Efficacy, safety, tolerability, and pharmacokinetics of risankizumab in pediatric subjects with active juvenile psoriatic arthritis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AbbVie Deutschland GmbH & Co. KG

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

29 Apr 2024 → ongoing

Decision date (initial)

2024-03-21

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

AbbVie Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Efficacy, Safety

The primary study objective is to assess efficacy, safety, tolerability, and PK of risankizumab with an adalimumab reference arm in children and adolescent subjects aged 5 to < 18 years with active jPsA who have had an inadequate response to, or are intolerant of, methotrexate (MTX) or other csDMARDs.

Secondary objectives 1

1. The secondary efficacy objectives are to assess the proportion of subjects who achieve the binary secondary endpoints and the mean of continuous endpoints as specified in Section 3.3 based on the ITT population.

Conditions and MedDRA coding

Juvenile Psoriatic Arthritis

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-001776-PIP02-17

Plan to share IPD

Yes

IPD plan description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information. To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/ For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Subjects must have a diagnosis of jPsA according to ILAR criteria for at least 3 months prior to Screening.
2. Active disease in ≥ 3 joints at screening and at Baseline (swelling not due to deformity, or limitation of motion with pain, tenderness, or both). Swelling alone meets the criteria for an active arthritic joint. In the absence of swelling, limitation of motion with pain or tenderness or both meet the criteria for an active arthritic joint.
3. Subject must have demonstrated an inadequate response (lack of efficacy after minimum 2-month duration of therapy at maximally tolerated dose), or intolerance to previous or current treatment with at least 1 of the following csDMARDs: MTX, sulfasalazine, leflunomide, or hydroxychloroquine.

Exclusion criteria 1

1. Subjects have any other autoimmune disease, rheumatic disease (including systemic JIA, rheumatoid factor-positive or rheumatoid factor-negative polyarticular JIA, extended oligoarticular JIA, persistent oligoarticular JIA, enthesitis-related arthritis, and undifferentiated JIA), or overlap syndrome.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is the achievement of JIA-ACR 30 response at Week 24.

Secondary endpoints 10

1. Achievement of JIA-ACR 50/70/90 response at Week 24
2. Percent change from Baseline in individual components of JIA-CRV at Week 24.
3. Change from Baseline in JADAS-10 and JADAS-27 at Week 24.
4. Achievement of MDA at Week 24 (defined as JADAS-10 of ≤6)
5. Achievement of inactive disease at Week 24 (defined as JADAS-10 of ≤2.7)
6. Change from Baseline in cJADAS-10 and cJADAS-27 at Week 24.
7. Change from Baseline in the Pain-VAS at Week 24
8. In subjects with PsO (at least 3% BSA at Baseline), achievement of PASI 75/90 at Week 24
9. In subjects with PsO (at least 3% BSA at Baseline), achievement of the sPGA of PsO of 'clear' or 'almost clear' (0/1) at Week 24.
10. In subjects with PsO (at least 3% BSA at Baseline), change from Baseline in CDLQI at Week 24.

Investigational products

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

Test 2

Comparator 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AbbVie Deutschland GmbH & Co. KG

Sponsor organisation

AbbVie Deutschland GmbH & Co. KG

Address

Knollstrasse

City

Ludwigshafen Am Rhein

Postcode

67061

Country

Germany

Scientific contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Public contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Third parties 7

Locations

5 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

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Corrective measures 1 · Art. 77 CTR

Results and documents

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

Documents 66 files

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

Application history

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