A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis

NCT07071519 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: M19-751
• Study Type: interventional
• Target: 120
• Locations: 9 countries
• Sites: 30

Brief Summary

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess how Risankizumab moves through the body as well as how safe and effective it is in treating pediatric participants with moderate to severely active UC. Adverse events and change in disease activity will be assessed. Risankizumab is an approved medication for moderate to severe UC in multiple countries and is being developed for the treatment of UC in pediatrics. This study is comprised of 3 cohorts that may participate in 3 substudies (SS). Cohort 1 will enroll participants with ages from 6 to less than 18 years. Cohort 2 will enroll participants with ages from 2 to less than 6 years. Cohort 3 will enroll participants with ages from 2 to less than 18 years. SS1 is an open-label induction period where participants will receive a weight-based induction regimen of risankizumab. SS2 is a double-blind maintenance period where participants will be randomized to receive 1 of 2 doses of weight-based maintenance regimen of risankizumab. SS3 is an open-label extension period where participants will receive risankizumab based off of their response in SS2. Around 120 pediatric participants with UC will be enrolled at around 80 sites worldwide. Participants in SS1 will receive risankizumab intravenously during the 12-week induction period. Participants in SS2 will receive risankizumab subcutaneously during the 52-week randomized maintenance period. Participants in SS3 will receive risankizumab subcutaneously during the 208-week open label period. Participants will be followed-up for approximately 140 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Conditions

Ulcerative Colitis

Keywords

risankizumab

Outcome Measures

Primary Outcomes (8)

• PK Lead-In Cohort 1: Maximum Observed Serum Concentration (Cmax)

  Maximum observed plasma concentration (Cmax)

  At Week 64

• PK Lead-In Cohort 2: Maximum Observed Serum Concentration (Cmax)

  Maximum observed plasma concentration (Cmax)

  At Week 64

• PK Lead-In Cohort 1: Time to Maximum Serum Concentration (Tmax)

  Time to maximum plasma concentration (Tmax)

  At Week 64

• PK Lead-In Cohort 2: Time to Maximum Serum Concentration (Tmax)

  Time to maximum plasma concentration (Tmax)

  At Week 64

• PK Lead-In Cohort 1: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau)

  Area under the serum concentration-time curve over the dosing interval (AUCtau)

  At Week 64

• PK Lead-In Cohort 2: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau)

  Area under the serum concentration-time curve over the dosing interval (AUCtau)

  At Week 64

• Expansion Cohort 3: Achievement of Clinical Remission per Modified Mayo Score (mMS) Among Week 12 Clinical Responders per mMS

  Clinical remission on the mMS is defined as defined as Stool Frequency Subscore (SFS) ≤ 1 and not greater than Baseline, Rectal Bleeding Subscore (RBS) = 0, and Mayo Endoscopic Subscore (MES) ≤ 1

  At Week 64

• Number of Participants With Adverse Events

  An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related

  Up to 292 Weeks

Secondary Outcomes (23)

• PK Lead-In Cohort 1: Achievement of clinical remission per mMS among Week 12 responders per mMS

  At Week 64

• PK Lead-In Cohort 2: Achievement of clinical remission per mMS among Week 12 responders per mMS

  At Week 64

• PK Lead-In Cohort 1: Achievement of clinical remission per mMS

  At Week 12

• PK Lead-In Cohort 2: Achievement of clinical remission per mMS

  At Week 12

• PK Lead-In Cohort 1: Achievement of clinical response per mMS

  At Week 12

Study Arms (15)

PK Cohort 1: SS1

EXPERIMENTAL

Cohort 1 will consist of 2 age groups (6 to \< 12 years and 12 to \< 18 years). SS1 is a 12-week induction period where participants will receive a weight-based dose of risankizumab. All participants who complete SS1 are eligible to enter SS2

Drug: Risankizumab

PK Cohort 1: SS2 Dose A

EXPERIMENTAL

Cohort 1 will consist of 2 age groups (6 to \< 12 years and 12 to \< 18 years). Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose A. Participants who complete SS2 will have the opportunity to enter the open-label long term extension SS3.

Drug: Risankizumab

PK Cohort 1: SS2 Dose B

EXPERIMENTAL

Cohort 1 will consist of 2 age groups (6 to \< 12 years and 12 to \< 18 years). Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose B. Participants who complete SS2 will have the opportunity to enter the open-label long term extension SS3.

Drug: Risankizumab

PK Cohort 1: SS3 Dose A

EXPERIMENTAL

Cohort 1 will consist of 2 age groups (6 to \< 12 years and 12 to \< 18 years). SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.

Drug: Risankizumab

PK Cohort 1: SS3 Dose B

EXPERIMENTAL

Cohort 1 will consist of 2 age groups (6 to \< 12 years and 12 to \< 18 years). SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.

Drug: Risankizumab

PK Cohort 2: SS1

EXPERIMENTAL

Cohort 2 will enroll participants aged 2 to less than 6 years. SS1 is a 12-week induction period where participants will receive a weight-based dose of risankizumab. All subjects who complete SS1 are eligible to enter SS2.

Drug: Risankizumab

PK Cohort 2: SS2 Dose A

EXPERIMENTAL

Cohort 2 will enroll participants aged 2 to less than 6 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose A. Participants who complete SS2 will have the opportunity to enter the open-label long-term extension SS3.

Drug: Risankizumab

PK Cohort 2: SS2 Dose B

EXPERIMENTAL

Cohort 2 will enroll participants aged 2 to less than 6 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose B. Participants who complete SS2 will have the opportunity to enter the open-label long-term extension SS3.

Drug: Risankizumab

PK Cohort 2: SS3 Dose A

EXPERIMENTAL

Cohort 2 will enroll participants aged 2 to less than 6 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.

Drug: Risankizumab

PK Cohort 2: SS3 Dose B

EXPERIMENTAL

Cohort 2 will enroll participants aged 2 to less than 6 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.

Drug: Risankizumab

Expansion Cohort 3: SS1

EXPERIMENTAL

Cohort 3 will enroll participants aged 2 to less than 18 years. SS1 is a 12-week induction period where participants will receive a weight-based dose of risankizumab. All participants who complete SS1 are eligible to enter SS2.

Drug: Risankizumab

Expansion Cohort 3: SS2 Dose A

EXPERIMENTAL

Cohort 3 will enroll participants aged 2 to less than 18 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose A. Participants who complete SS2 will have the opportunity to enter the open-label long term extension SS3.

Drug: Risankizumab

Expansion Cohort 3: SS2 Dose B

EXPERIMENTAL

Cohort 3 will enroll participants aged 2 to less than 18 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose B. Participants who complete SS2 will have the opportunity to enter the open-label long term extension SS3.

Drug: Risankizumab

Expansion Cohort 3: SS3 Dose A

EXPERIMENTAL

Cohort 3 will enroll participants aged 2 to less than 18 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.

Drug: Risankizumab

Expansion Cohort 3: SS3 Dose B

EXPERIMENTAL

Cohort 3 will enroll participants aged 2 to less than 18 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.

Drug: Risankizumab

Interventions

Risankizumab DRUG

Risankizumab intravenous (IV) infusion

Also known as: ABBV-066

Expansion Cohort 3: SS1; PK Cohort 1: SS1; PK Cohort 2: SS1

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• Participants 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).
• Participants 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (33)

