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

A Phase 3, Multi-Center Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Risankizumab With Open-Label Induction, Randomized Double-Blind Maintenance, and Open-Label Long-Term Extension Periods in Pediatric Subjects (2 to < 18 Years of Age) With Moderately to Severely Active Ulcerative Colitis

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.

Study Overview

• Status: Recruiting
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: Risankizumab; Drug: Risankizumab

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• Belgium
  • Brussels, Belgium, 1020
    • Recruiting
    • Hospital Universite Enfants Reine Fabiola /ID# 271860
  • Liège, Belgium, 4000
    • Recruiting
    • Centre Hospitalier Regional de la Citadelle /ID# 270459
  • Brussels Capital
    • Brussels, Brussels Capital, Belgium, 1200
      • Recruiting
      • Cliniques Universitaires UCL Saint-Luc /ID# 270123
• Brazil
  • Minas Gerais
    • Juiz de Fora, Minas Gerais, Brazil, 36033-318
      • Recruiting
      • Galileo Medical Research /ID# 271817
  • Paraná
    • Curitiba, Paraná, Brazil, 80250-060
      • Recruiting
      • Hospital Pequeno Príncipe /ID# 271814
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3B 6A8
      • Recruiting
      • Alberta Children's Hospital /ID# 272635
    • Edmonton, Alberta, Canada, T6G 1C9
      • Recruiting
      • Edmonton Clinic Health Academy /ID# 271168
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • Recruiting
      • London Health Sciences Centre - Verspeeten Family Cancer Centre /ID# 271157
• Germany
  • Brandenburg
    • Cottbus, Brandenburg, Germany, 03048
      • Recruiting
      • Medizinische Universitaet Lausitz - Carl Thiem /ID# 272023
  • Hesse
    • Kassel, Hesse, Germany, 34125
      • Recruiting
      • Klinikum Kassel /ID# 271546
  • North Rhine-Westphalia
    • Münster, North Rhine-Westphalia, Germany, 48149
      • Recruiting
      • Universitätsklinikum Münster - Albert Schweitzer Campus /ID# 271898
• Greece
  • Thessaloniki, Greece, 54642
    • Recruiting
    • General Hospital of Thessaloniki Hippokrateio /ID# 271939
  • Attica
    • Athens, Attica, Greece, 11527
      • Recruiting
      • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 270143
    • Chaïdári, Attica, Greece, 12462
      • Recruiting
      • University General Hospital Attikon /ID# 272361
• Italy
  • Trieste, Italy, 34137
    • Recruiting
    • Ospedale Infantile Burlo Garofolo /ID# 274442
  • Foggia
    • San Giovanni Rotondo, Foggia, Italy, 71013
      • Recruiting
      • Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 271889
  • Napoli
    • Naples, Napoli, Italy, 80131
      • Recruiting
      • Azienda Ospedaliera Universitaria Federico II - Naples /ID# 271895
  • Roma
    • Rome, Roma, Italy, 00168
      • Recruiting
      • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 272967
• Japan
  • Nagasaki, Japan, 852-8501
    • Not yet recruiting
    • Nagasaki University Hospital /ID# 281241
  • Aichi-ken
    • Nagakute, Aichi-ken, Japan, 480-1195
      • Not yet recruiting
      • Aichi Medical University Hospital /ID# 281613
  • Kagawa-ken
    • Kita-gun, Kagawa-ken, Japan, 761-0701
      • Not yet recruiting
      • Kagawa University Hospital /ID# 282010
  • Osaka
    • Izumi-Shi, Osaka, Japan, 594-1101
      • Not yet recruiting
      • Osaka Women's and Children's Hospital /ID# 280789
  • Tokyo
    • Shinjuku-ku, Tokyo, Japan, 160-0023
      • Not yet recruiting
      • Tokyo Medical University Hospital /ID# 280850
• Serbia
  • Novi Sad, Serbia, 21000
    • Recruiting
    • Institute for Child and Youth Health Care of Vojvodina /ID# 269961
  • Beograd
    • Belgrade, Beograd, Serbia, 11000
