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Tests treatment safety and results for Crohn's Disease
Official title Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease
ClinicalTrials.gov ID: NCT06332534
What this study is testing
What is Upadacitinib?
Upadacitinib is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for crohn's disease.
Also referred to as RINVOQ.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 17
You may be able to join if
- 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...
- Documented diagnosis of CD prior to Baseline, confirmed by colonoscopy during the screening period, with exclusion of current infection, colonic...
- Demonstrated an inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators (IMMs), and/or biologic therapy or in whom...
You likely can't join if
- 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...
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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; people with a history of gastric banding/segmentation are not excluded.
The study team makes the final eligibility decision.
Where it's taking place
- Oakland, California, United States
- Palo Alto, California, United States
- Aurora, Colorado, United States
- Hartford, Connecticut, United States
- Peoria, Illinois, United States
- Indianapolis, Indiana, United States
- Boston, Massachusetts, United States
- Minneapolis, Minnesota, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Cleveland, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Randwick, New South Wales, Australia
- Westmead, New South Wales, Australia
- South Brisbane, Queensland, Australia
- Clayton, Victoria, Australia
- Perth, Western Australia, Australia
- Edegem, Antwerpen, Belgium
- Brussels, Brussels Capital, Belgium
- Leuven, Vlaams-Brabant, Belgium
+ 60 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oakland, California, United States; Palo Alto, California, United States; Aurora, Colorado, United States; Hartford, Connecticut, United States; Peoria, Illinois, United States; Indianapolis, Indiana, United States and 74 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.