CP-101 for Ulcerative Colitis

Overseen By Jessica Allegretti

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Brigham and Women's Hospital

Must not be taking: Antibiotics

Disqualifiers: Severe UC, Crohn's, Antibiotic use, others

Compensation: Varies

Number of Visits: 19

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests CP-101, a new oral treatment for mild to moderate ulcerative colitis, a condition that inflames the colon. The study explores different doses to assess the treatment's effectiveness and safety. Participants will receive either a full dose of CP-101 or a combination of CP-101 and a placebo (a pill with no active medication). Individuals diagnosed with mild to moderate ulcerative colitis, with symptoms confirmed by a recent colonoscopy, might be suitable for this trial. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications, but it mentions that participants should have stable dosing of their current medications. It is best to discuss your specific medications with the trial team.

Is there any evidence suggesting that CP-101 is likely to be safe for humans?

Research has shown that CP-101 has been tested for safety. In previous studies, CP-101 was used in people with C. difficile infections, a different gut issue. The results indicated that CP-101 was generally safe for patients, with no major safety concerns and without causing serious side effects. This suggests that CP-101 might be safe for people with other gut issues like ulcerative colitis, but further research is necessary.

Since this trial is in the early stages, it primarily focuses on ensuring the treatment's safety. While CP-101 has shown promise before, this study aims to confirm its safety in people with ulcerative colitis. Participants will be closely monitored for any side effects to ensure their safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for ulcerative colitis, like mesalamine or corticosteroids, work by reducing inflammation in the colon. But CP-101 works differently, targeting the gut microbiome to restore balance and improve symptoms. Researchers are excited about CP-101 because it uses a novel approach by delivering beneficial bacteria directly to the gut in capsule form. This method could offer a new way to manage ulcerative colitis with potentially fewer side effects compared to traditional anti-inflammatory drugs.

What evidence suggests that CP-101 might be an effective treatment for Ulcerative Colitis?

Research has shown that CP-101 is designed to improve the balance of bacteria and other microorganisms in the gut. This method has shown promise in other conditions, such as repeated Clostridioides difficile infections (CDI), where CP-101 proved more effective than a placebo in reducing the recurrence of the infection. The treatment is generally safe and well-tolerated, similar to a placebo. In this trial, participants will receive either CP-101 alone or CP-101 with a placebo to evaluate its effectiveness for ulcerative colitis. The aim is to determine if CP-101 can boost gut health by increasing the variety of beneficial bacteria, potentially easing symptoms. Early results suggest this could be a promising new approach to managing gut issues in ulcerative colitis. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

Adults over 18 with mild-to-moderate Ulcerative Colitis extending at least 15 cm from the anal verge can join. They must have stable medication use and a recent colonoscopy confirming their condition. Excluded are those with severe UC, recent antibiotic or investigational drug use, certain infections, prior FMT treatment, significant medical conditions that could affect results, or inability to ingest capsules.

Inclusion Criteria

My ulcerative colitis is mild to moderate, with a Mayo score between 4 and 9.

I have been diagnosed with ulcerative colitis.

My condition is located more than 15 cm from the anal opening.

Exclusion Criteria

I have a history of Crohn's disease or indeterminate colitis.

I expect to take antibiotics soon for a planned procedure.

I have or might have a severely enlarged colon or a blockage in my small intestine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive CP101 or placebo with an initial induction dose of 10 capsules daily for 5 days, followed by either extended induction with CP101 or placebo through Week 8

8 weeks

Multiple visits for assessments at Day 6, Week 4, and Week 8

Follow-up

Participants are monitored for long-term safety, engraftment, and clinical outcomes through Week 24

16 weeks

Visits at Week 12, Week 16, and Week 24

What Are the Treatments Tested in This Trial?

Interventions

• CP-101

Trial Overview The trial is testing CP101, an oral microbiome therapeutic for Ulcerative Colitis. Participants will be randomly assigned to receive either a short or extended induction dosing of CP101. The study will monitor changes in the microbiome over several weeks up to Week 24.

How Is the Trial Designed?

Group I: CP101 Experimental Treatment 1 Intervention

Extended Induction: Participants will receive the short induction dose of CP101 comprising 10 capsules daily for 5 days. Participants in this arm will then receive an extended induction daily dose of five CP101 capsules through Week 8.

Group II: CP101 + Placebo Placebo Group 1 Intervention

Short Induction: Participants will receive the short induction dose of CP101 comprising 10 capsules daily for 5 days. Participants in this arm will then receive 5 capsules of placebo through Week 8.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05852574?cond=ulcerative%20colitis&country=United%20States&locStr=United%20States&viewType=Table&rank=10

Study Details | CP101 for the Treatment of Ulcerative Colitis Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring board, or DSMB.

2. ctv.veeva.com ctv.veeva.com/study/cp101-for-the-treatment-of-ulcerative-colitis

CP101 for the Treatment of Ulcerative Colitis The primary outcome, engraftment of CP101 associated microbes will be measured utilizing two baseline samples (prior to CP101 administration) ...

3. finchtherapeutics.com finchtherapeutics.com/wp-content/uploads/2022/08/DDW-2022_PRISM-EXT-Abstract.pdf

583: CP101, AN INVESTIGATIONAL ORALLY ... CP101 is an investigational orally administered microbiome therapeutic designed to restore microbiome diversity and enable early intervention in recurrent CDI.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39366468/

Safety and Tolerability of CP101, a Full-Spectrum, Oral ... CP101 was superior to placebo in reducing recurrent CDI with a safety profile similar to placebo. (ClinicalTrials.gov, Number NCT03110133).

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03110133

NCT03110133 | Efficacy, Safety, and Tolerability Study of ... The purpose of this study is to demonstrate the safety and effectiveness of CP101 to prevent recurrence of C. difficile. Subjects with confirmed C. difficile ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12558580/

Safety Outcomes in Patients With Ulcerative Colitis Using a ... We used RWD to investigate safety outcomes in 4 cohorts: (1) those receiving any UC treatment (UC overall), (2) those receiving advanced ...