Back to resultsVE202 in Patients With Mild-to-Moderate Ulcerative Colitis
Primary Purpose
Ulcerative Colitis, Colitis, Ulcerative
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VE202
Vancomycin Oral Capsule
VE202 Placebo
Vancomycin Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative Colitis, VE202, Vedanta, Clostridia
Eligibility Criteria
KEY INCLUSION CRITERIA
- 18 to 75 years of age
- Documented clinical and endoscopic diagnosis of UC at least 3 months prior to randomization
Active mild to moderate UC, as defined by the following:
- Disease that extends at least 15 cm from the anal verge
- A modified Mayo score of 4 to 8 with: (i.) Mayo endoscopic subscore of ≥ 2 based on screening flexible sigmoidoscopy; (ii.) Rectal bleeding score of ≥ 1
- Has never received a biologic agent, Janus kinase inhibitor, or sphingosine-1-phosphate modulator for the treatment of UC
- If receiving corticosteroids, dose must be stable for at least 4 weeks before randomization
- Doses of other allowable UC medications must be stable for at least 8 weeks before randomization
KEY EXCLUSION CRITERIA
- Known history of Crohn's disease (CD) or indeterminate colitis
- A known diagnosis of primary sclerosing cholangitis
- Allergy to VE202 or any of its components
- Allergy to vancomycin or any of its components
- A diagnosis of any non-IBD diarrheal illness (eg, Clostridioides difficile, celiac disease, parasitic infection) within 3 months prior to randomization
- Use of probiotics or herbal, botanical, or traditional medicinal preparations within the 2 weeks prior to randomization (consumption of food products such as yogurt, kefir, kombucha, and herbal teas is permissible)
- Receipt of Fecal Microbiota Transplantation (FMT) or other fecal-derived preparation within 6 months prior to randomization
- Prior colectomy, ostomy, or other intestinal surgery (excluding cholecystectomy or appendectomy)
- Receipt of any investigational biologic within 60 days or 5 half-lives prior to randomization, whichever is longer
Sites / Locations
- Dawn BarnesRecruiting
- GO ProsRecruiting
- Christina VelazquezRecruiting
- Danielle CorteseRecruiting
- Glenda Alfonso CastilloRecruiting
- Gastroenterology Research of America, LLCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Group A: Part 1 Active and Part 2 Placebo Treatment with Vancomycin pretreatment.
Group B: Part 1 Placebo and Part 2 Active Treatment with Vancomycin pretreatment.
Arm Description
In Part 1 of the study, patients in Group A will receive VE202 for 8 weeks. In Part 2 of the study, patients in Group A will receive VE202 placebo for 2 weeks. In Part 3, patients will be followed for safety for 1 year from the start of treatment.
In Part 1 of the study, patients in Group B will receive VE202 placebo for 8 weeks. In Part 2 of the study, patients in Group B will receive VE202 for 2 weeks. In Part 3, patients will be followed for safety for 1 year from the start of treatment.
Outcomes
Primary Outcome Measures
Proportion of participants with endoscopic response on flexible sigmoidoscopy after 8 weeks of treatment with VE202 or placebo.
Endoscopic response is defined as a reduction from baseline of 1 point or more in Mayo endoscopic subscore. The Mayo endoscopic subscore is evaluated on a scale of 0 to 3, with a higher score representing more severe disease.
Percentage of participants with Grade ≥ 3 Treatment-Emergent Adverse Events (TEAEs) that are treatment-related or Serious Adverse Events (SAEs) that are treatment-related in Part 1 and Part 2 of the study.
The safety of VE202 and placebo in Parts 1 and 2 of the study, which include an 8-week and 2-week course of treatment, respectively, will be evaluated.
Secondary Outcome Measures
Percentage of participants with endoscopic response on flexible sigmoidoscopy at Week 8, following treatment with VE202 for 2 weeks.
Endoscopic response is defined as a reduction from baseline of 1 point or more in Mayo endoscopic subscore. The Mayo endoscopic subscore is evaluated on a scale of 0 to 3, with a higher score representing more severe disease.
Number of participants with TEAEs, SAEs, and Adverse Events of Special Interest (AESIs) in Parts 1, 2, and 3 of the study.
The safety of VE202 and placebo in Parts 1, 2, and 3 of the study, which include an 8-week and 2-week course of treatment followed by a long-term follow-up period, will be evaluated. AESIs are defined as treatment-related Grade ≥2 TEAEs that are gastrointestinal or bacterial infections.
Percentage of participants with clinical remission at Week 8 of Part 1 and Week 8 of Part 2.
Participants will receive 8 weeks of VE202/placebo in Part 1 and 2 weeks of VE202/placebo in Part 2. Clinical remission is defined as attaining a Mayo stool frequency subscore of ≤1 and an improvement in stool frequency subscore of ≥1 point from baseline, a rectal bleeding subscore of 0 and an endoscopic subscore ≤1. Each component of the Mayo score is evaluated on a scale of 0 to 3, with a higher score representing more severe disease.
Percentage of participants with clinical response at Week 8 of Part 1 and Week 8 of Part 2.
Participants will receive 8 weeks of VE202/placebo in Part 1 and 2 weeks of VE202/placebo in Part 2. Clinical response is defined as having met the definition of clinical remission or having a decrease from baseline of ≥2 points and a decrease of ≥30% in modified Mayo score, with either a rectal bleeding score of 0 or a decrease in rectal bleeding of ≥1 point. Each component of the modified Mayo score (stool frequency, rectal bleeding, endoscopy findings) is evaluated on a scale of 0 to 3, with a higher score representing more severe disease.
Percentage of participants with endoscopic remission on flexible sigmoidoscopy at Week 8 of Part 1 and Week 8 of Part 2.
Participants will receive 8 weeks of VE202/placebo in Part 1 and 2 weeks of VE202/placebo in Part 2. Endoscopic response is defined as a Mayo endoscopic subscore of 0 or 1 point. The Mayo endoscopic subscore is evaluated on a scale of 0 to 3, with a higher score representing more severe disease.
Change in Mayo score compared with baseline at Week 8 of Part 1 and Week 8 of Part 2.
Participants will receive 8 weeks of VE202/placebo in Part 1 and 2 weeks of VE202/placebo in Part 2. The Mayo score is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician global assessment), with each parameter evaluated on a scale of 0 to 3. The total score ranges from 0 to 12, and a higher score represents more severe disease.
Histologic improvement at Week 8 of Part 1 and Week 8 of Part 2 as measured by Geboes score.
Participants will receive 8 weeks of VE202/placebo in Part 1 and 2 weeks of VE202/placebo in Part 2. The Geboes score encompasses 6 dimensions, each with 4 subcategories: architectural changes, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in the epithelium, crypt destruction, and erosions or ulcerations. The Geboes score ranges from grade 0 to 5.4. A higher Geboes score represents more severe disease.
Histologic improvement at Week 8 of Part 1 and Week 8 of Part 2 as measured by the Robarts Histopathology Index (RHI).
Participants will receive 8 weeks of VE202/placebo in Part 1 and 2 weeks of VE202/placebo in Part 2. The RHI provides a score between 0 and 33, based on the levels of chronic inflammatory infiltrate, neutrophils in lamina propria and epithelium, and erosion/ulceration. A higher RHI score represents more severe disease.
Change in fecal calprotectin levels after 2- and 8-week courses of VE202.
The change in fecal calprotectin level from baseline will be evaluated.
Change in colonization with VE202 strains detected in feces at various time points in patients treated with 2- and 8-week courses of VE202.
VE202 colonization will be characterized in patients treated with 2- and 8-week courses of VE202.
Change in the total percent of relative abundance of VE202 strains in feces at various time points in patients treated with 2- and 8-week courses of VE202.
VE202 colonization will be characterized in patients treated with 2- and 8-week courses of VE202.
Change in taxonomic composition of gut microbiome in patients treated with 2- and 8-week courses of VE202.
Microbiome composition will be evaluated by measuring the sum of species and the genera or higher-level taxonomic groupings at baseline and at subsequent time points in patients treated with 2- and 8-week courses of VE202 or placebo.
Change in fecal metabolite profiles at baseline and post-VE202 or placebo at various time points.
Short-chain fatty acid and bile acid concentrations will be evaluated at baseline and at subsequent time points in patients treated with 2- and 8-week courses of VE202 or placebo.
Number of participants with hospitalization or surgical procedure related to UC after 2- and 8-week courses of VE202.
To evaluate the impact of 2- and 8-week courses of VE202 on Inflammatory bowel disease (IBD) specific healthcare resource utilization.
Change in patient-reported outcome measures using the Inflammatory Bowel Disease Questionnaire (IBDQ) to evaluate the impact of 2- and 8-week courses of VE202 IBD-specific health-related quality of life.
The 32-item IBDQ uses a 7-point scale to assess disease-specific health-related quality of life across 4 dimensions: bowel symptoms, systemic symptoms, emotional wellbeing, and social function. The total IBDQ score is calculated by adding the scores within each domain. Scores can range from 32 to 224, with a higher score indicating a better outcome.
Change in patient-reported outcome measures using the EuroQoL-5D Health Assessment Questionnaire (EQ-5D) scores to evaluate the impact of 2- and 8-week courses of VE202 IBD-specific health-related quality of life.
The EuroQoL-5D Health Assessment Questionnaire (EQ-5D) is a standardized, self-administered, non-disease-specific instrument for measuring generic health status for routine clinical outcome measurement in the delivery of operational healthcare. Scores range from 0 to 100, with a higher score indicating better outcome.
Full Information
NCT ID
NCT05370885
First Posted
March 30, 2022
Last Updated
August 31, 2023
Sponsor
Vedanta Biosciences, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05370885
Brief Title
VE202 in Patients With Mild-to-Moderate Ulcerative Colitis
Official Title
Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of VE202 in Patients With Mild-to-Moderate Ulcerative Colitis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2023 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
November 10, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vedanta Biosciences, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A Phase 2 study to evaluate the safety, efficacy, and microbiota changes of VE202 in patients with mild to moderate ulcerative colitis (UC).
Detailed Description
A Phase 2 double-blind, placebo-controlled, randomized study to evaluate the safety, efficacy, and microbiota changes of VE202 in biologic-naïve patients with mild to moderate UC. In Parts 1 and 2 of the study, patients will receive VE202 or placebo for 8 weeks or 2 weeks. In Part 3, patients will be followed for safety for 1 year from the start of treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Colitis, Ulcerative
Keywords
Ulcerative Colitis, VE202, Vedanta, Clostridia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A: Part 1 Active and Part 2 Placebo Treatment with Vancomycin pretreatment.
Arm Type
Other
Arm Description
In Part 1 of the study, patients in Group A will receive VE202 for 8 weeks.
In Part 2 of the study, patients in Group A will receive VE202 placebo for 2 weeks.
In Part 3, patients will be followed for safety for 1 year from the start of treatment.
Arm Title
Group B: Part 1 Placebo and Part 2 Active Treatment with Vancomycin pretreatment.
Arm Type
Other
Arm Description
In Part 1 of the study, patients in Group B will receive VE202 placebo for 8 weeks.
In Part 2 of the study, patients in Group B will receive VE202 for 2 weeks.
In Part 3, patients will be followed for safety for 1 year from the start of treatment.
Intervention Type
Biological
Intervention Name(s)
VE202
Intervention Description
VE202 is a rationally defined, live biotherapeutic product for oral administration.
Intervention Type
Drug
Intervention Name(s)
Vancomycin Oral Capsule
Intervention Description
Vancomycin is an antibiotic used to treat or prevent infection
Intervention Type
Other
Intervention Name(s)
VE202 Placebo
Intervention Description
VE202 Placebo
Intervention Type
Other
Intervention Name(s)
Vancomycin Placebo
Intervention Description
Vancomycin Placebo
Primary Outcome Measure Information:
Title
Proportion of participants with endoscopic response on flexible sigmoidoscopy after 8 weeks of treatment with VE202 or placebo.
Description
Endoscopic response is defined as a reduction from baseline of 1 point or more in Mayo endoscopic subscore. The Mayo endoscopic subscore is evaluated on a scale of 0 to 3, with a higher score representing more severe disease.
Time Frame
8 Weeks
Title
Percentage of participants with Grade ≥ 3 Treatment-Emergent Adverse Events (TEAEs) that are treatment-related or Serious Adverse Events (SAEs) that are treatment-related in Part 1 and Part 2 of the study.
Description
The safety of VE202 and placebo in Parts 1 and 2 of the study, which include an 8-week and 2-week course of treatment, respectively, will be evaluated.
Time Frame
16 Weeks
Secondary Outcome Measure Information:
Title
Percentage of participants with endoscopic response on flexible sigmoidoscopy at Week 8, following treatment with VE202 for 2 weeks.
Description
Endoscopic response is defined as a reduction from baseline of 1 point or more in Mayo endoscopic subscore. The Mayo endoscopic subscore is evaluated on a scale of 0 to 3, with a higher score representing more severe disease.
Time Frame
8 Weeks
Title
Number of participants with TEAEs, SAEs, and Adverse Events of Special Interest (AESIs) in Parts 1, 2, and 3 of the study.
Description
The safety of VE202 and placebo in Parts 1, 2, and 3 of the study, which include an 8-week and 2-week course of treatment followed by a long-term follow-up period, will be evaluated. AESIs are defined as treatment-related Grade ≥2 TEAEs that are gastrointestinal or bacterial infections.
Time Frame
52 Weeks
Title
Percentage of participants with clinical remission at Week 8 of Part 1 and Week 8 of Part 2.
Description
Participants will receive 8 weeks of VE202/placebo in Part 1 and 2 weeks of VE202/placebo in Part 2. Clinical remission is defined as attaining a Mayo stool frequency subscore of ≤1 and an improvement in stool frequency subscore of ≥1 point from baseline, a rectal bleeding subscore of 0 and an endoscopic subscore ≤1. Each component of the Mayo score is evaluated on a scale of 0 to 3, with a higher score representing more severe disease.
Time Frame
8 Weeks
Title
Percentage of participants with clinical response at Week 8 of Part 1 and Week 8 of Part 2.
Description
Participants will receive 8 weeks of VE202/placebo in Part 1 and 2 weeks of VE202/placebo in Part 2. Clinical response is defined as having met the definition of clinical remission or having a decrease from baseline of ≥2 points and a decrease of ≥30% in modified Mayo score, with either a rectal bleeding score of 0 or a decrease in rectal bleeding of ≥1 point. Each component of the modified Mayo score (stool frequency, rectal bleeding, endoscopy findings) is evaluated on a scale of 0 to 3, with a higher score representing more severe disease.
Time Frame
8 Weeks
Title
Percentage of participants with endoscopic remission on flexible sigmoidoscopy at Week 8 of Part 1 and Week 8 of Part 2.
Description
Participants will receive 8 weeks of VE202/placebo in Part 1 and 2 weeks of VE202/placebo in Part 2. Endoscopic response is defined as a Mayo endoscopic subscore of 0 or 1 point. The Mayo endoscopic subscore is evaluated on a scale of 0 to 3, with a higher score representing more severe disease.
Time Frame
8 Weeks
Title
Change in Mayo score compared with baseline at Week 8 of Part 1 and Week 8 of Part 2.
Description
Participants will receive 8 weeks of VE202/placebo in Part 1 and 2 weeks of VE202/placebo in Part 2. The Mayo score is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician global assessment), with each parameter evaluated on a scale of 0 to 3. The total score ranges from 0 to 12, and a higher score represents more severe disease.
Time Frame
8 Weeks
Title
Histologic improvement at Week 8 of Part 1 and Week 8 of Part 2 as measured by Geboes score.
Description
Participants will receive 8 weeks of VE202/placebo in Part 1 and 2 weeks of VE202/placebo in Part 2. The Geboes score encompasses 6 dimensions, each with 4 subcategories: architectural changes, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in the epithelium, crypt destruction, and erosions or ulcerations. The Geboes score ranges from grade 0 to 5.4. A higher Geboes score represents more severe disease.
Time Frame
8 Weeks
Title
Histologic improvement at Week 8 of Part 1 and Week 8 of Part 2 as measured by the Robarts Histopathology Index (RHI).
Description
Participants will receive 8 weeks of VE202/placebo in Part 1 and 2 weeks of VE202/placebo in Part 2. The RHI provides a score between 0 and 33, based on the levels of chronic inflammatory infiltrate, neutrophils in lamina propria and epithelium, and erosion/ulceration. A higher RHI score represents more severe disease.
Time Frame
8 Weeks
Title
Change in fecal calprotectin levels after 2- and 8-week courses of VE202.
Description
The change in fecal calprotectin level from baseline will be evaluated.
Time Frame
52 Weeks
Title
Change in colonization with VE202 strains detected in feces at various time points in patients treated with 2- and 8-week courses of VE202.
Description
VE202 colonization will be characterized in patients treated with 2- and 8-week courses of VE202.
Time Frame
52 Weeks
Title
Change in the total percent of relative abundance of VE202 strains in feces at various time points in patients treated with 2- and 8-week courses of VE202.
Description
VE202 colonization will be characterized in patients treated with 2- and 8-week courses of VE202.
Time Frame
52 Weeks
Title
Change in taxonomic composition of gut microbiome in patients treated with 2- and 8-week courses of VE202.
Description
Microbiome composition will be evaluated by measuring the sum of species and the genera or higher-level taxonomic groupings at baseline and at subsequent time points in patients treated with 2- and 8-week courses of VE202 or placebo.
Time Frame
52 Weeks
Title
Change in fecal metabolite profiles at baseline and post-VE202 or placebo at various time points.
Description
Short-chain fatty acid and bile acid concentrations will be evaluated at baseline and at subsequent time points in patients treated with 2- and 8-week courses of VE202 or placebo.
Time Frame
52 Weeks
Title
Number of participants with hospitalization or surgical procedure related to UC after 2- and 8-week courses of VE202.
Description
To evaluate the impact of 2- and 8-week courses of VE202 on Inflammatory bowel disease (IBD) specific healthcare resource utilization.
Time Frame
52 weeks
Title
Change in patient-reported outcome measures using the Inflammatory Bowel Disease Questionnaire (IBDQ) to evaluate the impact of 2- and 8-week courses of VE202 IBD-specific health-related quality of life.
Description
The 32-item IBDQ uses a 7-point scale to assess disease-specific health-related quality of life across 4 dimensions: bowel symptoms, systemic symptoms, emotional wellbeing, and social function. The total IBDQ score is calculated by adding the scores within each domain. Scores can range from 32 to 224, with a higher score indicating a better outcome.
Time Frame
52 Weeks
Title
Change in patient-reported outcome measures using the EuroQoL-5D Health Assessment Questionnaire (EQ-5D) scores to evaluate the impact of 2- and 8-week courses of VE202 IBD-specific health-related quality of life.
Description
The EuroQoL-5D Health Assessment Questionnaire (EQ-5D) is a standardized, self-administered, non-disease-specific instrument for measuring generic health status for routine clinical outcome measurement in the delivery of operational healthcare. Scores range from 0 to 100, with a higher score indicating better outcome.
Time Frame
52 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
KEY INCLUSION CRITERIA
18 to 75 years of age
Documented clinical and endoscopic diagnosis of UC at least 3 months prior to randomization
Active mild to moderate UC, as defined by the following:
Disease that extends at least 15 cm from the anal verge
A modified Mayo score of 4 to 8 with: (i.) Mayo endoscopic subscore of ≥ 2 based on screening flexible sigmoidoscopy; (ii.) Rectal bleeding score of ≥ 1
Has never received a biologic agent, Janus kinase inhibitor, or sphingosine-1-phosphate modulator for the treatment of UC
If receiving corticosteroids, dose must be stable for at least 4 weeks before randomization
Doses of other allowable UC medications must be stable for at least 8 weeks before randomization
KEY EXCLUSION CRITERIA
Known history of Crohn's disease (CD) or indeterminate colitis
A known diagnosis of primary sclerosing cholangitis
Allergy to VE202 or any of its components
Allergy to vancomycin or any of its components
A diagnosis of any non-IBD diarrheal illness (eg, Clostridioides difficile, celiac disease, parasitic infection) within 3 months prior to randomization
Use of probiotics or herbal, botanical, or traditional medicinal preparations within the 2 weeks prior to randomization (consumption of food products such as yogurt, kefir, kombucha, and herbal teas is permissible)
Receipt of Fecal Microbiota Transplantation (FMT) or other fecal-derived preparation within 6 months prior to randomization
Prior colectomy, ostomy, or other intestinal surgery (excluding cholecystectomy or appendectomy)
Receipt of any investigational biologic within 60 days or 5 half-lives prior to randomization, whichever is longer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Garfield, MS
Phone
203.906.5693
Email
Consortium02-ctinquiries@vedantabio.com
First Name & Middle Initial & Last Name or Official Title & Degree
Azadeh Haghighizadeh, MS
Phone
571.251.5399
Email
Consortium02-ctinquiries@vedantabio.com
Facility Information:
Facility Name
Dawn Barnes
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305-1156
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dawn Barnes
Phone
334-305-2406
Email
dbarnes@dothangi.com
Facility Name
GO Pros
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paula Allain, LPN
Phone
239-403-9391
Email
pallainresearch@gmail.com
Facility Name
Christina Velazquez
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Arel
Phone
727-835-3261
Email
christina.arel@ariclinical.com
Facility Name
Danielle Cortese
City
Orlando
State/Province
Florida
ZIP/Postal Code
32808
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle Cortese, MSN, RN
Phone
407-512-1054
Email
DCORTESE@OMEGARCLLC.COM
Facility Name
Glenda Alfonso Castillo
City
New York
State/Province
New York
ZIP/Postal Code
10279
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Glenda Alfonso Castillo
Phone
718-737-3786
Email
galfonso.mcr@gmail.com
Facility Name
Gastroenterology Research of America, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Norma Quintanilla, M. Ac.
Phone
210-694-3848
Email
norma@gastroresearchers.com
12. IPD Sharing Statement
Learn more about this trial
VE202 in Patients With Mild-to-Moderate Ulcerative Colitis
We'll reach out to this number within 24 hrs