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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT05019742

Run by

Shanghai Pharma Biotherapeutics USA Inc.

People needed

3

Starts

2022-03-21

Expected to finish

2022-11-01

Last updated by the study team

2025-06-26

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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)
• 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.

Where it is running

• Clinical Research Associates, LLC — Huntsville, Alabama, United States
• Southern California Research Institute Medical Group, Inc. — Los Angeles, California, United States
• Facey Medical Group at Facey Medical Foundation — Mission Hills, California, United States
• Precision Research Institute — San Diego, California, United States
• Ventura Clinical Trials — Ventura, California, United States
• Clinical Research of West Florida — Clearwater, Florida, United States
• Velocity Clinical Research — Edgewater, Florida, United States
• Homestead Research Institute, Inc. — Homestead, Florida, United States
• IHS Health — Kissimmee, Florida, United States
• Bayside Clinical Research LLC — Trinity, Florida, United States
• Atlanta Center for Gastroenterology, P.C. — Decatur, Georgia, United States
• Gastroenterology Associates of Western Michigan, PLC — Wyoming, Michigan, United States
• NY Scientific — Brooklyn, New York, United States
• Southern Star Research Institute, LLC — San Antonio, Texas, United States
• Gastro Health & Nutrition - Victoria — Victoria, Texas, United States
• Velocity Clinical Research — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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