Trial Outcomes & Findings for A Study to Assess Efficacy and Safety of SER-287 in Adults With Active Mild-to-Moderate Ulcerative Colitis (NCT NCT03759041)
NCT ID: NCT03759041
Last Updated: 2022-08-12
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
203 participants
Primary outcome timeframe
After 10 weeks of induction dosing
Results posted on
2022-08-12
Participant Flow
Participant milestones
| Measure |
Placebo (After Placebo Pre-treatment)
Once-daily dosing of Placebo (after placebo pre-treatment)
Placebo for Vancomycin Pre-Treatment: Four times per day dosing of placebo pre-treatment
Placebo for SER-287: Once-daily dosing of Placebo for SER-287
|
SER-287 Induction Dosing (After Vancomycin Pre-treatment)
Once-daily dosing of SER-287 (Induction Dose, after vancomycin pre-treatment)
Vancomycin Pre-Treatment: Four times per day dosing of vancomycin pre-treatment
SER-287: Once-daily dosing of SER-287
|
SER-287 Step-Down Induction Dosing (After Vancomycin Pre-treatment)
Once-daily dosing of SER-287 (Step-Down Induction Dose, after vancomycin pre-treatment)
Vancomycin Pre-Treatment: Four times per day dosing of vancomycin pre-treatment
SER-287: Once-daily dosing of SER-287
|
|---|---|---|---|
|
Overall Study
STARTED
|
69
|
68
|
66
|
|
Overall Study
COMPLETED
|
42
|
34
|
38
|
|
Overall Study
NOT COMPLETED
|
27
|
34
|
28
|
Reasons for withdrawal
| Measure |
Placebo (After Placebo Pre-treatment)
Once-daily dosing of Placebo (after placebo pre-treatment)
Placebo for Vancomycin Pre-Treatment: Four times per day dosing of placebo pre-treatment
Placebo for SER-287: Once-daily dosing of Placebo for SER-287
|
SER-287 Induction Dosing (After Vancomycin Pre-treatment)
Once-daily dosing of SER-287 (Induction Dose, after vancomycin pre-treatment)
Vancomycin Pre-Treatment: Four times per day dosing of vancomycin pre-treatment
SER-287: Once-daily dosing of SER-287
|
SER-287 Step-Down Induction Dosing (After Vancomycin Pre-treatment)
Once-daily dosing of SER-287 (Step-Down Induction Dose, after vancomycin pre-treatment)
Vancomycin Pre-Treatment: Four times per day dosing of vancomycin pre-treatment
SER-287: Once-daily dosing of SER-287
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
10
|
10
|
|
Overall Study
Adverse Event
|
1
|
3
|
4
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
1
|
|
Overall Study
Study Terminated by Sponsor
|
15
|
16
|
10
|
|
Overall Study
Other reason for discontinuation
|
0
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
7
|
2
|
2
|
|
Overall Study
Subjects did not have a discontinuation page completed
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Assess Efficacy and Safety of SER-287 in Adults With Active Mild-to-Moderate Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
Placebo (After Placebo Pre-treatment)
n=69 Participants
Once-daily dosing of Placebo (after placebo pre-treatment)
Placebo for Vancomycin Pre-Treatment: Four times per day dosing of placebo pre-treatment
Placebo for SER-287: Once-daily dosing of Placebo for SER-287
|
SER-287 Induction Dosing (After Vancomycin Pre-treatment)
n=68 Participants
Once-daily dosing of SER-287 (Induction Dose, after vancomycin pre-treatment)
Vancomycin Pre-Treatment: Four times per day dosing of vancomycin pre-treatment
SER-287: Once-daily dosing of SER-287
|
SER-287 Step-Down Induction Dosing (After Vancomycin Pre-treatment)
n=66 Participants
Once-daily dosing of SER-287 (Step-Down Induction Dose, after vancomycin pre-treatment)
Vancomycin Pre-Treatment: Four times per day dosing of vancomycin pre-treatment
SER-287: Once-daily dosing of SER-287
|
Total
n=203 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46.6 years
STANDARD_DEVIATION 13.24 • n=99 Participants
|
45.7 years
STANDARD_DEVIATION 14.37 • n=107 Participants
|
44.4 years
STANDARD_DEVIATION 14.70 • n=206 Participants
|
45.6 years
STANDARD_DEVIATION 14.07 • n=7 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
98 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
105 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
177 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
56 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
170 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
NA Participants
n=99 Participants
|
NA Participants
n=107 Participants
|
NA Participants
n=206 Participants
|
NA Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Region of Enrollment
Canada
|
8 participants
n=99 Participants
|
12 participants
n=107 Participants
|
7 participants
n=206 Participants
|
27 participants
n=7 Participants
|
|
Region of Enrollment
United States
|
61 participants
n=99 Participants
|
56 participants
n=107 Participants
|
59 participants
n=206 Participants
|
176 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: After 10 weeks of induction dosingPopulation: Intent-to-treat
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.
Outcome measures
| Measure |
Placebo (After Placebo Pre-treatment)
n=69 Participants
Once-daily dosing of Placebo (after placebo pre-treatment)
Placebo for Vancomycin Pre-Treatment: Four times per day dosing of placebo pre-treatment
Placebo for SER-287: Once-daily dosing of Placebo for SER-287
|
SER-287 Induction Dosing (After Vancomycin Pre-treatment)
n=68 Participants
Once-daily dosing of SER-287 (Induction Dose, after vancomycin pre-treatment)
Vancomycin Pre-Treatment: Four times per day dosing of vancomycin pre-treatment
SER-287: Once-daily dosing of SER-287
|
SER-287 Step-Down Induction Dosing (After Vancomycin Pre-treatment)
n=66 Participants
Once-daily dosing of SER-287 (Step-Down Induction Dose, after vancomycin pre-treatment)
Vancomycin Pre-Treatment: Four times per day dosing of vancomycin pre-treatment
SER-287: Once-daily dosing of SER-287
|
|---|---|---|---|
|
Clinical Remission (Count of Participants)
|
8 Participants
|
7 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: After 10 weeks of induction dosingPopulation: Intent-to-treat
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.
Outcome measures
| Measure |
Placebo (After Placebo Pre-treatment)
n=69 Participants
Once-daily dosing of Placebo (after placebo pre-treatment)
Placebo for Vancomycin Pre-Treatment: Four times per day dosing of placebo pre-treatment
Placebo for SER-287: Once-daily dosing of Placebo for SER-287
|
SER-287 Induction Dosing (After Vancomycin Pre-treatment)
n=68 Participants
Once-daily dosing of SER-287 (Induction Dose, after vancomycin pre-treatment)
Vancomycin Pre-Treatment: Four times per day dosing of vancomycin pre-treatment
SER-287: Once-daily dosing of SER-287
|
SER-287 Step-Down Induction Dosing (After Vancomycin Pre-treatment)
n=66 Participants
Once-daily dosing of SER-287 (Step-Down Induction Dose, after vancomycin pre-treatment)
Vancomycin Pre-Treatment: Four times per day dosing of vancomycin pre-treatment
SER-287: Once-daily dosing of SER-287
|
|---|---|---|---|
|
Endoscopic Improvement (Count of Participants)
|
17 Participants
|
17 Participants
|
16 Participants
|
Adverse Events
Placebo (After Placebo Pre-treatment)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
SER-287 Induction Dosing (After Vancomycin Pre-treatment)
Serious events: 3 serious events
Other events: 23 other events
Deaths: 0 deaths
SER-287 Step-Down Induction Dosing (After Vancomycin Pre-treatment)
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (After Placebo Pre-treatment)
n=69 participants at risk
Once-daily dosing of Placebo (after placebo pre-treatment)
Placebo for Vancomycin Pre-Treatment: Four times per day dosing of placebo pre-treatment
Placebo for SER-287: Once-daily dosing of Placebo for SER-287
|
SER-287 Induction Dosing (After Vancomycin Pre-treatment)
n=68 participants at risk
Once-daily dosing of SER-287 (Induction Dose, after vancomycin pre-treatment)
Vancomycin Pre-Treatment: Four times per day dosing of vancomycin pre-treatment
SER-287: Once-daily dosing of SER-287
|
SER-287 Step-Down Induction Dosing (After Vancomycin Pre-treatment)
n=65 participants at risk
Once-daily dosing of SER-287 (Step-Down Induction Dose, after vancomycin pre-treatment)
Vancomycin Pre-Treatment: Four times per day dosing of vancomycin pre-treatment
SER-287: Once-daily dosing of SER-287
|
|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/69 • Adverse events presented here are for the 10-week Induction Treatment Period of the study, as well as the 1-week Pre-Treatment Period.
Adverse events are reported for subjects who received any amount of study drug.
|
1.5%
1/68 • Adverse events presented here are for the 10-week Induction Treatment Period of the study, as well as the 1-week Pre-Treatment Period.
Adverse events are reported for subjects who received any amount of study drug.
|
0.00%
0/65 • Adverse events presented here are for the 10-week Induction Treatment Period of the study, as well as the 1-week Pre-Treatment Period.
Adverse events are reported for subjects who received any amount of study drug.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
1.4%
1/69 • Adverse events presented here are for the 10-week Induction Treatment Period of the study, as well as the 1-week Pre-Treatment Period.
Adverse events are reported for subjects who received any amount of study drug.
|
1.5%
1/68 • Adverse events presented here are for the 10-week Induction Treatment Period of the study, as well as the 1-week Pre-Treatment Period.
Adverse events are reported for subjects who received any amount of study drug.
|
0.00%
0/65 • Adverse events presented here are for the 10-week Induction Treatment Period of the study, as well as the 1-week Pre-Treatment Period.
Adverse events are reported for subjects who received any amount of study drug.
|
|
Gastrointestinal disorders
Colon dysplasia
|
0.00%
0/69 • Adverse events presented here are for the 10-week Induction Treatment Period of the study, as well as the 1-week Pre-Treatment Period.
Adverse events are reported for subjects who received any amount of study drug.
|
1.5%
1/68 • Adverse events presented here are for the 10-week Induction Treatment Period of the study, as well as the 1-week Pre-Treatment Period.
Adverse events are reported for subjects who received any amount of study drug.
|
0.00%
0/65 • Adverse events presented here are for the 10-week Induction Treatment Period of the study, as well as the 1-week Pre-Treatment Period.
Adverse events are reported for subjects who received any amount of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/69 • Adverse events presented here are for the 10-week Induction Treatment Period of the study, as well as the 1-week Pre-Treatment Period.
Adverse events are reported for subjects who received any amount of study drug.
|
0.00%
0/68 • Adverse events presented here are for the 10-week Induction Treatment Period of the study, as well as the 1-week Pre-Treatment Period.
Adverse events are reported for subjects who received any amount of study drug.
|
1.5%
1/65 • Adverse events presented here are for the 10-week Induction Treatment Period of the study, as well as the 1-week Pre-Treatment Period.
Adverse events are reported for subjects who received any amount of study drug.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/69 • Adverse events presented here are for the 10-week Induction Treatment Period of the study, as well as the 1-week Pre-Treatment Period.
Adverse events are reported for subjects who received any amount of study drug.
|
0.00%
0/68 • Adverse events presented here are for the 10-week Induction Treatment Period of the study, as well as the 1-week Pre-Treatment Period.
Adverse events are reported for subjects who received any amount of study drug.
|
1.5%
1/65 • Adverse events presented here are for the 10-week Induction Treatment Period of the study, as well as the 1-week Pre-Treatment Period.
Adverse events are reported for subjects who received any amount of study drug.
|
Other adverse events
| Measure |
Placebo (After Placebo Pre-treatment)
n=69 participants at risk
Once-daily dosing of Placebo (after placebo pre-treatment)
Placebo for Vancomycin Pre-Treatment: Four times per day dosing of placebo pre-treatment
Placebo for SER-287: Once-daily dosing of Placebo for SER-287
|
SER-287 Induction Dosing (After Vancomycin Pre-treatment)
n=68 participants at risk
Once-daily dosing of SER-287 (Induction Dose, after vancomycin pre-treatment)
Vancomycin Pre-Treatment: Four times per day dosing of vancomycin pre-treatment
SER-287: Once-daily dosing of SER-287
|
SER-287 Step-Down Induction Dosing (After Vancomycin Pre-treatment)
n=65 participants at risk
Once-daily dosing of SER-287 (Step-Down Induction Dose, after vancomycin pre-treatment)
Vancomycin Pre-Treatment: Four times per day dosing of vancomycin pre-treatment
SER-287: Once-daily dosing of SER-287
|
|---|---|---|---|
|
Gastrointestinal disorders
Colitis ulcerative
|
8.7%
6/69 • Adverse events presented here are for the 10-week Induction Treatment Period of the study, as well as the 1-week Pre-Treatment Period.
Adverse events are reported for subjects who received any amount of study drug.
|
11.8%
8/68 • Adverse events presented here are for the 10-week Induction Treatment Period of the study, as well as the 1-week Pre-Treatment Period.
Adverse events are reported for subjects who received any amount of study drug.
|
10.8%
7/65 • Adverse events presented here are for the 10-week Induction Treatment Period of the study, as well as the 1-week Pre-Treatment Period.
Adverse events are reported for subjects who received any amount of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
1/69 • Adverse events presented here are for the 10-week Induction Treatment Period of the study, as well as the 1-week Pre-Treatment Period.
Adverse events are reported for subjects who received any amount of study drug.
|
14.7%
10/68 • Adverse events presented here are for the 10-week Induction Treatment Period of the study, as well as the 1-week Pre-Treatment Period.
Adverse events are reported for subjects who received any amount of study drug.
|
3.1%
2/65 • Adverse events presented here are for the 10-week Induction Treatment Period of the study, as well as the 1-week Pre-Treatment Period.
Adverse events are reported for subjects who received any amount of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/69 • Adverse events presented here are for the 10-week Induction Treatment Period of the study, as well as the 1-week Pre-Treatment Period.
Adverse events are reported for subjects who received any amount of study drug.
|
8.8%
6/68 • Adverse events presented here are for the 10-week Induction Treatment Period of the study, as well as the 1-week Pre-Treatment Period.
Adverse events are reported for subjects who received any amount of study drug.
|
4.6%
3/65 • Adverse events presented here are for the 10-week Induction Treatment Period of the study, as well as the 1-week Pre-Treatment Period.
Adverse events are reported for subjects who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.4%
1/69 • Adverse events presented here are for the 10-week Induction Treatment Period of the study, as well as the 1-week Pre-Treatment Period.
Adverse events are reported for subjects who received any amount of study drug.
|
5.9%
4/68 • Adverse events presented here are for the 10-week Induction Treatment Period of the study, as well as the 1-week Pre-Treatment Period.
Adverse events are reported for subjects who received any amount of study drug.
|
0.00%
0/65 • Adverse events presented here are for the 10-week Induction Treatment Period of the study, as well as the 1-week Pre-Treatment Period.
Adverse events are reported for subjects who received any amount of study drug.
|
Additional Information
Lisa von Moltke, MD, Chief Medical Officer
Seres Therapeutics
Phone: 617-945-9626
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER