A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Behçet Disease

NCT00866359 | Completed Phase 2 Results DMC

• 2 other identifiers: CC-10004-BCT-001EudraCT#: 2008-002722-11
• Study Type: interventional
• Target: 111
• Locations: 2 countries
• Sites: 7

Brief Summary

The purpose of this study is to assess whether Apremilast is safe and effective in the treatment of patients with Behcet Disease.

Conditions

Behcet Syndrome

Outcome Measures

Primary Outcomes (1)

• Number of Oral Ulcers at Day 85

  The number of oral ulcers were counted at each visit and at the end of the treatment period (starting point was at baseline).

  Day 85

Secondary Outcomes (20)

• Pain of Oral Ulcers as Measured by Visual Analog Scale (VAS) at Day 85

  Day 85

• Pain of Genital Ulcers as Measured by Visual Analog Scale (VAS) Scores at Day 85

  Baseline to Day 85

• Area Under the Curve (AUC) for the Number of Oral Ulcers From Day 1 to 85

  Day 1 to Day 85

• Area Under the Curve for the Number of Genital Ulcers From Day 1 to 85

  Day 1 to Day 85

• Area Under the Curve (AUC) for the Number of Oral Plus Genital Ulcers From Day 1 to 85

  Day 1 to Day 85

Other Outcomes (3)

• Percentage of Participants Who Were Genital Ulcer-free (Complete Response) at Day 85

  Baseline to Day 85

• Percentage of Participants Who Were Genital Ulcer-free (Complete Response) at Day 169

  Day 1 to Day 169

• Percentage of Participants Who Were Genital Ulcer-free (Complete Response)

  Day 1 to Day 197

Study Arms (2)

A. Apremilast

ACTIVE COMPARATOR

Drug: Apremilast (CC-10004)

B. Placebo Comparator

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Apremilast (CC-10004) DRUG

Treatment Phase Days 1-7: Titration from 10 mg BID apremilast tablets arm A (or matching placebo arm B) to 30 mg BID apremilast arm A(or matching placebo arm B) Day 8-84: Maintenance of 30 mg BID apremilast arm A (or matching placebo arm B) Dose reductions to 20 mg BID apremilast arm A (or matching placebo arm B) are permitted. Extension Phase All subjects will be given active drug Days 85-91: All placebo subjects from Treatment phase will be dose titrated from 10 mg BID apremilast tablets arm A to 30 mg BID Apremilast. Day 92-169: Maintenance of 30 mg BID apremilast arm A or dose reductions to 20 mg BID apremilast arm A (if not previously down titrated)

A. Apremilast

Placebo DRUG

Treatment Phase Days 1-7: Titration from 10mg BID matching placebo (arm B) to 30mg BID placebo (arm B) Day 8-84: Maintenance of 30mg BID placebo (arm B). Dose reductions to 20 mg BID matching placebo (arm B) are permitted. Extension Phase All subjects will be given active drug Days 85-91: All placebo subjects from Treatment phase will be dose titrated from 10 mg BID apremilast tablets arm A to 30 mg BID Apremilast. Day 92-169: Maintenance of 30 mg BID apremilast or dose reductions to 20 mg BID apremilast (if not previously down titrated)

B. Placebo Comparator

Eligibility Criteria

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

You may qualify if:

• Diagnosis of Behçet Disease. At the time of diagnosis, subjects must meet the international study group criteria for Behçet Disease
• Females of childbearing potential (FCBP) must have negative pregnancy tests and agree to use two forms of contraception throughout the study.
• Males must use barrier contraception (latex condoms) when engaging in reproductive sexual activity with FCBP
• Laboratory criteria: Hgb ≥ 9 g/dL, WBC count ≥ 3000 /microL and ≤14,000/microL, platelet count ≥ 100,000 /microL,, serum creatinine ≤ 1.5 mg/dL (≤ 132.6 μmol/L), total bilirubin ≤ 2.0 mg/dL, AST and ALT ≤ 1.5 X ULN
• Two or more oral ulcers over the 28 day period before screening, with or without current treatment
• Two or more oral ulcers at the time of randomization (Visit 2, Baseline)

You may not qualify if:

• Pregnant or breast feeding
• Any condition which places the subject at risk
• Systemic fungal infection
• History of TB infection within 3 years
• History of recurrent bacterial infection
• Mycobacterium TB as indicated by a positive PPD skin test
• History of incompletely treated Mycobacterium tuberculosis
• Clinically significant chest x-ray abnormality at screening.
• Clinically significant ECG abnormality at screening
• History of HIV infection
• History of congenital or acquired immunodeficiency
• Hepatitis B surface antigen positive or Hepatitis B core antibody positive at screening
• Antibodies to Hepatitis C at screening
• History of malignancy (except for treated basal-cell skin carcinomas \> 3 years prior to screening)
• Any active major organ involvement of Behçet Disease

Sponsors & Collaborators

• Amgen: lead

Study Sites (7)

Mayo Clinic - Rheumatology and Internal Medicine

Jacksonville, Florida, 32224, United States

Location

E5, Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Location

NYU Hospital for Joint Diseases

New York, New York, 10003, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Eskişehir Osmangazi University

Eskişehir, 26480, Turkey (Türkiye)

Location

University of Istanbul

Istanbul, 34098, Turkey (Türkiye)

Location

Selçuk University

Konya, 42080, Turkey (Türkiye)

Location

Related Publications (2)

• 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

• Hatemi G, Melikoglu M, Tunc R, Korkmaz C, Turgut Ozturk B, Mat C, Merkel PA, Calamia KT, Liu Z, Pineda L, Stevens RM, Yazici H, Yazici Y. Apremilast for Behcet's syndrome--a phase 2, placebo-controlled study. N Engl J Med. 2015 Apr 16;372(16):1510-8. doi: 10.1056/NEJMoa1408684.

  PMID: 25875256 DERIVED

MeSH Terms

Conditions

Behcet Syndrome

Interventions

apremilast

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular

Limitations and Caveats

Planned sample size not reached; slow enrollment

Results Point of Contact

• Title: Anne McClain
• Organization: Celgene Corporation

ClinicalTrialDisclosure@Celgene.com

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 2
• 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: March 18, 2009
• First Posted: March 20, 2009
• Study Start: August 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: June 19, 2020
• Results First Posted: August 27, 2014

Record last verified: 2020-06

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 (4); TU (3)