Study to Assess Adverse Events, Change in Disease Activity, and How Oral Upadacitinib Moves Through the Body of Pediatric Participants With Moderately to Severely Active Ulcerative Colitis.

NCT05782907 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: M14-6582022-501788-41-00
• Study Type: interventional
• Target: 122
• Locations: 23 countries
• Sites: 89

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 safe and effective Upadacitinib is in treating pediatric participants with UC. Adverse events and change in disease activity will be assessed. Upadacitinib (RINVOQ) is a drug approved in adults for moderate- to severely active UC and is being developed for moderate- to severely active UC in pediatric participants. This study is conducted in 2 periods: Period 1 is comprised of two phases: an 8-week open-label induction phase which means that the study doctor and patients know that participants will receive UPA Dose-A (or the adult equivalent based on body weight) followed by a 44-week double-blind maintenance phase meaning that neither the participants nor the study doctors will know which dose of upadacitinib will be given(UPA Dose B or Dose C). Period 2 is a 260 week open-label extension (OLE) of Period 1. Approximately 110 pediatric participants with moderate to severely active UC will be enrolled at up to 100 sites worldwide. Participants will receive upadacitinib oral tablets once daily or oral solution twice daily at approximately the same time each day, with or without food. Participants will be followed up for 30 days after each phase (i.e. after induction, maintenance, OLE) and only if a participant doesn't continue into the next phase. 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

Upadacitinib; RINVOQ; Ulcerative Colitis; UC; Corticosteroids; Immunosuppressants; Biologic Therapy

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Achieving Adapted Mayo score (AMS) Clinical Remission (Period 1)

  The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The AMS is a composite of the following subscores: stool frequency subscore (SFS), rectal bleeding subscore (RBS) and endoscopy subscore (MES). AMS ranges from 0 to 9 where higher scores represent more severe disease. Clinical remission is defined as an AMS \< or = 2, with SFS \< or = 1 and not higher than baseline, RBS of 0, and MES \< or = 1.

  Week 8

• Percentage of Participants Achieving AMS Clinical Remission Among Week 8 Responders per AMS (Period 1)

  The Mayo score is a tool designed to measure disease activity for ulcerative colitis. AMS ranges from 0 to 9 where higher scores represent more severe disease. Clinical remission is defined as an AMS ≤ 2, with SFS ≤ 1 and not higher than Baseline, RBS of 0, and MES ≤ 1.

  Week 52

Secondary Outcomes (9)

• Percentage of Participants Achieving Endoscopic Improvement (Period 1)

  Week 8

• Percentage of Participants Achieving Partial Mayo Score (PMS) Clinical Remission (Period 1)

  Week 8

• Percentage of Participants Achieving AMS Clinical Response (Period 1)

  Week 8

• Percentage of Participants Achieving Endoscopic Improvement Among Week 8 Responders per AMS (Period 1)

  Week 52

• Percentage of Participants Achieving PMS Clinical Remission Among Week 8 Responders per AMS (Period 1)

  Week 52

Study Arms (5)

Period 1- Open Label Induction Phase

EXPERIMENTAL

All participants in open label induction phase of Period 1 will receive upadacitinib Dose A for 8 weeks based on body weight.

Drug: Upadacitinib

Period 1- Double Blind Maintenance Phase

EXPERIMENTAL

Clinical responders at the end of open label induction phase of Period 1 will be randomly assigned to receive either upadacitinib Dose B or Dose C for 44 weeks based on body weight.

Drug: Upadacitinib

Period 2- Open Label Long Term Extension Phase Arm A

EXPERIMENTAL

Clinical non-responders outside of US after Period 1 induction phase will receive upadacitinib Dose A daily for 8 week extended induction phase in open label long term extension (OLE) Period 2. Clinical responders from extended induction phase in OLE will receive upadacitinib Dose B daily for up to 252 weeks in OLE period 2.

Drug: Upadacitinib

Period 2- Open Label Long Term Extension Phase Arm B

EXPERIMENTAL

Clinical non-responders in US after Period 1 induction phase or clinical responders with loss of response during maintenance phase will receive upadacitinib Dose B daily for up to 260 weeks in OLE Period 2.

Drug: Upadacitinib

Period 2- Long Term Extension Phase Arm C

EXPERIMENTAL

Clinical responders who complete Period 1 through Week 52 will receive upadacitinib Dose C daily for up to 260 weeks in OLE Period 2.

Drug: Upadacitinib

Interventions

Upadacitinib DRUG

Oral Solution/ Tablets

Also known as: RINVOQ

Period 1- Double Blind Maintenance Phase; Period 1- Open Label Induction Phase; Period 2- Long Term Extension Phase Arm C; Period 2- Open Label Long Term Extension Phase Arm A; Period 2- Open Label Long Term Extension Phase Arm B

Eligibility Criteria

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

You may qualify if:

• Active UC with an AMS of 5 to 9 points and endoscopic subscore of 2 to 3.
• Demonstrate an inadequate response, loss of response, intolerance, or medical contraindications to corticosteroids, immunosuppressants, and/or biologic therapy.

You may not qualify if:

• Partcipants with previous exposure to JAK inhibitors (e.g., tofacitinib, baricitinib, filgotinib, upadacitinib).
• Females who are pregnant, breastfeeding, or considering becoming pregnant during the study and for approximately 30 days after the last dose of study drug.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (89)

Phoenix Children's Hospital /ID# 250135

Phoenix, Arizona, 85016-7710, United States

Location

Arkansas Children's Hospital /ID# 250106

Little Rock, Arkansas, 72202, United States

Location

Kindred Medical Institute - Corona /ID# 255484

Corona, California, 92879-3104, United States

Location

UCSF Benioff Children's Hospital - Oakland /ID# 255067

Oakland, California, 94609, United States

Location

Lucile Packard Children's Hospital /ID# 258430

Palo Alto, California, 94304, United States

Location

Children's Hospital Colorado - Aurora /ID# 250110

Aurora, Colorado, 80045, United States

Location

Nemours/Alfred duPont Hospital for Children /ID# 255483

Wilmington, Delaware, 19803, United States

Location

Childrens Healthcare of Atlanta - Center for Advanced Pediatrics /ID# 255069

Atlanta, Georgia, 30329, United States

Location

Ann & Robert H. Lurie Children's Hospital of Chicago /ID# 254505

Chicago, Illinois, 60611, United States

Location

OSF St. Francis Medical Center /ID# 256968

Peoria, Illinois, 61637-0001, United States

Location

Massachusetts General Hospital /ID# 250142

Boston, Massachusetts, 02114, United States

Location

Boston Children's Hospital /ID# 250108

Boston, Massachusetts, 02115, United States

Location

NYU Langone Hospital - Long Island /ID# 250136

Mineola, New York, 11501, United States

Location

The Mount Sinai Hospital /ID# 250141

New York, New York, 10029, United States

Location

Univ NC Chapel Hill /ID# 254541

Chapel Hill, North Carolina, 27514-4220, United States

Location

Levine Children's Hospital /ID# 250131

Charlotte, North Carolina, 28203, United States

Location

UH Cleveland Medical Center /ID# 250134

Cleveland, Ohio, 44106, United States

Location

Children's Hospital of Philadelphia - Main /ID# 258773

Philadelphia, Pennsylvania, 19104-4319, United States

Location

Children's Specialty Group /ID# 256966

Norfolk, Virginia, 23507, United States

Location

University of Wisconsin - Madison /ID# 250632

Madison, Wisconsin, 53715-1218, United States

Location

Children's Hospital at Westmead /ID# 255556

Westmead, New South Wales, 2145, Australia

Location

Queensland Children's Hospital /ID# 261032

South Brisbane, Queensland, 4101, Australia

Location

Monash Health - Monash Medical Centre /ID# 254726

Clayton, Victoria, 3168, Australia

Location

Perth Children'S Hospital /ID# 254727

Perth, Western Australia, 6009, Australia

Location

Universitair Ziekenhuis Antwerpen /ID# 251184

Edegem, Antwerpen, 2650, Belgium

Location

Universitair Ziekenhuis Leuven /ID# 251185

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Hospital Pequeno Príncipe /ID# 251911

Curitiba, Paraná, 80250-060, Brazil

Location

Hospital e Maternidade Celso Pierro - PUC-Campinas /ID# 251912

Campinas, São Paulo, 13034-685, Brazil

Location

Rocco & Nazato Servicos Medicos /ID# 251910

São Paulo, São Paulo, 04543-011, Brazil

Location

UMHAT Sveti Georgi /ID# 251949

Plovdiv, 4002, Bulgaria

Location

Specialized Hospital For Active Treatment Of Children Diseases Prof. Ivan Mitev /ID# 251285

Sofia, 1606, Bulgaria

Location

UMHAT Multiprofile Hospital for Active Treatment Sveta Marina /ID# 251948

Varna, 9009, Bulgaria

Location

Alberta Health Services /ID# 252088

Edmonton, Alberta, T6G 1C9, Canada

Location

South Edmonton Gastroenterology /ID# 276669

Edmonton, Alberta, T6L 6K3, Canada

Location

BC Children's Hospital /ID# 250947

Vancouver, British Columbia, V6H 3V4, Canada

Location

IWK Health Center /ID# 250943

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Hospital for Sick Children /ID# 250945

Toronto, Ontario, M5G 1X8, Canada

Location

Fakultní Nemocnice Plzeň-Lochotín /ID# 253284

Pilsen, Plzen-jih, 323 00, Czechia

Location

Fakultní nemocnice v Motole /ID# 251955

Prague, Praha 5, 150 06, Czechia

Location

CHU Bordeaux - Hopital Pellegrin /ID# 253182

Bordeaux, Nouvelle-Aquitaine, 33076, France

Location

Hospices Civils de Lyon - Hôpital Femme Mère Enfant /ID# 251502

Bron, Rhone, 69500, France

Location

AP-HP - Hopital Necker /ID# 251658

Paris, 75015, France

Location

Hopitaux de Paris (AP-HP) - Hopital Robert Debre - CHU /ID# 252069

Paris, 75019, France

Location

CHU Toulouse - Hopital Paule de Viguier /ID# 252070

Toulouse, 31059, France

Location

Dr. von Haunerschen Kinderspital /ID# 251440

Munich, Bavaria, 80337, Germany

Location

Universitaetsklinikum Muenster /ID# 256763

Münster, North Rhine-Westphalia, 48149, Germany

Location

Klinikum St. Georg gGmbH /ID# 262481

Leipzig, Saxony, 04129, Germany

Location

Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 251434

Berlin, 13353, Germany

Location

Agia Sofia Hospital /ID# 250697

Athens, Attica, 11527, Greece

Location

University General Hospital of Heraklion PA.G.N.I /ID# 250696

Heraklion, Crete, 71500, Greece

Location

Debreceni Egyetem-Klinikai Kozpont /ID# 251835

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

Semmelweis Egyetem /ID# 251083

Budapest, 1085, Hungary

Location

Schneider Children's Medical Center /ID# 254833

Petah Tikva, Central District, 4920235, Israel

Location

Shaare Zedek Medical Center /ID# 254832

Jerusalem, Jerusalem, 91031, Israel

Location

Azienda Ospedaliero Universitaria Meyer /ID# 251624

Florence, Firenze, 50139, Italy

Location

Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 251625

Rome, Roma, 00161, Italy

Location

Ospedale Maggiore Carlo Alberto Pizzardi /ID# 251626

Bologna, 40133, Italy

Location

Tsujinaka Hospital - Kashiwanoha /ID# 251930

Kashiwa-shi, Chiba, 277-0871, Japan

Location

Kurume University Hospital /ID# 251927

Kurume-shi, Fukuoka, 830-0011, Japan

Location

Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 251928

Sapporo, Hokkaido, 060-0033, Japan

Location

Miyagi Children's Hospital /ID# 251931

Sendai, Miyagi, 989-3126, Japan

Location

Osaka Women's and Children's Hospital /ID# 252397

Izumi-Shi, Osaka, 594-1101, Japan

Location

