% and
• sPGA (Physician's Global Assessment) 3 (moderate) based on a 0 to 5 point scale
• Must be in general good health (except for psoriasis) as judged by the investigator, based on medical history, physical examination, and clinical laboratories.
• 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.
• 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.
• 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

You may not qualify if:

• 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.
• 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.
• 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.
• 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.
• 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, except for:
• treated (ie, cured) basal cell or squamous cell in situ skin carcinomas;
• 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.
• 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.
• Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
• Prolonged sun exposure or use of tanning booths, which may confound the ability to interpret data from the study.
• Prior treatment with apremilast.

Sponsors & Collaborators

• Amgen: lead

Study Sites (26)

UAB at Birmingham - The Kirklin Clinic

Birmingham, Alabama, 35233, United States

Location

Center For Dermatology

Fremont, California, 94538, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Blue Harbor Dermatology

Newport Beach, California, 92663, United States

Location

Center for Dermatology and Laser Surgery

Sacramento, California, 95819, United States

Location

East Bay Rheumatology Medical

San Leandro, California, 94578, United States

Location

Tien Q. Nguyen MD Inc

Tustin, California, 92780, United States

Location

UConn Health Center

Farmington, Connecticut, 06030, United States

Location

Dermatology Associates

Panama City, Florida, 32405-4542, United States

Location

USF Health Faculty Office Building-FOB

Tampa, Florida, 33612, United States

Location

Forward Clinical Trials Inc

Tampa, Florida, 33624, United States

Location

Dermatologic Surgery Specialists, P.C.

Macon, Georgia, 31217, United States

Location

Shideler Clinical Research Center

Carmel, Indiana, 46032, United States

Location

Dermatology Specialists, PSC

Louisville, Kentucky, 40202, United States

Location

DermResearch, PLLC

Louisville, Kentucky, 40217, United States

Location

Lawrence Green, MD, LLC

Rockville, Maryland, 20850, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Las Vegas Skin and Cancer Clinics

Las Vegas, Nevada, 89052, United States

Location

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520, United States

Location

Garden City Dermatology

Garden City, New York, 11530, United States

Location

Sadick Research Group

New York, New York, 10075, United States

Location

Dermatology Associates of Rochester PC

Rochester, New York, 14623, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267-0501, United States

Location

Dermatology and Laser Center of Charleston

Charleston, South Carolina, 29414, United States

Location

University of Utah School of Medicine

Salt Lake City, Utah, 84132, United States

Location

Dermatology Consultants, Inc.

Lynchburg, Virginia, 24501, United States

Location

Related Publications (3)

• 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.

  PMID: 34255891 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 DERIVED

• 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.

  PMID: 29462231 DERIVED

MeSH Terms

Conditions

Parapsoriasis

Interventions

apremilast

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Anne McClain, Senior Manager, Clinical Trial Disclosure
• Organization: Celgene Corporation

ClinicalTrialDisclosure@celgene.com

1-800-260-1599

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 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: April 3, 2015
• First Posted: April 24, 2015
• Study Start: April 20, 2015
• Primary Completion: February 12, 2016
• Study Completion: November 22, 2016
• Last Updated: June 5, 2023
• Results First Posted: June 6, 2017

Record last verified: 2020-04

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

US (26)