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Ulcerative ColitisPhase 3U-ASTOUNDNCT05782907

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.

A Phase 3 study testing Upadacitinib in people with Ulcerative Colitis, run by AbbVie at 89 sites in 23 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

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 safe and effective Upadacitinib is in treating pediatric participants with UC. 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?
Upadacitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
122 participants
Where
89 sitesin 23 countries
Study dates
6 Nov 2023to Oct 2031
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 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.

Who cannot join

  • 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.

Trial locations and contacts

89 sites in 23 countries.

89 sites in 23 countries

United States20 sites

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

    Atlanta, Georgia, 30329

  • Children's Hospital Colorado - Aurora /ID# 250110

    Aurora, Colorado, 80045

  • Massachusetts General Hospital /ID# 250142

    Boston, Massachusetts, 02114

  • Boston Children's Hospital /ID# 250108

    Boston, Massachusetts, 02115

  • Univ NC Chapel Hill /ID# 254541

    Chapel Hill, North Carolina, 27514-4220

  • Levine Children's Hospital /ID# 250131

    Charlotte, North Carolina, 28203

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

    Chicago, Illinois, 60611

  • UH Cleveland Medical Center /ID# 250134

    Cleveland, Ohio, 44106

  • Kindred Medical Institute - Corona /ID# 255484

    Corona, California, 92879-3104

  • Arkansas Children's Hospital /ID# 250106

    Little Rock, Arkansas, 72202

  • University of Wisconsin - Madison /ID# 250632

    Madison, Wisconsin, 53715-1218

  • NYU Langone Hospital - Long Island /ID# 250136

    Mineola, New York, 11501

  • The Mount Sinai Hospital /ID# 250141

    New York, New York, 10029

  • Children's Specialty Group /ID# 256966

    Norfolk, Virginia, 23507

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

    Oakland, California, 94609

  • Lucile Packard Children's Hospital /ID# 258430

    Palo Alto, California, 94304

  • OSF St. Francis Medical Center /ID# 256968

    Peoria, Illinois, 61637-0001

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

    Philadelphia, Pennsylvania, 19104-4319

  • Phoenix Children's Hospital /ID# 250135

    Phoenix, Arizona, 85016-7710

  • Nemours/Alfred duPont Hospital for Children /ID# 255483

    Wilmington, Delaware, 19803

Other trials in United States

Japan10 sites

  • Institute of Science Tokyo Hospital /ID# 251929

    Bunkyo-ku, Tokyo, 113-8519

  • Tokyo Metropolitan Children's Medical Center /ID# 252477

    Fuchu-shi, Tokyo, 183-8561

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

    Izumi-Shi, Osaka, 594-1101

  • Tsujinaka Hospital - Kashiwanoha /ID# 251930

    Kashiwa-shi, Chiba, 277-0871

  • Kurume University Hospital /ID# 251927

    Kurume-shi, Fukuoka, 830-0011

  • Osaka General Medical Center /ID# 253678

    Osaka, Osaka, 558-8558

  • Saitama Children's Medical Center /ID# 252362

    Saitama-shi, Saitama, 330-8777

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

    Sapporo, Hokkaido, 060-0033

  • Miyagi Children's Hospital /ID# 251931

    Sendai, Miyagi, 989-3126

  • National Center For Child Health And Development /ID# 251926

    Setagaya City, Tokyo, 157-8535

Other trials in Japan

Canada5 sites

  • Alberta Health Services /ID# 252088

    Edmonton, Alberta, T6G 1C9

  • South Edmonton Gastroenterology /ID# 276669

    Edmonton, Alberta, T6L 6K3

  • IWK Health Center /ID# 250943

    Halifax, Nova Scotia, B3K 6R8

  • Hospital for Sick Children /ID# 250945

    Toronto, Ontario, M5G 1X8

  • BC Children's Hospital /ID# 250947

    Vancouver, British Columbia, V6H 3V4

Other trials in Canada

France5 sites

  • CHU Bordeaux - Hopital Pellegrin /ID# 253182

    Bordeaux, New Aquitaine, 33076

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

    Bron, Rhone, 69500

  • AP-HP - Hopital Necker /ID# 251658

    Paris, 75015

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

    Paris, 75019

  • CHU Toulouse - Hopital Paule de Viguier /ID# 252070

    Toulouse, 31059

Other trials in France

United Kingdom5 sites

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

    Birmingham, B4 6NH

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

    London, Greater London, E1 2ES

  • Great Ormond Street Children's Hospital /ID# 252126

    London, Greater London, WC1N 3HZ

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

    Sheffield, England, S10 2TH

  • University Hospital Southampton NHS Foundation Trust /ID# 252097

    Southampton, Hampshire, SO16 6YD

Other trials in United Kingdom

Australia4 sites

  • Monash Health - Monash Medical Centre - Clayton /ID# 254726

    Clayton, Victoria, 3168

  • Perth Children'S Hospital /ID# 254727

    Perth, Western Australia, 6009

  • Queensland Children's Hospital /ID# 261032

    South Brisbane, Queensland, 4101

  • Children's Hospital at Westmead /ID# 255556

    Westmead, New South Wales, 2145

Other trials in Australia

Germany4 sites

  • Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 251434

    Berlin, 13353

  • Klinikum St. Georg gGmbH /ID# 262481

    Leipzig, Saxony, 04129

  • Dr. von Haunerschen Kinderspital /ID# 251440

    Munich, Bavaria, 80337

  • Universitaetsklinikum Muenster /ID# 256763

    Münster, North Rhine-Westphalia, 48149

Other trials in Germany

Spain4 sites

  • Hospital Universitario Vall de Hebron /ID# 252104

    Barcelona, 08035

  • Hospital Sant Joan de Deu /ID# 251194

    Esplugues de Llobregat, Barcelona, 08950

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

    Ferrol, A Coruna, 15405

  • Hospital Regional Universitario de Malaga /ID# 251193

    Málaga, 29011

Other trials in Spain

Brazil3 sites

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

    Campinas, São Paulo, 13034-685

  • Hospital Pequeno Príncipe /ID# 251911

    Curitiba, Paraná, 80250-060

  • Rocco & Nazato Servicos Medicos /ID# 251910

    São Paulo, São Paulo, 04543-011

Other trials in Brazil

Bulgaria3 sites

  • UMHAT Sveti Georgi /ID# 251949

    Plovdiv, 4002

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

    Sofia, 1606

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

    Varna, 9009

Other trials in Bulgaria

Italy3 sites

  • Ospedale Maggiore Carlo Alberto Pizzardi /ID# 251626

    Bologna, 40133

  • Azienda Ospedaliero Universitaria Meyer /ID# 251624

    Florence, Firenze, 50139

  • Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 251625

    Rome, Roma, 00161

Other trials in Italy

South Korea3 sites

  • Kyungpook National University Chilgok Hospital /ID# 252663

    Daegu, 41404

  • Seoul National University Hospital /ID# 252024

    Seoul, Seoul Teugbyeolsi, 03080

  • Samsung Medical Center /ID# 252023

    Seoul, Seoul Teugbyeolsi, 06351

Other trials in South Korea

Belgium2 sites

  • Universitair Ziekenhuis Antwerpen /ID# 251184

    Edegem, Antwerpen, 2650

  • Universitair Ziekenhuis Leuven /ID# 251185

    Leuven, Vlaams-Brabant, 3000

Other trials in Belgium

Czechia2 sites

  • Fakultní Nemocnice Plzeň-Lochotín /ID# 253284

    Pilsen, Plzen-jih, 323 00

  • Fakultni nemocnice Motol a Homolka /ID# 251955

    Prague, Praha 5, 150 06

Other trials in Czechia

Greece2 sites

  • Agia Sofia Hospital /ID# 250697

    Athens, Attica, 11527

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

    Heraklion, Crete, 71500

Other trials in Greece

Hungary2 sites

  • Semmelweis Egyetem /ID# 251083

    Budapest, 1085

  • Debreceni Egyetem-Klinikai Kozpont /ID# 251835

    Debrecen, Hajdú-Bihar, 4032

Other trials in Hungary

Israel2 sites

  • Shaare Zedek Medical Center /ID# 254832

    Jerusalem, Jerusalem, 91031

  • Schneider Children's Medical Center /ID# 254833

    Petah Tikva, Central District, 4920235

Other trials in Israel

Netherlands2 sites

  • Amsterdam UMC, locatie AMC /ID# 250845

    Amsterdam, North Holland, 1105 AZ

  • Universitair Medisch Centrum Groningen /ID# 252003

    Groningen, 9713 GZ

Other trials in Netherlands

New Zealand2 sites

  • Starship Child Health /ID# 254702

    Auckland, 0629

  • Christchurch Hospital. /ID# 254703

    Christchurch, Canterbury, 8011

Other trials in New Zealand

Poland2 sites

  • Gastromed Sp. z o.o /ID# 251290

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

  • Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 251289

    Warsaw, Masovian Voivodeship, 04-730

Other trials in Poland

Taiwan2 sites

  • National Taiwan University Hospital /ID# 251650

    Taipei, 100

  • Linkou Chang Gung Memorial Hospital /ID# 251654

    Taoyuan City, 333

Other trials in Taiwan

Mexico1 site

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

    San Pedro Garza García, Nuevo León, 66220

Other trials in Mexico

Puerto Rico1 site

  • Clinical Research Puerto Rico /ID# 266477

    San Juan, 00909-1711

Other trials in Puerto Rico

About this study

Official title: A Phase 3 Multicenter Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Upadacitinib With Open-Label Induction, Randomized, Double-Blind Maintenance and Open-Label Long-Term Extension in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis and Inadequate Response, Intolerance, or Medical Contraindications to Corticosteroids, Immunosuppressants, and/or Biologic Therapy

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.

Read more

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.

Being tested
Upadacitinib
Keywords
Upadacitinib, RINVOQ, Ulcerative Colitis, UC, Corticosteroids, Immunosuppressants, Biologic Therapy
Medical subject headings
Colitis, Ulcerative

What participants receive

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

  • UpadacitinibDrug

    Also called RINVOQ

    Oral Solution/ Tablets

Study groups in NCT05782907
Study groupRoleWhat they receive
Period 1- Open Label Induction PhaseExperimentalAll participants in open label induction phase of Period 1 will receive upadacitinib Dose A for 8 weeks based on body weight.
Receives: Drug: Upadacitinib
Period 1- Double Blind Maintenance PhaseExperimentalClinical 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.
Receives: Drug: Upadacitinib
Period 2- Open Label Long Term Extension Phase Arm AExperimentalClinical 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.
Receives: Drug: Upadacitinib
Period 2- Open Label Long Term Extension Phase Arm BExperimentalClinical 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.
Receives: Drug: Upadacitinib
Period 2- Long Term Extension Phase Arm CExperimentalClinical responders who complete Period 1 through Week 52 will receive upadacitinib Dose C daily for up to 260 weeks in OLE Period 2.
Receives: Drug: Upadacitinib

What is being measured

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

  1. 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.

    Measured: Week 8

  2. 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.

    Measured: Week 52

Secondary outcomes (9)

  1. Percentage of Participants Achieving Endoscopic Improvement (Period 1)

    Endoscopic Improvement is defined as MES < or = 1.

    Measured: Week 8

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

    The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The PMS is a composite of the following subscores: SFS, RBS and physician's global assessment (PGA). The PMS ranges from 0 to 9 with higher scores representing more severe disease. PMS clinical remission is defined as a PMS < or = 2 and no individual subscore > 1.

    Measured: Week 8

  3. Percentage of Participants Achieving AMS Clinical Response (Period 1)

    The adapted mayo score (AMS) is a composite of the following subscores: SFS, RBS and MES. AMS clinical response is defined as decrease in AMS by > or = 2 points and > or = 30% from baseline with a decrease in RBS of > or = 1 or an absolute RBS of 0 or 1.

    Measured: Week 8

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

    Endoscopic Improvement is defined as MES of < or = 1. The AMS is a composite of the following subscores: SFS, RBS and MES.

    Measured: Week 52

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

    The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The PMS ranges from 0 to 9 with higher scores representing more severe disease. PMS clinical remission is defined as a PMS < or = 2 and no individual subscore > 1. The AMS is a composite of the following subscores: SFS, RBS and MES.

    Measured: Week 52

  6. Percentage of Participants Achieving AMS Clinical Response Among Week 8 Responders per AMS (Period 1)

    The AMS is a composite of the following subscores: SFS, RBS and MES. AMS clinical response is defined as decrease in AMS by > or = 2 points and > or = 30% from baseline with a decrease in RBS of > or = 1 or an absolute RBS of 0 or 1.

    Measured: Week 52

  7. Percentage of Participants Achieving PMS Clinical Response Among Week 8 Clinical Responders per AMS (Period 1)

    The AMS is a composite of the following subscores: SFS, RBS and endoscopy MES. PMS clinical response is defined as decrease in PMS by > or = 2 points and > or = 30% from baseline with a decrease in RBS > or = 1 or an absolute RBS of 0 or 1.

    Measured: Week 52

  8. Percentage of Participants Achieving Corticosteroid-Free AMS Clinical Remission Among Week 8 Responders per AMS (Period 1)

    Corticosteroid-free AMS clinical remission is defined as being in AMS clinical remission and free of corticosteroids for >= 90 days immediately preceeding the timepoint of endpoint assessment. The AMS is a composite of the following subscores: SFS, RBS and MES.

    Measured: Week 52

  9. Percentage of Participants Achieving AMS Clinical Remission Among Week 8 Remitters per AMS (Period 1)

    The AMS is a composite of the following subscores: SFS, RBS and MES. Adapted Mayo score 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.

    Measured: Week 52

Timeline

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

  1. First posted24 Mar 2023
  2. Study start6 Nov 2023
  3. Primary completionAug 2028 (estimated)
  4. Study completionOct 2031 (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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05782907
Sponsor's protocol ID
M14-658
Other IDs
2022-501788-41-00
Acronym
U-ASTOUND
Status last verified
May 2026
First submitted
13 Mar 2023
Last updated
14 May 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 Upadacitinib in people with Ulcerative Colitis, run by AbbVie at 89 sites in 23 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 2 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: under way, not looking for participants, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 89 sites in United States, Japan, Canada, France, United Kingdom and 18 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Adapted Mayo score (AMS) Clinical Remission (Period 1) (time frame: Week 8). The study lists 2 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 NCT05782907.

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 14 May 2026.

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