Ulcerative ColitisPhase 1NCT02618187

A Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287 in Subjects With Mild-to-Moderate Ulcerative Colitis

A Phase 1 study testing SER-287 and Vancomycin Pre-Treat in people with Ulcerative Colitis, run by Seres Therapeutics, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A Multiple Dose Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287 in Subjects with Mild-to-Moderate Ulcerative Colitis. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Ulcerative Colitis
What is being tested?: SER-287 and Vancomycin Pre-Treat
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 58 participants
Where: 1 siteUnited States
Study dates: 13 Jan 2016to 26 Jan 2018
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Ulcerative colitis diagnosed by routine clinical, radiographic, endoscopic and pathologic criteria (preferably confirmed by colonoscopy and pathology records within last 2 years or if unavailable, will need approval by medical monitor) Active mild-moderate UC as determined by sigmoidoscopy within approximately 3 days of randomization to study

Who cannot join

Fever > 38.3°C
Known or suspected toxic megacolon and/or known small bowel ileus
Known history of Crohn's disease
Subjects with serum albumin <2.5 g/dL at baseline
CMV polymerase chain reaction (PCR) positive from blood plasma at screening
Known stool studies positive for ova and/or parasites or stool culture within the 30 days before enrollment

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Subjects on cyclosporine or triple immunosuppression, Triple immunosuppression will include any three of the following classes of drugs taken in combination: steroids (i.e., prednisone/budesonide/budesonide MMX), immunosuppressant (i.e., methotrexate/azathioprine/6-mercaptopurine), and/or other immunosuppressant (i.e., tacrolimus, cellcept).
Biologic medication (infliximab/ adalimumab/ golimumab/ certolizumab/vedolizumab/ustekinumab/natalizumab) use within 3 months prior to screening
Known active malignancy except for basal cell skin cancer, squamous cell skin cancer
Subjects with previous colectomy, ostomy, J-pouch, or previous intestinal surgery (excluding cholecystectomy, appendectomy)
Subjects with known history of celiac disease or gluten enteropathy
Subjects with Clostridium difficile positive stool at Screening Visit
Antibiotic use within the prior 1 month before randomization
Expected to receive antibiotics within 8 weeks of signing the Informed Consent Form (ICF) (i.e., for planned/anticipated procedure)
Received an investigational drug within 1 month before study entry
Received an investigational antibody or vaccine within 3 months before study entry
Previously enrolled in a SER-109/SER-287 study
Received an FMT within the last 6 months
Subjects with anatomic or medical contraindications to flexible sigmoidoscopy, including but not necessarily limited to toxic megacolon, gastrointestinal (GI) fistulas, immediate post-operative status from abdominal surgery, severe coagulopathy, large or symptomatic abdominal aortic aneurysm, or any subject where study physician deems subject at significant risk of complications of flexible sigmoidoscopy
Unable to stop steroid enemas or suppositories or mesalamine enemas or suppositories before screening visit
Unable to stop opiate treatment unless on a stable dose and no increase in dose planned for the duration of the study
Unable to stop probiotics before screening visit
Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy (subjects on maintenance chemotherapy may only be enrolled after consultation with medical monitor)
Known allergy or intolerance to oral vancomycin
-

Trial locations and contacts

1 site in 1 country.

United States1 site

Community Clinical Research Network
Marlborough, Massachusetts, 01752

Other trials in United States

About this study

Official title: A Phase 1B Multiple Dose Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287 in Subjects With Mild-to-Moderate Ulcerative Colitis

A Multiple Dose Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287 in Subjects with Mild-to-Moderate Ulcerative Colitis.

Read the detailed description

This is a Phase 1b multicenter, randomized, double-blind, placebo-controlled multiple dose study designed to evaluate the safety and tolerability of SER-287, and to evaluate the microbiome alterations and pharmacodynamics associated with two dosing regimens of SER-287 in adult subjects with active mild-to-moderate ulcerative colitis (UC).

Conditions: Ulcerative Colitis
Being tested: SER-287, Placebo, Placebo Pre-Treat, Vancomycin Pre-Treat
Medical subject headings: Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SER-287Drug
Also called Eubacterial Spores, Purified Suspension, Encapsulated
PlaceboDrug
Placebo Pre-TreatDrug
Vancomycin Pre-TreatDrug

Study groups in NCT02618187
Study group	Role	What they receive
Weekly SER-287, after Placebo Pre-Treat.	Experimental	Placebo pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks Receives: Drug: SER-287; Drug: Placebo Pre-Treat
Daily placebo, after Placebo Pre-Treat.	Placebo comparator	Placebo pre-treatment, followed by once daily placebo for 8 weeks Receives: Drug: Placebo; Drug: Placebo Pre-Treat
Daily SER-287, after Vanco. Pre-Treat.	Experimental	Vancomycin pre-treatment, followed by once daily dosing of SER-287 for 8 weeks Receives: Drug: SER-287; Drug: Vancomycin Pre-Treat
Weekly SER-287, after Vanco. Pre-Treat.	Experimental	Vancomycin pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks Receives: Drug: SER-287; Drug: Vancomycin Pre-Treat

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and Tolerability of SER-287
Treatment-Emergent Adverse Events Incidence by Treatment, System Organ Class and Preferred Term. The treatment period with SER-287 was eight weeks. All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
Measured: Day 246
Composition of the Intestinal Microbiome
Changes in the composition of the microbiome were characterized by whole metagenomic sequencing (WMS) of subjects' stool samples. Changes in the composition of the microbiome were measured by quantifying the number of unique types of spore-forming bacteria detected in subjects' stool samples after eight weeks of induction treatment versus baseline.
Measured: Baseline and 8 weeks
Engraftment of SER-287 Bacteria in All Treatment Arms
The stool microbiomes of SERES-101 subjects, before and after treatment with SER-287, were characterized using whole metagenomic sequencing (WMS). SER-287 drug product was also characterized using WMS. Microbiome engraftment was assessed by the number of spore-forming species in the drug product lots that were also detected in subjects' post-treatment fecal samples but not detected at baseline.
Measured: Baseline and 8 weeks

Secondary outcomes (2)

Clinical Remission
Defined as a Total Modified Mayo Score <= 2 and an endoscopic subscore <= 1.
The Total Modified Mayo Score is a measure of UC disease activity which ranges from 0 to 12 points and consists of four subscores (stool frequency, rectal bleeding, endoscopy, and physician global assessment), each graded from 0 to 3, with higher scores indicating more severe disease. The four components are summed together for a composite score, with a higher overall score indicating more severe disease (0 = no disease; 12 = worst disease). The Modified Mayo endoscopic subscore excludes friability from an endoscopic subscore of 1.
Measured: 8 weeks
Endoscopic Improvement
Defined as a decrease in endoscopic subscore >= 1
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jan 201626 Jan 2018

First posted1 Dec 2015 (estimated)
Study start13 Jan 2016
Primary completion6 Dec 2017
Study completion26 Jan 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02618187
Sponsor's protocol ID: SERES-101
Status last verified: Mar 2019
First submitted: 20 Nov 2015
Last updated: 20 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Henn MR, O'Brien EJ, Diao L, Feagan BG, Sandborn WJ, Huttenhower C, Wortman JR, McGovern BH, Wang-Weigand S, Lichter DI, Chafee M, Ford CB, Bernardo P, Zhao P, Simmons S, Tomlinson AD, Cook DN, Pomerantz RJ, Misra BK, Aunins JG, Trucksis M. A Phase 1b Safety Study of SER-287, a Spore-Based Microbiome Therapeutic, for Active Mild to Moderate Ulcerative Colitis. Gastroenterology. 2021 Jan;160(1):115-127.e30. doi: 10.1053/j.gastro.2020.07.048. Epub 2020 Aug 4.
PubMed 32763240

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ulcerative Colitis trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1B Multiple Dose Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287 in Subjects With Mild-to-Moderate Ulcerative Colitis
ClinicalTrials.gov ID: NCT02618187
Acronym / sponsor ID: SERES-101
Conditions: Ulcerative Colitis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: Seres Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 13 Jan 2016 (actual)
Primary completion: 6 Dec 2017 (actual)
Study completion: 26 Jan 2018 (actual)
First posted: 1 Dec 2015 (estimated)
Results: Posted 20 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A Multiple Dose Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287 in Subjects with Mild-to-Moderate Ulcerative Colitis.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Weekly SER-287, after Placebo Pre-Treat.	Experimental	Drug: SER-287, Drug: Placebo Pre-TreatPlacebo pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks
Daily placebo, after Placebo Pre-Treat.	Placebo comparator	Drug: Placebo, Drug: Placebo Pre-TreatPlacebo pre-treatment, followed by once daily placebo for 8 weeks
Daily SER-287, after Vanco. Pre-Treat.	Experimental	Drug: SER-287, Drug: Vancomycin Pre-TreatVancomycin pre-treatment, followed by once daily dosing of SER-287 for 8 weeks
Weekly SER-287, after Vanco. Pre-Treat.	Experimental	Drug: SER-287, Drug: Vancomycin Pre-TreatVancomycin pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Ulcerative colitis diagnosed by routine clinical, radiographic, endoscopic and pathologic criteria (preferably confirmed by colonoscopy and pathology records within last 2 years or if unavailable, will need approval by medical monitor) Active mild-moderate UC as determined by sigmoidoscopy within approximately 3 days of randomization to study

Key exclusion criteria (25 listed)

Fever > 38.3°C
Known or suspected toxic megacolon and/or known small bowel ileus
Known history of Crohn's disease
Subjects with serum albumin <2.5 g/dL at baseline
CMV polymerase chain reaction (PCR) positive from blood plasma at screening

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SER-287Also: Eubacterial Spores, Purified Suspension, Encapsulated	Drug	Daily SER-287, after Vanco. Pre-Treat., Weekly SER-287, after Placebo Pre-Treat., Weekly SER-287, after Vanco. Pre-Treat.
Placebo	Drug	Daily placebo, after Placebo Pre-Treat.
Placebo Pre-Treat	Drug	Daily placebo, after Placebo Pre-Treat., Weekly SER-287, after Placebo Pre-Treat.
Vancomycin Pre-Treat	Drug	Daily SER-287, after Vanco. Pre-Treat., Weekly SER-287, after Vanco. Pre-Treat.

Primary outcome

Safety and Tolerability of SER-287
Time frame: Day 246
Treatment-Emergent Adverse Events Incidence by Treatment, System Organ Class and Preferred Term. The treatment period with SER-287 was eight weeks. All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
Composition of the Intestinal Microbiome
Time frame: Baseline and 8 weeks
Changes in the composition of the microbiome were characterized by whole metagenomic sequencing (WMS) of subjects' stool samples. Changes in the composition of the microbiome were measured by quantifying the number of unique types of spore-forming bacteria detected in subjects' stool samples after eight weeks of induction treatment versus baseline.
Engraftment of SER-287 Bacteria in All Treatment Arms
Time frame: Baseline and 8 weeks
The stool microbiomes of SERES-101 subjects, before and after treatment with SER-287, were characterized using whole metagenomic sequencing (WMS). SER-287 drug product was also characterized using WMS. Microbiome engraftment was assessed by the number of spore-forming species in the drug product lots that were also detected in subjects' post-treatment fecal samples but not detected at baseline.

2 secondary outcomes

Clinical Remission
Time frame: 8 weeks
Endoscopic Improvement
Time frame: 8 weeks

Results and safety

Results posted to the registry on 20 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Weekly SER-287, After Placebo Pre-Treat.	15	13
Daily Placebo, After Placebo Pre-Treat.	11	9
Daily SER-287, After Vanco. Pre-Treat.	15	11
Weekly SER-287, After Vanco. Pre-Treat.	17	12

Primary outcome: Safety and Tolerability of SER-287

Time frame: Day 246. Count of participants. Unit: Participants

Measure	Weekly SER-287, After Placebo Pre-Treat. n = 15	Daily Placebo, After Placebo Pre-Treat. n = 11	Daily SER-287, After Vanco. Pre-Treat. n = 15	Weekly SER-287, After Vanco. Pre-Treat. n = 17
Gastrointestinal disorders (GI) - total	7	5	2	8
GI-Abdominal distension	0	0	0	1
GI-Abdominal pain	3	1	0	4
GI-Abdominal pain upper	1	0	0	0
GI-Abnormal faeces	0	0	0	1
GI-Bowel movement irregularity	0	0	0	2
GI-Colitis ulcerative (worsening)	1	1	0	1
GI-Constipation	1	0	2	0

Population analysed: Safety population

Primary outcome: Composition of the Intestinal Microbiome

Time frame: Baseline and 8 weeks. Mean (Standard Deviation). Unit: Richness of spore-forming species

Measure	Weekly SER-287, After Placebo Pre-Treat. n = 9	Daily Placebo, After Placebo Pre-Treat. n = 6	Daily SER-287, After Vanco. Pre-Treat. n = 10	Weekly SER-287, After Vanco. Pre-Treat. n = 13
Value	2.333 (8.588)	0.167 (9.475)	12.1 (9.871)	5.615 (9.134)

Weekly SER-287, After Placebo Pre-Treat. vs Daily Placebo, After Placebo Pre-Treat.: p = 0.766, Wilcoxon (Mann-Whitney)
Daily Placebo, After Placebo Pre-Treat. vs Daily SER-287, After Vanco. Pre-Treat.: p = 0.037, Wilcoxon (Mann-Whitney)
Daily Placebo, After Placebo Pre-Treat. vs Weekly SER-287, After Vanco. Pre-Treat.: p = 0.313, Wilcoxon (Mann-Whitney)

Population analysed: Sensitivity Analysis Population - 1 (all randomized subjects with an evaluable stool sample collected at baseline and one evaluable stool sample collected at Visit 12 or Early Termination (ET) visit collected within a 2 week window surrounding Visit 12)

Primary outcome: Engraftment of SER-287 Bacteria in All Treatment Arms

Time frame: Baseline and 8 weeks. Mean (Standard Deviation). Unit: Richness SER-287 spore-forming species

Measure	Weekly SER-287, After Placebo Pre-Treat. n = 9	Daily Placebo, After Placebo Pre-Treat. n = 6	Daily SER-287, After Vanco. Pre-Treat. n = 10	Weekly SER-287, After Vanco. Pre-Treat. n = 13
Value	7.222 (5.974)	4.333 (1.862)	16.7 (7.469)	13.615 (6.225)

Weekly SER-287, After Placebo Pre-Treat. vs Daily Placebo, After Placebo Pre-Treat.: p = 0.257, Wilcoxon (Mann-Whitney)
Daily Placebo, After Placebo Pre-Treat. vs Daily SER-287, After Vanco. Pre-Treat.: p = 0.001, Wilcoxon (Mann-Whitney)
Daily Placebo, After Placebo Pre-Treat. vs Weekly SER-287, After Vanco. Pre-Treat.: p = 0.001, Wilcoxon (Mann-Whitney)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 246. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Weekly SER-287, After Placebo Pre-Treat.	0 of 15 (0%)	8 of 15 (53.3%)	0 of 15
Daily Placebo, After Placebo Pre-Treat.	0 of 11 (0%)	2 of 11 (18.2%)	0 of 11
Daily SER-287, After Vanco. Pre-Treat.	1 of 15 (6.7%)	5 of 15 (33.3%)	0 of 15
Weekly SER-287, After Vanco. Pre-Treat.	0 of 17 (0%)	9 of 17 (52.9%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32763240Henn MR, O'Brien EJ, Diao L, Feagan BG, Sandborn WJ, Huttenhower C, Wortman JR, McGovern BH, Wang-Weigand S, Lichter DI, Chafee M, Ford CB, Bernardo P, Zhao P, Simmons S, Tomlinson AD, Cook DN, Pomerantz RJ, Misra BK, Aunins JG, Trucksis M. A Phase 1b Safety Study of SER-287, a Spore-Based Microbiome Therapeutic, for Active Mild to Moderate Ulcerative Colitis. Gastroenterology. 2021 Jan;160(1):115-127.e30. doi: 10.1053/j.gastro.2020.07.048. Epub 2020 Aug 4.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SER-287 and Vancomycin Pre-Treat in people with Ulcerative Colitis, run by Seres Therapeutics, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability of SER-287 (time frame: Day 246). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02618187, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2019.