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AzTrials

Ulcerative ColitisPhase 3MIGHTYNCT07071519

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

A Phase 3 study testing Risankizumab in people with Ulcerative Colitis, run by AbbVie at 72 sites in 16 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 2 to 17 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
Risankizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
72 sitesin 16 countries
Study dates
28 Jul 2025to Jul 2034
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

72 sites in 16 countries. Contact the study team or a site near you to ask about taking part.

ABBVIE CALL CENTER contact

844-663-3742

abbvieclinicaltrials@abbvie.com

72 sites in 16 countries

Japan14 sites, 14 recruiting

  • Juntendo University Hospital /ID# 280463

    Bunkyo-ku, Tokyo, 113-8431

    Recruiting

  • Institute of Science Tokyo Hospital /ID# 280694

    Bunkyo-ku, Tokyo, 113-8519

    Recruiting

  • Tokyo Metropolitan Children's Medical Center /ID# 280791

    Fuchu-shi, Tokyo, 183-8561

    Recruiting

  • Fukushima Medical University Hospital /ID# 281178

    Fukushima, 960-1295

    Recruiting

  • Hamamatsu University Hospital /ID# 281614

    Hamamatsu, Shizuoka, 431-3192

    Recruiting

  • Tsujinaka Hospital - Kashiwanoha /ID# 280303

    Kashiwa-shi, Chiba, 277-0871

    Recruiting

  • Kobe University Hospital /ID# 281796

    Kobe, Hyōgo, 650-0017

    Recruiting

  • Japanese Red Cross Kumamoto Hospital /ID# 280696

    Kumamoto, Kumamoto, 861-8520

    Recruiting

  • Kurume University Hospital /ID# 280792

    Kurume-shi, Fukuoka, 830-0011

    Recruiting

  • Gunma University Hospital /ID# 281179

    Maebashi, Gunma, 371-8511

    Recruiting

  • Aichi Children's Health And Medical Center /ID# 280462

    Ōbu, Aichi-ken, 474-8710

    Recruiting

  • Saga University Hospital /ID# 281232

    Saga, Saga-ken, 849-8501

    Recruiting

  • Saitama Children's Medical Center /ID# 280603

    Saitama-shi, Saitama, 330-8777

    Recruiting

  • National Center For Child Health And Development /ID# 280460

    Setagaya City, Tokyo, 157-8535

    Recruiting

Other trials in Japan

United States12 sites, 12 recruiting

  • Childrens Center For Digestive Health Care /ID# 273228

    Atlanta, Georgia, 30342

    Recruiting

  • University of Chicago Medical Center /ID# 271588

    Chicago, Illinois, 60637

    Recruiting

  • University Hospitals Cleveland Medical Center /ID# 271831

    Cleveland, Ohio, 44106

    Recruiting

  • University of Texas - Southwestern Medical Center /ID# 271835

    Dallas, Texas, 75235

    Recruiting

  • Patewood Medical Campus /ID# 272477

    Greenville, South Carolina, 29615

    Recruiting

  • Nicklaus Children's Hospital - Miami /ID# 271585

    Miami, Florida, 33155

    Recruiting

  • Goryeb Children's Hospital /ID# 271801

    Morristown, New Jersey, 07962

    Recruiting

  • The Children's Hospital of Philadelphia /ID# 273222

    Philadelphia, Pennsylvania, 19104

    Recruiting

  • Phoenix Children's Hospital /ID# 273015

    Phoenix, Arizona, 85016

    Recruiting

  • Upmc Children'S Hospital Of Pittsburgh /ID# 272328

    Pittsburgh, Pennsylvania, 15224

    Recruiting

  • Rady Children's Hospital /ID# 271873

    San Diego, California, 92123

    Recruiting

  • University of California San Francisco - Mission Bay /ID# 273022

    San Francisco, California, 94158

    Recruiting

Other trials in United States

China7 sites, 7 recruiting

  • The First Hospital of Jilin University - Changchun /ID# 279290

    Changchun, Jilin, 130021

    Recruiting

  • Hunan Children's Hospital /ID# 278111

    Changsha, Hunan, 410007

    Recruiting

  • Guangzhou Medical University Affiliated Women and Children's Medical Center /ID# 277962

    Guangzhou, Guangdong, 510620

    Recruiting

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine /ID# 277994

    Hangzhou, Zhejiang, 310018

    Recruiting

  • The Childrens Hospital of Zhejiang University School of Medicine /ID# 278815

    Hangzhou, Zhejiang, 310056

    Recruiting

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 278113

    Shanghai, Shanghai Municipality, 200025

    Recruiting

  • Henan Children's Hospital Zhengzhou Children's Hospital /ID# 278794

    Zhengzhou, Henan, 450018

    Recruiting

Other trials in China

South Korea5 sites, 5 recruiting

  • Seoul National University Hospital /ID# 272852

    Seoul, Seoul Teugbyeolsi, 03080

    Recruiting

  • Kangbuk Samsung Hospital /ID# 273333

    Seoul, Seoul Teugbyeolsi, 03181

    Recruiting

  • Yonsei University Health System - Severance Hospital /ID# 272894

    Seoul, Seoul Teugbyeolsi, 03722

    Recruiting

  • Samsung Medical Center /ID# 272862

    Seoul, Seoul Teugbyeolsi, 06351

    Recruiting

  • Pusan National University Yangsan Hospital /ID# 272769

    Yangsan, Gyeongsangnam-do, 50612

    Recruiting

Other trials in South Korea

Italy4 sites, 4 recruiting

  • Azienda Ospedaliera Universitaria Federico II - Naples /ID# 271895

    Naples, Napoli, 80131

    Recruiting

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

    Rome, Roma, 00168

    Recruiting

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

    San Giovanni Rotondo, Foggia, 71013

    Recruiting

  • Ospedale Infantile Burlo Garofolo /ID# 274442

    Trieste, 34137

    Recruiting

Other trials in Italy

Belgium3 sites, 3 recruiting

  • Cliniques Universitaires UCL Saint-Luc /ID# 270123

    Brussels, Brussels Capital, 1200

    Recruiting

  • Hospital Universite Enfants Reine Fabiola /ID# 271860

    Brussels, 1020

    Recruiting

  • Centre Hospitalier Regional de la Citadelle /ID# 270459

    Liège, 4000

    Recruiting

Other trials in Belgium

Brazil3 sites, 3 recruiting

  • Hospital Pequeno Principe /ID# 271814

    Curitiba, Paraná, 80250-060

    Recruiting

  • Galileo Medical Research /ID# 271817

    Juiz de Fora, Minas Gerais, 36033-318

    Recruiting

  • Hospital Sirio Libanes - Sao Paulo /ID# 271818

    São Paulo, 01308-050

    Recruiting

Other trials in Brazil

Canada3 sites, 3 recruiting

  • Alberta Children's Hospital /ID# 272635

    Calgary, Alberta, T3B 6A8

    Recruiting

  • University of Alberta Hospital /ID# 271168

    Edmonton, Alberta, T6G 2B7

    Recruiting

  • London Health Sciences Centre - Verspeeten Family Cancer Centre /ID# 271157

    London, Ontario, N6A 5W9

    Recruiting

Other trials in Canada

Germany3 sites, 3 recruiting

  • Medizinische Universitaet Lausitz - Carl Thiem /ID# 272023

    Cottbus, Brandenburg, 03048

    Recruiting

  • Klinikum Kassel /ID# 271546

    Kassel, Hesse, 34125

    Recruiting

  • Universitaetsklinikum Muenster /ID# 271898

    Münster, North Rhine-Westphalia, 48149

    Recruiting

Other trials in Germany

Greece3 sites, 3 recruiting

  • Thoracic General Hospital of Athens I Sotiria /ID# 270143

    Athens, Attica, 11527

    Recruiting

  • University General Hospital Attikon /ID# 272361

    Chaïdári, Attica, 12462

    Recruiting

  • General Hospital of Thessaloniki Hippokrateio /ID# 271939

    Thessaloniki, 54642

    Recruiting

Other trials in Greece

Serbia3 sites, 3 recruiting

  • University Children's Hospital /ID# 269960

    Belgrade, Beograd, 11000

    Recruiting

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

    Belgrade-Vračar, Beograd, 11000

    Recruiting

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

    Novi Sad, 21000

    Recruiting

Other trials in Serbia

Sweden3 sites, 3 recruiting

  • Sahlgrenska Universitetssjukhuset /ID# 271675

    Gothenburg, Västra Götaland County, 413 46

    Site Coordinator, +46313435865

    Recruiting

  • Karolinska University Hospital Solna /ID# 271679

    Solna, Stockholm County, 171 64

    Recruiting

  • Sodersjukhuset /ID# 271678

    Stockholm, Stockholm County, 118 83

    Recruiting

Other trials in Sweden

United Kingdom3 sites, 3 recruiting

  • Addenbrookes Hospital /ID# 271489

    Cambridge, Cambridgeshire, CB2 2QQ

    Recruiting

  • Alder Hey Children's NHS Foundation Trust /ID# 271533

    Liverpool, L12 2AP

    Recruiting

  • Sheffield Children's Hospital NHS Foundation Trust /ID# 271490

    Sheffield, England, S10 2TH

    Recruiting

Other trials in United Kingdom

Poland2 sites, 2 recruiting

  • Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa w Bialymstoku /ID# 276771

    Bialystok, Podlaskie Voivodeship, 15-274

    Recruiting

  • Centrum Zdrowia Mdm /ID# 276942

    Warsaw, Masovian Voivodeship, 00-189

    Recruiting

Other trials in Poland

Spain2 sites, 2 recruiting

  • Hospital Teresa Herrera - CHUAC /ID# 271459

    A Coruña, A Coruna, 15006

    Recruiting

  • Hospital Universitario Puerta de Hierro - Majadahonda /ID# 271466

    Majadahonda, Madrid, 28222

    Recruiting

Other trials in Spain

Taiwan2 sites, 2 recruiting

  • Taichung Veterans General Hospital /ID# 269242

    Taichung, 407219

    Recruiting

  • National Taiwan University Hospital /ID# 269244

    Taipei, 100

    Recruiting

Other trials in Taiwan

About this study

Official title: 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.

Read more

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.

Being tested
Risankizumab
Keywords
risankizumab
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RisankizumabDrug

    Also called ABBV-066

    Risankizumab intravenous (IV) infusion

  • RisankizumabDrug

    Also called ABBV-066

    Risankizumab subcutaneous (SC) injection

Study groups in NCT07071519
Study groupRoleWhat they receive
PK Cohort 1: SS1ExperimentalCohort 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
Receives: Drug: Risankizumab
PK Cohort 1: SS2 Dose AExperimentalCohort 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.
Receives: Drug: Risankizumab
PK Cohort 1: SS2 Dose BExperimentalCohort 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.
Receives: Drug: Risankizumab
PK Cohort 1: SS3 Dose AExperimentalCohort 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.
Receives: Drug: Risankizumab
PK Cohort 1: SS3 Dose BExperimentalCohort 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.
Receives: Drug: Risankizumab
PK Cohort 2: SS1ExperimentalCohort 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.
Receives: Drug: Risankizumab
PK Cohort 2: SS2 Dose AExperimentalCohort 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.
Receives: Drug: Risankizumab
PK Cohort 2: SS2 Dose BExperimentalCohort 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.
Receives: Drug: Risankizumab
PK Cohort 2: SS3 Dose AExperimentalCohort 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.
Receives: Drug: Risankizumab
PK Cohort 2: SS3 Dose BExperimentalCohort 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.
Receives: Drug: Risankizumab
Expansion Cohort 3: SS1ExperimentalCohort 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.
Receives: Drug: Risankizumab
Expansion Cohort 3: SS2 Dose AExperimentalCohort 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.
Receives: Drug: Risankizumab
Expansion Cohort 3: SS2 Dose BExperimentalCohort 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.
Receives: Drug: Risankizumab
Expansion Cohort 3: SS3 Dose AExperimentalCohort 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.
Receives: Drug: Risankizumab
Expansion Cohort 3: SS3 Dose BExperimentalCohort 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.
Receives: Drug: Risankizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Maximum observed plasma concentration (Cmax)

    Measured: At Week 64

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

    Maximum observed plasma concentration (Cmax)

    Measured: At Week 64

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

    Time to maximum plasma concentration (Tmax)

    Measured: At Week 64

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

    Time to maximum plasma concentration (Tmax)

    Measured: At Week 64

  5. 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)

    Measured: At Week 64

  6. 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)

    Measured: At Week 64

  7. 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

    Measured: At Week 64

  8. 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

    Measured: Up to 292 Weeks

Secondary outcomes (23)

  1. 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

    Measured: At Week 64

  2. 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

    Measured: At Week 64

  3. 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

    Measured: At Week 12

  4. 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

    Measured: At Week 12

  5. 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.

    Measured: At Week 12

  6. 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.

    Measured: At Week 12

  7. PK Lead-In Cohort 1: Achievement of endoscopic improvement

    Endoscopic improvement defined as MES ≤ 1

    Measured: At Week 12

  8. PK Lead-In Cohort 2: Achievement of endoscopic improvement

    Endoscopic improvement defined as MES ≤ 1

    Measured: At Week 12

  9. 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.

    Measured: At Week 12

  10. 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.

    Measured: At Week 12

  11. 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.

    Measured: At Week 64

  12. 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.

    Measured: At Week 64

  13. PK Lead-In Cohort 1: Achievement of endoscopic improvement among Week 12 responders per mMS

    Endoscopic improvement defined as MES ≤ 1

    Measured: At Week 64

  14. PK Lead-In Cohort 2: Achievement of endoscopic improvement among Week 12 responders per mMS

    Endoscopic improvement defined as MES ≤ 1

    Measured: At Week 64

  15. 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

    Measured: Up to Week 64

  16. 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

    Measured: Up to Week 64

  17. Expansion Cohort 3: Achievement of clinical remission per mMS

    Measured: At Week 12

  18. Expansion Cohort 3: Achievement of clinical response per mMS

    Measured: At Week 12

  19. Expansion Cohort 3: Achievement of endoscopic improvement

    Measured: At Week 12

  20. Expansion Cohort 3: Symptomatic response per partial mMS

    Measured: At Week 12

  21. Expansion Cohort 3: Achievement of clinical response per mMS among Week 12 responders per mMS

    Measured: At Week 64

  22. Expansion Cohort 3: Achievement of endoscopic improvement among Week 12 responders per mMS

    Measured: At Week 64

  23. Expansion Cohort 3: Achievement of corticosteroid-free clinical remission per mMS among Week 12 responders per mMS

    Measured: At Week 64

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2025
  2. Study start28 Jul 2025
  3. Primary completionJul 2034 (estimated)
  4. Study completionJul 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07071519
Sponsor's protocol ID
M19-751
Other IDs
2024-514695-41-00
Acronym
MIGHTY
Status last verified
Oct 2026
First submitted
8 Jul 2025
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Risankizumab in people with Ulcerative Colitis, run by AbbVie at 72 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in Japan, United States, China, South Korea, Italy and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PK Lead-In Cohort 1: Maximum Observed Serum Concentration (Cmax) (time frame: At Week 64). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07071519.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.

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