A Study to Assess the Adverse Events, Effectiveness, and How the Drug Moves through the Body of Intravenous and Subcutaneous Injections of Risankizumab in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis

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] - Digestive System Diseases [C06]

Trial duration

17 Oct 2025 → ongoing

Decision date (initial)

2025-08-29

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

AbbVie Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Pharmacokinetic

The objective of this study is to assess the PK, efficacy, and safety of risankizumab in pediatric subjects aged 2 to < 18 years old with moderately to severely active ulcerative colitis (UC).

Conditions and MedDRA coding

Ulcerative Colitis

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

EMA paediatric investigation plan (PIP)

EMEA-001776-PIP04-17

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. Active ulcerative colitis (UC) with an modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central reader).
2. Demonstrated intolerance or inadequate response (IR) to one or more of the following categories of drugs: aminosalicylates (except in countries where failure of this drug class is not sufficient for eligibility), oral locally acting corticosteroids, systemic steroids (prednisone or equivalent), immunomodulators (IMMs), and/or biologic therapies, as outlined in the protocol.
3. Subjects must have a documented history of UC for at least 3 months prior to Baseline, confirmed by colonoscopy during the screening period, with exclusion of current infection, colonic dysplasia and/or malignancy. Documentation of pathology results consistent with the diagnosis of UC must be available.

Exclusion criteria 2

1. Subjects who have had a major surgery performed within 12 weeks prior to Baseline or planned during the conduct of the study (e.g., inguinal hernia repair, cholecystectomy, intestinal resection).
2. Subjects who have concurrent clinically significant medical conditions other than the indication being studied or any other reason that the investigator determines would interfere with the subject's participation in this study, would make the subject an unsuitable candidate to receive study treatment, or would put the subject at risk by participating in the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. PK Lead-in Cohort 1 and Cohort 2: Maximum Observed Serum Concentration (Cmax)
2. PK Lead-in Cohort 1 and Cohort 2: Time to Maximum Serum Concentration (Tmax)
3. PK Lead-in Cohort 1 and Cohort 2: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau)
4. Expansion Cohort 3: Achievement of Clinical Remission per Modified Mayo Score (mMS) at Week 64 Among Week 12 Clinical Responders per mMS

Secondary endpoints 15

1. PK Lead-In Cohort 1 and Cohort 2: Achievement of clinical remission per mMS at Week 64 among Week 12 responders per mMS
2. PK Lead-In Cohort 1 and Cohort 2: Achievement of clinical remission per mMS at Week 12
3. PK Lead-In Cohort 1 and Cohort 2: Achievement of clinical response per mMS at Week 12
4. PK Lead-In Cohort 1 and Cohort 2: Achievement of endoscopic improvement at Week 12
5. PK Lead-In Cohort 1 and Cohort 2: Symptomatic response per partial mMS at Week 12
6. PK Lead-In Cohort 1 and Cohort 2: Achievement of clinical response per mMS at Week 64 among Week 12 responders per mMS
7. PK Lead-In Cohort 1 and Cohort 2: Achievement of endoscopic improvement at Week 64 among Week 12 responders per mMS
8. PK Lead-In Cohort 1 and Cohort 2: Ability to discontinue corticosteroids prior to Week 64 (at least 90 days without corticosteroid exposure) and achievement of clinical remission per mMS among Week 12 responders per mMS
9. Expansion Cohort 3: Achievement of clinical remission per mMS at Week 12
10. Expansion Cohort 3: Achievement of clinical response per mMS at Week 12
11. Expansion Cohort 3: Achievement of endoscopic improvement at Week 12
12. Expansion Cohort 3: Symptomatic response per partial mMS at Week 12
13. Expansion Cohort 3: Achievement of clinical response per mMS at Week 64 among Week 12 responders per mMS
14. Expansion Cohort 3: Achievement of endoscopic improvement at Week 64 among Week 12 responders per mMS
15. Expansion Cohort 3: Achievement of corticosteroid-free clinical remission per mMS at Week 64 among Week 12 responders per mMS

Investigational products

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

Test 3

Placebo 1

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 5

Locations

6 EU/EEA countries · 20 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 63 files

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

Application history

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