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

NCT ID: NCT01232283

Last Updated: 2022-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 413 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-22
• Study Completion Date: 2016-11-30

Brief Summary

This study will evaluate the effects of an experimental (being tested) study drug 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 is 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 will test efficacy (improvement of signs and symptoms) and safety of apremilast in patients with moderate to severe psoriasis.

Conditions

Plaque Psoriasis

Study Design

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

Study Groups

Apremilast

Participants were initially randomized 2:1 and received apremilast 30 mg twice a day (BID). Participants maintained dosing through Week 32. At Week 32, responders, those with a Psoriasis Area Severity Index response -≥75 (PASI-75) and partial responders (≥PASI-50) were re-randomized 1:1 to apremilast 30 mg BID or matching placebo (treatment withdrawal). Participants could resume apremilast 30 mg BID at the time of loss of 50% of improvement in PASI score response which was observed at Week 32 compared to baseline), and no later than Week 52. At Week 52, the non-responders (\<PASI-50) had the option of adding topical therapies and/or phototherapy to their treatment regimen. Those re-randomized to apremilast 30 mg BID continued dosing through Week 52. At Week 52, participants continued treatment with apremilast 30 mg BID.

Group Type: EXPERIMENTAL

Apremilast

Intervention Type: DRUG

Apremilast 30mg by mouth (PO) twice a day (BID) for 32 weeks

Placebo

Intervention Type: DRUG

Identically matching placebo by mouth BID for first 16 weeks. Placebo participants will be switched to receive apremilast 30 mg BID at Week 16-32.

Topical or Phototherapy Therapy

Intervention Type: OTHER

Topical therapies such as low-potency or weak corticosteroids or phototherapies such as light therapy are added for non-responders at Week 32, (\< PASI-50) and added to their treatment regimen. The decision to add these treatments during this phase can only be made at the Week 32 visit.

Placebo

Participants will be initially randomized to placebo, identically matching during Weeks 0-16. At Week 16, Placebo participants will be switched to receive apremilast 30 mg BID. All participants will maintain Apremilast dosing through Week 32. At Week 32, participants originally randomized to placebo at baseline (Week 0) and are considered non-responders i( \< PASI-50) will have the option of adding topical therapies and/or phototherapy to their Apremilast treatment regimen. At Week 52, all participants will continue treatment with apremilast 30 mg BID. Participants will be followed and evaluated for safety and efficacy for up to an additional 4 years (years 2 through 5).

Group Type: PLACEBO_COMPARATOR

Apremilast

Intervention Type: DRUG

Apremilast 30mg by mouth (PO) twice a day (BID) for 32 weeks

Placebo

Intervention Type: DRUG

Identically matching placebo by mouth BID for first 16 weeks. Placebo participants will be switched to receive apremilast 30 mg BID at Week 16-32.

Topical or Phototherapy Therapy

Intervention Type: OTHER

Topical therapies such as low-potency or weak corticosteroids or phototherapies such as light therapy are added for non-responders at Week 32, (\< PASI-50) and added to their treatment regimen. The decision to add these treatments during this phase can only be made at the Week 32 visit.

Interventions

Apremilast

Apremilast 30mg by mouth (PO) twice a day (BID) for 32 weeks

Intervention Type: DRUG

Placebo

Identically matching placebo by mouth BID for first 16 weeks. Placebo participants will be switched to receive apremilast 30 mg BID at Week 16-32.

Intervention Type: DRUG

Topical or Phototherapy Therapy

Topical therapies such as low-potency or weak corticosteroids or phototherapies such as light therapy are added for non-responders at Week 32, (\< PASI-50) and added to their treatment regimen. The decision to add these treatments during this phase can only be made at the Week 32 visit.

Intervention Type: OTHER

Other Intervention Names

CC-10004; Otezla

Eligibility Criteria

Inclusion Criteria

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

2. Diagnosis of chronic plaque psoriasis for at least 12 months prior to Screening

a. Have moderate to severe plaque psoriasis at Screening and Baseline

3. Must meet all laboratory criteria

4. 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

5. 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.

Exclusion Criteria

1. Other than psoriasis, history of any clinically significant (as determined by the Investigator) or other major uncontrolled disease.

2. Pregnant or breast feeding

3. History of allergy to any component of the study drug

4. Hepatitis B surface antigen positive at Screening

5. Anti-hepatitis C antibody positive at Screening

6. Active tuberculosis (TB) or a history of incompletely treated TB

7. Clinically significant abnormality on 12-Lead ECG at Screening

8. Clinically significant abnormal chest x-ray

9. History of positive human immunodeficiency virus (HIV), or have congenital or acquired immunodeficiency

10. Active substance abuse or a history of substance abuse within 6 months prior to Screening

11. Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening

12. 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)

13. Psoriasis flare or rebound within 4 weeks prior to Screening

14. Evidence of skin conditions that would interfere with clinical assessments

15. Topical therapy within 2 weeks of randomization

16. Systemic therapy for psoriasis within 4 weeks prior to randomization

17. Use of phototherapy within 4 weeks prior to randomization (ie, UVB, PUVA)

18. Adalimumab, etanercept, infliximab, or certolizumab pegol within 12 weeks prior to randomization

19. Alefacept, briakinumab, or ustekinumab within 24 weeks prior to randomization

20. Use of any investigational drug within 4 weeks prior to randomization

21. Prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources

22. 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

Arizona Skin and Laser Therapy Inst., Ltd.

Phoenix, Arizona, United States

Burke Pharmaceutical Research

Hot Springs, Arkansas, United States

Bakersfield Dermatology and Skin Cancer Medical Group

Bakersfield, California, United States

Dermatology Research Associates

Los Angeles, California, United States

Clinical Science Institute

Santa Monica, California, United States

Florida Academic Dermatology Center

Miami, Florida, United States

Advanced Medical Research

Atlanta, Georgia, United States

MedaPhase Inc.

Newnan, Georgia, United States

Northwestern University Northwestern Medical Faculty Foundation

Chicago, Illinois, United States

Tufts Medical Center

Boston, Massachusetts, United States

PMG Research of Winston-Salem

Winston-Salem, North Carolina, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Clinical Partners, LLC

Johnston, Rhode Island, United States

Radiant Research, Inc.

Anderson, South Carolina, United States

Austin Dermatology Associates

Austin, Texas, United States

Modern Research Associates PLLC

Dallas, Texas, United States

Center for Clinical Studies

Houston, Texas, United States

Center for Clinical Studies

Webster, Texas, United States

Virginia Medical Research

Norfolk, Virginia, United States

Medizinische Universitat Wien, Universitatsklinik fur Dermatologie. Abteilung fur Immundermatologie

Vienna, , Austria

Northwest Dermatology and Laser Centre

Calgary, Alberta, Canada

Stratica Medical

Edmonton, Alberta, Canada

NewLab Clinical Research

St. John's, Newfoundland and Labrador, Canada

Skin Center for Dermatology

Peterborough, Ontario, Canada

Windsor Clinical Research Inc.

Winsor, Ontario, Canada

Q & T Research Sherbrooke Inc.

Sherbrooke, Quebec, Canada

Centre de Recherche Dermatologique du Quebec Metropolitain CRDQ

Québec, , Canada

Bispebjerg Hospital

Copenhagen, , Denmark

Centre d'lnvestigation Clinique, Hopital Jean Minjoz

Besançon, , France

Hospital haut leveque

Pessac, , France

Larrey University Hospital

Toulouse, , France

Dr. med. Beatrice Gerlach

Dresden, , Germany

Universitatsklinikum Hamburg-Eppendorf / IVDP

Hamburg, , Germany

Universitäts-Hautklinik Kiel

Kiel, , Germany

Universitatsklinikum Leipzig

Leipzig, , Germany

Hautarztpraxis Mahlow

Mahlow, , Germany

Universita degli Studi di Napoli Federico II

Napoli, , Italy

Istituto Dermatologico San Gallicano IRCCS Dermatologia Clinica

Rome, , Italy

A.O.U. Integrata di Verona Universitá degli Studi di Verona Sezione di Dermatologia e Venerologia

Verona, , Italy

Hospital Abente y Lago

A Coruña, , Spain

Hospital Universitario Fundacion Alcorcon

Alcorcón, , Spain

Hospital Universitari Germans Trias i Pujol

Badalona (Barcelona), , Spain

Hospital Universitario La Princesa

Madrid, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hopitaux Universitaires de Geneve-HUG

Geneva, , Switzerland

University of Zurich Hospital

Zurich, , Switzerland

Countries

United States; Austria; Canada; Denmark; France; Germany; Italy; Spain; Switzerland

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)

Other Identifiers

CC-10004-PSOR-009

Identifier Type: -

Identifier Source: org_study_id