A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis
NCT ID: NCT07196748
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
882 participants
INTERVENTIONAL
2025-10-01
2032-01-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Double-blind (DB) Induction Study: Icotrokinra
Adult participants will be randomized to receive icotrokinra daily, orally starting at induction Week 0 (Week I-0). At Week I-12, all participants will be evaluated for clinical response and will enter the Maintenance study.
Icotrokinra
Icotrokinra tablet will be administered orally.
DB Induction Study: Placebo
Adult participants will be randomized to receive placebo daily, orally starting at Week I-0. At Week I-12, all participants will be evaluated for clinical response and will enter the Maintenance study.
Placebo
Placebo tablet will be administered orally.
DB Maintenance Study: Icotrokinra
Adult participants who are in clinical response to icotrokinra at the end of the Induction study will enter the Maintenance study and be randomized to receive icotrokinra daily, orally starting at maintenance Week 0 (Week M-0) through Week M-40. Participants who are clinical nonresponders to icotrokinra or placebo will also enter the Maintenance study directly and receive icotrokinra daily. After completion of the Maintenance study through Week M-40, eligible participants can participate in a long-term extension (LTE).
Icotrokinra
Icotrokinra tablet will be administered orally.
DB Maintenance Study: Placebo
Adult participants who are in clinical response to icotrokinra at the end of the Induction study will enter the Maintenance study and be randomized to receive placebo daily, orally starting at Week M-0 through Week M-40. Participants who are clinical responders to placebo will also enter the Maintenance study directly and continue to receive placebo daily. After completion of the Maintenance study through Week M-40, eligible participants can participate in a LTE.
Placebo
Placebo tablet will be administered orally.
Open-label (OL) Induction Phase: Icotrokinra
Adolescent participants will enter the Induction phase and receive icotrokinra daily, orally. At Week I-12 all participants will be evaluated for clinical response and will enter the Maintenance phase.
Icotrokinra
Icotrokinra tablet will be administered orally.
OL Maintenance Phase: Icotrokinra
Adolescent participants who are in clinical response to icotrokinra will enter the Maintenance phase at Week M-0 and continue to receive icotrokinra daily, orally up to Week M-40. Participants who are nonresponders to icotrokinra will also enter the Maintenance phase to receive icotrokinra daily. After completion of the Maintenance phase through Week M-40, eligible participants can participate in a LTE.
Icotrokinra
Icotrokinra tablet will be administered orally.
Interventions
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Icotrokinra
Icotrokinra tablet will be administered orally.
Placebo
Placebo tablet will be administered orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Moderately to severely active UC, defined as a baseline (Week I-0) modified Mayo score of 5 to 9, inclusive, using the endoscopy subscore obtained during the central review of the screening video endoscopy
* An endoscopy subscore greater than or equal to (\>=) 2 as obtained during central review of the screening video endoscopy
* For adolescent participants \>=12 to less than (\<) 18 years of age, body weight must be \>=40 kilograms (kg) at baseline (Week I-0)
* Adult female participants of childbearing potential and all adolescent female participants must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin \[β-hCG\]) at screening and a negative urine pregnancy test at Week I-0 prior to administration of study intervention and agree to further pregnancy tests
* Demonstrated an inadequate response, loss of response, or failure to tolerate previous conventional therapy (advanced drug therapy \[ADT\]-naïve) or advanced therapy defined as biologics and/or advanced oral agents for the treatment of UC (ADT-inadequate responder \[IR\]) as defined in the protocol
Exclusion Criteria
* Presence of a stoma
* Presence or history of a fistula
* Colonic resection within 24 weeks before baseline or any other intra-abdominal or other major surgery performed within 12 weeks before baseline
* History of extensive colonic resection (that is, less than \[\<\] 30 centimeter \[cm\] of colon remaining) or colonic resection that could impair the use of disease severity assessments (for example Mayo Score) to assess response to study intervention
12 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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AZ Gastro Care
Chandler, Arizona, United States
Clinnova Research
Anaheim, California, United States
Southern California Research Center
Coronado, California, United States
Om Research LLC
Lancaster, California, United States
TLC Clinical Research Inc
Los Angeles, California, United States
GastroIntestinal Bioscience
Los Angeles, California, United States
Om Research LLC
Oxnard, California, United States
Clinical Applications Laboratories, Inc
San Diego, California, United States
Medical Associates Research Group, Inc.
San Diego, California, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
Nuvance Health Danbury Hospital
Danbury, Connecticut, United States
American Institute of Research
Cutler Bay, Florida, United States
Nature Coast Clinical Research
Inverness, Florida, United States
Florida Research Institute
Lakewood Rch, Florida, United States
GCP Clinical Research
Tampa, Florida, United States
Children's Center for Digestive Health Care
Atlanta, Georgia, United States
Gastroenterolgy Associates of Central GA
Macon, Georgia, United States
Cotton O'Neil Digestive Health Center
Topeka, Kansas, United States
Tri-State Gastroenterology Assoc
Crestview Hills, Kentucky, United States
Delta Research Partners, LLC
West Monroe, Louisiana, United States
Westchester Putnam Gastroenterology
Carmel, New York, United States
Manhattan Clinical Research LLC
New York, New York, United States
New York Gastroenterology Associates
New York, New York, United States
Gastro Intestinal Research Institute of Northern Ohio LLC
Westlake, Ohio, United States
Digestive Disease Specialists Inc
Oklahoma City, Oklahoma, United States
The Oregon Clinic
Portland, Oregon, United States
Susquehanna Research Group
Harrisburg, Pennsylvania, United States
Digestive Disease Associates
Rock Hill, South Carolina, United States
DFW Clinical Trials
Carrollton, Texas, United States
Victorium Clinical Research
Houston, Texas, United States
Southern Star Research Institute, LLC
San Antonio, Texas, United States
Tyler Research Institute, LLC
Tyler, Texas, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States
GEDYT
AAI, , Argentina
Monash Medical Centre
Clayton, , Australia
Concord Repatriation General Hospital
Concord, , Australia
St Vincents Hospital Melbourne
Fitzroy, , Australia
John Hunter Hospital
New Lambton Heights, , Australia
Royal Melbourne Hospital
Parkville, , Australia
Mater Hospital Brisbane
South Brisbane, , Australia
GIRI Gastrointestinal Research Institute
Vancouver, British Columbia, Canada
Viable Clinical Research
Kentville, Nova Scotia, Canada
Barrie GI Associates
Barrie, Ontario, Canada
London Digestive Disease Institute
London, Ontario, Canada
West GTA Research Inc
Mississauga, Ontario, Canada
ABP Research Services Corp.
Oakville, Ontario, Canada
Toronto Immune and Digestive Health Institute Inc
Toronto, Ontario, Canada
Clinique IMD
Montreal, Quebec, Canada
Affiliated Hospital of Hainan Medical University
Haikou, , China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, , China
Heilongjiang Provincial Hospital
Harbin, , China
Huizhou Central People's Hospital
Huizhou, , China
The First Affiliated Hospital of Ningbo University
Ningbo, , China
Wuxi People s Hospital
Wuxi, , China
APHP - Hopital Henri Mondor
Créteil, , France
Institut Prive MICI Clinique des Cedres
Échirolles, , France
CHU de Lille Hopital Claude Huriez
Lille, , France
CHU de Limoges Hopital Dupuytren
Limoges, , France
CHU de Montpellier Hopital Saint Eloi
Montpellier, , France
Jules Verne Clinic
Nantes, , France
Hopital Saint-Antoine
Paris, , France
CHU de Bordeaux - Hospital Haut-Leveque
Pessac, , France
Hospices Civils de Lyon CHU Lyon Sud
Pierre-Bénite, , France
CHU Toulouse - Hopital de Rangueil
Toulouse, , France
CHRU de Nancy - Hopitaux de Brabois
Vandœuvre-lès-Nancy, , France
Krankenhaus Waldfriede Mitte
Berlin, , Germany
Medizinisches Versorgungszentrum (MVZ) Dachau
Dachau, , Germany
Evangelismos S A
Athens, , Greece
Assuta MC
Ashdod, , Israel
Shamir Medical Center Assaf Harofeh
Be’er Ya‘aqov, , Israel
Bnai Zion Medical Center
Haifa, , Israel
Rambam Health Care Campus
Haifa, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Galilee Medical Center
Nahariya, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Juntendo University Hospital Urayasu
Chiba, , Japan
Ginza central clinic
Chūōku, , Japan
Sai Gastroenterology Proctology
Fujiidera-shi, , Japan
Fukui Prefectural Hospital
Fukui-shi, , Japan
Saiseikai Fukuoka General Hospital
Fukuoka, , Japan
Gamagori City Hospital
Gamagōri, , Japan
National Hospital Organization Mito Medical Center
Higashiibaraki-gun, , Japan
Hirosaki General Medical Center
Hirosaki, , Japan
Kagoshima IBD Gastroenterology Clinic
Kagoshima, , Japan
National Hospital Organization Kanazawa Medical Center
Kanazawa, , Japan
Tsujinaka Hospital Kashiwanoha
Kashiwa, , Japan
Kobe University Hospital
Kobe, , Japan
Aoyama Naika Clinic
Kobe, , Japan
Japanese Red Cross Kumamoto Hospital
Kumamoto, , Japan
Takano Hospital
Kumamoto, , Japan
Takagi Clinic
Miyagi, , Japan
Hyogo Medical University Hospital
Nishinomiya Shi, , Japan
Nakagami Hospital
Okinawa, , Japan
Kinshukai Infusion Clinic
Osaka, , Japan
National Hospital Organization Osaka National Hospital
Osaka, , Japan
Japanese Red Cross Osaka Hospital
Osaka, , Japan
Oita Red Cross Hospital
Ōita, , Japan
Sapporo Tokushukai Hospital
Sapporo, , Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
Sapporo, , Japan
Matsuda Hospital
Shizuoka, , Japan
Tokyo Metropolitan Bokutoh Hospital
Sumida Ku, , Japan
National Hospital Organization Shizuoka Medical Center
Sunto-gun, , Japan
Hospital Sultanah Bahiyah
Alor Star, , Malaysia
Hospital Ampang
Ampang, , Malaysia
Hospital Sultanah Aminah
Johor Bahru, , Malaysia
Sultan Idris Shah Hospital
Kajang, , Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, , Malaysia
University Malaya Medical Centre
Kuala Lumpur, , Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, , Malaysia
NZOZ Centrum Medyczne KERmed
Bydgoszcz, , Poland
Centrum Medyczne Plejady
Krakow, , Poland
Pratia Poznan
Poznan, , Poland
Endoskopia Sp z o.o.
Sopot, , Poland
Medon Clinical Research
Warsaw, , Poland
Uls Loures Odivelas - Hosp. Loures
Loures, , Portugal
S C Delta Health Care S R L
Bucharest, , Romania
Hosp. Clinic de Barcelona
Barcelona, , Spain
Hosp. Virgen Macarena
Seville, , Spain
Changhua Christian Hospital
Changhua, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Fairfield General Hospital
Greater Manchester, , United Kingdom
Whiston Hospital
Rainhill, , United Kingdom
Stepping Hill Hospital
Stockport, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2025-521381-10-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
77242113UCO3001
Identifier Type: -
Identifier Source: org_study_id