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New treatment option for Ileal Pouch
Official title Study of EXE-346 Live Biotherapeutic to Reduce High Bowel Movement Frequency in Subjects With an IPAA (PROF)
ClinicalTrials.gov ID: NCT05938465
What this study is testing
What is EXE-346?
EXE-346 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for ileal pouch.
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
- The aim of this study is to assess the safety and preliminary efficacy of treatment with EXE-346, a live biotherapeutic, which may reduce bowel movement frequency in patients with an ileal pouch-anal anastomosis (IPAA) and lead to a higher quality of life.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 8 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Phase 1b Only
- Subject is a male or female and is between the age of 18 to 70 years, inclusive, at screening.
- Subject has had a documented pouchoscopy within 12 months prior to screening.
- Subject or the subject's legally authorized representative is willing and able to provide written informed consent prior to the initiation of any...
- Subject has an average daily bowel movement frequency of at least 10 bowel movements recorded during screening and has correctly completed at least 7...
You likely can't join if
- people meeting any of the criteria specified below for the study phase in which they are enrolling will be excluded from the study. Exclusion...
- Subject has Crohn's-like disease of the pouch, as indicated by their most recent pouchoscopy during the 12 months prior to screening.
- Subject has a stricture of the IPAA or afferent limb stricture, as indicated by their most recent pouchoscopy during the 12 months prior to screening.
- Subject has taken biologics, azathioprine, or methotrexate within the 12 weeks prior to screening or systemic steroids within 4 weeks of screening.
- Subject has a positive reverse transcriptase-PCR diagnostic test for SARS-CoV-2 within the 14 days prior to screening.
- Subject has uncontrolled hypertension (systolic pressure \>160 mm Hg or diastolic pressure \>95 mm Hg on at least 2 measures performed at least 10...
See the full eligibility criteria
Who can join
- Phase 1b Only
- Subject is a male or female and is between the age of 18 to 70 years, inclusive, at screening.
- Subject has had a documented pouchoscopy within 12 months prior to screening.
- Subject or the subject's legally authorized representative is willing and able to provide written informed consent prior to the initiation of any study-related procedures.
- Subject has an average daily bowel movement frequency of at least 10 bowel movements recorded during screening and has correctly completed at least 7 days of eDiary entries during the screening period (Days -13 to 0).
- Phase 2 Double-Blinded Part Only
- Subject is a male or female and is aged 18 years or older at screening.
- Subject is willing and able to provide written informed consent prior to the initiation of any study-related procedures.
- Subject has an average daily bowel movement frequency of at least 10 bowel movements recorded during screening and has correctly completed at least 7 days of eDiary entries during the screening period (Days -21 to 0).
- Both Phase 1b and Phase 2 Double-Blinded Parts
- Subject has had an IPAA for at least 6 months prior to screening.
- Female people of childbearing potential must have a negative serum pregnancy test result at screening and must not be lactating and/or breastfeeding.
- people (female people of childbearing potential and male people with partners of childbearing potential) must agree to use proper contraceptive methods (see Section 13.2 for contraceptive guidance) to avoid pregnancy...
- Optional Open-Label Extension Phase Only
- people must have completed the Phase 2 double-blinded part of the study and are willing to participate in the optional open-label extension phase. Note: people who discontinued study treatment in the Phase 2...
- people must understand the study procedures, the risks involved, and are willing to continue to adhere to the study visit/protocol schedule.
What rules you out
- people meeting any of the criteria specified below for the study phase in which they are enrolling will be excluded from the study. Exclusion Criteria - Phase 1b Only
- Subject has Crohn's-like disease of the pouch, as indicated by their most recent pouchoscopy during the 12 months prior to screening.
- Subject has a stricture of the IPAA or afferent limb stricture, as indicated by their most recent pouchoscopy during the 12 months prior to screening.
- Subject has taken biologics, azathioprine, or methotrexate within the 12 weeks prior to screening or systemic steroids within 4 weeks of screening.
- Subject has a positive reverse transcriptase-PCR diagnostic test for SARS-CoV-2 within the 14 days prior to screening.
- Subject has uncontrolled hypertension (systolic pressure \>160 mm Hg or diastolic pressure \>95 mm Hg on at least 2 measures performed at least 10 minutes apart) at screening. Exclusion Criteria - Phase 2 Double Blinded...
- Subject has Crohn's-like disease of the pouch, as indicated by the pouchoscopy conducted during study screening.
- Subject has isolated severe cuffitis without pouch inflammation (endoscopic mPDAI score of 2 or lower), as indicated by the pouchoscopy conducted during study screening.
- Subject has a clinically significant stricture of the IPAA or afferent limb stricture which requires surgery or recurrent dilations more than every 3 months, as indicated by the pouchoscopy conducted during study...
- Subject has taken biologics, azathioprine, methotrexate or small molecules (e.g., JAK inhibitors, S1P receptor modulators) within the 12 weeks prior to screening or systemic steroids within 4 weeks prior to screening.
- Subject has a positive reverse transcriptase-PCR diagnostic test for SARS-CoV-2 within the 7 days prior to screening, per subject self report.
- Subject has an average daily bowel movement frequency of \>25 bowel movements recorded during the screening period (Days -21 to 0).
- Subject is taking opioid therapy as a long-term treatment or has taken opioids within 2 weeks prior to screening.
- Subject has taken probiotics within 2 weeks prior to screening.
- Subject has previously received EXE-346 for any duration. people who participated in Phase 1b are excluded from Phase 2.
- Subject has a concurrent, clinically significant, serious, unstable or uncontrolled medical or psychiatric condition that, in the opinion of the investigator, might confound study results, pose additional risk to the...
- Subject has enterocutaneous or recto- or pouch-vaginal fistula.
- Subject has active Clostridium difficile infection.
- Subject has known or suspected active CMV infection.
- Subject initiated a new treatment with antibiotics or antimotility therapies within the 2 weeks prior to screening or plans to start a new or change doses of a current treatment during the study period (screening visit...
- Subject is taking NSAIDs as a long-term treatment (ie, consistent use for at least 4 days/week each month). Acute use of NSAIDs is allowed.
- Subject has a known history or positive test during screening for HIV, HIV-1, HIV-2, or active HBV or HCV. Active HCV infection is defined as a subject with a positive hepatitis C antibody and detectable hepatitis C...
- Subject has a history of malignancy within the 5 years prior to screening, with the exception of nonmelanoma skin cancer that has been treated with no evidence of recurrence, treated cervical dysplasia, or treated in...
- Subject has estimated glomerular filtration rate \<30 mL/min/1.73 m2 at screening.
- Subject has known hypersensitivity to EXE-346 or any product components.
- Female subject is pregnant or lactating and/or breastfeeding.
- Subject has participated in any clinical study of an approved or nonapproved investigational medicinal product within the 30 days prior to screening.
- Subject has any disorder that, in the investigator's opinion, might jeopardize the subject's safety or compliance with the protocol, including but not limited to:
- Decompensated liver disease
- Elevation of AST, ALT, or bilirubin \>2 × ULN
- Primary sclerosing cholangitis with elevated transaminases Exclusion Criteria - Optional Open-Label Extension Phase Only 1\. people who have developed any medical or psychologic condition, which was excluded in the...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Jacksonville, Florida, United States
- Grand Rapids, Michigan, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Hershey, Pennsylvania, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 study runs about 8 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Jacksonville, Florida, United States; Grand Rapids, Michigan, United States; Rochester, Minnesota, United States; St Louis, Missouri, United States; New York, New York, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.