A Long-term Extension Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis

Psoriasis Clinical Trial

Official title:

A Phase 3b, Multi Center, Open-label, Long-term Extension Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04175613
• Other study ID #: CC-10004-PPSO-004
• Secondary ID: U1111-1242-35372
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 20, 2019
• Est. completion date: February 22, 2027

Study information

• Verified date: May 2024
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was created to provide subjects who complete Week 52 (end of Apremilast Extension Phase) of study CC-10004-PPSO-003 the option to continue to receive open-label apremilast therapy. The study will consist of up to 208 weeks of long-term treatment followed by an 8-week observational follow-up phase.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: February 22, 2027
• Est. primary completion date: February 22, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

Inclusion Criteria:

Subject must satisfy the following criteria to be enrolled in the study:

1. Subject is male or female 6 to 17 years of age, inclusive, at the time the informed consent document is signed by the legal guardian.

2. Subject must have a weight of = 20 kg.

3. Subjects must have an age and sex specific BMI value no lower in range than the 5th percentile on the Centers for Disease Control (CDC) growth chart for children and adolescents.

4. Subject must have completed Week 52 (Apremilast Extension Phase) of Study CC-10004-PPSO-003.

5. Subject is able to sign an assent with a legal guardian/s who understand/s and voluntarily sign/s an informed consent prior to any study-related assessments/procedures being conducted.

6. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.

7. All female subjects of childbearing potential (FCBP) must either practice abstinence from heterosexual contact or use one of the approved contraceptive options as described below while on apremilast and for at least 28 days after administration of the last dose of apremilast. For the purpose of this study, a female subject is considered of childbearing potential if she is = 12 years old or has reached menarche, whichever occurred first. At the time of study entry, and at any time during the study when a female subject of childbearing potential's contraceptive measures or ability to become pregnant changes, the Investigator will educate the subject regarding abstinence or contraception options and the correct and consistent use of effective contraceptive methods in order to successfully prevent pregnancy. Females of childbearing potential must have a negative pregnancy test at each visit. All FCBP 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 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 or nonlatex 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. NOTE: Option 2 may not be acceptable as a contraception option in all countries per local guidelines/regulations. Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

1. Subject has a condition, including the presence of laboratory abnormalities, or psychiatric illness, that would place the subject at unacceptable risk if he/she were to participate in the study.

2. Subject has a condition that confounds the ability to interpret data from the study.

3. Subject has evidence of skin conditions, other than psoriasis, that would interfere with clinical assessments.

4. Subject is pregnant or breastfeeding.

5. Subject has guttate, erythrodermic, or pustular psoriasis.

6. Subject has active tuberculosis (TB) or a history of incompletely treated TB.

7. Subject answers "Yes" to any question on the Columbia-Suicide Severity Rating Scale at Visit 16 of study CC-10004-PPSO-003.

8. Subject plans concurrent use of the following therapies that may have a possible effect on psoriasis.

1. Conventional systemic therapy for psoriasis (including but not limited to cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate, thioguanine, hydroxyurea, sirolimus, sulfasalazine, azathioprine, and fumaric acid esters)

2. Biologic therapy:

i. Etanercept (or biosimilar) treatment ii. Adalimumab (or biosimilar) treatment iii. Other TNF or interleukin (IL)-17 blockers (such as infliximab, certolizumab pegol, secukinumab, ixekizumab, brodalumab, or their biosimilars) iv. Anti-IL-12 or anti-IL-23 treatment (such as ustekinumab, guselkumab, or tildrakizumab) c) Use of any investigational drug other than apremilast

9. Subject has prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources.

10. Children in Care: a child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Apremilast
Apremilast dose will be increased from 20 mg BID to 30 mg BID for those subjects that reach a weight of 50 kg or more during the study

Locations

Country	Name	City	State
Belgium	Centre Hospitalier Universitaire Saint Pierre	Brussels
Belgium	Cliniques Universitaires Saint Luc	Brussels
Belgium	Universitair Ziekenhuis Gent	Gent
Canada	Stollery Childrens Hospital	Edmonton	Alberta
Canada	Karma Clinical Trials	St. John's	Newfoundland and Labrador
Canada	AvantDerm	Toronto	Ontario
Canada	Winnipeg Clinic Dermatology Research	Winnipeg	Manitoba
Czechia	Synexus Czech sro	Praha
Czechia	Fakultni nemocnice Kralovske Vinohrady	Praha 10
France	Cabinet du Docteur Ruer-Mulard Mireille	Martigues
France	Centre Hospitalier Universitaire de Toulouse - Hopital Larrey	Toulouse
Israel	Soroka University Medical Center	Bear Sheva
Italy	Azienda Ospedaliero Universitaria Di Cagliari	Cagliari
Italy	Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milano
Italy	Azienda Ospedaliera di Padova	Padova
Russian Federation	Altai State Medical University	Barnaul
Russian Federation	Chelyabinsk Regional Clinical Skin and Venereal Dispensary	Chelyabinsk
Russian Federation	Ural Scientific Research Institute of Dermatovenereology and Immunopathology	Ekaterinburg
Russian Federation	Republican Clinical Dermatology and Venerology Dispensary	Kazan
Russian Federation	Clinical Dispensary of Dermatology and Venereology of Krasnodar Territory of the Ministry of Health	Krasnodar
Russian Federation	Moscow Scientific Practical Center of Dermatology Venerology and Cosmetology	Moscow
Russian Federation	National Medical Research Center for Children Health	Moscow
Russian Federation	State Scientific Center for Dermatovenereology and Cosmetology	Moscow
Russian Federation	LLC Medical Center Zdorovaya Semiya	Novosibirsk
Russian Federation	LLC PiterKlinika	Saint Petersburg
Russian Federation	Pierre Wolkenshtein Skin Diseases Clinic LLC	Saint Petersburg
Russian Federation	Saint Petersburg State Pediatric Medical University	Saint Petersburg
Russian Federation	Bashkiria State Medical University	Ufa
Russian Federation	Yarosavl State Medical Academy	Yaroslavl
Spain	General University Hospital of Alicante	Alicante
Spain	Hopsital Germans Trias I Pujol	Badalona
Spain	Hospital Sant Joan de Deu	Esplugues de Llobregat	Cataluña
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital General Universitario Gregorio Maranon	Madrid
Spain	Hospital Infantil Universitario Nino Jesus	Madrid
Spain	Hospital La Paz	Madrid
Spain	Hospital Marques de Valdecilla	Santander
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Wright State Physicians	Fairborn	Ohio
United States	Johnson Dermatology Clinic	Fort Smith	Arkansas
United States	Dawes Fretzin Dermatology Group Inc	Indianapolis	Indiana
United States	First OC Dermatology	Irvine	California
United States	Solutions Through Advanced Research Inc	Jacksonville	Florida
United States	Skin Care Physicians of Georgia	Macon	Georgia
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin
United States	Ciocca Dermatology	Miami	Florida
United States	Stanford University School of Medicine	Palo Alto	California
United States	Phoenix Childrens Hospital	Phoenix	Arizona
United States	Driscoll Childrens Hospital	San Antonio	Texas
United States	California Dermatology Institute	Thousand Oaks	California

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Czechia,  France,  Israel,  Italy,  Russian Federation,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events (AEs)	An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.	Up to approximately 4 years
Primary	Columbia-Suicide Severity Rating Scale (C-SSRS)	Questionnaire to monitor depression, suicidal thoughts and behavior	Collected at each study visit throughout the life of the study - up to 4 years
Primary	Weight of patients treated with Apremilast	Body weight in kg	Collected at each study visit throughout the life of the study - up to 4 years
Primary	Mean body mass index of the patient treated with Apremilast	BMI (combined outcome of weight and height in the form of kg/m^2)	Collected at each study visit throughout the life of the study - up to 4 years
Primary	Height patients treated with Apremilast	Height (inches or centimeters) will be collected for all pediatric subjects and descriptively summarized	Collected at each study visit throughout the life of the study - up to 4 years
Primary	Assessment of sexual maturity	Sexual maturation, assessed by Tanner staging system, will be conducted for all pediatric subjects and descriptively summarized	Collected every 52 weeks throughout the life of the study - up to 4 years
Secondary	Static Physician Global Assessment (sPGA)	is the assessment by the Investigator of the overall disease severity 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.	Collected at each study visit throughout the life of the study - up to 4 years

External Links

•   AmgenTrials clinical trials website