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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02307513
Date of registration: 02/12/2014
Prospective Registration: Yes
Primary sponsor: Amgen
Public title: A Phase 3 Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Active Behçet's Disease
Scientific title: A Phase 3, Multicenter, Randomized, Doubleblind, Placebo-controlled, Parallel Group Study, Followed by an Active-treatment Phase to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Subjects With Active Behcet's Disease
Date of first enrolment: December 30, 2014
Target sample size: 207
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02307513
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 3
Countries of recruitment
France Germany Greece Israel Italy Japan Korea, Republic of Lebanon
Turkey United States
Contacts
Name:     MD
Address: 
Telephone:
Email:
Affiliation:  Amgen
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Understand and voluntarily sign an informed consent document prior to any study
related assessments/procedures being conducted.

2. Male and female subjects =18 years of age at the time of signing the informed consent
document.

3. Able to adhere to the study visit schedule and other protocol requirements.

4. Diagnosed with Behcet's disease meeting th4 International Study Group (ISG) criteria,

5. Oral ulcers that occurred at least 3 times in the previous 12-month period, including
oral ulcers at the screening visit.

6. Subjects must have at least 2 oral ulcers at Visit 1 (Screening Visit), and:

1. At least 2 oral ulcers at Visit 2 (day of randomization), when Visit 2 occurs at
least 14 days after Visit 1. OR

2. 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.

7. Have prior treatment with at least 1 non-biologic Behçet's disease therapy, such as,
but not limited to, topical corticosteroids, or systemic treatment.

8. 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.

9. 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.

Exclusion Criteria: The presence of any of the following will exclude a subject from the
study enrollment. Disease Specific Exclusions:

1. Behçet's disease-related active major organ involvement - pulmonary (eg, pulmonary
artery aneurysm), vascular (eg, thrombophlebitis), gastrointestinal (eg, ulcers along
the gastrointestinal tract), and central nervous systems (eg, meningoencephalitis)
manifestations, and ocular lesions (eg, uveitis) requiring immunosuppressive therapy;
however:

1. Previous major organ involvement is allowed if it occurred at least 1 year prior
to Visit 1 (Screening Visit) and is not active at time of enrollment.

2. Subjects with mild BD-related ocular lesions not requiring systemic
immunosuppressive therapy are allowed.

3. Subjects with BD-related arthritis and BD-skin manifestations are also allowed.

2. Previous exposure to biologic therapies for the treatment of BD oral ulcers ( Previous
biologic therapy exposure is allowed for other indications, including other
manifestations of BD)

3. Prior use of apremilast.

4. Use of any investigational medication within 4 weeks prior to Visit 2 or 5
pharmacokinetic/pharmacodynamic half-lives (whichever is longer).

5. Current use of strong cytochrome P450 enzyme inducers (eg, rifampin, phenobarbital,
carbamazepine, phenytoin)

6. Having received concomitant immune modulating therapy (except oral or topical
corticosteroids) within:

- Seven days prior to Visit 2 (Baseline Visit; day of randomization) for
colchicines

- Ten days prior to Visit 2 (Baseline Visit; day of randomization) for azathioprine
and mycophenolate mofetil

- Four weeks (28 days) prior to Visit 2 (Baseline Visit; day of randomization) for
cyclosporine, methotrexate, cyclophosphamide, thalidomide, and dapsone.

Note: Oral and topical corticosteroids must have been tapered as appropriate and
discontinued prior to the day of Visit 2 (day of randomization).

- At least 5 terminal half-lives for all biologics, including, but not limited to,
those listed below; within:

- Four weeks prior to Visit 2 (Baseline Visit; day of randomization) for etanercept

- Eight weeks prior to Visit 2 (Baseline Visit; day of randomization) for
infliximab

- Ten weeks prior to Visit 2 (Baseline Visit; day of randomization) for adalimumab,
golimumab, certolizumab, abatacept, an



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Behçet's Syndrome
Intervention(s)
Drug: Apremilast
Drug: Placebo
Primary Outcome(s)
Area Under the Curve (AUC) for the Number of Oral Ulcers (Counts) From Baseline Through Week 12 (AUC Week 0-12) [Time Frame: Baseline to Week 12]
Secondary Outcome(s)
Change From Baseline in Behçet's Disease Quality of Life (BD Qol) Scores at Week 12 [Time Frame: Baseline to Week 12]
Change From Baseline in Disease Activity as Measured by Behçet's Disease Current Activity Form (BDCAF): Behçet's Disease Current Activity Index (BDCAI) at Week 12 [Time Frame: Baseline to Week 12]
Change From Baseline in Disease Activity as Measured by Behçet's Disease Current Activity Form (BDCAF): Clinician's Overall Perception of Disease Activity at Week 12 [Time Frame: Baseline to Week 12]
Change From Baseline in Disease Activity as Measured by Behçet's Disease Current Activity Form (BDCAF): Patient's Perception of Disease Activity at Week 12 [Time Frame: Baseline to Week 12]
Change From Baseline in Disease Activity as Measured by Behçet's Syndrome Activity Score (BSAS) at Week 12 [Time Frame: Baseline to Week 12]
Change From Baseline in Genital Ulcer Pain as Measured by VAS Score at Week 12 [Time Frame: Baseline to Week 12]
Change From Baseline in Oral Ulcer Pain as Measured by Visual Analogue Scale (VAS) Score at Week 12 [Time Frame: Baseline to Week 12]
Change From Baseline in the Total Score of the Static Physician's Global Assessment (PGA) of Skin Lesions of BD at Week 12 [Time Frame: Baseline to Week 12]
Number of Oral Ulcers Following Loss of Complete Response Through Week 12 [Time Frame: Baseline to Week 12]
Number of Participants With TEAEs During the Apremilast-Exposure Period [Time Frame: From lst dose of APR (for those randomized to APR at Week 0 or for those randomized to placebo and switched to APR at Week 12) after 28 days of last APR dose; median duration of APR treatment = 52 weeks (placebo/APR arm) and 63.86 weeks for APR/APR arm]
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo- Controlled Period [Time Frame: From the date of the first dose of IP in the placebo-controlled phase to the date of the first dose of apremilast (APR) in the active treatment phase; median duration of treatment = 12 weeks]
Percentage of Participants Who Achieved an Oral Ulcer Complete Response (Oral Ulcer-Free) by Week 6 and Remained Oral Ulcer-Free for at Least 6 Additional Weeks [Time Frame: Baseline to Week 12]
Percentage of Participants Who Experienced a Complete Response For Genital Ulcers at Week 12 [Time Frame: At Week 12]
Percentage of Participants Who Experienced an Oral Ulcer Complete Response at Week 12 [Time Frame: At Week 12]
Percentage of Participants With no Oral Ulcers Following a Complete Response [Time Frame: Baseline to Week 12]
Time to Oral Ulcer Resolution (Complete Response) [Time Frame: Baseline to Week 12]
Time to Recurrence of Oral Ulcers Following Loss of CR Who Had a CR Prior to Week 12 [Time Frame: Baseline through Week 12]
Secondary ID(s)
2014-002108-25
CC-10004-BCT-002
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 11/09/2019
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT02307513
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