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Evaluation of SPH3127 in Patients With Mild-to-Moderate Ulcerative Colitis

Primary Purpose

Ulcerative Colitis

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SPH3127
Placebo
Sponsored by
Shanghai Pharma Biotherapeutics USA Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring mild-to-moderate, selective renin inhibitor

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Signed Informed Consent Form (ICF);
  2. Adult males and females ≥ 18 to < 70 years of age on the day of signing the ICF.
  3. A diagnosis of UC (documented or confirmed at screening) will be eligible provided they have mild-to-moderate active UC extending ≥ 15 cm from the anal verge.
  4. At screening/baseline, a Modified Mayo Clinic Score (MMCS) from 4-9, a rectal bleeding subscore ≥ 1, and a Mayo Clinic Endoscopic Subscale (MCES) score ≥ 2 determined by central reading.
  5. Patient has a negative urine drug screen (e.g., amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, opiates, methadone) at Screening.
  6. Patient has a negative alcohol breath test at Screening.
  7. Female patients who have a negative pregnancy test at Screening and who agree to use adequate birth control methods throughout the entire study (and extension, if applicable) or who is post-menopausal (i.e., amenorrhea ≥ 1 year) or who have been surgically sterilized.
  8. Male patients with partners of child-bearing potential who agree to use adequate birth control methods throughout the entire study (and extension, if applicable) or who have been surgically sterilized.

Exclusion Criteria:

  1. Diagnosis of severe UC, defined as the presence of ≥ 6 bloody stools daily with one or more of the following: (1) oral temperature > 37.8°C or > 100.0°F; (2) pulse > 90 beats/min; (3) hemoglobin concentration < 10.5 g/dL; or erythrocyte sedimentation ratio (ESR) > 30.
  2. Patients treated with oral mesalamine >2.4 g/d, systemic steroids or rectal steroids within 4 weeks prior to randomization, rectal mesalamine (within 2 weeks), immunomodulators or immunosuppressant drugs, including, but not limited to, IL-6 inhibitors, TNF inhibitors, anti-IL-1 agents and JAK inhibitors within 5 half-lives prior to randomization, antibiotics, anti-diarrheals (within 2 weeks), drugs blocking the renin-angiotensin system (e.g., direct renin inhibitors, angiotensin converting enzyme inhibitors, or angiotensin II receptor blockers) (within 4 weeks) or administration of any investigational drug (within 4 weeks). Because SPH3127 is a direct renin inhibitor with the potential to reduce blood pressure, other classes of antihypertensives (e.g., calcium channel blockers, beta blockers, diuretics, direct vasodilators, alpha blockers, central α2 antagonists) (within 4 weeks) will also be excluded. Drugs, herbal medicines and substances that inhibit or induce CYP3A4 (e.g., ritonavir, itraconazole, grapefruit juice) (within 2 weeks or 5 half-lives, whichever is longer) will be excluded.
  3. History of colectomy or partial colectomy, colorectal dysplasia, Crohn's disease, toxic megacolon, or bleeding disorders.
  4. A stool sample positive for enteric pathogens, including Clostridium difficile.
  5. Patients with an estimated glomerular filtration rate (eGFR) < 60.
  6. Patients with hepatic impairment or history of liver cirrhosis.
  7. Serum creatinine > 1.5 times the upper limit of normal, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin (TBIL) or alkaline phosphatase (ALP) > 2 times the upper limit of normal.
  8. Serious underlying disease other than UC.
  9. Previous participation in clinical trials with SPH3127
  10. Known hypersensitivity to tablet ingredients or history of a significant allergic reaction to any drug as determined by the investigator.
  11. Known seropositivity or positive test at screening for an active viral/bacterial infection with:

    • Hepatitis B virus (HBV) (except seropositivity due to HBV vaccination)
    • Hepatitis C virus
    • Human immunodeficiency virus
    • COVID-19 (only active infection excluded)
    • Tuberculosis
  12. Known clinically relevant immunological disorders.
  13. History of severe allergic or anaphylactic reactions.
  14. History of malignancy, unless deemed cured by adequate treatment with no evidence of recurrence for a minimum 3 years before screening; completely eradicated non-melanoma skin cancer (such as basal cell carcinoma or squamous cell carcinoma) is not exclusionary.
  15. Clinically relevant abnormalities detected on ECG regarding either rhythm or conduction (e.g., QTcF > 450 ms or a known long QT syndrome). A first-degree heart block or sinus arrhythmia will not be considered a significant abnormality.
  16. Low blood pressure at screening (i.e., SBP < 90 mmHg or DBP < 60 mmHg).
  17. Clinically relevant abnormalities detected on vital signs prior to dosing.
  18. Significant blood loss (including blood donation > 500 mL) or transfusion of any blood product within 12 weeks prior to the IP administration or scheduled transfusion within 4 weeks after the end of the trial.
  19. Treatment with any drug known to have a well-defined potential for toxicity to a major organ in the last 3 months preceding the initial investigational product (IP) administration.
  20. Concurrent participation, or participation within 30 days prior to the IP administration or 5 half-lives of the investigational drug (whichever is longer), in any drug/device or biologic investigational research trial.
  21. Women who are breastfeeding.
  22. Vaccination (including influenza and COVID-19) within the last 4 weeks prior to randomization.
  23. History of drug or alcohol abuse.
  24. Is an investigator, sub-investigator, research assistant, pharmacist, trial coordinator, or other staff of a relative who is directly involved in the conduct of the trial.
  25. Any condition or circumstances that in the opinion of the investigator may make a subject unlikely or unable to complete the trial or comply with trial procedures and requirements.

Sites / Locations

  • Clinical Research Associates, LLCRecruiting
  • Southern California Research Institute Medical Group, Inc.Recruiting
  • Facey Medical Group at Facey Medical FoundationRecruiting
  • Precision Research InstituteRecruiting
  • Ventura Clinical TrialsRecruiting
  • Clinical Research of West FloridaRecruiting
  • Velocity Clinical ResearchRecruiting
  • Homestead Research Institute, Inc.Recruiting
  • IHS HealthRecruiting
  • Bayside Clinical Research LLCRecruiting
  • Atlanta Center for Gastroenterology, P.C.Recruiting
  • Gastroenterology Associates of Western Michigan, PLCRecruiting
  • NY ScientificRecruiting
  • Southern Star Research Institute, LLCRecruiting
  • Gastro Health & Nutrition - VictoriaRecruiting
  • Velocity Clinical ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Placebo

SPH3127 50 mg

SPH3127 100 mg

Arm Description

2 placebo tablets, 1 in the morning and 1 in the evening, daily for 8 weeks. After 8 weeks, optional randomization to 1 of 2 SPH3127 daily treatment arms for an additional 10 months

1 50 mg SPH3127 tablet in the morning and 1 placebo tablet in the evening daily for 8 weeks. After 8 weeks, optional continuation of daily treatment for an additional 10 months.

1 50 mg SPH3127 tablet in the morning and 1 50 mg SPH3127 tablet in the evening daily for 8 weeks. After 8 weeks, optional continuation of daily treatment for an additional 10 months.

Outcomes

Primary Outcome Measures

Change from baseline in Modified Mayo Clinical Score (MMCS)
The MMCS is a scale with three 4-point domains (stool frequency, rectal bleeding, mucosal appearance at endoscopy). Reductions in score represent clinical improvement.
Change from baseline in Modified Mayo Clinical Score (MMCS)
The MMCS is a scale with three 4-point domains (stool frequency, rectal bleeding, mucosal appearance at endoscopy). Reductions in score represent clinical improvement.