Osaka General Medical Center /ID# 253678

Osaka, Osaka, 558-8558, Japan

Location

Saitama Children's Medical Center /ID# 252362

Saitama-shi, Saitama, 330-8777, Japan

Location

Institute of Science Tokyo Hospital /ID# 251929

Bunkyo-ku, Tokyo, 113-8519, Japan

Location

Tokyo Metropolitan Children's Medical Center /ID# 252477

Fuchu-shi, Tokyo, 183-8561, Japan

Location

National Center For Child Health And Development /ID# 251926

Setagaya City, Tokyo, 157-8535, Japan

Location

Servicios de Oncologia Medica Integral SA de CV /ID# 252974

San Pedro Garza García, Nuevo León, 66220, Mexico

Location

Amsterdam UMC, locatie AMC /ID# 250845

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Universitair Medisch Centrum Groningen /ID# 252003

Groningen, 9713 GZ, Netherlands

Location

Christchurch Hospital. /ID# 254703

Christchurch, Canterbury, 8011, New Zealand

Location

Starship Child Health /ID# 254702

Auckland, 0629, New Zealand

Location

Gastromed Sp. z o.o /ID# 251290

Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

Location

Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 251289

Warsaw, Masovian Voivodeship, 04-730, Poland

Location

Clinical Research Puerto Rico /ID# 266477

San Juan, 00909-1711, Puerto Rico

Location

Seoul National University Hospital /ID# 252024

Seoul, Seoul Teugbyeolsi, 03080, South Korea

Location

Samsung Medical Center /ID# 252023

Seoul, Seoul Teugbyeolsi, 06351, South Korea

Location

Kyungpook National University Chilgok Hospital /ID# 252663

Daegu, 41404, South Korea

Location

Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 252105

Ferrol, A Coruna, 15405, Spain

Location

Hospital Sant Joan de Deu /ID# 251194

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Hospital Universitario Vall de Hebron /ID# 252104

Barcelona, 08035, Spain

Location

Hospital Regional Universitario de Malaga /ID# 251193

Málaga, 29011, Spain

Location

National Taiwan University Hospital /ID# 251650

Taipei City, Taipei, 100, Taiwan

Location

Linkou Chang Gung Memorial Hospital /ID# 251654

Taoyuan, 333, Taiwan

Location

Sheffield Children's Hospital NHS Foundation Trust /ID# 251600

Sheffield, England, S10 2TH, United Kingdom

Location

Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 251917

London, Greater London, E1 2ES, United Kingdom

Location

Great Ormond Street Children's Hospital /ID# 252126

London, Greater London, WC1N 3HZ, United Kingdom

Location

University Hospital Southampton NHS Foundation Trust /ID# 252097

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Birmingham Women's and Children's NHS Foundation Trust /ID# 253072

Birmingham, B4 6NH, United Kingdom

Location

Related Links

• This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

upadacitinib

Condition Hierarchy (Ancestors)

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

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 24, 2023
• Study Start: November 6, 2023
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): October 1, 2033
• Last Updated: December 26, 2025

Record last verified: 2025-12

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 (20); BE (2); HU (2); PR (1); KR (3); AU (4); GR (2); NZ (2); BU (3); ES (4); JP (10); PL (2); NL (2); IL (2); CZ (2); GB (5); BR (3); DE (4); CA (5); IT (3); TW (2); ME (1); FR (5)