Efficacy and Safety Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis



Status:Recruiting
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:6 - 17
Updated:3/27/2019
Start Date:December 3, 2018
End Date:September 14, 2021
Contact:Associate Director Clinical Trial Disclosure
Email:clinicaltrialdisclosure@celgene.com
Phone:1-888-260-1599

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A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN PEDIATRIC SUBJECTS FROM 6 THROUGH 17 YEARS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the
efficacy and safety of apremilast (CC-10004) in pediatric subjects with moderate to severe
plaque psoriasis.

At least 230 pediatric subjects (ages 6 through 17 years) will be randomized 2:1 to receive
either apremilast or placebo for the first 16 weeks and then all subjects will receive
apremilast during the 36 week Extension Phase for a total of 52 weeks. Randomization to
apremilast arm or placebo arm will be stratified by age group (6 to 11 years or 12 to 17
years). Subjects will receive apremilast treatment of either 20 mg twice daily (BID) or 30 mg
BID, depending on weight. This Phase 3 study is being conducted to evaluate the safety and
efficacy of apremilast in the treatment of pediatric subjects.

Treatment will be assigned by weight with subjects 20 kg to < 50 kg receiving apremilast 20
mg BID or placebo BID and subjects ≥ 50 kg receiving apremilast 30 mg BID or placebo BID.
Total study duration is up to 71 weeks. Subjects completing all 52 weeks of the treatment and
extension phase will be able to enter the Long-term study. Subjects not entering the
Long-term study will return for 3 observational follow-up visits, 4, 8 and 14 weeks after
last dose of study drug.

Inclusion Criteria:

1. Males or female subjects 6 to 17 years of age, inclusive, at the time the informed
consent form is signed by the legal guardian

2. Subjects must have a weight of ≥ 20 kg

3. Diagnosis of chronic plaque psoriasis for at least 6 months prior to Screening.

4. Has moderate to severe plaque psoriasis at Screening and Baseline as defined by:

- PASI score ≥ 12; and

- Body surface area (BSA) ≥ 10%; and

- sPGA ≥ 3 (moderate to severe)

5. Disease inadequately controlled by or inappropriate for topical therapy for psoriasis

6. Candidate for systemic therapy or phototherapy

Exclusion Criteria:

1. Guttate, erythrodermic, or pustular psoriasis at Screening and Baseline

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

3. Prior history of suicide attempt at any time in the subject's lifetime prior to
Screening or randomization in the study, or major psychiatric illness requiring
hospitalization within 3 years prior to signing the assent and informed consent

4. Answer "Yes" to any question on the Columbia-Suicide Severity Rating Scale during
Screening or at Baseline

5. Current or planned concurrent use of the following therapies that may have a possible
effect on psoriasis

a. Topical therapy within 2 weeks prior to randomization (including but not limited to
topical corticosteroids, topical retinoid or vitamin D analog preparations,
tacrolimus, pimecrolimus, or anthralin/dithranol)

Exceptions*:

i. Low potency or weak corticosteroids (please refer to the Investigators' Manual)
will be allowed as background therapy for treatment of the face, axillae and groin in
accordance with manufacturer's suggested usage ii. Unmedicated skin moisturizer (eg,
Eucerin®) will also be permitted for body lesions

*Subjects should not use these topical treatments within 24 hours prior to the clinic
visit.

b. Conventional systemic therapy for psoriasis within 4 weeks prior to randomization
c. Phototherapy treatment (ie, ultraviolet B [UVB], PUVA) within 4 weeks prior to
randomization d. Biologic therapy within 4 weeks prior to randomization or 5 PK/PD
half-lives (whichever is longer).
We found this trial at
33
sites
9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
(414) 266-2000
Children's Hospital of Wisconsin Nothing matters more than our children. At Children's Hospital of Wisconsin,...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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450 Clarkson Avenue
Brooklyn, New York 11203
(718) 270-1000
SUNY Downstate Medical Center Formally known as The State University of New York Health Science...
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3533 South Alameda Street
Corpus Christi, Texas 78411
(361) 694-5000
Driscoll Children's Hospital Driscoll Children's Hospital was built because Clara Driscoll's will requested that a...
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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Beverly, Massachusetts 01915
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Beverly Hills, California 90211
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Dallas, Texas 75231
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725 University Boulevard
Fairborn, Ohio 45324
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Forest Hills, New York 11375
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5921 Riley Park Drive
Fort Smith, Arkansas 72916
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17271 Brookhurst Street
Fountain Valley, California 92708
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Henderson, Nevada 89074
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6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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Indianapolis, Indiana 46256
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Macon, Georgia 31217
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600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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Miami, Florida 33173
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1400 NW 12th Ave
Miami, Florida 33136
(305) 689-5511
University of Miami Hospital The University of Miami changed the face of modern health care...
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Palo Alto, California 94304
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1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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Rochester, Minnesota 55905
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San Antonio, Texas 78218
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San Luis Obispo, California 93401
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1821 Wilshire Boulevard
Santa Monica, California 90403
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757 Westwood Plaza
Santa Monica, California 90095
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Thousand Oaks, California 91320
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West Jordan, Utah 84088
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