Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Ileal Pouch-anal Anastomosis (ipaa)
• Age: Between 18 Year(s) - 99 Year(s)
• Gender: Male or Female

• Other Inclusion Criteria:
  

  Phase 1b Only
  1. Subject is a male or female and is between the age of 18 to 65 years, inclusive, at screening.
  2. Subject has had a documented pouchoscopy within 12 months prior to screening.

  Phase 2 Double-Blinded Part Only
  1. Subject is a male or female and is aged 18 years or older at screening.

  Both Phase 1b and Phase 2 Double-Blinded Parts
  1. Subject or the subject's legally acceptable representative is willing and able to provide written informed consent prior to the initiation of any study-related procedures.
  2. Subject has had an IPAA for at least 6 months prior to screening.
  3. Female subjects of childbearing potential must have a negative serum pregnancy test result at screening and must not be lactating and/or breastfeeding.
  4. Subjects (female subjects of childbearing potential and male subjects with partners of childbearing potential) must agree to use proper contraceptive methods to avoid pregnancy during the study.

  
  

You may not be eligible for this study if the following are true:

• Phase 1b Only
  1. Subject has Crohn's-like disease of the pouch, as indicated by their most recent pouchoscopy during the 12 months prior to screening.
  2. 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.

  Phase 2 Double Blinded Part Only
  1. Subject has Crohn's-like disease of the pouch, as indicated by the pouchoscopy conducted during study screening.
  2. Subject has isolated severe cuffitis without pouch inflammation (endoscopic mPDAI score of 2 or lower).
  3. Subject has a stricture of the IPAA or afferent limb stricturem as indicated by the pouchoscopy conducted during study screening.

  Both Phase 1b and Phase 2 Double-Blinded Part
  1. Subject has enterocutaneous or recto- or pouch-vaginal fistula.
  2. Subject has active Clostridium difficile infection.
  3. Subject has known or suspected active CMV infection.
  4. 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 through the safety follow-up visit.
  5. Subject has taken biologics, azathioprine, or methotrexate within the 12 weeks prior to screening or systemic steroids within 4 weeks of screening. Subjects taking antibiotics to treat antibiotic-dependent pouchitis or antidiarrheal medication are eligible for the study provided they have been on the therapy at a stable dose for at least 2 weeks prior to screening.
  6. Subject has taken biologics, azathioprine, or methotrexate within the 12 weeks prior to screening or systemic steroids within 4 weeks of screening.
  7. 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.
  8. Subject has a known history or positive test during screening for HIV, HIV-1, HIV-2, or active HBV or HCV.
  9. Subject has a positive reverse transcriptase-PCR diagnostic test for SARS-CoV-2 within the 14 days prior to screening.
  10. 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 situ grade 1 cervical cancer.
  11. Subject has known hypersensitivity to EXE-346 or any product components.
  12. Female subject is pregnant or lactating and/or breastfeeding.
  13. Subject has participated in any clinical study of an approved or nonapproved investigational medicinal product within the 30 days prior to screening.