Ulcerative Colitis
Conditions
Brief summary
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
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).
Interventions
Sponsors
Seres Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
1. Fever \> 38.3°C 2. Known or suspected toxic megacolon and/or known small bowel ileus 3. Known history of Crohn's disease 4. Subjects with serum albumin \<2.5 g/dL at baseline 5. CMV polymerase chain reaction (PCR) positive from blood plasma at screening 6. Known stool studies positive for ova and/or parasites or stool culture within the 30 days before enrollment 7. 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). 8. Biologic medication (infliximab/ adalimumab/ golimumab/ certolizumab/vedolizumab/ustekinumab/natalizumab) use within 3 months prior to screening 9. Known active malignancy except for basal cell skin cancer, squamous cell skin cancer 10. Subjects with previous colectomy, ostomy, J-pouch, or previous intestinal surgery (excluding cholecystectomy, appendectomy) 11. Subjects with known history of celiac disease or gluten enteropathy 12. Subjects with Clostridium difficile positive stool at Screening Visit 13. Antibiotic use within the prior 1 month before randomization 14. Expected to receive antibiotics within 8 weeks of signing the Informed Consent Form (ICF) (i.e., for planned/anticipated procedure) 15. Received an investigational drug within 1 month before study entry 16. Received an investigational antibody or vaccine within 3 months before study entry 17. Previously enrolled in a SER-109/SER-287 study 18. Received an FMT within the last 6 months 19. 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 20. Unable to stop steroid enemas or suppositories or mesalamine enemas or suppositories before screening visit 21. Unable to stop opiate treatment unless on a stable dose and no increase in dose planned for the duration of the study 22. Unable to stop probiotics before screening visit 23. Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy (subjects on maintenance chemotherapy may only be enrolled after consultation with medical monitor) 24. Known allergy or intolerance to oral vancomycin \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability of SER-287 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Remission | 8 weeks | 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. |
| Endoscopic Improvement | 8 weeks | Defined as a decrease in endoscopic subscore \>= 1 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Weekly SER-287, After Placebo Pre-Treat. Placebo pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks
Eubacterial Spores, Purified Suspension, Encapsulated
Placebo Pre-Treat | 15 |
| Daily Placebo, After Placebo Pre-Treat. Placebo pre-treatment, followed by once daily placebo for 8 weeks
Placebo
Placebo Pre-Treat | 11 |
| Daily SER-287, After Vanco. Pre-Treat. Vancomycin pre-treatment, followed by once daily dosing of SER-287 for 8 weeks
Eubacterial Spores, Purified Suspension, Encapsulated
Vancomycin Pre-Treat | 15 |
| Weekly SER-287, After Vanco. Pre-Treat. Vancomycin pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks
Eubacterial Spores, Purified Suspension, Encapsulated
Vancomycin Pre-Treat | 17 |
| Total | 58 |
Baseline characteristics
| Characteristic | Daily Placebo, After Placebo Pre-Treat. | Daily SER-287, After Vanco. Pre-Treat. | Weekly SER-287, After Vanco. Pre-Treat. | Weekly SER-287, After Placebo Pre-Treat. | Total |
|---|---|---|---|---|---|
| Age, Continuous | 45.8 years STANDARD_DEVIATION 15.2 | 47.8 years STANDARD_DEVIATION 18.59 | 47.9 years STANDARD_DEVIATION 11.18 | 46.5 years STANDARD_DEVIATION 16.12 | 47.1 years STANDARD_DEVIATION 15 |
| Montreal Classification Extensive UC (pancolitis) | 3 Participants | 6 Participants | 5 Participants | 5 Participants | 19 Participants |
| Montreal Classification Left-sided UC (distal UC) | 8 Participants | 5 Participants | 10 Participants | 10 Participants | 33 Participants |
| Montreal Classification Ulcerative Proctitis | 0 Participants | 4 Participants | 2 Participants | 0 Participants | 6 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 2 Participants | 1 Participants | 3 Participants | 7 Participants |
| Race/Ethnicity, Customized Other - Indian | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 8 Participants | 12 Participants | 15 Participants | 12 Participants | 47 Participants |
| Receiving UC Treatment Prior to or On Date of First Pre-treatment Dose No | 2 Participants | 3 Participants | 6 Participants | 2 Participants | 13 Participants |
| Receiving UC Treatment Prior to or On Date of First Pre-treatment Dose Yes | 9 Participants | 12 Participants | 11 Participants | 13 Participants | 45 Participants |
| Severity of UC Mild | 3 Participants | 6 Participants | 10 Participants | 6 Participants | 25 Participants |
| Severity of UC Moderate | 8 Participants | 9 Participants | 7 Participants | 9 Participants | 33 Participants |
| Sex: Female, Male Female | 7 Participants | 8 Participants | 7 Participants | 9 Participants | 31 Participants |
| Sex: Female, Male Male | 4 Participants | 7 Participants | 10 Participants | 6 Participants | 27 Participants |
| Time Since First UC Diagnosis | 138.2 months STANDARD_DEVIATION 85.91 | 152.9 months STANDARD_DEVIATION 143.77 | 142.1 months STANDARD_DEVIATION 105.41 | 149.1 months STANDARD_DEVIATION 141.34 | 146.0 months STANDARD_DEVIATION 120.12 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 11 | 0 / 15 | 0 / 17 |
| other Total, other adverse events | 8 / 15 | 2 / 11 | 5 / 15 | 9 / 17 |
| serious Total, serious adverse events | 0 / 15 | 0 / 11 | 1 / 15 | 0 / 17 |
Outcome results
Primary
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.
Time frame: Baseline and 8 weeks
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Weekly SER-287, After Placebo Pre-Treat. | Composition of the Intestinal Microbiome | 2.333 Richness of spore-forming species | Standard Deviation 8.588 |
| Daily Placebo, After Placebo Pre-Treat. | Composition of the Intestinal Microbiome | 0.167 Richness of spore-forming species | Standard Deviation 9.475 |
| Daily SER-287, After Vanco. Pre-Treat. | Composition of the Intestinal Microbiome | 12.1 Richness of spore-forming species | Standard Deviation 9.871 |
| Weekly SER-287, After Vanco. Pre-Treat. | Composition of the Intestinal Microbiome | 5.615 Richness of spore-forming species | Standard Deviation 9.134 |
p-value: 0.766Wilcoxon (Mann-Whitney)
p-value: 0.037Wilcoxon (Mann-Whitney)
p-value: 0.313Wilcoxon (Mann-Whitney)
p-value: 0.384Wilcoxon (Mann-Whitney)
p-value: 0.237Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Baseline and 8 weeks
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Weekly SER-287, After Placebo Pre-Treat. | Engraftment of SER-287 Bacteria in All Treatment Arms | 7.222 Richness SER-287 spore-forming species | Standard Deviation 5.974 |
| Daily Placebo, After Placebo Pre-Treat. | Engraftment of SER-287 Bacteria in All Treatment Arms | 4.333 Richness SER-287 spore-forming species | Standard Deviation 1.862 |
| Daily SER-287, After Vanco. Pre-Treat. | Engraftment of SER-287 Bacteria in All Treatment Arms | 16.7 Richness SER-287 spore-forming species | Standard Deviation 7.469 |
| Weekly SER-287, After Vanco. Pre-Treat. | Engraftment of SER-287 Bacteria in All Treatment Arms | 13.615 Richness SER-287 spore-forming species | Standard Deviation 6.225 |
p-value: 0.257Wilcoxon (Mann-Whitney)
p-value: 0.001Wilcoxon (Mann-Whitney)
p-value: 0.001Wilcoxon (Mann-Whitney)
p-value: 0.009Wilcoxon (Mann-Whitney)
p-value: 0.168Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Day 246
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Weekly SER-287, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | GI-Abdominal pain upper | 1 Participants |
| Weekly SER-287, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | Investigations | 0 Participants |
| Weekly SER-287, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | GI-Dyspepsia | 0 Participants |
| Weekly SER-287, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | GI-Oesophagitis | 0 Participants |
| Weekly SER-287, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | GI-Faecal incontinence | 0 Participants |
| Weekly SER-287, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | Injury, poisoning and procedural complications | 0 Participants |
| Weekly SER-287, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | GI-Flatulence | 0 Participants |
| Weekly SER-287, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | GI-Frequent bowel movements | 1 Participants |
| Weekly SER-287, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | Respiratory, thoracic and mediastinal disorders | 1 Participants |
| Weekly SER-287, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | Infections and infestations | 1 Participants |
| Weekly SER-287, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | GI-Gastrooesophageal reflux disease | 1 Participants |
| Weekly SER-287, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | GI-Mucous stools | 0 Participants |
| Weekly SER-287, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | GI-Rectal discharge | 1 Participants |
| Weekly SER-287, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | GI-Vomiting | 1 Participants |
| Weekly SER-287, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | Gastrointestinal disorders (GI) - total | 7 Participants |
| Weekly SER-287, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | Skin and subcutaneous tissue disorders | 0 Participants |
| Weekly SER-287, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | Reproductive system and breast disorders | 0 Participants |
| Weekly SER-287, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | GI-Abdominal distension | 0 Participants |
| Weekly SER-287, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | GI-Diarrhoea | 2 Participants |
| Weekly SER-287, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | Immune system disorders | 0 Participants |
| Weekly SER-287, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | GI-Abdominal pain | 3 Participants |
| Weekly SER-287, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | Psychiatric disorders | 0 Participants |
| Weekly SER-287, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | Musculoskeletal and connective tissue disorders | 3 Participants |
| Weekly SER-287, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | GI-Abnormal faeces | 0 Participants |
| Weekly SER-287, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | GI-Nausea | 3 Participants |
| Weekly SER-287, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | Nervous system disorders | 0 Participants |
| Weekly SER-287, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | GI-Bowel movement irregularity | 0 Participants |
| Weekly SER-287, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | GI-Colitis ulcerative (worsening) | 1 Participants |
| Weekly SER-287, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | GI-Constipation | 1 Participants |
| Weekly SER-287, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | General disorders & administration site conditions | 0 Participants |
| Weekly SER-287, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | Metabolism and nutrition disorders | 0 Participants |
| Weekly SER-287, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | GI-Diarrhoea haemorrhagic | 0 Participants |
| Daily Placebo, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | GI-Abdominal distension | 0 Participants |
| Daily Placebo, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | Musculoskeletal and connective tissue disorders | 0 Participants |