Secondary Outcome Measures

Change from baseline in Robarts Histopathology Index (RHI)
The RHI is a scale with four 4-point grading domains (chronic inflammatory infiltrate, lamina propria neutrophils, neutrophils in the epithelium, and erosions or ulcerations) for colon tissue samples taken during endoscopy.
Change from baseline in Robarts Histopathology Index (RHI)
The RHI is a scale with four 4-point grading domains (chronic inflammatory infiltrate, lamina propria neutrophils, neutrophils in the epithelium, and erosions or ulcerations) for colon tissue samples taken during endoscopy.
Change from baseline in UC-100 score
The UC-100 is a composite score (i.e., 1 + 16 × Mayo Clinical stool frequency subscore [0 to 3] + 6 × Mayo Clinical endoscopic subscore [0 to 3] + 1 × RHI score [0 to 33]), that ranges from 1 (no disease activity) to 100 (severe disease activity)
Change from baseline in UC-100 score
The UC-100 is a composite score (i.e., 1 + 16 × Mayo Clinical stool frequency subscore [0 to 3] + 6 × Mayo Clinical endoscopic subscore [0 to 3] + 1 × RHI score [0 to 33]), that ranges from 1 (no disease activity) to 100 (severe disease activity)
Change from baseline in fecal calprotectin
Fecal calprotectin is a biochemical measurement of the protein calprotectin in the stool. Elevated fecal calprotectin indicates the migration of neutrophils to the intestinal mucosa, which occurs during intestinal inflammation caused by inflammatory bowel disease. Reductions in stool calprotectin are a marker of positive clinical activity.
Incidence and severity of adverse events
The incidence of each reported adverse event (regardless of its relationship to study drug) will be tabulated and classified using the latest version of the Medical Dictionary for Regulatory Activities (MedDRA) classification system. The severity of each adverse event will be graded as mild (event is easily tolerated by the subject and does not affect the patient's usual daily activities), moderate (event causes the subject sufficient discomfort and interferes with the patient's usual daily activities) or severe (event is incapacitating and causes considerable interference with the subject's usual daily activities).
Incidence and severity of adverse events
The incidence of each reported adverse event (regardless of its relationship to study drug) will be tabulated and classified using the latest version of the Medical Dictionary for Regulatory Activities (MedDRA) classification system. The severity of each adverse event will be graded as mild (event is easily tolerated by the subject and does not affect the patient's usual daily activities), moderate (event causes the subject sufficient discomfort and interferes with the patient's usual daily activities) or severe (event is incapacitating and causes considerable interference with the subject's usual daily activities).

Full Information

First Posted
August 13, 2021
Last Updated
April 4, 2022
Sponsor
Shanghai Pharma Biotherapeutics USA Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05019742
Brief Title
Evaluation of SPH3127 in Patients With Mild-to-Moderate Ulcerative Colitis
Official Title
A Double-Blind, Placebo-Controlled Trial to Investigate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of SPH3127 in Patients With Mild-to-Moderate Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2022 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Pharma Biotherapeutics USA Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
SPH3127-US-01 is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, pharmacokinetics, and preliminary efficacy of SPH3127 for the treatment of mild-to-moderate ulcerative colitis.
Detailed Description
SPH3127-US-01 is a proof-of-concept multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, pharmacokinetics, and preliminary efficacy of of daily oral administration of SPH3127 or placebo for 8 weeks in patients with mild-to-moderate ulcerative colitis. After meeting all inclusion and exclusion criteria, eligible patients will be randomized to receive SPH3127 (50 mg daily, 50 mg twice daily) or placebo tablets; all patients will take 2 tablets (SPH3127 or placebo) twice a day for 8 weeks. All randomized subjects will have the opportunity to enter an active-treatment extension (50 mg SPH3127 once or twice daily) for an additional 10 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
mild-to-moderate, selective renin inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
randomized, double-blind, placebo-controlled
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Experimental
Arm Description
2 placebo tablets, 1 in the morning and 1 in the evening, daily for 8 weeks. After 8 weeks, optional randomization to 1 of 2 SPH3127 daily treatment arms for an additional 10 months
Arm Title
SPH3127 50 mg
Arm Type
Experimental
Arm Description
1 50 mg SPH3127 tablet in the morning and 1 placebo tablet in the evening daily for 8 weeks. After 8 weeks, optional continuation of daily treatment for an additional 10 months.
Arm Title
SPH3127 100 mg
Arm Type
Experimental
Arm Description
1 50 mg SPH3127 tablet in the morning and 1 50 mg SPH3127 tablet in the evening daily for 8 weeks. After 8 weeks, optional continuation of daily treatment for an additional 10 months.
Intervention Type
Drug
Intervention Name(s)
SPH3127
Intervention Description
SPH3127 - selective renin inhibitor
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change from baseline in Modified Mayo Clinical Score (MMCS)
Description
The MMCS is a scale with three 4-point domains (stool frequency, rectal bleeding, mucosal appearance at endoscopy). Reductions in score represent clinical improvement.
Time Frame
Screening (baseline) to Day 56 (main study)
Title
Change from baseline in Modified Mayo Clinical Score (MMCS)
Description
The MMCS is a scale with three 4-point domains (stool frequency, rectal bleeding, mucosal appearance at endoscopy). Reductions in score represent clinical improvement.
Time Frame
Screening (baseline) to Day 336 (optional additional 10 months active treatment extension)
Secondary Outcome Measure Information:
Title
Change from baseline in Robarts Histopathology Index (RHI)
Description
The RHI is a scale with four 4-point grading domains (chronic inflammatory infiltrate, lamina propria neutrophils, neutrophils in the epithelium, and erosions or ulcerations) for colon tissue samples taken during endoscopy.
Time Frame
Screening (baseline) to Day 56 (main study)
Title
Change from baseline in Robarts Histopathology Index (RHI)
Description
The RHI is a scale with four 4-point grading domains (chronic inflammatory infiltrate, lamina propria neutrophils, neutrophils in the epithelium, and erosions or ulcerations) for colon tissue samples taken during endoscopy.
Time Frame
Screening (baseline) to Day 336 (optional additional 10 months active treatment extension)
Title
Change from baseline in UC-100 score
Description
The UC-100 is a composite score (i.e., 1 + 16 × Mayo Clinical stool frequency subscore [0 to 3] + 6 × Mayo Clinical endoscopic subscore [0 to 3] + 1 × RHI score [0 to 33]), that ranges from 1 (no disease activity) to 100 (severe disease activity)
Time Frame
Screening (baseline) to Day 56 (main study)
Title
Change from baseline in UC-100 score
Description
The UC-100 is a composite score (i.e., 1 + 16 × Mayo Clinical stool frequency subscore [0 to 3] + 6 × Mayo Clinical endoscopic subscore [0 to 3] + 1 × RHI score [0 to 33]), that ranges from 1 (no disease activity) to 100 (severe disease activity)
Time Frame
Screening (baseline) to Day 336 (optional additional 10 months active treatment extension)
Title
Change from baseline in fecal calprotectin
Description
Fecal calprotectin is a biochemical measurement of the protein calprotectin in the stool. Elevated fecal calprotectin indicates the migration of neutrophils to the intestinal mucosa, which occurs during intestinal inflammation caused by inflammatory bowel disease. Reductions in stool calprotectin are a marker of positive clinical activity.
Time Frame
Screening (baseline) to Day 56 (main study)
Title
Incidence and severity of adverse events
Description
The incidence of each reported adverse event (regardless of its relationship to study drug) will be tabulated and classified using the latest version of the Medical Dictionary for Regulatory Activities (MedDRA) classification system. The severity of each adverse event will be graded as mild (event is easily tolerated by the subject and does not affect the patient's usual daily activities), moderate (event causes the subject sufficient discomfort and interferes with the patient's usual daily activities) or severe (event is incapacitating and causes considerable interference with the subject's usual daily activities).
Time Frame
Screening (signing of informed consent form) to Day 56 (main study)
Title
Incidence and severity of adverse events
Description
The incidence of each reported adverse event (regardless of its relationship to study drug) will be tabulated and classified using the latest version of the Medical Dictionary for Regulatory Activities (MedDRA) classification system. The severity of each adverse event will be graded as mild (event is easily tolerated by the subject and does not affect the patient's usual daily activities), moderate (event causes the subject sufficient discomfort and interferes with the patient's usual daily activities) or severe (event is incapacitating and causes considerable interference with the subject's usual daily activities).
Time Frame
Screening (signing of informed consent form) to Day 336 (optional additional 10 months active treatment extension)
Other Pre-specified Outcome Measures:
Title
Mean plasma Cmax of SPH4336
Description
Mean maximum plasma concentration post morning oral dose
Time Frame
Day 1, 28 and 56
Title
Mean plasma AUC0-8h of SPH4336
Description
Mean area under the plasma concentration-time curve from 0 to 8 h post morning oral dose
Time Frame
Day 1, 28 and 56

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed Informed Consent Form (ICF); Adult males and females ≥ 18 to < 70 years of age on the day of signing the ICF. A diagnosis of UC (documented or confirmed at screening) will be eligible provided they have mild-to-moderate active UC extending ≥ 15 cm from the anal verge. At screening/baseline, a Modified Mayo Clinic Score (MMCS) from 4-9, a rectal bleeding subscore ≥ 1, and a Mayo Clinic Endoscopic Subscale (MCES) score ≥ 2 determined by central reading. Patient has a negative urine drug screen (e.g., amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, opiates, methadone) at Screening. Patient has a negative alcohol breath test at Screening. Female patients who have a negative pregnancy test at Screening and who agree to use adequate birth control methods throughout the entire study (and extension, if applicable) or who is post-menopausal (i.e., amenorrhea ≥ 1 year) or who have been surgically sterilized. Male patients with partners of child-bearing potential who agree to use adequate birth control methods throughout the entire study (and extension, if applicable) or who have been surgically sterilized. Exclusion Criteria: Diagnosis of severe UC, defined as the presence of ≥ 6 bloody stools daily with one or more of the following: (1) oral temperature > 37.8°C or > 100.0°F; (2) pulse > 90 beats/min; (3) hemoglobin concentration < 10.5 g/dL; or erythrocyte sedimentation ratio (ESR) > 30. Patients treated with oral mesalamine >2.4 g/d, systemic steroids or rectal steroids within 4 weeks prior to randomization, rectal mesalamine (within 2 weeks), immunomodulators or immunosuppressant drugs, including, but not limited to, IL-6 inhibitors, TNF inhibitors, anti-IL-1 agents and JAK inhibitors within 5 half-lives prior to randomization, antibiotics, anti-diarrheals (within 2 weeks), drugs blocking the renin-angiotensin system (e.g., direct renin inhibitors, angiotensin converting enzyme inhibitors, or angiotensin II receptor blockers) (within 4 weeks) or administration of any investigational drug (within 4 weeks). Because SPH3127 is a direct renin inhibitor with the potential to reduce blood pressure, other classes of antihypertensives (e.g., calcium channel blockers, beta blockers, diuretics, direct vasodilators, alpha blockers, central α2 antagonists) (within 4 weeks) will also be excluded. Drugs, herbal medicines and substances that inhibit or induce CYP3A4 (e.g., ritonavir, itraconazole, grapefruit juice) (within 2 weeks or 5 half-lives, whichever is longer) will be excluded. History of colectomy or partial colectomy, colorectal dysplasia, Crohn's disease, toxic megacolon, or bleeding disorders. A stool sample positive for enteric pathogens, including Clostridium difficile. Patients with an estimated glomerular filtration rate (eGFR) < 60. Patients with hepatic impairment or history of liver cirrhosis. Serum creatinine > 1.5 times the upper limit of normal, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin (TBIL) or alkaline phosphatase (ALP) > 2 times the upper limit of normal. Serious underlying disease other than UC. Previous participation in clinical trials with SPH3127 Known hypersensitivity to tablet ingredients or history of a significant allergic reaction to any drug as determined by the investigator. Known seropositivity or positive test at screening for an active viral/bacterial infection with: Hepatitis B virus (HBV) (except seropositivity due to HBV vaccination) Hepatitis C virus Human immunodeficiency virus COVID-19 (only active infection excluded) Tuberculosis Known clinically relevant immunological disorders. History of severe allergic or anaphylactic reactions. History of malignancy, unless deemed cured by adequate treatment with no evidence of recurrence for a minimum 3 years before screening; completely eradicated non-melanoma skin cancer (such as basal cell carcinoma or squamous cell carcinoma) is not exclusionary. Clinically relevant abnormalities detected on ECG regarding either rhythm or conduction (e.g., QTcF > 450 ms or a known long QT syndrome). A first-degree heart block or sinus arrhythmia will not be considered a significant abnormality. Low blood pressure at screening (i.e., SBP < 90 mmHg or DBP < 60 mmHg). Clinically relevant abnormalities detected on vital signs prior to dosing. Significant blood loss (including blood donation > 500 mL) or transfusion of any blood product within 12 weeks prior to the IP administration or scheduled transfusion within 4 weeks after the end of the trial. Treatment with any drug known to have a well-defined potential for toxicity to a major organ in the last 3 months preceding the initial investigational product (IP) administration. Concurrent participation, or participation within 30 days prior to the IP administration or 5 half-lives of the investigational drug (whichever is longer), in any drug/device or biologic investigational research trial. Women who are breastfeeding. Vaccination (including influenza and COVID-19) within the last 4 weeks prior to randomization. History of drug or alcohol abuse. Is an investigator, sub-investigator, research assistant, pharmacist, trial coordinator, or other staff of a relative who is directly involved in the conduct of the trial. Any condition or circumstances that in the opinion of the investigator may make a subject unlikely or unable to complete the trial or comply with trial procedures and requirements.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kenneth W Locke, PhD
Phone
8587755354
Email
kenneth@sphbio.com
First Name & Middle Initial & Last Name or Official Title & Degree
Li-Wei Jen
Phone
8583959254
Email
jenliwei@sphbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth W. Locke, PhD
Organizational Affiliation
Shanghai Pharma Biotherapeutics USA Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Research Associates, LLC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey G Garber, MD
Phone
256-535-5945
Email
GarberMD@cra-al.biz
Facility Name
Southern California Research Institute Medical Group, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adebambo O Ojuri, M.D.
Phone
310-935-0660
Email
a.ojuri@westgastro.com
Facility Name
Facey Medical Group at Facey Medical Foundation
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magued F Beshay, M.D.
Phone
818-365-9531
Email
mbeshay@facey.com
Facility Name
Precision Research Institute
City
San Diego
State/Province
California
ZIP/Postal Code
92114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taddese T Desta, M.D.
Phone
619-501-0371
Email
DrDesta@prisandiego.com
Facility Name
Ventura Clinical Trials
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Hazan, M.D.
Phone
805-339-0549
Email
sabinehazan@aim.com
Facility Name
Clinical Research of West Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leonard J Dunn, M.D.
Phone
727-461-7793
Email
ldunn@crwf.com
Facility Name
Velocity Clinical Research
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaret M Chang, M.D.
Phone
386-424-5777
Email
mchang@velocityclinical.com
Facility Name
Homestead Research Institute, Inc.
City
Homestead
State/Province
Florida
ZIP/Postal Code
33030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria T Nualart
Phone
786-243-6616
Email
mtnualart@hresearchi.com
Facility Name
IHS Health
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Syed K Latiff, MD
Phone
407-530-4370
Email
slateef@ihshealths.com
Facility Name
Bayside Clinical Research LLC
City
Trinity
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tatiana L Hernandez, M.D.
Phone
813-536-3263
Email
DrHernandez@Baysideclinicalresearch.com
Facility Name
Atlanta Center for Gastroenterology, P.C.
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David B Rausher, M.D.
Phone
404-296-1986
Facility Name
Gastroenterology Associates of Western Michigan, PLC
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allan G Coates, D.O.
Phone
616-328-5344
Email
acoates@gastro-assoc-wm.com
Facility Name
NY Scientific
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Igor Grosman, D.O.
Phone
718-332-0600
Email
igrosman@nyscientific.net
Facility Name
Southern Star Research Institute, 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
Jeff S Bullock, M.D.
Phone
210-581-2812
Email
js_bull@yahoo.com
Facility Name
Gastro Health & Nutrition - Victoria
City
Victoria
State/Province
Texas
ZIP/Postal Code
77904
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dharmendra Verma, M.D.
Phone
361-485-2695
Facility Name
Velocity Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harold G Preiksaitis, M.D.
Phone
509-456-5433
Email
hpreiksaitis@velocityclinical.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of SPH3127 in Patients With Mild-to-Moderate Ulcerative Colitis

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