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RECRUITINGPhase 3INTERVENTIONAL

Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - Weight at Screening and Baseline must be ≥ 10 kg - Moderate to severe CD defined as 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, 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 Should NOT Join This Trial: - 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 UC, indeterminate colitis, or monogenic IBD; - Fulminant colitis or toxic megacolon; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Weight at Screening and Baseline must be ≥ 10 kg * Moderate to severe CD defined as 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, 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 UC, indeterminate colitis, or monogenic IBD; * Fulminant colitis or toxic megacolon; * Gastrointestinal 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.

Treatments Being Tested

DRUG

Upadacitinib

Oral Solution/ Extended-Release Tablets

Locations (20)

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
Sydney Children's Hospital /ID# 262352
Randwick, New South Wales, Australia
Children's Hospital at Westmead /ID# 262350
Westmead, New South Wales, Australia
Queensland Children's Hospital /ID# 262351
South Brisbane, Queensland, Australia
Monash Health - Monash Medical Centre /ID# 262878
Clayton, Victoria, Australia
Perth Children'S Hospital /ID# 272905
Perth, Western Australia, Australia
Uza /Id# 261745
Edegem, Antwerpen, Belgium
Cliniques Universitaires UCL Saint-Luc /ID# 261741
Brussels, Brussels Capital, Belgium
Universitair Ziekenhuis Leuven /ID# 261740
Leuven, Vlaams-Brabant, Belgium