Crohn's DiseasePhase 3U-EMPOWERNCT06332534
Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease
A Phase 3 study testing Upadacitinib in people with Crohn's Disease, run by AbbVie at 85 sites in 18 countries.
Trial summary
Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Crohn's Disease
- 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
- 111 participants
- Where
- 85 sitesin 18 countries
- Study dates
- 8 Aug 2024to Jan 2031
- Phase
- Phase 3
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
- Weight at Screening and Baseline must be >= 10 kg
- Moderate to severe Crohn's Disease (CD) defined as Pediatric Crohn's Disease Activity Index (PCDAI) > 30 and endoscopic evidence of mucosal inflammation as documented by a centrally read SES-CD of >= 6 (or SES-CD of >=4 for isolated ileal disease) excluding the presence of narrowing component.
- Documented diagnosis of CD prior to Baseline, confirmed by colonoscopy during the screening period, with exclusion of current infection, colonic dysplasia and/or malignancy. Appropriate documentation of biopsy results consistent with the diagnosis of CD, in the assessment of the investigator, must be available
- Demonstrated an inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators (IMMs), and/or biologic therapy or in whom use of those therapies is medically contraindicated. For participants in the US and South Korea, participants must have demonstrated an inadequate response, loss of response, or intolerance to one or more anti-TNFs (tumor necrosis factor).
Who cannot join
- History of:
- A diagnosis of CD prior to 2 years of age.
- Currently known complications of CD such as:
- Active abscess (abdominal or perianal);
- Symptomatic bowel strictures;
- More than 2 missing segments of the following 5 intestinal segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum;
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- Ostomy or ileoanal pouch;
- Surgical bowel resection within the past 3 months prior to Baseline, or a history of more than 3 bowel resections.
- Japan participants only: positive result of beta-D-glucan or two consecutive indeterminate results of beta-D-glucan during the Screening period (screening for Pneumocystis jiroveci infection)
- History of any of the following:
- Current diagnosis of ulcerative colitis (UC), indeterminate colitis, or monogenic inflammatory bowel disease (IBD);
- Fulminant colitis or toxic megacolon;
- Gastrointestinal (GI) perforation (other than due to appendicitis or mechanical injury), diverticulitis, or significantly increased risk for GI perforation per investigator judgment including history of volvulus and/or intussusception (telescoping of bowels);
- Current diagnosis of any primary immune deficiency
- Conditions that could interfere with drug absorption including but not limited to short bowel syndrome or gastric bypass surgery; subjects with a history of gastric banding/segmentation are not excluded.
Trial locations and contacts
85 sites in 18 countries.
85 sites in 18 countries
United States12 sites
Children's Hospital Colorado - Aurora /ID# 262207
Aurora, Colorado, 80045
Boston Children's Hospital /ID# 262191
Boston, Massachusetts, 02115
Univ NC Chapel Hill /ID# 262198
Chapel Hill, North Carolina, 27514-4220
UH Cleveland Medical Center /ID# 262188
Cleveland, Ohio, 44106
Connecticut Children's Medical Center - Hartford /ID# 262256
Hartford, Connecticut, 06106
Indiana University Health Riley Hospital for Children /ID# 262215
Indianapolis, Indiana, 46202
MNGI Digestive Health, P. A. /ID# 262204
Minneapolis, Minnesota, 55413-2195
Icahn School of Medicine at Mount Sinai /ID# 262216
New York, New York, 10029
UCSF Benioff Children's Hospital - Oakland /ID# 262217
Oakland, California, 94609
Lucile Packard Children's Hospital /ID# 262193
Palo Alto, California, 94304
OSF St. Francis Medical Center /ID# 262192
Peoria, Illinois, 61637-0001
Children's Hospital of Philadelphia - Main /ID# 262197
Philadelphia, Pennsylvania, 19104-4319
China10 sites
Beijing Children's Hospital /ID# 262258
Beijing, Beijing Municipality, 100045
Hunan Children's Hospital /ID# 262512
Changsha, Hunan, 410007
Guangzhou Medical University Affiliated Women and Children's Medical Center /ID# 262596
Guangzhou, Guangdong, 510620
The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 272807
Guangzhou, Guangdong, 510655
The Children's Hospital of Zhejiang University School of Medicine /ID# 262337
Hangzhou, Zhejiang, 310003
Jiangxi Provincial Children's Hospital /ID# 262295
Nanchang, Jiangxi, 330006
Children's Hospital of Shanghai /ID# 262356
Shanghai, Shanghai Municipality, 200062
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 262502
Shanghai, Shanghai Municipality, 200065
Shengjing Hospital of China Medical University /ID# 262301
Shenyang, Liaoning, 110022
Henan Children's Hospital Zhengzhou Children's Hospital /ID# 262300
Zhengzhou, Henan, 450018
Japan10 sites
Institute of Science Tokyo Hospital /ID# 262510
Bunkyo-ku, Tokyo, 113-8519
Tokyo Metropolitan Children's Medical Center /ID# 262550
Fuchu-shi, Tokyo, 183-8561
Osaka Women's and Children's Hospital /ID# 262549
Izumi-Shi, Osaka, 594-1101
Tsujinaka Hospital - Kashiwanoha /ID# 262454
Kashiwa-shi, Chiba, 277-0871
Kurume University Hospital /ID# 262455
Kurume-shi, Fukuoka, 830-0011
Saga University Hospital /ID# 262753
Saga, Saga-ken, 849-8501
Saitama Children's Medical Center /ID# 262461
Saitama-shi, Saitama, 330-8777
Miyagi Children's Hospital /ID# 262459
Sendai, Miyagi, 989-3126
National Center For Child Health And Development /ID# 262456
Setagaya City, Tokyo, 157-8535
Toyama Prefectural Central Hospital /ID# 262739
Toyama, Toyama, 930-8550
Belgium6 sites
Cliniques Universitaires UCL Saint-Luc /ID# 261741
Brussels, Brussels Capital, 1200
Hospital Universite Enfants Reine Fabiola /ID# 261744
Brussels, 1020
Uza /Id# 261745
Edegem, Antwerpen, 2650
Universitair Ziekenhuis Leuven /ID# 261740
Leuven, Vlaams-Brabant, 3000
CHR de la Citadelle /ID# 261749
Liège, 4000
UCL Namur University Hospital, Site Sainte-Elisabeth /ID# 261750
Namur, 5000
Australia5 sites
Monash Health - Monash Medical Centre - Clayton /ID# 262878
Clayton, Victoria, 3168
Perth Children'S Hospital /ID# 272905
Perth, Western Australia, 6009
Sydney Children's Hospital /ID# 262352
Randwick, New South Wales, 2031
Queensland Children's Hospital /ID# 262351
South Brisbane, Queensland, 4101
Children's Hospital at Westmead /ID# 262350
Westmead, New South Wales, 2145
Brazil5 sites
Hospital Pequeno Principe /ID# 262600
Curitiba, Paraná, 80250-060
Galileo Medical Research Ltda /ID# 262602
Juiz de Fora, Minas Gerais, 36033-318
Santo Antonio Children's Hospital /ID# 262601
Porto Alegre, Rio Grande do Sul, 90240-510
Rocco & Nazato Servicos Medicos /ID# 262485
São Paulo, São Paulo, 04543-011
Hospital Sirio Libanes - Sao Paulo /ID# 262670
São Paulo, 01308-050
Spain5 sites
Hospital Sant Joan de Deu /ID# 262599
Esplugues de Llobregat, Barcelona, 08950
Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 262226
Ferrol, A Coruna, 15405
Hospital Regional Universitario de Malaga /ID# 262228
Málaga, 29011
Hospital Universitario Virgen del Rocio /ID# 262712
Seville, 41013
Hospital Clinico Universitario Lozano Blesa /ID# 262227
Zaragoza, 50009
United Kingdom5 sites
Addenbrookes Hospital /ID# 262707
Cambridge, Cambridgeshire, CB2 2QQ
Royal Hospital for Children and Young People /ID# 262388
Edinburgh, EH16 4TJ
Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 262811
London, Greater London, E1 2ES
Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 262778
Norwich, Norfolk, NR4 7UY
Sheffield Children's Hospital NHS Foundation Trust /ID# 261832
Sheffield, England, S10 2TH
Italy4 sites
Azienda Ospedaliera Universitaria Gaetano Martino /ID# 262380
Messina, 98125
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 275276
Milan, 20122
Ospedale Pediatrico Bambino Gesu /ID# 262379
Rome, Roma, 00165
Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 262384
San Giovanni Rotondo, Foggia, 71013
Canada3 sites
IWK Health Center /ID# 262543
Halifax, Nova Scotia, B3K 6R8
CHU Sainte-Justine /ID# 262096
Montreal, Quebec, H3T 1C5
BC Children's Hospital /ID# 262237
Vancouver, British Columbia, V6H 3V4
France3 sites
Hospices Civils de Lyon - Hopital Femme Mere Enfant /ID# 263422
Bron, Rhone, 69500
CHU de CAEN - Hopital de la Cote de Nacre /ID# 262311
Caen, Calvados, 14033
Hopitaux de Paris (AP-HP) - Hopital Robert Debre - CHU /ID# 262308
Paris, 75019
Greece3 sites
Agia Sofia Hospital /ID# 261792
Athens, Attica, 11527
Thoracic General Hospital of Athens I Sotiria /ID# 261790
Athens, Attica, 11527
University General Hospital of Heraklion PA.G.N.I /ID# 261791
Heraklion, Crete, 71500
Puerto Rico3 sites
Clinical Research Investigator Group /ID# 262357
Bayamón, 00960
Puerto Rico Health Institute /ID# 262358
Dorado, 00646
Clinical Research Puerto Rico /ID# 279595
San Juan, 00909-1711
South Korea3 sites
Seoul National University Hospital /ID# 262324
Seoul, Seoul Teugbyeolsi, 03080
Yonsei University Health System - Severance Hospital /ID# 262721
Seoul, Seoul Teugbyeolsi, 03722
Samsung Medical Center /ID# 262323
Seoul, Seoul Teugbyeolsi, 06351
Bulgaria2 sites
UMHAT Sveti Georgi /ID# 262590
Plovdiv, 4002
Specialized Hospital For Active Treatment Of Children Diseases Prof. Ivan Mitev /ID# 262589
Sofia, 1606
New Zealand2 sites
Christchurch Hospital. /ID# 262577
Christchurch, Canterbury, 8011
Starship Child Health /ID# 262576
Grafton, Auckland, 1023
Poland2 sites
Gastromed Sp. z o.o /ID# 262367
Torun, Kuyavian-Pomeranian Voivodeship, 87-100
Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 262366
Warsaw, Masovian Voivodeship, 04-730
Taiwan2 sites
National Taiwan University Hospital /ID# 261695
Taipei, 100
Linkou Chang Gung Memorial Hospital /ID# 261696
Taoyuan City, 333
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 Crohn's Disease and Inadequate Response, Intolerance, or Medical Contraindications to Corticosteroids, Immunosuppressants, and/or Biologic Therapy
Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective oral Upadacitinib is in treating moderately to severely active Crohn's Disease in pediatric participants aged 2 to 18 years old who have had inadequate response, loss of response, intolerance, or medical contraindications to corticosteroids, immunosuppressants, and/or biologic therapy.
Upadacitinib (RINVOQ) is a drug approved in adults for moderate- to severely active CD and is being developed for moderate- to severely active CD in pediatric participants. This study is conducted in 2 periods: Period 1 is comprised of two phases: a 12-week open-label induction phase which means that the study doctor and participants know that participants will receive UPA Dose-A (or the adult equivalent based on body weight) followed by a 52-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 156-week open-label extension of Period 1. Approximately 110 pediatric participants with moderate to severely active CD will be enrolled at approximately 92 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 have a safety follow up for 30 days after discontinuation from any time point within the study.
There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular (weekly, monthly) 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
- Crohn's Disease
- Being tested
- Upadacitinib
- Keywords
- Crohn's Disease, Upadacitinib, RINVOQ
- Medical subject headings
- Crohn Disease
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/ Extended-Release Tablets
| Study group | Role | What they receive |
|---|---|---|
| Period 1: Open Label Induction Phase (Dose A) | Experimental | All participants in the open label induction phase of Period 1 will receive upadacitinib Dose A for 12 weeks based on body weight. Receives: Drug: Upadacitinib |
| Period 1: Double-Blind Maintenance Phase (Dose B) | Experimental | Clinical responders per PCDAI at the end of open label induction phase of Period 1 will be randomly assigned to receive Dose B or C for 52 weeks (oral solution dose will be based on body weight) Receives: Drug: Upadacitinib |
| Period 1: Double-Blind Maintenance Phase (Dose C) | Experimental | Clinical responders per PCDAI at the end of open label induction phase of Period 1 will be randomly assigned to receive either upadacitinib Dose C or B for 52 weeks (oral solution dose will be based on body weight) Receives: Drug: Upadacitinib |
| Period 2: Open Label Long-Term Extension Phase Cohort 1 | Experimental | Participants receiving double-blind maintenance therapy with upadacitinib Dose B or upadacitinib Dose C daily in Period 1 who complete the Week 64 visit will receive upadacitinib Dose B daily for up to 156 weeks. Receives: Drug: Upadacitinib |
| Period 2: Open Label Long-Term Extension Phase Cohort 2 | Experimental | Participants who were receiving rescue therapy with open-label upadacitinib Dose C during maintenance phase in Period 1 and completed the Week 64 visit will continue to receive upadacitinib Dose C daily for up to 156 weeks. Receives: Drug: Upadacitinib |
| Period 2: Open Label Long-Term Extension Phase Cohort 3 | Experimental | Participants who did not achieve clinical response per PCDAI at Week 12 of Period 1 will receive an extended treatment with open-label upadacitinib Dose C daily for an additional 12 weeks. If they are responders after 12 weeks extended treatment, they will continue, otherwise they may be discontinued at the discretion of the investigator Receives: Drug: Upadacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who achieved clinical response per the Pediatric Crohn's Disease Activity Index (PCDAI) at Week 12, with clinical remission per the PCDAI at Week 64
PCDAI is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical remission was defined as PCDAI ≤ 10.
Measured: At Week 64
Achievement of endoscopic response at Week 64 in participants who achieved clinical response per PCDAI at Week 12.
Endoscopic response is defined as > 50% reduction in Simple Endoscopic Score for Crohn's Disease (SES-CD) score from Baseline (or for participants with a Baseline SES-CD of 4, at least a 2-point reduction from Baseline), as scored by a central reader.
Measured: 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 participant 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: Through Week 156
Secondary outcomes (7)
Achievement of clinical remission per PCDAI
Clinical remission per PCDAI is defined as PCDAI ≤ 10.
Measured: Week 12
Achievement of endoscopic response
Endoscopic response is defined as > 50% reduction in SES-CD score from Baseline (or for participants with a Baseline SES-CD of 4, at least a 2-point reduction from Baseline), as scored by a central reader.
Measured: Week 12
Achievement of endoscopic remission
Endoscopic remission is defined as SES-CD ≤ 4 with at least a 2-point reduction from Baseline and no subscore > 1, as scored by a central reader
Measured: Week 12
Achievement of clinical response per PCDAI
Clinical response is defined as reduction in PCDAI of ≥ 15 points from Baseline
Measured: Week 12
Achievement of clinical response per PCDAI at Week 64 in participants who achieved clinical response per PCDAI at Week 12
Measured: Week 64
Achievement of endoscopic remission at Week 64 in participants who achieved clinical response per PCDAI at Week 12
Endoscopic remission is defined as SES-CD ≤ 4 with at least a 2-point reduction from Baseline and no subscore > 1, as scored by a central reader
Measured: Week 64
Achievement of corticosteroid (CS)-free clinical remission per PCDAI at Week 64 in participants who achieved clinical response per PCDAI at Week 12
CS-free clinical remission per PCDAI: clinical remission per PCDAI and not receiving corticosteroids at Week 12 (for Period 1 induction endpoint[s]); or for at least 90 days prior to the study visit at which endpoint is assessed (for Period 1 maintenance endpoint[s] and Period 2 endpoint[s]).
Measured: Week 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start8 Aug 2024
- Primary completionJan 2031 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332534
- Sponsor's protocol ID
- M14-671
- Other IDs
- 2023-509618-12, 2023
- Acronym
- U-EMPOWER
- Status last verified
- Oct 2026
- First submitted
- 19 Mar 2024
- Last updated
- 16 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.