      • Recruiting
      • University Children's Hospital /ID# 269960
    • Belgrade-Vračar, Beograd, Serbia, 11000
      • Recruiting
      • Institut za zdravstvenu zastitu majke i deteta Srbije Dr Vukan Cupic /ID# 270696
• South Korea
  • Gyeongsangnam-do
    • Yangsan, Gyeongsangnam-do, South Korea, 50612
      • Recruiting
      • Pusan National University Yangsan Hospital /ID# 272769
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, South Korea, 03080
      • Recruiting
      • Seoul National University Hospital /ID# 272852
    • Seoul, Seoul Teugbyeolsi, South Korea, 06351
      • Recruiting
      • Samsung Medical Center /ID# 272862
    • Seoul, Seoul Teugbyeolsi, South Korea, 03181
      • Recruiting
      • Kangbuk Samsung Hospital /ID# 273333
    • Seoul, Seoul Teugbyeolsi, South Korea, 03722
      • Recruiting
      • Yonsei University Health System Severance Hospital /ID# 272894
• Spain
  • A Coruna
    • A Coruña, A Coruna, Spain, 15006
      • Recruiting
      • Hospital Teresa Herrera - CHUAC /ID# 271459
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Recruiting
      • Hospital Universitario Puerta de Hierro - Majadahonda /ID# 271466
• Sweden
  • Stockholm County
    • Solna, Stockholm County, Sweden, 171 64
      • Recruiting
      • Karolinska University Hospital Solna /ID# 271679
    • Stockholm, Stockholm County, Sweden, 118 83
      • Recruiting
      • Sodersjukhuset /ID# 271678
  • Västra Götaland County
    • Gothenburg, Västra Götaland County, Sweden, 413 46
      • Recruiting
      • Sahlgrenska Universitetssjukhuset /ID# 271675
      • Contact: Site Coordinator; Phone Number: +46313435865
• Taiwan
  • Taichung, Taiwan, 407
    • Recruiting
    • Taichung Veterans General Hospital /ID# 269242
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital /ID# 269244
• United Kingdom
  • Liverpool, United Kingdom, L12 2AP
    • Recruiting
    • Alder Hey Children's NHS Foundation Trust /ID# 271533
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
      • Recruiting
      • Addenbrookes Hospital /ID# 271489
  • England
    • Sheffield, England, United Kingdom, S10 2TH
      • Recruiting
      • Sheffield Children's Hospital NHS Foundation Trust /ID# 271490
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Recruiting
      • Phoenix Children's Hospital /ID# 273015
  • California
    • San Diego, California, United States, 92123
      • Recruiting
      • Rady Children's Hospital /ID# 271873
    • San Francisco, California, United States, 94158
      • Recruiting
      • University of California San Francisco - Mission Bay /ID# 273022
  • Florida
    • Miami, Florida, United States, 33155
      • Recruiting
      • Nicklaus Children'S Hospital - Miami - Southwest 62nd Avenue /ID# 271585
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Recruiting
      • Childrens Center For Digestive Health Care /ID# 273228
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago Medical Center /ID# 271588
  • New Jersey
    • Morristown, New Jersey, United States, 07962
      • Recruiting
      • Goryeb Children's Hospital /ID# 271801
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals Cleveland Medical Center /ID# 271831
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • The Children's Hospital of Philadelphia /ID# 273222
    • Pittsburgh, Pennsylvania, United States, 15224
      • Recruiting
      • Upmc Children'S Hospital Of Pittsburgh /ID# 272328
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Recruiting
      • Patewood Medical Campus /ID# 272477

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

- 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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

15

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PK Cohort 1: SS3 Dose A; 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; Risankizumab intravenous (IV) infusion; Other Names: ABBV-066; Drug: Risankizumab; Risankizumab subcutaneous (SC) injection; Other Names: ABBV-066
Experimental: PK Cohort 1: SS3 Dose B; 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; Risankizumab intravenous (IV) infusion; Other Names: ABBV-066; Drug: Risankizumab; Risankizumab subcutaneous (SC) injection; Other Names: ABBV-066
Experimental: PK Cohort 2: SS1; 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; Risankizumab intravenous (IV) infusion; Other Names: ABBV-066; Drug: Risankizumab; Risankizumab subcutaneous (SC) injection; Other Names: ABBV-066
Experimental: PK Cohort 2: SS3 Dose A; 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; Risankizumab intravenous (IV) infusion; Other Names: ABBV-066; Drug: Risankizumab; Risankizumab subcutaneous (SC) injection; Other Names: ABBV-066
Experimental: PK Cohort 2: SS3 Dose B; 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; Risankizumab intravenous (IV) infusion; Other Names: ABBV-066; Drug: Risankizumab; Risankizumab subcutaneous (SC) injection; Other Names: ABBV-066
Experimental: Expansion Cohort 3: SS3 Dose A; 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; Risankizumab intravenous (IV) infusion; Other Names: ABBV-066; Drug: Risankizumab; Risankizumab subcutaneous (SC) injection; Other Names: ABBV-066
Experimental: Expansion Cohort 3: SS3 Dose B; 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; Risankizumab intravenous (IV) infusion; Other Names: ABBV-066; Drug: Risankizumab; Risankizumab subcutaneous (SC) injection; Other Names: ABBV-066
Experimental: PK Cohort 1: SS1; 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; Risankizumab intravenous (IV) infusion; Other Names: ABBV-066; Drug: Risankizumab; Risankizumab subcutaneous (SC) injection; Other Names: ABBV-066
Experimental: PK Cohort 1: SS2 Dose A; 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; Risankizumab intravenous (IV) infusion; Other Names: ABBV-066; Drug: Risankizumab; Risankizumab subcutaneous (SC) injection; Other Names: ABBV-066
Experimental: PK Cohort 1: SS2 Dose B; 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; Risankizumab intravenous (IV) infusion; Other Names: ABBV-066; Drug: Risankizumab; Risankizumab subcutaneous (SC) injection; Other Names: ABBV-066
Experimental: PK Cohort 2: SS2 Dose A; 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; Risankizumab intravenous (IV) infusion; Other Names: ABBV-066; Drug: Risankizumab; Risankizumab subcutaneous (SC) injection; Other Names: ABBV-066
Experimental: PK Cohort 2: SS2 Dose B; 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; Risankizumab intravenous (IV) infusion; Other Names: ABBV-066; Drug: Risankizumab; Risankizumab subcutaneous (SC) injection; Other Names: ABBV-066
Experimental: Expansion Cohort 3: SS1; 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; Risankizumab intravenous (IV) infusion; Other Names: ABBV-066; Drug: Risankizumab; Risankizumab subcutaneous (SC) injection; Other Names: ABBV-066
Experimental: Expansion Cohort 3: SS2 Dose A; 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; Risankizumab intravenous (IV) infusion; Other Names: ABBV-066; Drug: Risankizumab; Risankizumab subcutaneous (SC) injection; Other Names: ABBV-066
Experimental: Expansion Cohort 3: SS2 Dose B; 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; Risankizumab intravenous (IV) infusion; Other Names: ABBV-066; Drug: Risankizumab; Risankizumab subcutaneous (SC) injection; Other Names: ABBV-066

