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New treatment option for Crohns Disease
Official title Treatment of Moderate to Severe Refractory Crohn's Disease
ClinicalTrials.gov ID: NCT06721962
What this study is testing
What is TRX103?
TRX103 is an investigational medicine, being studied as a potential treatment for crohns disease.
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
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Male and females ≥ 18 and ≤ 65 years of age at time of consent.
- Weight of ≥ 40 kg.
- Medical history and biological evidence of active bowel inflammation documented by:
- Minimum of approximate 1 year of Crohn's disease diagnosis confirmed through Endoscopy, and;
- Endoscopic evidence of CD diagnosis at least 3 months prior to and/or at Screening (SES-CD ≥ 6 for ilealcolonic or ≥ 4 isolated ileal disease by...
You likely can't join if
- Prior organ transplant, or allogeneic bone marrow, peripheral blood, or cord blood stem cell transplant. Note: Blood transfusion are not exclusionary...
- Received another investigational agent or therapy, within 28 days of planned TRX103 infusion (or 5 half-lives, whichever is longer) and/or have not...
- Received any approved treatment for CD within the designated washout period (including off-label use of approved therapies) as per the protocol.
- Strictures, active fistulae (including perianal), or abscess by computed tomography (CT) or magnetic resonance enterography (MRE) or Endoscopy within...
- Positive serology for HIV.
- Positive hepatitis-B surface antigen. Subject may be included if they are HBV PCR negative.
See the full eligibility criteria
Who can join
- Male and females ≥ 18 and ≤ 65 years of age at time of consent.
- Weight of ≥ 40 kg.
- Medical history and biological evidence of active bowel inflammation documented by:
- Minimum of approximate 1 year of Crohn's disease diagnosis confirmed through Endoscopy, and;
- Endoscopic evidence of CD diagnosis at least 3 months prior to and/or at Screening (SES-CD ≥ 6 for ilealcolonic or ≥ 4 isolated ileal disease by central reader)
- Active disease defined as moderate to severe active CD at Screening defined by all of the following:
- Evidence of mucosal inflammation, defined as SES-CD ≥ 6 (≥ 4 for people with isolated ileal disease), and;
- CDAI total scores ≥ 220
- Subject on treatment with corticosteroids may be included if they meet the following:
- prednisone or equivalent dose ≤ 20 mg/day; or
- budesonide ≤ 9 mg/day; or
- has been on a stable dose for at least 7 days prior to TRX103 dose.
- Advanced therapy-refractory disease defined by: Failure of two or more advanced approved therapies. Prior therapies may be inclusive of any combination of the following:
- TNF-alpha inhibitors
- IL-12/23 inhibitors
- Anti-integrins
- JAK inhibitors Failure of therapies are defined as either non-response (primary failure), complete loss of response (secondary failure) or intolerant to therapy at a dose indicated for CD.
- Primary failure is defined as:
- When a subject does not achieve a response after having received the induction doses of a CD approved drug per prescribing information. Induction period is defined as 12-weeks.
- A response is defined as CDAI score that reduces by ≥ 100-point from Baseline or by Physician assessment.
- Secondary failure, or relapse defined as:
- people who respond to the therapy or achieves remission after an induction regimen per prescribing information, but subsequently lose response or relapses during maintenance treatment.
- Relapse is defined as an increase in the CDAI score from maintenance of ≥ 100 points and a CDAI score \> 220, and/or SES-CD score ≥ 6 (or ≥ 4 if isolated ileal disease) or by Physician assessment.
- Intolerant to therapy, defined as:
- When a subject is unable to cope with the side effects or mechanism of actions of the treatment and/or experiences unacceptable side effects when dosed at appropriate therapeutic levels.
- Absence of uncontrolled bacterial, viral, or fungal infection at time of enrollment.
- people must be able to understand and sign informed consent and be willing and able to complete all specified procedures and visits.
What rules you out
- Prior organ transplant, or allogeneic bone marrow, peripheral blood, or cord blood stem cell transplant. Note: Blood transfusion are not exclusionary if it occurred ≥ 3 years (- 3 months) of TRX103 infusion.
- Received another investigational agent or therapy, within 28 days of planned TRX103 infusion (or 5 half-lives, whichever is longer) and/or have not recovered from treatment related toxicities.
- Received any approved treatment for CD within the designated washout period (including off-label use of approved therapies) as per the protocol.
- Strictures, active fistulae (including perianal), or abscess by computed tomography (CT) or magnetic resonance enterography (MRE) or Endoscopy within 6 months of Screening.
- Positive serology for HIV.
- Positive hepatitis-B surface antigen. Subject may be included if they are HBV PCR negative.
- Hepatitis C virus (HCV RNA detectable in any subject with anti-HCV antibodies).
- Subject with active or chronic recurring infections or untreated latent Tuberculosis (TB).
- Current diagnosis of ulcerative colitis (UC), indeterminate colitis or CD isolated to colon only (the colitis must be related to CD and inclusive of ileal with or without colonic involvement).
- people with the following known complications of Crohn's Disease
- active diverticulitis,
- active fistulae or abscess,
- abscess (abdominal or perianal) - abscess with no evidence of pus when pressed upon are permitted,
- impassable fibrotic strictures - Patients with strictures passable by dilation are permitted,
- symptomatic bowel strictures - must be confirmed via endoscopy and/or radiologically,
- fulminant colitis,
- toxic megacolon,
- ostomy or ileoanal pouch - previous temporary ostomy pouch, followed by a reversal is permitted,
- diagnosed with short gut or short bowel syndrome,
- or any other manifestation that might require surgery while enrolled in the study.
- Subject with surgical bowel resection within the past 3 months prior to Screening, or a history of \> 2 bowel resections. Note: Surgery for temporary use of an ostomy bag or reconnection of the gut post colostomy use is...
- people that are pregnant, breast feeding, or aim to become pregnant during the 12 month study period. (people, males and females, must agree to use a highly effective method of contraception).
- Screening laboratory and other analyses show any of the following abnormal results:
- Serum aspartate transaminase or alanine transaminase \> 3.0 × upper limit of normal;
- Total white blood cell count \< 2,000/μL;
- Estimated glomerular filtration rate by simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula or by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation \< 40 mL/min/1.73 m2;
- Hemoglobin \< 8 g/dL;
- Bilirubin ≥ 2 x ULN;
- Platelet count \< 100,000/μL;
- Absolute neutrophil count \< 1,200/μL;
- Absolute lymphocytes count \< 750/μL.
- Any subject with a history of significant renal, hepatic, pulmonary, or cardiac dysfunction, or on treatment to support cardiac dysfunction.
- Any serious illness, uncontrolled inter-current illness, psychiatric illness, active or uncontrolled infection, or other medical condition or history, including laboratory results, which, in the Investigator's opinion:
- places the subject at increased risk during participation in the study, and/or;
- interferes with the subject's capacity to provide informed consent and their participation in the study, and/or;
- interferes with the interpretation of the results.
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Sacramento, California, United States
- San Francisco, California, United States
- Gainesville, Florida, United States
- Chicago, Illinois, United States
- Iowa City, Iowa, United States
- Louisville, Kentucky, United States
- Ann Arbor, Michigan, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Cleveland, Ohio, United States
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, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Sacramento, California, United States; San Francisco, California, United States; Gainesville, Florida, United States; Chicago, Illinois, United States; Iowa City, Iowa, United States and 6 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.