Actively Recruiting
Treatment of Moderate to Severe Refractory Crohn's Disease
Led by Tr1X, Inc. · Updated on 2025-12-10
39
Participants Needed
13
Research Sites
90 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research study is testing an investigational research product called TRX103 as a possible treatment for individuals suffering from Crohn's Disease (CD). The primary purpose of this study is to learn how safe and effective different doses of TRX103 are when administered to individuals with CD.
CONDITIONS
Official Title
Treatment of Moderate to Severe Refractory Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants aged 18 to 65 years at consent.
- Weighing at least 40 kg.
- Diagnosed with Crohn's Disease for approximately 1 year confirmed by endoscopy.
- Endoscopic evidence of Crohn's Disease within 3 months before or at screening.
- Moderate to severe active Crohn's Disease at screening with SES-CD scores of at least 6 (or 4 for isolated ileal disease).
- Crohn's Disease Activity Index (CDAI) score of 220 or higher.
- On corticosteroid treatment at a stable dose: prednisone ≤20 mg/day or budesonide ≤9 mg/day for at least 7 days before TRX103 dosing.
- Failure of two or more advanced approved therapies including TNF-alpha inhibitors, IL-12/23 inhibitors, anti-integrins, or JAK inhibitors.
- No uncontrolled bacterial, viral, or fungal infections at enrollment.
- Able to understand and sign informed consent and complete all study procedures.
You will not qualify if you...
- Prior organ transplant or allogeneic bone marrow, peripheral blood, or cord blood stem cell transplant.
- Received another investigational therapy within 28 days before TRX103 infusion or not recovered from related toxicities.
- Received any approved Crohn's Disease treatment during required washout periods.
- Presence of strictures, active fistulae, or abscess within 6 months before screening.
- Positive tests for HIV, hepatitis B surface antigen (unless HBV PCR negative), or hepatitis C virus.
- Active or chronic infections or untreated latent tuberculosis.
- Diagnosis of ulcerative colitis, indeterminate colitis, or Crohn's colitis without ileal involvement.
- Certain Crohn's Disease complications including active diverticulitis, active fistulae or abscess, impassable strictures, fulminant colitis, toxic megacolon, ostomy or ileoanal pouch, short gut syndrome, or other conditions requiring surgery during the study.
- Surgical bowel resection within 3 months before screening or history of more than two bowel resections.
- Pregnant, breastfeeding, or planning pregnancy during the study.
- Abnormal laboratory results including elevated liver enzymes, low blood counts, impaired kidney function, or others specified.
- History of significant organ dysfunction or serious illnesses that increase risk or interfere with study participation or results interpretation.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 13 locations
1
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
University of California, Davis
Sacramento, California, United States, 95817
Actively Recruiting
3
University of California, San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
4
University of Florida
Gainesville, Florida, United States, 32608
Actively Recruiting
5
Northwestern
Chicago, Illinois, United States, 60611
Actively Recruiting
6
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
7
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
8
University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
9
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
10
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
11
Washington University in St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
12
Mount Sinai Health Systems
New York, New York, United States, 10029
Actively Recruiting
13
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
T
Tr1X Clinical Trials Tr1X Clinical Trials
CONTACT
S
Study Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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