Phoenix Children's Hospital /ID# 273015

Phoenix, Arizona, 85016, United States

RECRUITING

Nicklaus Children'S Hospital - Miami - Southwest 62nd Avenue /ID# 271585

Miami, Florida, 33155, United States

RECRUITING

Childrens Center For Digestive Health Care /ID# 273228

Atlanta, Georgia, 30342, United States

RECRUITING

Goryeb Children's Hospital /ID# 271801

Morristown, New Jersey, 07962, United States

RECRUITING

Upmc Children'S Hospital Of Pittsburgh /ID# 272328

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

Patewood Medical Campus /ID# 272477

Greenville, South Carolina, 29615, United States

RECRUITING

Cliniques Universitaires UCL Saint-Luc /ID# 270123

Brussels, Brussels Capital, 1200, Belgium

RECRUITING

Centre Hospitalier Régional de la Citadelle /ID# 270459

Liège, Liege, 4000, Belgium

RECRUITING

Hospital Universite Enfants Reine Fabiola /ID# 271860

Brussels, 1020, Belgium

RECRUITING

Medizinische Universitaet Lausitz - Carl Thiem /ID# 272023

Cottbus, Brandenburg, 03048, Germany

RECRUITING

Klinikum Kassel /ID# 271546

Kassel, Hesse, 34125, Germany

RECRUITING

Universitaetsklinikum Muenster /ID# 271898

Münster, North Rhine-Westphalia, 48149, Germany

RECRUITING

General Hospital of Chest Diseases of Athens SOTIRIA /ID# 270143

Athens, Attica, 11527, Greece

RECRUITING

University General Hospital Attikon /ID# 272361

Athens, Attica, 12462, Greece

RECRUITING

General Hospital of Thessaloniki Hippokrateio /ID# 271939

Thessaloniki, 54642, Greece

RECRUITING

Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 271889

San Giovanni Rotondo, Foggia, 71013, Italy

RECRUITING

Azienda Ospedaliera Universitaria Federico II /ID# 271895

Naples, Napoli, 80131, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 272967

Rome, Roma, 00168, Italy

RECRUITING

Ospedale Infantile Burlo Garofolo /ID# 274442

Trieste, 34137, Italy

RECRUITING

University Children's Hospital /ID# 269960

Belgrade, Beograd, 11000, Serbia

RECRUITING

Institut za zdravstvenu zastitu majke i deteta Srbije Dr Vukan Cupic /ID# 270696

Belgrade-Vračar, Beograd, 11000, Serbia

RECRUITING

Institute for Child and Youth Health Care of Vojvodina /ID# 269961

Novi Sad, 21000, Serbia

RECRUITING

Pusan National University Yangsan Hospital /ID# 272769

Yangsan, Gyeongsangnam-do, 50612, South Korea

RECRUITING

Seoul National University Hospital /ID# 272852

Seoul, Seoul Teugbyeolsi, 03080, South Korea

RECRUITING

Kangbuk Samsung Hospital /ID# 273333

Seoul, Seoul Teugbyeolsi, 03181, South Korea

RECRUITING

Yonsei University Health System Severance Hospital /ID# 272894

Seoul, Seoul Teugbyeolsi, 03722, South Korea

RECRUITING

Samsung Medical Center /ID# 272862

Seoul, Seoul Teugbyeolsi, 06351, South Korea

RECRUITING

Hospital Teresa Herrera - CHUAC /ID# 271459

A Coruña, A Coruna, 15006, Spain

RECRUITING

Hospital Universitario Puerta de Hierro - Majadahonda /ID# 271466

Majadahonda, Madrid, 28222, Spain

RECRUITING

Sodersjukhuset /ID# 271678

Stockholm, Stockholm County, 118 83, Sweden

RECRUITING

Sahlgrenska Universitetssjukhuset /ID# 271675

Gothenburg, Västra Götaland County, 413 46, Sweden

RECRUITING

Taichung Veterans General Hospital /ID# 269242

Taichung, 407, Taiwan

RECRUITING

National Taiwan University Hospital /ID# 269244

Taipei, 100, Taiwan

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

risankizumab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 17, 2025
• Study Start: July 28, 2025
• Primary Completion (Estimated): July 1, 2034
• Study Completion (Estimated): July 1, 2034
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

US (6); KR (5); GR (3); IT (4); DE (3); ES (2); SE (2); BE (3); TW (2)