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Live Biotherapeutic
EXE-346 for Ileal Pouch (PROF Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Exegi Pharma, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
PROF Trial Summary
This trial aims to study the safety and potential benefits of a live biotherapeutic, EXE-346, for patients with IPAA and reduce their bowel movements, improving their quality of life.
Who is the study for?
Adults with an ileal pouch-anal anastomosis (IPAA) experiencing at least 10 bowel movements daily, who've kept a diary of this during screening. They must not be pregnant or breastfeeding and agree to use contraception. Exclusions include long-term NSAID users, those with certain pouch complications or infections, recent biologic or steroid treatments, significant past illnesses like cancer within 5 years (except some skin cancers), and severe kidney issues.Check my eligibility
What is being tested?
The trial is testing EXE-346, a live biotherapeutic product against a placebo to see if it can reduce the frequency of bowel movements in patients with IPAA. The goal is to improve their quality of life by potentially normalizing bowel function.See study design
What are the potential side effects?
While specific side effects for EXE-346 are not listed here, common side effects from live biotherapeutics may include digestive discomfort, bloating, gas, and potential allergic reactions for those sensitive to the components.
PROF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1b: Incidence, Severity, Relatedness, and Frequency of Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)
Phase 1b: Number of Participants with Abnormal Physical Examinations
Phase 1b: Number of Participants with Abnormal Safety Labs
+13 moreSecondary outcome measures
Phase 1b: Bowel Movement Consistency
Phase 1b: Bowel Movement Frequency
Phase 1b: Nighttime Awakening Frequency
+2 morePROF Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Phase 2: Active ArmExperimental Treatment1 Intervention
EXE-346 live biotherapeutic product, 1500x10^9 CFU BID, 8 weeks
Group II: Phase 2 Open Label Extension (optional)Experimental Treatment1 Intervention
EXE-346 live biotherapeutic product, 1500x10^9 CFU BID, 8 weeks
Group III: Phase 1b Open LabelExperimental Treatment1 Intervention
EXE-346 live biotherapeutic product, 1500x10^9 colony forming units (CFU) twice daily (BID), 4 weeks
Group IV: Phase 2: Placebo ArmPlacebo Group1 Intervention
Powder containing same inactive ingredients as EXE-346 but none of the active ingredients, BID, 8 weeks
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Who is running the clinical trial?
Exegi Pharma, LLCLead Sponsor
2 Previous Clinical Trials
173 Total Patients Enrolled
The Emmes Company, LLCIndustry Sponsor
145 Previous Clinical Trials
1,051,441 Total Patients Enrolled
Melody Khorrami, PharmD, RPhStudy DirectorExegi Pharma, LLC
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I regularly take NSAIDs at least 4 days a week every month.My pouchoscopy shows I have Crohn's-like disease of the pouch.I have tested positive for HIV, HBV, or HCV.My screening showed a narrowing in my pouch or its connecting limb.I have or might have an active CMV infection.I am 18 years or older.I have had an ileal pouch-anal anastomosis (IPAA) surgery more than 6 months ago.I haven't had cancer in the last 5 years, except for certain skin, cervical conditions.I have not started or changed antibiotics or diarrhea medicine in the last 2 weeks.My blood pressure is high and not under control.I am currently pregnant or breastfeeding.I have severe inflammation in my cuff but not in my pouch, with a low mPDAI score.I am between 18 and 65 years old.I do not have any health conditions that could make this study unsafe for me.I have had a pouchoscopy within the last year.I agree to use birth control during the study.I have not taken biologics, azathioprine, methotrexate in the last 12 weeks or steroids in the last 4 weeks.I am not pregnant, breastfeeding, and have a negative pregnancy test.I have had at least 10 bowel movements daily and kept a diary for 7 days during screening.I have a narrowing in my bowel connection or its entrance, confirmed by a recent exam.I am currently infected with Clostridium difficile.I have Crohn's-like symptoms in my pouch, confirmed by a recent pouchoscopy.I have a fistula connecting my intestine to my skin or vagina.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1b Open Label
- Group 2: Phase 2: Active Arm
- Group 3: Phase 2: Placebo Arm
- Group 4: Phase 2 Open Label Extension (optional)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you provide me with a tally of the research centers conducting this investigation?
"As of now, 4 sites are enrolling participants for this clinical trial. These locations include Rochester, Saint Louis and Chapel Hill as well as other nearby cities. To relieve the burden of travel costs, it is beneficial to pick a site that is closest to you if you hope to participate in the study."
Answered by AI
Are individuals aged 40 and older being admitted into this trial?
"The eligibility requirements for this trial specify that patients must be 18 and over, but no older than 65."
Answered by AI
May I be considered to join this experiment?
"Qualified applicants for this clinical trial must have an ileal pouch and be between 18-65 years old. This research is currently looking to recruit 50 individuals in total."
Answered by AI
Are there any vacant slots for participants in this experiment?
"According to clinicaltrials.gov this research is not presently taking in participants, as the trial was first published on September 1st 2023 and has been updated most recently on July 3rd 2023. However, there are three other trials that are currently seeking individuals for their studies."
Answered by AI
Can you define the primary aims of this research project?
"Exegi Pharma, LLC has indicated that the main metric of success for this trial will be Phase 1b: Number of Participants with Abnormal Physical Examinations. This measure is to be taken over a period of 4 weeks and secondary outcomes include changes in bowel movement consistency and nighttime awakening frequency from baseline measurements."
Answered by AI
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