Apremilast Study in Children with Active Juvenile Psoriatic Arthritis

• Register: EUCTR
• Last refreshed on: 15 April 2024
• Main ID: EUCTR2019-002788-88-GR
• Date of registration: 01/02/2022
• Prospective Registration: Yes
• Primary sponsor: Amgen Inc.
• Public title: Apremilast Study in Children with Active Juvenile Psoriatic Arthritis
• Scientific title: A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD)
• Date of first enrolment: 14/04/2022
• Target sample size: 60
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-002788-88
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Belgium, France, Germany, Greece, Italy, Lithuania, Netherlands, Poland, Portugal, Romania, South Africa, Spain, Turkey, United Kingdom

Contacts

• Affiliation: Amgen Hellas ?.?.?.

• Affiliation: Amgen Hellas ?.?.?.

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male or Female subjects 5 to less than 18 years of age at the time of randomization.
2. Confirmed diagnosis of JPsA according to the International League of Associations for Rheumatology (ILAR) Edmonton Revision (Petty, 2001) classification criteria of at least 6 months duration:
-Arthritis and psoriasis, OR
-Arthritis with at least 2 of the following:
-Dactylitis
-Nail pitting or onycholysis
- Psoriasis in a first-degree relative
3. Active disease: at least 3 active joints (including distal interphalangeal joints).
4. Inadequate response (at least 2 months) or intolerance to = 1 DMARD, (which may include MTX or biologic agents).

Other protocol-defined inclusion criteria apply
Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion criteria:
1.Exclusions per ILAR Edmonton Revision (Edmonton, 2001) criteria for JPsA include:
- Arthritis in an HLA-B27-positive male with arthritis onset after 6 years of age
- Ankylosing spondylitis, sacroiliitis with inflammatory bowel disease, - Reiter's syndrome, acute anterior uveitis, or a history of one of these disorders in a first-degree relative
- History of IgM rheumatoid factor on at least 2 occasions at least 3 months apart
- Presence of systemic JIA.
2. Rheumatic autoimmune disease other than PsA, including, but not limited to: systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or fibromyalgia.
3. Prior history of or current inflammatory joint disease other than PsA (eg, gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease).
4. History or evidence of any other clinically significant disorder, condition or disease that could pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
5. Female subject who is (or plans to become) pregnant or breastfeeding.
6. Female subject of childbearing potential unwilling to use 1 highly effective method of contraception.

Other protocol-defined exclusion criteria apply.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Juvenile psoriatic arthritis
MedDRA version: 20.0 Level: LLT Classification code 10079454 Term: Systemic juvenile idiopathic arthritis System Organ Class: 100000004859

Intervention(s)

Trade Name: Otezla
Product Name: Apremilast 10 mg
Product Code: AMG-407
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Apremilast
CAS Number: 608141-41-9
Current Sponsor code: AMG-407
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Trade Name: Otezla

Product Name: Apremilast 20 mg
Product Code: AMG-407
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Apremilast
CAS Number: 608141-41-9
Current Sponsor code: AMG-407
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Trade Name: Otezla
Product Name: Apremilast 30 mg
Product Code: AMG-407
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Apremilast
CAS Number: 608141-41-9
Current Sponsor code: AMG-407
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: Apremilast
Product Code: AMG407
Pharmaceutical Form: Oral suspension
INN or Proposed INN: Apremilast
Current Sponsor code: AMG-407
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Oral suspension
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: Estimate the efficacy of apremilast compared with placebo in the treatment of Juvenile Psoriatic Arthritis(JPsA) in pediatric subjects 5 to less than 18 years of age;

Primary end point(s): Number of participants achieving ACR Pedi 30

Timepoint(s) of evaluation of this end point: from baseline (week 0) to week 16

Secondary Objective: Estimate effect of apremilast compared to placebo on pain in pediatric subjects (5 to less than 18 years) with JPsA;
Estimate effect of apremilast compared to placebo on ACR Pedi 20/50/70/90 response, respective core components, and on juvenile arthritis disease activity in pediatric subjects with JPsA;
Estimate impact on HRQoL in pediatric subjects with JPsA;
Estimate efficacy of apremilast compared to placebo for overall JPsA related disease activity in pediatric subjects with JPsA;
Estimate effect of apremilast compared to placebo on psoriatic arthritis flares in pediatric subjects with JPsA;
Estimate effect of apremilast compared to placebo on psoriatic skin disease in pediatric subjects with JPsA;
Estimate safety and tolerability of apremilast compared with placebo in pediatric subjects with JPsA;
Characterize pharmacokinetics of apremilast in pediatric subjects with JPsA;
Evaluate taste and acceptability of apremilast tablet and suspension in pediatric subjects with JPsA.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: (a) from baseline (week 0) to week 16
(b) from baseline (week 0) to week 56
(c) at baseline (week 0) and week 52 (or Early Termination visit)
(d) from week 2 to week 52 (or Early Termination visit)
(e) at baseline (week 0) and week 2

Secondary end point(s): - Change in subject's assessment of pain (a);
- Number of participants achieving ACR Pedi 20/50/70/90 (a);
- Change in Childhood Heath Assessment Questionnaire (CHAQ) (a);
- Change in Juvenile Arthritis Disease Activity Score (JADAS) (a);
- Number of participants who experience PsA flares (a);
- PASI-75 response at week 16 for subjects with a baseline psoriasis BSA equal or more than 3% (a);
- Number of participants who experience treatment-emergent adverse events (type, frequency, severity and relationship to apremilast) (b);
- Number of participants who experience clinically significant laboratory tests, vital sign or physical examination measurements (b);
- Occurrence, severity, and frequency of suicide/suicide-related ideations and behaviors as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) Questionnaire (b);
- Body weight, height and BMI (b);
- Tanner Staging Assessment of sexual maturity (c);
- Plasma concentrations of apremilast (d);
- Taste and acceptability (e);

Secondary ID(s)

20190529

2019-002788-88-AT

Source(s) of Monetary Support

Amgen Inc.

Ethics review

Status: Approved
Approval date: 14/04/2022
Contact: