A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms (OptIMMize-1)

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] - Immune System Diseases [C20]

Trial duration

13 Aug 2021 → 15 Oct 2024

Decision date (initial)

2023-07-28

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

AbbVie Inc

External identifiers

EU CT number

2023-504156-10-00

EudraCT number

2019-004141-32

ClinicalTrials.gov

NCT04435600

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Efficacy, Safety

The objective of this study is to evaluate the PK, safety, and efficacy of risankizumab in subjects from 6 to less than 18 years of age with moderate to severe plaque Ps. The hypothesis corresponding to the primary objective is that the safety and efficacy of treatment with risankizumab for moderate to severe Ps in the pediatric population is similar to the response observed in the adult population.

Secondary objectives 1

1. Not applicable.

Conditions and MedDRA coding

Plaque Psoriasis.

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-001776-PIP01-15

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 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. Diagnosis of chronic plaque psoriasis for at least 6 months before the Baseline Visit.
2. Stable severe or moderate to severe plaque psoriasis as defined in each study part by body surface area (BSA) psoriasis involvement and scores on the PASI and sPGA.
3. Candidate for systemic therapy as assessed by the investigator and meet the disease activity criteria at both the Screening and Baseline Visits per the protocol.

Exclusion criteria 1

1. Concurrent clinically significant medical conditions other than the indication being studied or any other reason that the investigator determines would interfere with the participant's participation in this study, would make the participant an unsuitable candidate to receive study drug, or would put the participant at risk by participating in the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Co-primary Endpoints: - Achievement of PASI 75 (defined as at least 75% improvement from baseline in PASI) at Week 16 of initial treatment.
2. Achievement of sPGA clear or almost clear (0 or 1) at Week 16 of initial treatment

Secondary endpoints 15

1. Ranked Secondary Endpoints: Achievement of PASI 90 (defined as at least 90% improvement from baseline in PASI) at Week 16 of initial treatment.
2. Achievement of PASI 100 (defined as 100% improvement from baseline in PASI) at Week 16 of initial treatment.
3. Achievement of sPGA clear or almost clear at (0 or 1) at Week 0 and Week 16 of the retreatment phase in Part 2.
4. Non-ranked Secondary Efficacy Endpoints: Achievement of PASI 50 (defined as at least 50% improvement from baseline in PASI) at Week 16 of initial treatment
5. Achievement of PASI 50 (defined as at least 50% improvement from baseline in PASI) at Week 0 and Week 16 of the re-treatment phase in Part 2.
6. Achievement of PASI 90 (defined as at least 90% improvement from baseline in PASI) at Week 0 and Week 16 of the retreatment phase in Part 2.
7. Achievement of PASI 100 (defined as 100% improvement from baseline in PASI) at Week 0 and Week 16 of the retreatment phase in Part 2.
8. Achievement of a PASI 75 (defined as at least 75% improvement from baseline in PASI) at Week 0 and Week 16 of the retreatment phase in Part 2
9. Change in Children's Dermatology Life Quality Index (CDLQI) from Week 0 to Week 16 of initial treatment in Part 2
10. Change in CDLQI from Week 0 to Week 16 of re-treatment phase of Part 2
11. Change in Family Dermatology Life Quality Index (FDLQI) from Week 0 to Week 16 of initial treatment in Part 2
12. Change in FDLQI from Week 0 to Week 16 of re-treatment phase of Part 2
13. Change in Itch Numerical Rating Scale (Itch NRS) from Week 0 to Week 16 of initial treatment in Part 2
14. Change in Itch NRS from Week 0 to Week 16 of re-treatment phase in Part 2
15. Achievement of ≥ 4-point improvement from baseline in the Itch Numerical Rating Scale (in patients with Baseline score ≥ 4) at Week 16 of initial treatment in Part 2

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 4

Locations

3 EU/EEA countries · 16 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

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 10 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