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK Lead-In Cohort 1: Achievement of clinical remission per mMS among Week 12 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
PK Lead-In Cohort 2: Achievement of clinical remission per mMS among Week 12 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
PK Lead-In Cohort 1: Achievement of clinical remission per mMS	Clinical remission on the mMS is 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 12
PK Lead-In Cohort 2: Achievement of clinical remission per mMS	Clinical remission on the mMS is 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 12
PK Lead-In Cohort 1: Achievement of clinical response per mMS	Clinical response per mMS is defined as decrease in mMS by ≥ 2 points and ≥ 30% from Baseline with a decrease in Rectal Bleeding Subscore (RBS) of ≥ 1 or an absolute RBS of 0 or 1.	At Week 12
PK Lead-In Cohort 2: Achievement of clinical response per mMS	Clinical response per mMS is defined as decrease in mMS by ≥ 2 points and ≥ 30% from Baseline with a decrease in Rectal Bleeding Subscore (RBS) of ≥ 1 or an absolute RBS of 0 or 1.	At Week 12
PK Lead-In Cohort 1: Achievement of endoscopic improvement	Endoscopic improvement defined as MES ≤ 1	At Week 12
PK Lead-In Cohort 2: Achievement of endoscopic improvement	Endoscopic improvement defined as MES ≤ 1	At Week 12
PK Lead-In Cohort 1: Symptomatic response per partial mMS	Symptomatic response per partial mMS is defined as decrease in partial mMS by ≥ 1 points and ≥ 30% from Baseline with decrease in RBS of ≥ 1 or an absolute RBS of 0 or 1.	At Week 12
PK Lead-In Cohort 2: Symptomatic response per partial mMS	Symptomatic response per partial mMS is defined as decrease in partial mMS by ≥ 1 points and ≥ 30% from Baseline with decrease in RBS of ≥ 1 or an absolute RBS of 0 or 1.	At Week 12
PK Lead-In Cohort 1: Achievement of clinical response per mMS among Week 12 responders per mMS	Clinical response per mMS is defined as decrease in mMS by ≥ 2 points and ≥ 30% from Baseline with a decrease in Rectal Bleeding Subscore (RBS) of ≥ 1 or an absolute RBS of 0 or 1.	At Week 64
PK Lead-In Cohort 2: Achievement of clinical response per mMS among Week 12 responders per mMS	Clinical response per mMS is defined as decrease in mMS by ≥ 2 points and ≥ 30% from Baseline with a decrease in Rectal Bleeding Subscore (RBS) of ≥ 1 or an absolute RBS of 0 or 1.	At Week 64
PK Lead-In Cohort 1: Achievement of endoscopic improvement among Week 12 responders per mMS	Endoscopic improvement defined as MES ≤ 1	At Week 64
PK Lead-In Cohort 2: Achievement of endoscopic improvement among Week 12 responders per mMS	Endoscopic improvement defined as MES ≤ 1	At Week 64
Expansion Cohort 3: Achievement of clinical remission per mMS		At Week 12
Expansion Cohort 3: Achievement of clinical response per mMS		At Week 12
Expansion Cohort 3: Achievement of endoscopic improvement		At Week 12
Expansion Cohort 3: Symptomatic response per partial mMS		At Week 12
Expansion Cohort 3: Achievement of clinical response per mMS among Week 12 responders per mMS		At Week 64
Expansion Cohort 3: Achievement of endoscopic improvement among Week 12 responders per mMS		At Week 64
Expansion Cohort 3: Achievement of corticosteroid-free clinical remission per mMS among Week 12 responders per mMS		At Week 64
PK Lead-In Cohort 1: Achievement of corticosteroid-free (at least 90 days without corticosteroid exposure) clinical remission per mMS at Week 64 among Week 12 responders per mMS		Up to Week 64
PK Lead-In Cohort 2: Achievement of corticosteroid-free (at least 90 days without corticosteroid exposure) clinical remission per mMS at Week 64 among Week 12 responders per mMS		Up to Week 64

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2025
• Primary Completion (Estimated): July 1, 2034
• Study Completion (Estimated): July 1, 2034

Study Registration Dates

• First Submitted: July 8, 2025
• First Submitted That Met QC Criteria: July 8, 2025
• First Posted (Actual): July 17, 2025

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 17, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: risankizumab
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Immunologic Factors; Physiological Effects of Drugs; risankizumab
• Other Study ID Numbers: M19-751; 2024-514695-41-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (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.
• IPD Sharing Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes