A Seamless Phase 1b Study to Evaluate Safety, Tolerability and Efficacy of SER-301 in Adult Subjects with Active Mild-to-Moderate Ulcerative Colitis (Part 2)

Conditions

None listed

Brief summary

This is a seamless Phase 1b multicentre study to evaluate safety, tolerability, and efficacy of SER-301 in adult participants with active mild-to-moderate UC. SER-301 is a live microbiome therapeutic – a designed set of diverse, human-commensal bacterial strains, administered as oral capsules. This study has a seamless design, as it is composed of two study parts, each with different objectives, with an operationally seamless transition in between. Participants will be enrolled into either Part 1 or Part 2. Part 2 is randomised, double-blind, placebo-controlled. Approximately 50 participants will be randomised 2:3 to receive either 10 weeks of once-daily placebo following 6 days of placebo (4 times daily) or 10 weeks of once-daily induction treatment with SER-301 following 6 days of vancomycin pre-conditioning (4 times daily), respectively.

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Interventions

This is a seamless Phase 1b multicentre study to evaluate safety, tolerability, and efficacy of SER-301 in adult participants with active mild-to-moderate UC. SER-301 is a live microbiome therapeutic - a designed set of 18 live human-commensal bacterial strains representing different species administered as oral capsules. Each strain was purified from the stool of healthy donors and used to establish pure bacterial cell lines suitable for further good manufacturing practice use. The strains wer

This is a seamless Phase 1b multicentre study to evaluate safety, tolerability, and efficacy of SER-301 in adult participants with active mild-to-moderate UC. SER-301 is a live microbiome therapeutic - a designed set of 18 live human-commensal bacterial strains representing different species administered as oral capsules. Each strain was purified from the stool of healthy donors and used to establish pure bacterial cell lines suitable for further good manufacturing practice use. The strains were selected based on their pharmacological properties and safety profile, including genomic and microbiological characterisation of the strains. SER-301 drug product consists of 2 different capsule types each containing a different formulation containing a part of the total SER-301 composition. Two capsules of each part are delivered in the complete dose for a total of 4 capsules once-daily, or 5.1 x 10^7 colony forming units (CFU). • SER-301 Part 1 is a liquid formulation of bacterial spores containing 10 strains delivered in 2 oral capsules. Part 1 contains 5.6 x 10^6 CFU. • SER-301 Part 2 is a dry powder formulation of vegetative bacteria containing 8 strains delivered in 2 oral capsules. Part 2 contains 4.5 x 10^7 CFU. This study has a seamless design, as it is composed of two study parts, with an operationally seamless transition in between. Both study parts share objectives of safety, tolerability, and engraftment measures. Part 2 also has some additional clinical and exploratory objectives. Participants will be enrolled into either Part 1 or Part 2 of the study, but not both. This record describes Part 2 only. Part 2 is randomised, double-blind, placebo-controlled. Approximately 50 participants will be randomised 2:3 to receive either 10 weeks of once-daily placebo following 6 days of placebo (4 times daily) or 10 weeks of once-daily induction treatment with SER-301 following 6 days of vancomycin pre-conditioning (125mg oral capsules, 4 times daily), respectively. Adherence will be monitored throughout the study. All remaining drug should be returned by participants to the clinical site where drug accountability, including capsule count to monitor compliance, will take place and participants will also be asked to complete a diary where they will record daily symptoms.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

No

Inclusion criteria

Inclusion Criteria Documented diagnosis of UC prior to screening endoscopy Active mild-to-moderate UC as determined by a 3-Component Modified Mayo Score Minimum disease extent of 15 cm from the anal verge, confirmed at the screening endoscopy Naïve to UC treatment or with an inadequate response to, loss of response to, or intolerance of, at least one of the following conventional therapies: 5-ASA compounds, corticosteroids or immunomodulators (e.g., 6-MP, AZA, methotrexate)

Exclusion criteria

Exclusion Criteria Known history of Crohn’s disease On steroid medication who are unable to have steroids tapered, and be completely off steroids at least 2 weeks prior to screening Unable to stop steroid enemas or suppositories, or 5-ASA enemas or suppositories, at least 2 weeks prior to screening Previously received any investigational or approved biologic therapy Previously received any investigational or approved non-biologic therapy, except for those specifically listed in the Permitted Concomitant Medications (e.g., stable dose of 6-MP, AZA, methotrexate) Major gastrointestinal surgery (not including appendectomy or cholecystectomy) within 2 months prior to screening

Outcome results