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Sponsor ID
CC-10004-PPSO-003

Efficacy and safety study of Apremilast (CC-10004) in pediatric subjects from 6 through 17 Years of age with moderate to severe plaque psoriasis

Sponsor ID
CC-10004-PPSO-003
Clinicaltrials.gov ID
NCT03701763
EUCTIS ID
N/A
EudraCT ID
2018-002918-12
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Study Details

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.

Additional Study Details

Phase
Phase 3
Product
N/A
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
245
Additional Study Details

Protocol Summary

Primary Outcome Measures

Proportion of subjects with an sPGA score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline

Timeframe: Up to week 16

Secondary Outcome Measures

Proportion of subjects who achieve at least a 75% reduction in PASI (PASI-75) from baseline

Timeframe: Up to week 16

Proportion of subjects who achieve at least a 50% reduction in PASI (PASI-50) from baseline

Timeframe: Up to week 16

Percent change from baseline in total PASI score

Timeframe: Up to week 16

Percent change from baseline in affected Body Surface Area (BSA)

Timeframe: Up to week 16

Proportion of subjects who achieve CDLQI (0/1)

Timeframe: Up to week 16

Change from baseline in CDLQI score

Timeframe: Up to week 16

Adverse Events (AEs)

Timeframe: From enrollment until at least 28 days after completion of study treatment

Stool Diary

Timeframe: From Baseline up to week 56

Columbia-Suicide Severity Rating Scale (C-SSRS)

Timeframe: From Baseline up to Week 52

Tanner Stages

Timeframe: At Baseline and week 52

Psoriasis disease flare

Timeframe: From Baseline up to week 52

Psoriasis Rebound

Timeframe: 4 week follow-up, 8 week follow-up, and 14 week follow-up visits

Height Measurement

Timeframe: Up to week 66

Weight Measurement

Timeframe: Up to week 66

Study Documents

Plain Language Summary of Results
Available Language(s): English, Spanish (United States), Spanish, Russian, Polish, Dutch, Hebrew, Italian, Arabic (Israel), Hungarian, French, Dutch (Belgium), French (Canadian), French (Belgium)
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Locations

Location
Status
Contact Us
Location
Hospital Universitari Germans Trias i Pujol Can Ruti
Badalona, Spain, 08916
Status
Recruiting
Location
Hospital Sant Joan de Deu
Barcelona, Spain, 08950
Status
Recruiting
Location
Altai State Medical University
Barnaul, Russian Federation, 656038
Status
Recruiting
Location
Azienda Ospedaliero Universitaria Di Bologna Policlinico S Orsola Malpighi
Bologna, Italy, 40138
Status
Recruiting
Location
Centre Hospitalier Universitaire Lyon
Bron cedex, France, 69677
Status
Recruiting
Location
Medical University of South Carolina
Charleston, SC, United States, 29425
Status
Recruiting
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Study Info
Age
6 - 17 Years
Condition
  • Psoriasis
    • Sex
    All
    Trial Dates
    Dec 2018 - Apr 2022
    Inclusion and Exclusion Criteria
    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).