Ulcerative ColitisPhase 2ECO-RESETNCT03759041

A Study to Assess Efficacy and Safety of SER-287 in Adults With Active Mild-to-Moderate Ulcerative Colitis

A Phase 2 study testing Vancomycin Pre-Treatment and SER-287 in people with Ulcerative Colitis, run by Seres Therapeutics, Inc. at 93 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter Study to Assess Efficacy and Safety of SER-287 in Adults with Active Mild-to-Moderate Ulcerative Colitis Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Ulcerative Colitis
What is being tested?: Vancomycin Pre-Treatment and SER-287
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 203 participants
Where: 93 sitesin 2 countries
Study dates: 19 Dec 2018to 13 Oct 2021
Phase: Phase 2
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Documented diagnosis of UC at least three months prior to screening, and with a minimum disease extent of 15 cm from the anal verge
Active mild-to-moderate UC
Inadequate response to, loss of response to, or intolerance of, at least one of the following conventional therapies: 5-ASA compounds, corticosteroids, 6-mercaptopurine (6-MP) or azathioprine (AZA), anti-TNFα, anti-integrin or tofacitinib

Who cannot join

Known history of Crohn's disease
No previous history of treatment for UC (treatment-naïve)
Subjects on steroid medication who are unable to have steroids tapered and be completely off steroids at least two weeks prior to screening
Unable to stop steroid enemas or suppositories, or 5-ASA enemas or suppositories, at least two weeks prior to screening
Subjects who have received any investigational or approved biologic therapy within eight weeks or five half-lives prior to screening (whichever is longer)
Subjects who have received any investigational or approved non-biologic therapy, except for those specifically listed in the Permitted Concomitant Medications, for the treatment of underlying disease, within 30 days or five half-lives prior to screening (whichever is longer)
Major gastrointestinal surgery (not including appendectomy or cholecystectomy) within two months before screening, or any history of total colectomy

Trial locations and contacts

93 sites in 2 countries.

Country

City, postcode or hospital

93 sites in 2 countries

United States81 sites

(Investigator site)
Ann Arbor, Michigan, 48109
(Investigator site)
Asheville, North Carolina, 28801
(Investigator site)
Athens, Georgia, 30607
(Investigator site)
Atlanta, Georgia, 30322
(Investigator site)
Baltimore, Maryland, 21287
(Investigator site)
Bedford, Texas, 76022
(Investigator site)
Boca Raton, Florida, 33487
(Investigator site)
Bridgeton, Missouri, 63044
(Investigator site)
Chapel Hill, North Carolina, 27599
(Investigator site)
Chicago, Illinois, 60611
(Investigator site)
Chicago, Illinois, 60612
(Investigator site)
Chicago, Illinois, 60637
(Investigator site)
Cincinnati, Ohio, 45219
(Investigator site)
Clearwater, Florida, 33762
(Investigator site)
Columbia, South Carolina, 29203
(Investigator site)
Creve Coeur, Missouri, 63141
(Investigator site)
Crystal River, Florida, 34429
(Investigator site)
Danbury, Connecticut, 06810
(Investigator site)
Durham, North Carolina, 27710
(Investigator site)
Farmington Hills, Michigan, 48334
(Investigator site)
Fort Lauderdale, Florida, 33308
(Investigator site)
Fort Sam Houston, Texas, 78219
(Investigator site)
Glen Burnie, Maryland, 21208
(Investigator site)
Great Neck, New York, 11021
(Investigator site)
Greenville, South Carolina, 29615
(Investigator site)
Hamden, Connecticut, 06518
(Investigator site)
Hartsdale, New York, 10530
(Investigator site)
Hialeah, Florida, 33012
(Investigator site)
Houston, Texas, 77030
(Investigator site)
Houston, Texas, 77043
(Investigator site)
Houston, Texas, 77090
(Investigator site)
Indianapolis, Indiana, 46202
(Investigator site)
Jacksonville, Florida, 32256
(Investigator site)
La Jolla, California, 92037
(Investigator site)
Lake Charles, Louisiana, 70601
(Investigator site)
Lancaster, California, 93534
(Investigator site)
Las Vegas, Nevada, 89123
(Investigator site)
Lebanon, New Hampshire, 03756
(Investigator site)
Leesburg, Virginia, 20176
(Investigator site)
Lexington, Kentucky, 40536
(Investigator site)
Los Angeles, California, 90067
(Investigator site)
Lynchburg, Virginia, 24502
(Investigator site)
Madison, Wisconsin, 53792
(Investigator site)
Marietta, Georgia, 30060
(Investigator site)
McAllen, Texas, 78504
(Investigator site)
Memphis, Tennessee, 38119
(Investigator site)
Metairie, Louisiana, 70006
(Investigator site)
Miami, Florida, 33136
(Investigator site)
Miami, Florida, 33176
(Investigator site)
Milwaukee, Wisconsin, 53215
(Investigator site)
Monroe, Louisiana, 71201
(Investigator site)
Mountain View, California, 94040
(Investigator site)
Naples, Florida, 34102
(Investigator site)
Nashville, Tennessee, 37212
(Investigator site)
New Orleans, Louisiana, 70121
(Investigator site)
New York, New York, 10016
(Investigator site)
New York, New York, 10032
(Investigator site)
North Little Rock, Arkansas, 72117
(Investigator site)
Ocala, Florida, 34474
(Investigator site)
Ogden, Utah, 84405
(Investigator site)
Oklahoma City, Oklahoma, 73104
(Investigator site)
Orlando, Florida, 32803
(Investigator site)
Phoenix, Arizona, 85018
(Investigator site)
Pompano Beach, Florida, 33060
(Investigator site)
Port Orange, Florida, 32127
(Investigator site)
Raleigh, North Carolina, 27612
(Investigator site)
Reno, Nevada, 89511
(Investigator site)
Reston, Virginia, 20191
(Investigator site)
Richmond, Virginia, 23249
(Investigator site)
Rochester, Minnesota, 55905
(Investigator site)
Salt Lake City, Utah, 84124
(Investigator site)
San Antonio, Texas, 78229
(Investigator site)
San Diego, California, 92103
(Investigator site)
San Diego, California, 92123
(Investigator site)
Shreveport, Louisiana, 71105
(Investigator site)
Spokane, Washington, 99202
(Investigator site)
Tampa, Florida, 33609
(Investigator site)
Temple, Texas, 76508
(Investigator site)
Wheat Ridge, Colorado, 80033
(Investigator site)
Winston-Salem, North Carolina, 27103
(Investigator site)
Winston-Salem, North Carolina, 27157

Other trials in United States

Canada12 sites

(Investigator site)
Bridgewater, Ontario, B4V 3K9
(Investigator site)
Edmonton, Alberta, T6G 2L7
(Investigator site)
Edmonton, Alberta, T6L 6K3
(Investigator site)
Greater Sudbury, Ontario, P3C 5K6
(Investigator site)
Greenfield Park, Quebec, J4V 2H1
(Investigator site)
Lindsay, Ontario, K9V 5G6
(Investigator site)
London, Ontario, N6A 5A5
(Investigator site)
London, Ontario, N6A 5W9
(Investigator site)
New Westminster, British Columbia, V3L 3W4
(Investigator site)
Saskatoon, Saskatchewan, S7N 0W8
(Investigator site)
Toronto, Ontario, M5T 3A9
(Investigator site)
Vaughan, Ontario, L4L 4Y7

Other trials in Canada

About this study

Official title: ECO-RESET: A Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter Study to Assess Efficacy and Safety of SER-287 in Adults With Active Mild-to-Moderate Ulcerative Colitis

A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter Study to Assess Efficacy and Safety of SER-287 in Adults with Active Mild-to-Moderate Ulcerative Colitis

Read the detailed description

This is a Phase 2B randomized, double-blind, placebo-controlled, multiple dose, multicenter study designed to evaluate the efficacy, safety and microbiome alterations associated with two dose levels of SER-287, after pre-treatment with vancomycin, in adult subjects, age 18-80, with active mild-to-moderate ulcerative colitis (UC).

Conditions: Ulcerative Colitis
Being tested: Vancomycin Pre-Treatment, Placebo for Vancomycin Pre-Treatment, SER-287, Placebo for SER-287
Keywords: microbiome
Medical subject headings: Colitis, Ulcerative

What participants receive

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

Vancomycin Pre-TreatmentDrug
Four times per day dosing of vancomycin pre-treatment
Placebo for Vancomycin Pre-TreatmentDrug
Four times per day dosing of placebo pre-treatment
SER-287Drug
Also called Eubacterial Spores, Purified Suspension, Encapsulated
Once-daily dosing of SER-287
Placebo for SER-287Drug
Once-daily dosing of Placebo for SER-287

Study groups in NCT03759041
Study group	Role	What they receive
Placebo (after placebo pre-treatment)	Placebo comparator	Once-daily dosing of Placebo (after placebo pre-treatment) Receives: Drug: Placebo for Vancomycin Pre-Treatment; Drug: Placebo for SER-287
SER-287 Induction Dosing (after vancomycin pre-treatment)	Experimental	Once-daily dosing of SER-287 (Induction Dose, after vancomycin pre-treatment) Receives: Drug: Vancomycin Pre-Treatment; Drug: SER-287
SER-287 Step-Down Induction Dosing (after vancomycin pre-treatment)	Experimental	Once-daily dosing of SER-287 (Step-Down Induction Dose, after vancomycin pre-treatment) Receives: Drug: Vancomycin Pre-Treatment; Drug: SER-287

What is being measured

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

Clinical Remission (Count of Participants)
Clinical remission for the induction treatment period:
- Stool Frequency subscore = 0 or 1, with at least 1-point decrease from baseline
- Rectal Bleeding subscore = 0
- Endoscopic subscore = 0 or 1 on modified Mayo Score, with at least 1-point decrease from baseline
- No occurrence of UC Flare during the treatment period
Clinical remission was measured using 3 components of the modified Mayo Score (stool frequency, rectal bleeding and endoscopic subscore), a measure of UC disease activity. These 3 components are each graded from 0 to 3, and are summed together for a composite score, with a higher overall score indicating more severe disease (0 = no disease; 9 = worst disease). The modified Mayo endoscopic subscore excludes friability from an endoscopic subscore of 1.
Measured: After 10 weeks of induction dosing

Secondary outcomes (1)

Endoscopic Improvement (Count of Participants)
Endoscopic subscore decrease from baseline of at least 1 point, as assessed by flexible sigmoidoscopy or colonoscopy.
Endoscopic improvement was measured using the modified Mayo Score endoscopic subscore, graded from 0 to 3, with higher scores indicating more severe disease. The modified Mayo endoscopic subscore excludes friability from an endoscopic subscore of 1.
Measured: After 10 weeks of induction dosing

Timeline

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

19 Dec 201813 Oct 2021

First posted29 Nov 2018
Study start19 Dec 2018
Primary completion28 May 2021
Study completion13 Oct 2021

Why it stopped: Due to the lack of a clinical efficacy signal in the induction treatment phase, Seres closed the dosing phases of open label and maintenance portions of the study. Patients who had received prior doses were followed for safety data.

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.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 203 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03759041
Sponsor's protocol ID: SERES-201
Acronym: ECO-RESET
Status last verified: Jul 2022
First submitted: 27 Nov 2018
Last updated: 12 Aug 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

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 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ECO-RESET: A Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter Study to Assess Efficacy and Safety of SER-287 in Adults With Active Mild-to-Moderate Ulcerative Colitis
ClinicalTrials.gov ID: NCT03759041
Acronym / sponsor ID: ECO-RESET / SERES-201
Conditions: Ulcerative Colitis
Keywords: microbiome
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Due to the lack of a clinical efficacy signal in the induction treatment phase, Seres closed the dosing phases of open label and maintenance portions of the study. Patients who had received prior doses were followed for safety data.
Enrolment: 203 participants (actual)
Lead sponsor: Seres Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 19 Dec 2018 (actual)
Primary completion: 28 May 2021 (actual)
Study completion: 13 Oct 2021 (actual)
First posted: 29 Nov 2018 (actual)
Results: Posted 21 Jun 2022

Clinical summary

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

A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter Study to Assess Efficacy and Safety of SER-287 in Adults with Active Mild-to-Moderate Ulcerative Colitis

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Placebo (after placebo pre-treatment)	Placebo comparator	Drug: Placebo for Vancomycin Pre-Treatment, Drug: Placebo for SER-287Once-daily dosing of Placebo (after placebo pre-treatment)
SER-287 Induction Dosing (after vancomycin pre-treatment)	Experimental	Drug: Vancomycin Pre-Treatment, Drug: SER-287Once-daily dosing of SER-287 (Induction Dose, after vancomycin pre-treatment)
SER-287 Step-Down Induction Dosing (after vancomycin pre-treatment)	Experimental	Drug: Vancomycin Pre-Treatment, Drug: SER-287Once-daily dosing of SER-287 (Step-Down Induction Dose, after vancomycin pre-treatment)

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Documented diagnosis of UC at least three months prior to screening, and with a minimum disease extent of 15 cm from the anal verge
Active mild-to-moderate UC
Inadequate response to, loss of response to, or intolerance of, at least one of the following conventional therapies: 5-ASA compounds, corticosteroids, 6-mercaptopurine (6-MP) or azathioprine (AZA), anti-TNFα, anti-integrin or tofacitinib

Key exclusion criteria (7 listed)

Known history of Crohn's disease
No previous history of treatment for UC (treatment-naïve)
Subjects on steroid medication who are unable to have steroids tapered and be completely off steroids at least two weeks prior to screening
Unable to stop steroid enemas or suppositories, or 5-ASA enemas or suppositories, at least two weeks prior to screening
Subjects who have received any investigational or approved biologic therapy within eight weeks or five half-lives prior to screening (whichever is longer)

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
Vancomycin Pre-TreatmentFour times per day dosing of vancomycin pre-treatment	Drug	SER-287 Induction Dosing (after vancomycin pre-treatment), SER-287 Step-Down Induction Dosing (after vancomycin pre-treatment)
Placebo for Vancomycin Pre-TreatmentFour times per day dosing of placebo pre-treatment	Drug	Placebo (after placebo pre-treatment)
SER-287Also: Eubacterial Spores, Purified Suspension, EncapsulatedOnce-daily dosing of SER-287	Drug	SER-287 Induction Dosing (after vancomycin pre-treatment), SER-287 Step-Down Induction Dosing (after vancomycin pre-treatment)
Placebo for SER-287Once-daily dosing of Placebo for SER-287	Drug	Placebo (after placebo pre-treatment)

Primary outcome

Clinical Remission (Count of Participants)
Time frame: After 10 weeks of induction dosing
Clinical remission for the induction treatment period: * Stool Frequency subscore = 0 or 1, with at least 1-point decrease from baseline * Rectal Bleeding subscore = 0 * Endoscopic subscore = 0 or 1 on modified Mayo Score, with at least 1-point decrease from baseline * No occurrence of UC Flare during the treatment period Clinical remission was measured using 3 components of the modified Mayo Score (stool frequency, rectal bleeding and endoscopic subscore), a measure of UC disease activity. These 3 components are each graded from 0 to 3, and are summed together for a composite score, with a higher overall score indicating more severe disease (0 = no disease; 9 = worst disease). The modified Mayo endoscopic subscore excludes friability from an endoscopic subscore of 1.

1 secondary outcome

Endoscopic Improvement (Count of Participants)
Time frame: After 10 weeks of induction dosing

Results and safety

Results posted to the registry on 21 Jun 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo (After Placebo Pre-treatment)	69	42
SER-287 Induction Dosing (After Vancomycin Pre-treatment)	68	34
SER-287 Step-Down Induction Dosing (After Vancomycin Pre-treatment)	66	38

Primary outcome: Clinical Remission (Count of Participants)

Time frame: After 10 weeks of induction dosing. Count of participants. Unit: Participants

Measure	Placebo (After Placebo Pre-treatment) n = 69	SER-287 Induction Dosing (After Vancomycin Pre-treatment) n = 68	SER-287 Step-Down Induction Dosing (After Vancomycin Pre-treatment) n = 66
Value	8	7	7

Population analysed: Intent-to-treat

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events presented here are for the 10-week Induction Treatment Period of the study, as well as the 1-week Pre-Treatment Period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo (After Placebo Pre-treatment)	1 of 69 (1.4%)	6 of 69 (8.7%)	0 of 69
SER-287 Induction Dosing (After Vancomycin Pre-treatment)	3 of 68 (4.4%)	23 of 68 (33.8%)	0 of 68
SER-287 Step-Down Induction Dosing (After Vancomycin Pre-treatment)	1 of 65 (1.5%)	12 of 65 (18.5%)	0 of 65

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Ulcerative Colitis

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RecruitingObservational study
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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.

Lisa von Moltke, MD study director

Seres Therapeutics, Inc.

93 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vancomycin Pre-Treatment and SER-287 in people with Ulcerative Colitis, run by Seres Therapeutics, Inc. at 93 sites in 2 countries.

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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 12 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 93 sites in United States, Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 21 Jun 2022). 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?

Clinical Remission (Count of Participants) (time frame: After 10 weeks of induction dosing). 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 NCT03759041.

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 12 Aug 2022.