RecruitingPhase 1/2

Study of EXE-346 Live Biotherapeutic to Reduce High Bowel Movement Frequency in Subjects With an IPAA (PROF)

United States50 participantsStarted 2023-11-06

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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).
. 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).
. Subject has had an IPAA for at least 6 months prior to screening.

Exclusion criteria

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Phase 1b: Incidence, Severity, Relatedness, and Frequency of Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)

Timeframe: 4 weeks

Phase 1b: Number of Participants with Abnormal Physical Examinations

Timeframe: 4 weeks

Phase 1b: Number of Participants with Abnormal Vital Signs

Timeframe: 4 weeks

Phase 1b: Number of Participants with Abnormal Safety Labs

Timeframe: 4 weeks

Phase 1b: Study Treatment Discontinuation Due to Treatment Emergent Adverse Events (TEAEs)

Timeframe: 4 weeks

Phase 2: Incidence, Severity, Relatedness, and Frequency of Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)

Timeframe: 8 weeks

Phase 2: Number of Participants with Abnormal Physical Examinations

Timeframe: 8 weeks

Trial details

NCT IDNCT05938465

SponsorExegi Pharma, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-05-31

Contact for this trial

Emmes Project Management

301-251-1161 PROF_Study@emmes.com

View on ClinicalTrials.gov More Ileal Pouch trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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).
. 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).
. Subject has had an IPAA for at least 6 months prior to screening.

Exclusion criteria

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

What they're measuring

Phase 1b: Incidence, Severity, Relatedness, and Frequency of Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)

Timeframe: 4 weeks

Phase 1b: Number of Participants with Abnormal Physical Examinations

Timeframe: 4 weeks

Phase 1b: Number of Participants with Abnormal Vital Signs

Timeframe: 4 weeks

Phase 1b: Number of Participants with Abnormal Safety Labs

Timeframe: 4 weeks

Phase 1b: Study Treatment Discontinuation Due to Treatment Emergent Adverse Events (TEAEs)

Timeframe: 4 weeks

Phase 2: Incidence, Severity, Relatedness, and Frequency of Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)

Timeframe: 8 weeks

Phase 2: Number of Participants with Abnormal Physical Examinations

Timeframe: 8 weeks