A Phase 3 Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Active Behçet's Disease

Completed · Phase 3 · Has a placebo group

Conditions studied: Behçet's Syndrome

In brief

The main objective of this study is to evaluate the efficacy and safety of apremilast in the treatment of oral ulcers in adults with active Behçet's disease (BD).

Key facts

Study ID

NCT02307513

Run by

Amgen

People needed

207

Starts

2014-12-30

Expected to finish

2020-07-17

Last updated by the study team

2021-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.
• Male and female subjects ≥ 18 years of age at the time of signing the informed consent document.
• Able to adhere to the study visit schedule and other protocol requirements.
• Diagnosed with Behcet's disease meeting th4 International Study Group (ISG) criteria,
• Oral ulcers that occurred at least 3 times in the previous 12-month period, including oral ulcers at the screening visit.
• Subjects must have at least 2 oral ulcers at Visit 1 (Screening Visit), and:
• At least 2 oral ulcers at Visit 2 (day of randomization), when Visit 2 occurs at least 14 days after Visit 1. OR
• At least 3 oral ulcers at Visit 2 (day of randomization), when Visit 2 occurs at any time between 1 day and 42 days after Visit 1.
• Have prior treatment with at least 1 non-biologic Behçet's disease therapy, such as, but not limited to, topical corticosteroids, or systemic treatment.
• Candidate for systemic therapy, for the treatment of oral ulcers.
• a. A candidate for systemic therapy is a subject judged by the study Investigator as someone whose mucocutaneous ulcers are considered inappropriate for topical therapy based on the severity of disease and extent of the affected area, or whose oral ulcers cannot be adequately controlled by topical therapy.
• Laboratory Measures: Must meet the following laboratory measures:
• Hemoglobin > 9 g/dL
• White blood cell (WBC) count ≥ 3000 /L(≥ 3.0 X 10\^9/L) and ≤ 14,000/L (≤ 14 X 10\^9/L )
• Platelet count ≥ 100,000 /L (≥ 100 X 10\^9/L)
• Serum creatinine ≤ 1.5 mg/dL (≤ 132.6 μmol/L)
• Total bilirubin ≤ 2.0 mg/dL
• Aspartate transaminase (AST [serum glutamic oxaloacetic transaminase, SGOT]) and alanine transaminase (ALT [serum glutamate pyruvic transaminase, SGPT]) ≥ 1.5 X ULN. Subjects who fail screening due to ≥ 1.5 X ULN AST/SGOT and/or ALT/SGPT will be allowed to repeat AST/SGOT and/or ALT/SGPT tests within the screening phase. Repeat test results should be ≤ ULN (within reference range) to be eligible.
• Laboratory tests will be allowed to be repeated 1 time if, in the Investigator's clinical judgment, there is a reasonable possibility of the repeat tests not meeting the exclusion values, and with concurrence from the Medical Monitor.
• Contraception Requirements:
• All Females of Child Bearing Potential (FCBP) must use one of the approved contraceptive options as described below while taking apremilast and for at least 28 days after administration of the last dose of the apremilast.
• At the time of study entry, and at any time during the study when a FCBP's contraceptive measures or ability to become pregnant changes, the Investigator will educate the subject regarding contraception options and the correct and consistent use of effective contraceptive methods in order to successfully prevent pregnancy.
• All FCBP must have a negative pregnancy test at Visits 1 and 2. All FCBP subjects 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 non-latex 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 (latex or non-latex condoms NOT made out of natural [animal] membrane [for example, polyurethane]) while on IP and for at least 28 days after the last dose of IP.

Where it is running

• University of California Davis Medical Center — Sacramento, California, United States
• Millennium Research — Ormond Beach, Florida, United States
• Arthritis and Rheumatology of Georgia — Atlanta, Georgia, United States
• Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States
• Advanced Rheumatology — Lansing, Michigan, United States
• Shores Rheumatology — Saint Clair Shores, Michigan, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• New York Methodist Hospital — Brooklyn, New York, United States
• NYU Langone Medical Center — New York, New York, United States
• University of Pennsylvania Health Systems — Philadelphia, Pennsylvania, United States
• Hopital de La Conception — Marseille, France
• Pitié-Salpêtriere Hospital Paris — Paris, France
• Hopital Cochin — Paris, France
• Hospital Saint Louis — Paris, France
• Charite Universitaetsmedizin Berlin — Berlin, Germany
• Stadtisches Klinikum Dessau — Dessau, Germany
• Asklepios Rheumazentrum Hamburg — Hamburg, Germany
• Navy Hospital of Athens — Athens, Greece
• Athens General Hospital 'G Gennimatas' — Athens, Greece
• Laiko General Hospital of Athens — Athens, Greece
• Ippokratio General Hospital of Thessaloniki — Thessaloniki, Greece
• Bnai Zion Medical Center — Haifa, Israel
• Rambam Health Care Campus — Haifa, Israel
• Hadassah Medical Organization — Jerusalem, Israel
• Arizona Arthritis and Rheumatology Research, PLLC — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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