| Daily Placebo, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | GI-Diarrhoea | 2 Participants |
| Daily Placebo, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | GI-Dyspepsia | 1 Participants |
| Daily Placebo, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | Psychiatric disorders | 1 Participants |
| Daily Placebo, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | Injury, poisoning and procedural complications | 2 Participants |
| Daily Placebo, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | GI-Colitis ulcerative (worsening) | 1 Participants |
| Daily Placebo, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | GI-Faecal incontinence | 0 Participants |
| Daily Placebo, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | GI-Oesophagitis | 0 Participants |
| Daily Placebo, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | GI-Abdominal pain | 1 Participants |
| Daily Placebo, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | GI-Flatulence | 0 Participants |
| Daily Placebo, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | General disorders & administration site conditions | 1 Participants |
| Daily Placebo, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | Infections and infestations | 3 Participants |
| Daily Placebo, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | Skin and subcutaneous tissue disorders | 0 Participants |
| Daily Placebo, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | GI-Frequent bowel movements | 0 Participants |
| Daily Placebo, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | GI-Abdominal pain upper | 0 Participants |
| Daily Placebo, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | Metabolism and nutrition disorders | 0 Participants |
| Daily Placebo, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | Nervous system disorders | 0 Participants |
| Daily Placebo, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | Immune system disorders | 0 Participants |
| Daily Placebo, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | Respiratory, thoracic and mediastinal disorders | 0 Participants |
| Daily Placebo, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | GI-Mucous stools | 0 Participants |
| Daily Placebo, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | GI-Abnormal faeces | 0 Participants |
| Daily Placebo, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | GI-Rectal discharge | 0 Participants |
| Daily Placebo, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | GI-Gastrooesophageal reflux disease | 0 Participants |
| Daily Placebo, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | Reproductive system and breast disorders | 0 Participants |
| Daily Placebo, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | GI-Constipation | 0 Participants |
| Daily Placebo, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | GI-Vomiting | 0 Participants |
| Daily Placebo, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | Investigations | 0 Participants |
| Daily Placebo, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | Gastrointestinal disorders (GI) - total | 5 Participants |
| Daily Placebo, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | GI-Diarrhoea haemorrhagic | 1 Participants |
| Daily Placebo, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | GI-Bowel movement irregularity | 0 Participants |
| Daily Placebo, After Placebo Pre-Treat. | Safety and Tolerability of SER-287 | GI-Nausea | 0 Participants |
| Daily SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | GI-Diarrhoea haemorrhagic | 0 Participants |
| Daily SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | GI-Gastrooesophageal reflux disease | 0 Participants |
| Daily SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | General disorders & administration site conditions | 1 Participants |
| Daily SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | Infections and infestations | 4 Participants |
| Daily SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | GI-Vomiting | 0 Participants |
| Daily SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | GI-Nausea | 1 Participants |
| Daily SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | GI-Oesophagitis | 0 Participants |
| Daily SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | GI-Rectal discharge | 0 Participants |
| Daily SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | Gastrointestinal disorders (GI) - total | 2 Participants |
| Daily SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | GI-Abdominal distension | 0 Participants |
| Daily SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | GI-Abdominal pain | 0 Participants |
| Daily SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | GI-Abdominal pain upper | 0 Participants |
| Daily SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | GI-Abnormal faeces | 0 Participants |
| Daily SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | GI-Bowel movement irregularity | 0 Participants |
| Daily SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | GI-Colitis ulcerative (worsening) | 0 Participants |
| Daily SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | GI-Constipation | 2 Participants |
| Daily SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | GI-Diarrhoea | 0 Participants |
| Daily SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | GI-Dyspepsia | 0 Participants |
| Daily SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | GI-Faecal incontinence | 0 Participants |
| Daily SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | GI-Flatulence | 0 Participants |
| Daily SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | GI-Frequent bowel movements | 0 Participants |
| Daily SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | GI-Mucous stools | 0 Participants |
| Daily SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | Immune system disorders | 0 Participants |
| Daily SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | Injury, poisoning and procedural complications | 0 Participants |
| Daily SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | Investigations | 0 Participants |
| Daily SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | Metabolism and nutrition disorders | 1 Participants |
| Daily SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | Musculoskeletal and connective tissue disorders | 2 Participants |
| Daily SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | Nervous system disorders | 3 Participants |
| Daily SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | Psychiatric disorders | 1 Participants |
| Daily SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | Reproductive system and breast disorders | 0 Participants |
| Daily SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | Respiratory, thoracic and mediastinal disorders | 1 Participants |
| Daily SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | Skin and subcutaneous tissue disorders | 3 Participants |
| Weekly SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | Injury, poisoning and procedural complications | 0 Participants |
| Weekly SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | GI-Diarrhoea haemorrhagic | 0 Participants |
| Weekly SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | GI-Diarrhoea | 2 Participants |
| Weekly SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | GI-Oesophagitis | 1 Participants |
| Weekly SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | Investigations | 1 Participants |
| Weekly SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | GI-Constipation | 0 Participants |
| Weekly SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | GI-Colitis ulcerative (worsening) | 1 Participants |
| Weekly SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | GI-Nausea | 1 Participants |
| Weekly SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | Metabolism and nutrition disorders | 1 Participants |
| Weekly SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | GI-Bowel movement irregularity | 2 Participants |
| Weekly SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | Skin and subcutaneous tissue disorders | 1 Participants |
| Weekly SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | Musculoskeletal and connective tissue disorders | 1 Participants |
| Weekly SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | GI-Abnormal faeces | 1 Participants |
| Weekly SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | GI-Abdominal pain upper | 0 Participants |
| Weekly SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | Respiratory, thoracic and mediastinal disorders | 2 Participants |
| Weekly SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | Nervous system disorders | 1 Participants |
| Weekly SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | GI-Abdominal pain | 4 Participants |
| Weekly SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | GI-Abdominal distension | 1 Participants |
| Weekly SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | General disorders & administration site conditions | 3 Participants |
| Weekly SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | Psychiatric disorders | 0 Participants |
| Weekly SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | Gastrointestinal disorders (GI) - total | 8 Participants |
| Weekly SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | GI-Rectal discharge | 0 Participants |
| Weekly SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | GI-Mucous stools | 1 Participants |
| Weekly SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | GI-Gastrooesophageal reflux disease | 0 Participants |
| Weekly SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | GI-Vomiting | 1 Participants |
| Weekly SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | Immune system disorders | 1 Participants |
| Weekly SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | GI-Frequent bowel movements | 0 Participants |
| Weekly SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | GI-Flatulence | 3 Participants |
| Weekly SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | Infections and infestations | 6 Participants |
| Weekly SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | GI-Faecal incontinence | 1 Participants |
| Weekly SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | GI-Dyspepsia | 0 Participants |
| Weekly SER-287, After Vanco. Pre-Treat. | Safety and Tolerability of SER-287 | Reproductive system and breast disorders | 1 Participants |
Secondary
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.
Time frame: 8 weeks
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Weekly SER-287, After Placebo Pre-Treat. | Clinical Remission | 2 Participants |
| Daily Placebo, After Placebo Pre-Treat. | Clinical Remission | 0 Participants |
| Daily SER-287, After Vanco. Pre-Treat. | Clinical Remission | 6 Participants |
| Weekly SER-287, After Vanco. Pre-Treat. | Clinical Remission | 3 Participants |
p-value: 0.492395% CI: [-3.87, 30.54]Fisher Exact
p-value: 0.023795% CI: [15.21, 64.79]Fisher Exact
p-value: 0.257995% CI: [-0.47, 35.77]Fisher Exact
Secondary
Endoscopic Improvement
Defined as a decrease in endoscopic subscore \>= 1
Time frame: 8 weeks
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Weekly SER-287, After Placebo Pre-Treat. | Endoscopic Improvement | 5 Participants |
| Daily Placebo, After Placebo Pre-Treat. | Endoscopic Improvement | 1 Participants |
| Daily SER-287, After Vanco. Pre-Treat. | Endoscopic Improvement | 6 Participants |
| Weekly SER-287, After Vanco. Pre-Treat. | Endoscopic Improvement | 4 Participants |
p-value: 0.197395% CI: [-5.04, 53.53]Fisher Exact
p-value: 0.178395% CI: [0.86, 60.96]Fisher Exact
p-value: 0.619595% CI: [-11.93, 40.81]Fisher Exact