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

NCT05019742 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: SPH3127-US-01
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 16

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.

Conditions

Ulcerative Colitis

Keywords

mild-to-moderate; selective renin inhibitor

Outcome Measures

Primary Outcomes (2)

• Number of Patients With Clinical Remission

  Number of patients with Clinical remission from baseline to Day 56

  Screening (baseline) to Day 56

• Number of Patients With Endoscopic Remission

  Number of patients with Endoscopic remission from baseline to Day 56

  Screening (baseline) to Day 56

Secondary Outcomes (1)

• Number of Patients Reporting Adverse Events

  Baseline to Day 56 or date of study termination for the 3 patients (i.e., < 80 days per patient)

Study Arms (3)

Placebo

EXPERIMENTAL

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

Drug: Placebo

SPH3127 50 mg

EXPERIMENTAL

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.

Drug: SPH3127

SPH3127 100 mg

EXPERIMENTAL

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.

Drug: SPH3127

Interventions

SPH3127 DRUG

SPH3127 - selective renin inhibitor

SPH3127 100 mg; SPH3127 50 mg

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Shanghai Pharma Biotherapeutics USA Inc.: lead

Study Sites (16)

Clinical Research Associates, LLC

Huntsville, Alabama, 35801, United States

Location

Southern California Research Institute Medical Group, Inc.

Los Angeles, California, 90045, United States

Location

Facey Medical Group at Facey Medical Foundation

Mission Hills, California, 91345, United States

Location

Precision Research Institute

San Diego, California, 92114, United States

Location

Ventura Clinical Trials

Ventura, California, 93003, United States

Location

Clinical Research of West Florida

Clearwater, Florida, 33765, United States

Location

Velocity Clinical Research

Edgewater, Florida, 32132, United States

Location

Homestead Research Institute, Inc.

Homestead, Florida, 33030, United States

Location

IHS Health

Kissimmee, Florida, 34741, United States

Location

Bayside Clinical Research LLC

Trinity, Florida, 34655, United States

Location

Atlanta Center for Gastroenterology, P.C.

Decatur, Georgia, 30033, United States

Location

Gastroenterology Associates of Western Michigan, PLC

Wyoming, Michigan, 49519, United States

Location

NY Scientific

Brooklyn, New York, 11235, United States

Location

Southern Star Research Institute, LLC

San Antonio, Texas, 78229, United States

Location

Gastro Health & Nutrition - Victoria

Victoria, Texas, 77904, United States

Location

Velocity Clinical Research

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

SPH3127

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: CSO
• Organization: Shanghai Pharma Biotherapeutics USA Inc.

kenneth@sphbio.com

8587755354

Study Officials

• Kenneth W. Locke, PhD

  Shanghai Pharma Biotherapeutics USA Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized, double-blind, placebo-controlled

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: August 25, 2021
• Study Start: March 21, 2022
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: June 26, 2025
• Results First Posted: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)