EXE-346 for Ileal Pouch
(PROF Trial)
Recruiting in Palo Alto (17 mi)
+9 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: Exegi Pharma, LLC
Must not be taking: Biologics, Opioids, Probiotics, others
Disqualifiers: Crohn's-like disease, Stricture, Hypertension, others
Trial Summary
What is the purpose of this trial?This trial tests EXE-346, a mix of eight good bacteria, to help patients with IPAA who have frequent bowel movements. The treatment aims to balance the gut environment and reduce bathroom trips, improving their quality of life.
Do I need to stop my current medications to join the trial?
The trial requires that you stop taking certain medications before joining. Specifically, you must not have taken biologics, azathioprine, methotrexate, or small molecules like JAK inhibitors within 12 weeks before screening, and systemic steroids within 4 weeks before screening. Additionally, you should not have taken opioids or probiotics within 2 weeks before screening, and you should not start new antibiotics or antimotility therapies or change doses of current treatments during the study.
What data supports the effectiveness of the drug EXE-346 for treating ileal pouch complications?
The research does not provide direct evidence for the effectiveness of EXE-346, but similar treatments like infliximab have shown effectiveness in treating Crohn's disease-like complications and refractory pouchitis after ileal pouch-anal anastomosis surgery.
12345Eligibility Criteria
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.Inclusion Criteria
I am 18 years or older.
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.
[Phase 2 OL extension only] Subject must understand the study procedures, the risks involved, and be willing to continue to adhere to the study visit/protocol schedule.
+7 more
Exclusion Criteria
I regularly take NSAIDs at least 4 days a week every month.
Subject has participated in any clinical study of an approved or unapproved investigational medicinal product within the 30 days prior to screening.
My pouchoscopy shows I have Crohn's-like disease of the pouch.
+18 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Phase 1b Treatment
Open label, single-arm study to assess the safety of EXE-346 administered orally
4 weeks
Regular visits for safety assessments
Phase 2 Treatment
Randomized, double-blinded study to assess the safety and efficacy of EXE-346 compared with placebo
8 weeks
Regular visits for efficacy and safety assessments
Open-label Extension (optional)
Participants may opt into continuation of treatment with EXE-346 for additional safety and efficacy assessment
8 weeks
Regular visits for safety and efficacy assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Penn State Health (Milton S. Hershey Medical Center)Hershey, PA
Mayo Clinic Department of GastroenterolyRochester, MN
NYU Langone HealthNew York, NY
Corewell HealthGrand Rapids, MI
More Trial Locations
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Who Is Running the Clinical Trial?
Exegi Pharma, LLCLead Sponsor
The Emmes Company, LLCIndustry Sponsor
References
Reporting Templates for MRI and Water-Soluble Contrast Enema in Patients With Ileal Pouch-Anal Anastomosis: Experience From a Large Referral Center. [2021]Ileal pouch-anal anastomosis (IPAA) surgery is the reference standard surgical procedure for treatment of ulcerative colitis and most patients with familial adenomatous polyposis. This procedure allows preservation of fecal continence and gastrointestinal continuity. However, it is associated with a wide variety of complications, which often have nonspecific and overlapping clinical presentations, making imaging an important part of workup for pouch dysfunction. The purpose of this article is to propose structured reporting templates for MRI and water-soluble contrast enema (WSCE), based on our referral pouch center's experience, in patients who have undergone IPAA surgery. We review salient surgical technique, pouch anatomy, and imaging protocols, with an emphasis on a systematic search pattern for evaluation of ileal pouch complications using proposed structured reporting templates for MRI and WSCE.
Restorative Proctocolectomy in Ulcerative Colitis: Effect of Preoperative Immunomodulatory Therapy on Postoperative Complications and Pouch Failure. [2022]Patients with ulcerative colitis are often treated with multiple immunomodulative agents to achieve remission. In refractory disease, the next option is frequently proctocolectomy with ileal pouch-anal anastomosis. No consensus exists as to whether immunomodulatory therapy at the time of ileal pouch surgery leads to any increase in postoperative complications. Our aim was to assess, in ulcerative colitis patients with restorative proctocolectomy, the effect of preoperative anti-tumor necrosis factor therapy and corticosteroids on postoperative complications and pouch failure.
Infliximab and/or azathioprine in the treatment of Crohn's disease-like complications after IPAA. [2017]Ileal pouch-anal anastomosis continues to be confounded by Crohn's disease-like complications after surgery. Such patients experience significant morbidity and often require either pouch excision or diversion. This study evaluated the effectiveness in our hands of infliximab and/or azathioprine/6-mercaptopurine in treating this patient population.
Ileal Pouch Excision can Be Performed With Similar Outcomes in Obese Patients Compared to Nonobese Counterparts: An Assessment From American College of Surgeons National Surgical Quality Improvement Program. [2022]Failed pouches may tend to be managed with only a loop ileostomy in obese patients due to some safety concerns. The effect of obesity on ileal pouch excision outcomes is poorly studied. In our study, we aimed to assess the short-term outcomes after ileal pouch excision in obese patients compared to their nonobese counterparts.
Efficacy of infliximab in refractory pouchitis and Crohn's disease-related complications of the pouch: a Belgian case series. [2022]Up to 25% of inflammatory bowel disease (IBD) patients undergoing surgery with an ileal pouch-anal anastomosis (IPAA) will develop chronic pouchitis not responding to antibiotics. In case reports, thiopurine analogs and infliximab (IFX) have been proposed as effective therapy in this setting. We analyzed the long-term efficacy of IFX in Belgian patients with refractory pouch complications.
The innovative use of a large-scale industry biomedical consortium to research the genetic basis of drug induced serious adverse events. [2014]The International Serious Adverse Event Consortium (SAEC) is a pharmaceutical industry and FDA led international (501 c3 non-profit) consortium, focused on identifying and validating DNA-variants useful in predicting the risk of drug induced, rare serious adverse events (SAEs). As such, it functions with the explicit purpose of enhancing the 'public good'. Its members are (i) organizations engaged principally in the business of discovering, developing and marketing pharmaceutical products, or (ii) a charitable, governmental, or other non-profit organization with an interest in researching the molecular basis of drug response.Drug-induced, rare SAEs present significant health issues for patients; and pose challenges for the safe use of approved drugs and the development of new drugs. Examples of drug-induced, rare SAEs include hepatotoxicity, QT prolongation, rhabdomyolosis, serious skin rashes (e.g. SJS), edema, acute renal failure, acute hypersensitivity, anemias/neutropenias, excessive weigh gain, retinopathy, vasculitis, among others. The rarity of such drug induced SAEs and the absence of effective government surveillance/research networks, makes it extremely difficult for any one company or research entity to accrue enough SAE cases and controls to conduct effective whole genome studies. Central to the notion of the SAEC is industry, government and health care providers can join forces to make use of a variety of sample and data resources in researching the genetic basis of these events.The purpose of the SAEC is threefold:•To carry out research directed toward the discovery of DNA-variants clinically useful in understanding and predicting the risk of drug induced serious adverse events and similar scientific research.•To ensure the widespread availability of the results of such research to the scientific research community and the public at large for no charge through publication and web-based methods; and•To educate the scientific research and medical communities about issues related to severe adverse drug reactions and about issues related to the Consortium's research.The SAEC was launched in late September of 2007 with the scientific, technical and financial support of eight founding industrial research-funding members (i.e. Abbott, GSK, J & J, Novartis, Pfizer, Roche, Sanofi-Aventis and Wyeth). Additional members are being added as the consortium executes its phase one research program and develops its future plans.The Consortium's will focus initially on two research projects. It will attempt to identify DNA variants associated with drug-induced liver-disease and serious skin rashes [e.g. Stevens-Johnson syndrome ('SJS') and toxic epidermal necrolysis ('TEN')]. These two projects, while important in their own right, will also allow the SAEC to generate initial results in a reasonable time frame (owing to the availability of established case-control DNA sample collections) and build its core operations. Simultaneous with the Phase 1 research activities, the SAEC will plan follow on, hypothesis driven studies (post whole genome association studies) for DILI and SJS and explore the feasibility of whole genome research on additional SAEs. Our long term goal is to discover and validate genetic markers predictive of the major drug induced, rare SAEs and make these available at no cost at the same time, unencumbered by any intellectual property constraints, to all researchers and developers of clinical diagnostics.
Trends of Mesh Utilization for Stress Urinary Incontinence Before and After the 2011 Food and Drug Administration Notification Between FPMRS-Certified and Non-FPMRS-Certified Physicians: A Statewide All-Payer Database Analysis. [2022]To investigate the utilization of mesh slings for stress urinary incontinence (SUI) across time - before and after the 2011 US Food and Drug Administration (FDA) public health notification regarding an increase in adverse events related to transvaginal mesh (TVM) for pelvic organ prolapse (POP) repair - and among FPMRS-certified urologists and gynecologists and non-FPMRS counterparts using a statewide database.
The international serious adverse events consortium. [2018]The International Serious Adverse Events Consortium is generating novel insights into the genetics and biology of drug-induced serious adverse events, and thereby improving pharmaceutical product development and decision-making.
Vaccinovigilance in Europe--need for timeliness, standardization and resources. [2015]To identify gaps in the systems for reporting adverse events following immunization (AEFI) in Europe by means of an interactive database constructed using a standardized approach.
[Adverse events in general and digestive surgery departments in Spanish hospitals]. [2019]To determine the incidence of patients with adverse events (AE) in Spanish general surgery units, describe the immediate causes of AE, identify avoidable AE, and determine the impact of these events.