Long-term Study of Apremilast (CC-10004) in Pediatric Subjects from 6 Through 17 Years of Age with Moderate to Severe Plaque Psoriasis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Amgen Inc.

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

27 May 2020 → 12 Dec 2025

Decision date (initial)

2023-08-30

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Amgen Inc., US

External identifiers

EU CT number

2023-503600-83-00

EudraCT number

2019-003497-13

WHO UTN

U1111-1242-3537

ClinicalTrials.gov

NCT04175613

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To evaluate the long-term safety of apremilast in children and adolescents (ages 6 through 17 years) with moderate to severe plaque psoriasis.

Secondary objectives 1

1. To evaluate the maintenance of effect as measured by static Physician Global Assessment (sPGA).

Conditions and MedDRA coding

Moderate to Severe Plaque Psoriasis

Study design 2 periods

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-000715-PIP03-11

Plan to share IPD

Yes

IPD plan description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request. Information on IPD sharing Access Criteria, Time Frame and Supporting Information Type is available at ClinicalTrials.gov (https://clinicaltrials.gov/study/NCT04175613 ) and at Amgen Clinical Trials portal (http://www.amgen.com/datasharing).

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

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 (CDC, 2000).
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.

Exclusion criteria 5

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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. Adverse Events: Type, frequency, severity, and relationship to apremilast from Week 0 (Visit 1) through end of Observational Follow-up for the entire study duration
2. Columbia-Suicide Severity Rating Scale (C-SSRS) Questionnaire to monitor depression, suicidal thoughts and behavior for the entire study duration
3. Tanner Staging. Assessment of sexual maturity at Week 0 (Visit 1) and then every 52 weeks. Also early termination visit.
4. Body weight, height and BMI: Monitor growth - Height and body weight are measured at each visit

Secondary endpoints 1

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amgen Inc.

Sponsor organisation

Amgen Inc.

Address

1 Amgen Center Drive

City

Thousand Oaks

Postcode

91320-1799

Country

United States

Scientific contact point

Organisation

Amgen Inc.

Contact name

Wendy Zhang, MD

Public contact point

Organisation

Amgen Inc.

Contact name

N/A

Third parties 3

Locations

4 EU/EEA countries · 15 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 15 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications