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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02618187
Recruitment Status : Completed
First Posted : December 1, 2015
Results First Posted : June 20, 2019
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
Seres Therapeutics, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Ulcerative Colitis
Interventions Drug: SER-287
Drug: Placebo
Drug: Placebo Pre-Treat
Drug: Vancomycin Pre-Treat
Enrollment 58
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Weekly SER-287, After Placebo Pre-Treat. Daily Placebo, After Placebo Pre-Treat. Daily SER-287, After Vanco. Pre-Treat. Weekly SER-287, After Vanco. Pre-Treat.
Hide Arm/Group Description

Placebo pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks

Eubacterial Spores, Purified Suspension, Encapsulated

Placebo Pre-Treat

Placebo pre-treatment, followed by once daily placebo for 8 weeks

Placebo

Placebo Pre-Treat

Vancomycin pre-treatment, followed by once daily dosing of SER-287 for 8 weeks

Eubacterial Spores, Purified Suspension, Encapsulated

Vancomycin Pre-Treat

Vancomycin pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks

Eubacterial Spores, Purified Suspension, Encapsulated

Vancomycin Pre-Treat

Period Title: Overall Study
Started 15 11 15 17
Completed [1] 13 10 13 13
Completed [2] 13 9 11 12
Not Completed 2 2 4 5
[1]
Subjects Completed Visit 12 Endoscopy (8-week treatment)
[2]
Subjects Completed Visit 13 (short-term safety follow-up)
Arm/Group Title Weekly SER-287, After Placebo Pre-Treat. Daily Placebo, After Placebo Pre-Treat. Daily SER-287, After Vanco. Pre-Treat. Weekly SER-287, After Vanco. Pre-Treat. Total
Hide Arm/Group Description

Placebo pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks

Eubacterial Spores, Purified Suspension, Encapsulated

Placebo Pre-Treat

Placebo pre-treatment, followed by once daily placebo for 8 weeks

Placebo

Placebo Pre-Treat

Vancomycin pre-treatment, followed by once daily dosing of SER-287 for 8 weeks

Eubacterial Spores, Purified Suspension, Encapsulated

Vancomycin Pre-Treat

Vancomycin pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks

Eubacterial Spores, Purified Suspension, Encapsulated

Vancomycin Pre-Treat

Total of all reporting groups
Overall Number of Baseline Participants 15 11 15 17 58
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 11 participants 15 participants 17 participants 58 participants
46.5  (16.12) 45.8  (15.20) 47.8  (18.59) 47.9  (11.18) 47.1  (15.00)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 11 participants 15 participants 17 participants 58 participants
Female
9
  60.0%
7
  63.6%
8
  53.3%
7
  41.2%
31
  53.4%
Male
6
  40.0%
4
  36.4%
7
  46.7%
10
  58.8%
27
  46.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 11 participants 15 participants 17 participants 58 participants
White
12
  80.0%
8
  72.7%
12
  80.0%
15
  88.2%
47
  81.0%
Asian
0
   0.0%
1
   9.1%
0
   0.0%
1
   5.9%
2
   3.4%
Black or African American
3
  20.0%
1
   9.1%
2
  13.3%
1
   5.9%
7
  12.1%
Other - Indian
0
   0.0%
1
   9.1%
1
   6.7%
0
   0.0%
2
   3.4%
Montreal Classification  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 11 participants 15 participants 17 participants 58 participants
Ulcerative Proctitis
0
   0.0%
0
   0.0%
4
  26.7%
2
  11.8%
6
  10.3%
Left-sided UC (distal UC)
10
  66.7%
8
  72.7%
5
  33.3%
10
  58.8%
33
  56.9%
Extensive UC (pancolitis)
5
  33.3%
3
  27.3%
6
  40.0%
5
  29.4%
19
  32.8%
Severity of UC  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 11 participants 15 participants 17 participants 58 participants
Mild
6
  40.0%
3
  27.3%
6
  40.0%
10
  58.8%
25
  43.1%
Moderate
9
  60.0%
8
  72.7%
9
  60.0%
7
  41.2%
33
  56.9%
Receiving UC Treatment Prior to or On Date of First Pre-treatment Dose  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 11 participants 15 participants 17 participants 58 participants
No
2
  13.3%
2
  18.2%
3
  20.0%
6
  35.3%
13
  22.4%
Yes
13
  86.7%
9
  81.8%
12
  80.0%
11
  64.7%
45
  77.6%
Time Since First UC Diagnosis  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 15 participants 11 participants 15 participants 17 participants 58 participants
149.1  (141.34) 138.2  (85.91) 152.9  (143.77) 142.1  (105.41) 146.0  (120.12)
1.Primary Outcome
Title Safety and Tolerability of SER-287
Hide Description 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.
Time Frame Day 246
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Weekly SER-287, After Placebo Pre-Treat. Daily Placebo, After Placebo Pre-Treat. Daily SER-287, After Vanco. Pre-Treat. Weekly SER-287, After Vanco. Pre-Treat.
Hide Arm/Group Description:

Placebo pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks

Eubacterial Spores, Purified Suspension, Encapsulated

Placebo Pre-Treat

Placebo pre-treatment, followed by once daily placebo for 8 weeks

Placebo

Placebo Pre-Treat

Vancomycin pre-treatment, followed by once daily dosing of SER-287 for 8 weeks

Eubacterial Spores, Purified Suspension, Encapsulated

Vancomycin Pre-Treat

Vancomycin pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks

Eubacterial Spores, Purified Suspension, Encapsulated

Vancomycin Pre-Treat

Overall Number of Participants Analyzed 15 11 15 17
Measure Type: Count of Participants
Unit of Measure: Participants
Gastrointestinal disorders (GI) - total
7
  46.7%
5
  45.5%
2
  13.3%
8
  47.1%
GI-Abdominal distension
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.9%
GI-Abdominal pain
3
  20.0%
1
   9.1%
0
   0.0%
4
  23.5%
GI-Abdominal pain upper
1
   6.7%
0
   0.0%
0
   0.0%
0
   0.0%
GI-Abnormal faeces
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.9%
GI-Bowel movement irregularity
0
   0.0%
0
   0.0%
0
   0.0%
2
  11.8%
GI-Colitis ulcerative (worsening)
1
   6.7%
1
   9.1%
0
   0.0%
1
   5.9%
GI-Constipation
1
   6.7%
0
   0.0%
2
  13.3%
0
   0.0%
GI-Diarrhoea
2
  13.3%
2
  18.2%
0
   0.0%
2
  11.8%
GI-Diarrhoea haemorrhagic
0
   0.0%
1
   9.1%
0
   0.0%
0
   0.0%
GI-Dyspepsia
0
   0.0%
1
   9.1%
0
   0.0%
0
   0.0%
GI-Faecal incontinence
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.9%
GI-Flatulence
0
   0.0%
0
   0.0%
0
   0.0%
3
  17.6%
GI-Frequent bowel movements
1
   6.7%
0
   0.0%
0
   0.0%
0
   0.0%
GI-Gastrooesophageal reflux disease
1
   6.7%
0
   0.0%
0
   0.0%
0
   0.0%
GI-Mucous stools
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.9%
GI-Nausea
3
  20.0%
0
   0.0%
1
   6.7%
1
   5.9%
GI-Oesophagitis
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.9%
GI-Rectal discharge
1
   6.7%
0
   0.0%
0
   0.0%
0
   0.0%
GI-Vomiting
1
   6.7%
0
   0.0%
0
   0.0%
1
   5.9%
General disorders & administration site conditions
0
   0.0%
1
   9.1%
1
   6.7%
3
  17.6%
Immune system disorders
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.9%
Infections and infestations
1
   6.7%
3
  27.3%
4
  26.7%
6
  35.3%
Injury, poisoning and procedural complications
0
   0.0%
2
  18.2%
0
   0.0%
0
   0.0%
Investigations
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.9%
Metabolism and nutrition disorders
0
   0.0%
0
   0.0%
1
   6.7%
1
   5.9%
Musculoskeletal and connective tissue disorders
3
  20.0%
0
   0.0%
2
  13.3%
1
   5.9%
Nervous system disorders
0
   0.0%
0
   0.0%
3
  20.0%
1
   5.9%
Psychiatric disorders
0
   0.0%
1
   9.1%
1
   6.7%
0
   0.0%
Reproductive system and breast disorders
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.9%
Respiratory, thoracic and mediastinal disorders
1
   6.7%
0
   0.0%
1
   6.7%
2
  11.8%
Skin and subcutaneous tissue disorders
0
   0.0%
0
   0.0%
3
  20.0%
1
   5.9%
2.Primary Outcome
Title Composition of the Intestinal Microbiome
Hide Description 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.
Time Frame Baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Weekly SER-287, After Placebo Pre-Treat. Daily Placebo, After Placebo Pre-Treat. Daily SER-287, After Vanco. Pre-Treat. Weekly SER-287, After Vanco. Pre-Treat.
Hide Arm/Group Description:

Placebo pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks

Eubacterial Spores, Purified Suspension, Encapsulated

Placebo Pre-Treat

Placebo pre-treatment, followed by once daily placebo for 8 weeks

Placebo

Placebo Pre-Treat

Vancomycin pre-treatment, followed by once daily dosing of SER-287 for 8 weeks

Eubacterial Spores, Purified Suspension, Encapsulated

Vancomycin Pre-Treat

Vancomycin pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks

Eubacterial Spores, Purified Suspension, Encapsulated

Vancomycin Pre-Treat

Overall Number of Participants Analyzed 9 6 10 13
Mean (Standard Deviation)
Unit of Measure: Richness of spore-forming species
2.333  (8.588) 0.167  (9.475) 12.1  (9.871) 5.615  (9.134)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Weekly SER-287, After Placebo Pre-Treat., Daily Placebo, After Placebo Pre-Treat.
Comments [Not Specified]
Type of Statistical Test Other
Comments Null hypothesis: the two groups compared show no difference in mean ranks Alternative hypothesis: the two groups compared show a difference in mean ranks
Statistical Test of Hypothesis P-Value 0.766
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments 2-sided
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Daily Placebo, After Placebo Pre-Treat., Daily SER-287, After Vanco. Pre-Treat.
Comments [Not Specified]
Type of Statistical Test Other
Comments Null hypothesis: the two groups compared show no difference in mean ranks Alternative hypothesis: the two groups compared show a difference in mean ranks
Statistical Test of Hypothesis P-Value 0.037
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments 2-sided
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Daily Placebo, After Placebo Pre-Treat., Weekly SER-287, After Vanco. Pre-Treat.
Comments [Not Specified]
Type of Statistical Test Other
Comments Null hypothesis: the two groups compared show no difference in mean ranks Alternative hypothesis: the two groups compared show a difference in mean ranks
Statistical Test of Hypothesis P-Value 0.313
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments 2-sided
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Weekly SER-287, After Placebo Pre-Treat., Weekly SER-287, After Vanco. Pre-Treat.
Comments [Not Specified]
Type of Statistical Test Other
Comments Null hypothesis: the two groups compared show no difference in mean ranks Alternative hypothesis: the two groups compared show a difference in mean ranks
Statistical Test of Hypothesis P-Value 0.384
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments 2-sided
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Daily SER-287, After Vanco. Pre-Treat., Weekly SER-287, After Vanco. Pre-Treat.
Comments [Not Specified]
Type of Statistical Test Other
Comments Null hypothesis: the two groups compared show no difference in mean ranks Alternative hypothesis: the two groups compared show a difference in mean ranks
Statistical Test of Hypothesis P-Value 0.237
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments 2-sided
3.Primary Outcome
Title Engraftment of SER-287 Bacteria in All Treatment Arms
Hide Description 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.
Time Frame Baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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 two-week window surrounding Visit 12)
Arm/Group Title Weekly SER-287, After Placebo Pre-Treat. Daily Placebo, After Placebo Pre-Treat. Daily SER-287, After Vanco. Pre-Treat. Weekly SER-287, After Vanco. Pre-Treat.
Hide Arm/Group Description:

Placebo pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks

Eubacterial Spores, Purified Suspension, Encapsulated

Placebo Pre-Treat

Placebo pre-treatment, followed by once daily placebo for 8 weeks

Placebo

Placebo Pre-Treat

Vancomycin pre-treatment, followed by once daily dosing of SER-287 for 8 weeks

Eubacterial Spores, Purified Suspension, Encapsulated

Vancomycin Pre-Treat

Vancomycin pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks

Eubacterial Spores, Purified Suspension, Encapsulated

Vancomycin Pre-Treat

Overall Number of Participants Analyzed 9 6 10 13
Mean (Standard Deviation)
Unit of Measure: Richness SER-287 spore-forming species
7.222  (5.974) 4.333  (1.862) 16.7  (7.469) 13.615  (6.225)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Weekly SER-287, After Placebo Pre-Treat., Daily Placebo, After Placebo Pre-Treat.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Weekly SER-287, after Placebo Pre-Treat. tested against Daily placebo, after Placebo Pre-Treat., for superiority
Statistical Test of Hypothesis P-Value 0.257
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments 1-sided
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Daily Placebo, After Placebo Pre-Treat., Daily SER-287, After Vanco. Pre-Treat.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Daily SER-287, After Vanco. Pre-Treat. tested against Daily Placebo, After Placebo Pre-Treat., for superiority
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments 1-sided
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Daily Placebo, After Placebo Pre-Treat., Weekly SER-287, After Vanco. Pre-Treat.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Weekly SER-287, After Vanco. Pre-Treat. tested against Daily Placebo, After Placebo Pre-Treat., for superiority
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments 1-sided
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Weekly SER-287, After Placebo Pre-Treat., Weekly SER-287, After Vanco. Pre-Treat.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Weekly SER-287, After Vanco. Pre-Treat. tested against Weekly SER-287, After Placebo Pre-Treat., for superiority
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments 1-sided
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Daily SER-287, After Vanco. Pre-Treat., Weekly SER-287, After Vanco. Pre-Treat.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Daily SER-287, After Vanco. Pre-Treat., tested against Weekly SER-287, After Vanco. Pre-Treat., for superiority
Statistical Test of Hypothesis P-Value 0.168
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments 1-sided
4.Secondary Outcome
Title Clinical Remission
Hide Description

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.

Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, where the following were counted as missing: missing post-treatment endoscopy; adding UC medication for a flare during the treatment period; early termination prior to Day 48
Arm/Group Title Weekly SER-287, After Placebo Pre-Treat. Daily Placebo, After Placebo Pre-Treat. Daily SER-287, After Vanco. Pre-Treat. Weekly SER-287, After Vanco. Pre-Treat.
Hide Arm/Group Description:

Placebo pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks

Eubacterial Spores, Purified Suspension, Encapsulated

Placebo Pre-Treat

Placebo pre-treatment, followed by once daily placebo for 8 weeks

Placebo

Placebo Pre-Treat

Vancomycin pre-treatment, followed by once daily dosing of SER-287 for 8 weeks

Eubacterial Spores, Purified Suspension, Encapsulated

Vancomycin Pre-Treat

Vancomycin pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks

Eubacterial Spores, Purified Suspension, Encapsulated

Vancomycin Pre-Treat

Overall Number of Participants Analyzed 15 11 15 17
Measure Type: Count of Participants
Unit of Measure: Participants
2
  13.3%
0
   0.0%
6
  40.0%
3
  17.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Weekly SER-287, After Placebo Pre-Treat., Daily Placebo, After Placebo Pre-Treat.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4923
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate difference (SER-287 - placebo)
Estimated Value 13.3
Confidence Interval (2-Sided) 95%
-3.87 to 30.54
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Daily Placebo, After Placebo Pre-Treat., Daily SER-287, After Vanco. Pre-Treat.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0237
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate difference (SER-287 - placebo)
Estimated Value 40.0
Confidence Interval (2-Sided) 95%
15.21 to 64.79
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Daily Placebo, After Placebo Pre-Treat., Weekly SER-287, After Vanco. Pre-Treat.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2579
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate difference (SER-287 - placebo)
Estimated Value 17.6
Confidence Interval (2-Sided) 95%
-0.47 to 35.77
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Endoscopic Improvement
Hide Description Defined as a decrease in endoscopic subscore >= 1
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, where the following were counted as missing: missing post-treatment endoscopy; adding UC medication for a flare during the treatment period; early termination prior to Day 48
Arm/Group Title Weekly SER-287, After Placebo Pre-Treat. Daily Placebo, After Placebo Pre-Treat. Daily SER-287, After Vanco. Pre-Treat. Weekly SER-287, After Vanco. Pre-Treat.
Hide Arm/Group Description:

Placebo pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks

Eubacterial Spores, Purified Suspension, Encapsulated

Placebo Pre-Treat

Placebo pre-treatment, followed by once daily placebo for 8 weeks

Placebo

Placebo Pre-Treat

Vancomycin pre-treatment, followed by once daily dosing of SER-287 for 8 weeks

Eubacterial Spores, Purified Suspension, Encapsulated

Vancomycin Pre-Treat

Vancomycin pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks

Eubacterial Spores, Purified Suspension, Encapsulated

Vancomycin Pre-Treat

Overall Number of Participants Analyzed 15 11 15 17
Measure Type: Count of Participants
Unit of Measure: Participants
5
  33.3%
1
   9.1%
6
  40.0%
4
  23.5%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Weekly SER-287, After Placebo Pre-Treat., Daily Placebo, After Placebo Pre-Treat.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1973
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate difference (SER-287 - placebo)
Estimated Value 24.2
Confidence Interval (2-Sided) 95%
-5.04 to 53.53
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Daily Placebo, After Placebo Pre-Treat., Daily SER-287, After Vanco. Pre-Treat.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1783
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate difference (SER-287 - placebo)
Estimated Value 30.9
Confidence Interval (2-Sided) 95%
0.86 to 60.96
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Daily Placebo, After Placebo Pre-Treat., Weekly SER-287, After Vanco. Pre-Treat.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6195
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate difference (SER-287 - placebo)
Estimated Value 14.4
Confidence Interval (2-Sided) 95%
-11.93 to 40.81
Estimation Comments [Not Specified]
Time Frame Day 246
Adverse Event Reporting Description 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.
 
Arm/Group Title Weekly SER-287, After Placebo Pre-Treat. Daily Placebo, After Placebo Pre-Treat. Daily SER-287, After Vanco. Pre-Treat. Weekly SER-287, After Vanco. Pre-Treat.
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Placebo pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks

Eubacterial Spores, Purified Suspension, Encapsulated

Placebo Pre-Treat

Placebo pre-treatment, followed by once daily placebo for 8 weeks

Placebo

Placebo Pre-Treat

Vancomycin pre-treatment, followed by once daily dosing of SER-287 for 8 weeks

Eubacterial Spores, Purified Suspension, Encapsulated

Vancomycin Pre-Treat

Vancomycin pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks

Eubacterial Spores, Purified Suspension, Encapsulated

Vancomycin Pre-Treat

All-Cause Mortality
Weekly SER-287, After Placebo Pre-Treat. Daily Placebo, After Placebo Pre-Treat. Daily SER-287, After Vanco. Pre-Treat. Weekly SER-287, After Vanco. Pre-Treat.
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)      0/11 (0.00%)      0/15 (0.00%)      0/17 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Weekly SER-287, After Placebo Pre-Treat. Daily Placebo, After Placebo Pre-Treat. Daily SER-287, After Vanco. Pre-Treat. Weekly SER-287, After Vanco. Pre-Treat.
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/11 (0.00%)      1/15 (6.67%)      0/17 (0.00%)    
Psychiatric disorders         
Worsening depression  [1]  0/15 (0.00%)  0/11 (0.00%)  1/15 (6.67%)  0/17 (0.00%) 
Indicates events were collected by systematic assessment
[1]
The one case of worsening depression was reported as moderate severity, and probably not or likely not related to study drug, as determined by the investigator.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Weekly SER-287, After Placebo Pre-Treat. Daily Placebo, After Placebo Pre-Treat. Daily SER-287, After Vanco. Pre-Treat. Weekly SER-287, After Vanco. Pre-Treat.
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/15 (53.33%)      2/11 (18.18%)      5/15 (33.33%)      9/17 (52.94%)    
Gastrointestinal disorders         
Abdominal pain  [1]  3/15 (20.00%)  4 1/11 (9.09%)  1 0/15 (0.00%)  0 4/17 (23.53%)  5
Constipation  [1]  1/15 (6.67%)  2 0/11 (0.00%)  0 2/15 (13.33%)  2 0/17 (0.00%)  0
Diarrhea  [1]  2/15 (13.33%)  3 2/11 (18.18%)  3 0/15 (0.00%)  0 2/17 (11.76%)  2
Flatulence  [1]  0/15 (0.00%)  0 0/11 (0.00%)  0 0/15 (0.00%)  0 3/17 (17.65%)  4
Nausea  [1]  3/15 (20.00%)  4 0/11 (0.00%)  0 1/15 (6.67%)  2 1/17 (5.88%)  1
Infections and infestations         
Upper Respiratory Tract Infection  [1]  0/15 (0.00%)  0 0/11 (0.00%)  0 2/15 (13.33%)  2 1/17 (5.88%)  1
Musculoskeletal and connective tissue disorders         
Back pain  [1]  3/15 (20.00%)  4 0/11 (0.00%)  0 1/15 (6.67%)  1 1/17 (5.88%)  2
Nervous system disorders         
Headache  [1]  0/15 (0.00%)  0 0/11 (0.00%)  0 3/15 (20.00%)  4 1/17 (5.88%)  1
Indicates events were collected by systematic assessment
[1]
Treatment-emergent adverse event
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Proposed publications must be submitted to Sponsor for review at least 30 days prior to publication. Sponsor can require removal of confidential information other than study data and Site/Investigator agree to consider Sponsor’s suggestions with respect to the presentation of study data. Sponsor can force publication to be deferred for a period of up to 60 days in order to file any patents.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Michele Trucksis, Chief Medical Officer
Organization: Seres Therapeutics
Phone: 617-945-9626
EMail: mtrucksis@serestherapeutics.com
Layout table for additonal information
Responsible Party: Seres Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02618187     History of Changes
Other Study ID Numbers: SERES-101
First Submitted: November 20, 2015
First Posted: December 1, 2015
Results First Submitted: September 25, 2018
Results First Posted: June 20, 2019
Last Update Posted: June 20, 2019