Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease
Recruiting · NCT06332534 · Interventional (participants receive a specific treatment) · Lead sponsor: AbbVie
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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. 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.
Who can take part
Inclusion criteria
- 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).
Exclusion criteria
- 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;
- 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.
Where it is running
60 locations listed across 11 US states.
- UCSF Benioff Children's Hospital - Oakland /ID# 262217 - Oakland, California, United States
- Lucile Packard Children's Hospital /ID# 262193 - Palo Alto, California, United States
- Children's Hospital Colorado - Aurora /ID# 262207 - Aurora, Colorado, United States
- Connecticut Children's Medical Center - Hartford /ID# 262256 - Hartford, Connecticut, United States
- OSF St. Francis Medical Center /ID# 262192 - Peoria, Illinois, United States
- Indiana University Health Riley Hospital for Children /ID# 262215 - Indianapolis, Indiana, United States
- Boston Children's Hospital /ID# 262191 - Boston, Massachusetts, United States
- MNGI Digestive Health, P. A. /ID# 262204 - Minneapolis, Minnesota, United States
- Icahn School of Medicine at Mount Sinai /ID# 262216 - New York, New York, United States
- Univ NC Chapel Hill /ID# 262198 - Chapel Hill, North Carolina, United States
- UH Cleveland Medical Center /ID# 262188 - Cleveland, Ohio, United States
- Children's Hospital of Philadelphia - Main /ID# 262197 - Philadelphia, Pennsylvania, United States
- Clinical Research Investigator Group /ID# 262357 - Bayamón, Puerto Rico
- Hospital Universite Enfants Reine Fabiola /ID# 261744 - Brussels, Belgium
- Puerto Rico Health Institute /ID# 262358 - Dorado, Puerto Rico
- Royal Hospital for Children and Young People /ID# 262388 - Edinburgh, United Kingdom
- CHR de la Citadelle /ID# 261749 - Liège, Belgium
- Azienda Ospedaliera Universitaria Gaetano Martino /ID# 262380 - Messina, Italy
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 275276 - Milan, Italy
- Hospital Regional Universitario de Malaga /ID# 262228 - Málaga, Spain
- UCL Namur University Hospital, Site Sainte-Elisabeth /ID# 261750 - Namur, Belgium
- Hopitaux de Paris (AP-HP) - Hopital Robert Debre - CHU /ID# 262308 - Paris, France
- UMHAT Sveti Georgi /ID# 262590 - Plovdiv, Bulgaria
- Clinical Research Puerto Rico /ID# 279595 - San Juan, Puerto Rico
- Hospital Universitario Virgen del Rocio /ID# 262712 - Seville, Spain
- Specialized Hospital For Active Treatment Of Children Diseases Prof. Ivan Mitev /ID# 262589 - Sofia, Bulgaria
- Hospital Sirio Libanes - Sao Paulo /ID# 262670 - São Paulo, Brazil
- National Taiwan University Hospital /ID# 261695 - Taipei, Taiwan
- Linkou Chang Gung Memorial Hospital /ID# 261696 - Taoyuan City, Taiwan
- Hospital Clinico Universitario Lozano Blesa /ID# 262227 - Zaragoza, Spain
- Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 262226 - Ferrol, A Coruna, Spain
- Uza /Id# 261745 - Edegem, Antwerpen, Belgium
- Agia Sofia Hospital /ID# 261792 - Athens, Attica, Greece
- General Hospital of Chest Diseases of Athens SOTIRIA /ID# 261790 - Athens, Attica, Greece
- Starship Child Health /ID# 262576 - Grafton, Auckland, New Zealand
- Hospital Sant Joan de Deu /ID# 262599 - Esplugues de Llobregat, Barcelona, Spain
- Beijing Children's Hospital /ID# 262258 - Beijing, Beijing Municipality, China
- BC Children's Hospital /ID# 262237 - Vancouver, British Columbia, Canada
- Cliniques Universitaires UCL Saint-Luc /ID# 261741 - Brussels, Brussels Capital, Belgium
- CHU de CAEN - Hopital de la Cote de Nacre /ID# 262311 - Caen, Calvados, France
- Addenbrookes Hospital /ID# 262707 - Cambridge, Cambridgeshire, United Kingdom
- Christchurch Hospital. /ID# 262577 - Christchurch, Canterbury, New Zealand
- Tsujinaka Hospital - Kashiwanoha /ID# 262454 - Kashiwa-shi, Chiba, Japan
- University General Hospital of Heraklion PA.G.N.I /ID# 261791 - Heraklion, Crete, Greece
- Sheffield Children's Hospital NHS Foundation Trust /ID# 261832 - Sheffield, England, United Kingdom
- Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 262384 - San Giovanni Rotondo, Foggia, Italy
- Kurume University Hospital /ID# 262455 - Kurume-shi, Fukuoka, Japan
- Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 262811 - London, Greater London, United Kingdom
- Guangzhou Medical University Affiliated Women and Children's Medical Center /ID# 262596 - Guangzhou, Guangdong, China
- The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 272807 - Guangzhou, Guangdong, China
- Henan Children's Hospital Zhengzhou Children's Hospital /ID# 262300 - Zhengzhou, Henan, China
- Hunan Children's Hospital /ID# 262512 - Changsha, Hunan, China
- Jiangxi Provincial Children's Hospital /ID# 262295 - Nanchang, Jiangxi, China
- Gastromed Sp. z o.o /ID# 262367 - Torun, Kuyavian-Pomeranian Voivodeship, Poland
- Shengjing Hospital of China Medical University /ID# 262301 - Shenyang, Liaoning, China
- Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 262366 - Warsaw, Masovian Voivodeship, Poland
- Galileo Medical Research Ltda /ID# 262602 - Juiz de Fora, Minas Gerais, Brazil
- Miyagi Children's Hospital /ID# 262459 - Sendai, Miyagi, Japan
- Sydney Children's Hospital /ID# 262352 - Randwick, New South Wales, Australia
- Children's Hospital at Westmead /ID# 262350 - Westmead, New South Wales, Australia
Showing 60 of 85 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →