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

NCT01194219 | Completed Phase 3 Results

• 1 other identifier: CC-10004-PSOR-008
• Study Type: interventional
• Target: 844
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluated the effects of an 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 was 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 was able to test for efficacy (improvement of signs and symptoms) and safety of apremilast in patients with moderate to severe psoriasis.

Conditions

Plaque Psoriasis

Keywords

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) at Week 16 From Baseline

  PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement is missing.

  Baseline to Week 16

Secondary Outcomes (13)

• Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) With At Least 2 Points Reduction From Baseline

  Baseline to Week 16

• Percent Change From Baseline in Percent of Affected Body Surface Area (BSA) at Week 16

  Baseline and Week 16

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

  Baseline to Week 16

• Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score (PASI-50) at Week 16 From Baseline

  Baseline to Week 16

• Change From Baseline in Pruritus Visual Analog Scale (VAS) Score at Week 16

  Baseline and Week 16

Study Arms (3)

Apremilast

ACTIVE COMPARATOR

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.

Drug: Apremilast; Drug: Placebo

Placebo

PLACEBO COMPARATOR

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.

Drug: Apremilast; Drug: Placebo

Apremilast 30 mg

ACTIVE COMPARATOR

Apremilast 30 mg by mouth (PO) twice a day (BID). Participants initially randomized to apremilast 30 mg BID, and who were able to demonstrate a Psoriasis Area Severity Index (PASI) -75 response at week 32 were randomized (1 to 1) to either apremilast 30 mg BID or oral placebo (until effect is lost). At relapse/loss of response to therapy prior to Week 52 (the time at which 75% improvement in PASI score compared to baseline was lost) or at Week 52, participants were re-treated with apremilast 30 mg BID for the duration of their participation in the study. Non-responders or partial responders (PASI response \<75) received additional topical therapies or phototherapy beginning at Week 32.

Drug: Apremilast; Drug: Placebo; Drug: Topical treatments or phototherapy

Interventions

Apremilast DRUG

Also known as: CC-10004, Otezla

Apremilast; Apremilast 30 mg; Placebo

Placebo DRUG

Identical matching placebo

Apremilast; Apremilast 30 mg; Placebo

Topical treatments or phototherapy DRUG

At week 32, participants considered partial responders or non-responders had the option of adding topical therapies and/or phototherapy to their treatment regimen.

Also known as: Corticosteroid creams, Light Therapy

Apremilast 30 mg

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
• 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.

You may not qualify if:

• 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 Electrocardiogram (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

Sponsors & Collaborators

• Amgen: lead

Related Publications (2)

• 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 RESULT

• 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

MeSH Terms

Interventions

apremilast; Therapeutics; Phototherapy

Results Point of Contact

• Title: Anne McClain
• Organization: Celgene Corporation

ClinicalTrialDisclosure@Celgene.com

1-888-260-1599

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 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: August 31, 2010
• First Posted: September 2, 2010
• Study Start: September 9, 2010
• Primary Completion: February 23, 2012
• Study Completion: November 22, 2016
• Last Updated: March 15, 2022
• Results First Posted: November 5, 2014

Record last verified: 2020-04