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

NCT03701763 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: CC-10004-PPSO-003U1111-1219-31122018-002918-12
• Study Type: interventional
• Target: 245
• Locations: 10 countries
• Sites: 99

Brief Summary

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.

Conditions

Psoriasis

Keywords

Pediatric; 6 through 17 years; Plaque Psoriasis; Psoriasis; CC-10004; Apremilast; Otezla; Children; Adolescents; SPROUT

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16

  The sPGA is the assessment by the Investigator of the overall disease severity of plaque psoriasis at the time of evaluation. The sPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation. The results presented are for the percentage of participants with a sPGA response. An sPGA response was defined as a score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline at Week 16.

  Baseline to Week 16

Secondary Outcomes (29)

• Percentage of Participants Who Achieved At Least 75% Reduction in Psoriasis Area Severity Index (PASI-75) From Baseline at Week 16

  Baseline and Week 16

• Percentage of Participants Who Achieved At Least 50% Reduction in Psoriasis Area Severity Index (PASI-50) From Baseline at Week 16

  Baseline and Week 16

• Percentage Change From Baseline in Total PASI Score at Week 16

  Baseline and Week 16

• Percentage Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16

  Baseline and Week 16

• Percentage of Participants Who Achieved a Children's Dermatology Life Quality Index (CDLQI) Score of 0 or 1 at Week 16

  Week 16

Study Arms (3)

Administration of Apremilast (CC-10004) - 20mg

EXPERIMENTAL

Apremilast 20mg Twice Daily (BID)

Drug: Apremilast (CC-10004)

Administration of Apremilast (CC-10004) - 30mg

EXPERIMENTAL

Apremilast 30mg Twice Daily (BID)

Drug: Apremilast (CC-10004)

Administration of Placebo

PLACEBO COMPARATOR

Placebo tablet Twice Daily (BID)

Other: Placebo

Interventions

Apremilast (CC-10004) DRUG

Apremilast (CC-10004)

Administration of Apremilast (CC-10004) - 20mg; Administration of Apremilast (CC-10004) - 30mg

Placebo OTHER

Placebo

Administration of Placebo

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Males or female subjects 6 to 17 years of age, inclusive, at the time the informed consent form is signed by the legal guardian
• Subjects must have a weight of ≥ 20 kg
• Diagnosis of chronic plaque psoriasis for at least 6 months prior to Screening.
• 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)
• Disease inadequately controlled by or inappropriate for topical therapy for psoriasis
• Candidate for systemic therapy or phototherapy

You may not qualify if:

• Guttate, erythrodermic, or pustular psoriasis at Screening and Baseline
• Psoriasis flare or rebound within 4 weeks prior to Screening
• 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
• Answer "Yes" to any question on the Columbia-Suicide Severity Rating Scale during Screening or at Baseline
• 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).

Sponsors & Collaborators

• Amgen: lead

Study Sites (99)

University of Alabama Birmingham

Birmingham, Alabama, 35233, United States

Location

Phoenix Childrens Hospital

Phoenix, Arizona, 85016, United States

Location

Johnson Dermatology Clinic

Fort Smith, Arkansas, 72916, United States

Location

Zenith Research Inc.

Beverly Hills, California, 90212, United States

Location

First OC Dermatology

Fountain Valley, California, 92708, United States

Location

Avance Clinical Trials

Laguna Niguel, California, 92677, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

Coastal Family Dermatology

San Luis Obispo, California, 93401, United States

Location

University of California Los Angeles

Santa Monica, California, 90404, United States

Location

California Dermatology Institute

Thousand Oaks, California, 91320, United States

Location

Solutions Through Advanced Research Inc

Jacksonville, Florida, 32256, United States

Location

Glick Skin Institute Clinical Research

Margate, Florida, 33063, United States

Location

University of Miami Hospital

Miami, Florida, 33136, United States

Location

Ciocca Dermatology

Miami, Florida, 33173, United States

Location

University of South Florida Health Morsani Center for Advanced Healthcare

Tampa, Florida, 33612-4742, United States

Location

Skin Care Physicians of Georgia

Macon, Georgia, 31217, United States

Location

Treasure Valley Medical Research

Meridian, Idaho, 83646, United States

Location

DeNova Research

Chicago, Illinois, 60602, United States

Location

Dawes Fretzin Dermatology Group Inc

Indianapolis, Indiana, 46256, United States

Location

Epiphany Dermatology of Kansas, LLC

Overland Park, Kansas, 66210, United States

Location

ActivMed Practices and Research Inc

Beverly, Massachusetts, 01915, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

J Woodson Dermatology and Associates Ltd

Henderson, Nevada, 89052, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

Forest Hills Dermatology Group

Forest Hills, New York, 11375, United States

Location

SUNY Downstate Medical Center

Manhasset, New York, 11030, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Wright State Physicians

Fairborn, Ohio, 45324, United States

Location

Essential Medical Research, LLC

Tulsa, Oklahoma, 74137, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Arlington Research Center

Arlington, Texas, 76011, United States

Location

Driscoll Childrens Hospital

Corpus Christi, Texas, 78411, United States

Location

Modern Research Associates PLLC

Dallas, Texas, 75231, United States

Location

Mosaic Dermatology

Houston, Texas, 77065, United States

Location

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

Location

Jordan Valley Dermatology Center

West Jordan, Utah, 84088, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53715, United States

Location

Childrens Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Centre Hospitalier Universitaire Saint Pierre

Brussels, 1000, Belgium

Location

Cliniques Universitaires St Luc

Brussels, 1200, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Kirk Barber Research

Calgary, Alberta, T2G 1B1, Canada

Location

Stollery Children's Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Enverus Medical Research

Surrey, British Columbia, V3R 6A7, Canada

Location

Winnipeg Clinic Dermatology Research

Winnipeg, Manitoba, R3C 0N2, Canada

Location

Karma Clinical Trials

St. John's, Newfoundland and Labrador, A1A 4Y3, Canada

Location

AvantDerm

Toronto, Ontario, M5A 3R6, Canada

Location

CHU Saint-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Fakultni nemocnice Hradec Kralove

Hradec Králové, 500 05, Czechia

Location

Fakultni nemocnice Kralovske Vinohrady

Prague, 110 00, Czechia

Location

Synexus Czech sro

Prague, 120 00, Czechia

Location

Centre Hospitalier Victor Dupouy Argenteuil

Argenteuil, 95107, France

Location

Centre Hospitalier Universitaire Lyon

Bron, 69677, France

Location

Cabinet du Docteur Ruer-Mulard Mireille

Martigues, 13500, France

Location

Hotel Dieu CHU Nantes

Nantes, 44093, France

Location

Centre Hospitalier Universitaire de Nice

Nice, 06202, France

Location

Hopital Necker

Paris, 75015, France

Location

Centre Hospitalier de Cornouaille - Hopital Laennec

Quimper, 29018, France

Location

CHU Saint Etienne Hopital Nord

Saint-Priest En Jarrez, 42055, France

Location

Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

Toulouse, 31059, France

Location

Centre Hospitalier de Valence

Valence, 26000, France

Location

Chaim Sheba Medical Center

Ramat Gan, 5262000, Israel

Location

Azienda Ospedaliero Universitaria Di Bologna Policlinico S Orsola Malpighi

Bologna, 40138, Italy

Location

Azienda Ospedaliera Universitaria di Cagliari

Cagliari, 09124, Italy

Location

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Azienda Ospedaliera Universitaria Federico II

Napoli, 80131, Italy

Location

Azienda Ospedaliera di Padova

Padua, 35128, Italy

Location

Azienda Ospedaliera di Reggio Emilia Arcispedale Santa Maria Nuova

Reggio Emilia, 42123, Italy

Location

Policlinico Tor Vergata

Roma, 00133, Italy

Location

Istituto Dermatologico San Gallicano IRCCS Dermatologia Clinica

Roma, 00144, Italy

Location

Radboud university medical center

Nijmegen, Netherlands

Location

Altai State Medical University

Barnaul, 656038, Russia

Location

Chelyabinsk Regional Clinical Skin and Venereal Dispensary

Chelyabinsk, 454092, Russia

Location

Republican Clinical Dermatology and Venerology Dispensary

Kazan', 420004, Russia

Location

Clinical Dispensary of Dermatology and Venereology of Krasnodar Territory of the Ministry of Health

Krasnodar, 350020, Russia

Location

State Scientific Center for Dermatovenereology and Cosmetology

Moscow, 107076, Russia

Location

Russian Children's Clinical Hospital

Moscow, 117997, Russia

Location

Moscow Scientific Practical Center of Dermatology Venerology and Cosmetology

Moscow, 119071, Russia

Location

National Medical Research Center for Children's Health

Moscow, 119991, Russia

Location

LLC Medical Center Zdorovaya Semiya

Novosibirsk, 630099, Russia

Location

Pierre Wolkenshtein Skin Diseases Clinic LLC

Saint Petersburg, 191123, Russia

Location

LLC PiterKlinika

Saint Petersburg, 196158, Russia

Location

Saint Petersburg State Pediatric Medical University

Saint Petesburg, 194100, Russia

Location

Bashkiria State Medical University

Ufa, 450008, Russia

Location

Yarosavl State Medical Academy

Yaroslavl, 150000, Russia

Location

Ural Scientific Research Institute of Dermatovenereology and Immunopathology

Yekaterinburg, 620076, Russia

Location

Hospital Marques de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital General Universitario de Alicante

Alicante, Valencia, 03010, Spain

Location

Hospital Universitari Germans Trias i Pujol Can Ruti

Badalona, 08916, Spain

Location

Hospital Sant Joan de Deu

Barcelona, 08950, Spain

Location

Hospital Puerta del Mar

Cadiz, 11009, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, 14001, Spain

Location

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

Location

Hospital Infantil Universitario Nino Jesus

Madrid, 28009, Spain

Location

Hospital 12 de Octubre

Madrid, 28041, Spain

Location

Hospital La Paz

Madrid, 28046, Spain

Location

Complexo Hospitalario De Pontevedra

Pontevedra, 36001, Spain

Location

Hospital Universitario Virgen del Rocio - PPDS

Seville, 41013, Spain

Location

Related Publications (1)

• Fiorillo L, Becker E, de Lucas R, Belloni-Fortina A, Armesto S, Elewski B, Maes P, Oberoi RK, Paris M, Zhang W, Zhang Z, Arkin L. Efficacy and safety of apremilast in pediatric patients with moderate-to-severe plaque psoriasis: 16-week results from SPROUT, a randomized controlled trial. J Am Acad Dermatol. 2024 Jun;90(6):1232-1239. doi: 10.1016/j.jaad.2023.11.068. Epub 2024 Jan 23.

  PMID: 38266683 BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Psoriasis

Interventions

apremilast

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

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 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: October 10, 2018
• Study Start: December 19, 2018
• Primary Completion: April 25, 2022
• Study Completion: March 27, 2023
• Last Updated: December 16, 2024
• Results First Posted: December 7, 2023

Record last verified: 2024-12

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

CZ (3); ES (12); BE (3); NL (1); IL (1); FR (10); IT (8); US (39); RU (15); CA (7)