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Trial Acronym
SER-301-001 (cohort 1)
Registration Number
ACTRN12620000963921
Scientific Title
A Seamless Phase 1b Study to Evaluate Safety, Tolerability and Efficacy of SER-301 in Adult Subjects with Active Mild-to-Moderate Ulcerative Colitis
Brief Summary
Key Inclusion Criteria
Key Exclusion Criteria
Trial Locations
Primary Sponsor
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. Participants will be enrolled into either Part 1 or Part 2 of the study, but not both. This record describes Part 1 only. Part 1 is open-label. Approximately 15 participants will be enrolled in 2 sub-cohorts to receive 10 weeks of once-daily open-label induction treatment with SER-301 following 6 days of vancomycin pre-conditioning (125mg oral capsules, 4 times daily). • Part 1A: 5 participants will be dosed with SER-301 after vancomycin pre-conditioning. If no significant safety concerns are reported after all 5 participants have completed pre-conditioning and 7 days of SER-301 dosing, enrollment in Cohort 1B will proceed. • Part 1B: The remaining 10 additional participants will be dosed with SER-301 after vancomycin pre-conditioning. If no significant safety concerns are reported after all 10 participants have completed pre-conditioning and 7 days of SER-301 dosing, enrollment in Cohort 2 will proceed. 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.
Inclusion Criteria * Both Male or Female, 18-65 years of age * 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 * 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
Trial Location Name
Address
Status
Royal Prince Alfred Hospital (Gastroenterology and Hepatology)
Royal Prince Alfred Hospital, Missenden Road, Camperdown NSW, Australia
Closed
Primary Contact :
Simone Strasser,
clinicaltrials@gesa.org.au
, 02 9515 8578
Secondary Contact :
Lisa Lo,
Lisa.Lo@health.nsw.gov.au
, 02 9515 7383
Seres Therapeutics, Inc.
Website URL
Link Name
Link URL
N/A
N/A
Secondary IDs
N/A
Study Type
Interventional
Intervention Code
Treatment - Drugs
Phase
Phase 1
Minimum Age
18
Maximum Age
65
Date Registered
25/05/2021
Date Closed
N/A
Status
Closed
Enrolment Type
By Specialist and/or Surgeon Referral
Mutation Status and Biomarker
N/A
Is it a Cohort Trial?
Yes
Is this a Tele-Trial?
No
Can healthy volunteer participate?
No
Cohort Details
Cohort Name
Description
Status
Cohort 1
Open-label
Open
Discipline
Health Condition
Category
Sub Category
Gastroenterology
Inflammatory Bowel Disease
Ulcerative Colitis
N/A
Trial ID
21050584
