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

Last updated: November 24, 2023
Sponsor: Shanghai Pharma Biotherapeutics USA Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Crohn's Disease

Ulcers

Colic

Treatment

Placebo

SPH3127

Clinical Study ID

NCT05019742
SPH3127-US-01
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 providedthey 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 bleedingsubscore ≥ 1, and a Mayo Clinic Endoscopic Subscale (MCES) score ≥ 2 determined bycentral 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 useadequate birth control methods throughout the entire study (and extension, ifapplicable) or who is post-menopausal (i.e., amenorrhea ≥ 1 year) or who have beensurgically sterilized.
  8. Male patients with partners of child-bearing potential who agree to use adequate birthcontrol methods throughout the entire study (and extension, if applicable) or who havebeen surgically sterilized.

Exclusion

Exclusion Criteria:

  1. Diagnosis of severe UC, defined as the presence of ≥ 6 bloody stools daily with one ormore of the following: (1) oral temperature > 37.8°C or > 100.0°F; (2) pulse > 90beats/min; (3) hemoglobin concentration < 10.5 g/dL; or erythrocyte sedimentationratio (ESR) > 30.
  2. Patients treated with oral mesalamine >2.4 g/d, systemic steroids or rectal steroidswithin 4 weeks prior to randomization, rectal mesalamine (within 2 weeks),immunomodulators or immunosuppressant drugs, including, but not limited to, IL-6inhibitors, TNF inhibitors, anti-IL-1 agents and JAK inhibitors within 5 half-livesprior to randomization, antibiotics, anti-diarrheals (within 2 weeks), drugs blockingthe renin-angiotensin system (e.g., direct renin inhibitors, angiotensin convertingenzyme inhibitors, or angiotensin II receptor blockers) (within 4 weeks) oradministration of any investigational drug (within 4 weeks). Because SPH3127 is adirect renin inhibitor with the potential to reduce blood pressure, other classes ofantihypertensives (e.g., calcium channel blockers, beta blockers, diuretics, directvasodilators, alpha blockers, central α2 antagonists) (within 4 weeks) will also beexcluded. Drugs, herbal medicines and substances that inhibit or induce CYP3A4 (e.g.,ritonavir, itraconazole, grapefruit juice) (within 2 weeks or 5 half-lives, whicheveris 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 allergicreaction to any drug as determined by the investigator.
  11. Known seropositivity or positive test at screening for an active viral/bacterialinfection with:
  • Hepatitis B virus (HBV) (except seropositivity due to HBV vaccination)
  • Hepatitis C virus
  • Human immunodeficiency virus
  • COVID-19 (only active infection excluded)
  • Tuberculosis
  1. Known clinically relevant immunological disorders.
  2. History of severe allergic or anaphylactic reactions.
  3. History of malignancy, unless deemed cured by adequate treatment with no evidence ofrecurrence for a minimum 3 years before screening; completely eradicated non-melanomaskin cancer (such as basal cell carcinoma or squamous cell carcinoma) is notexclusionary.
  4. Clinically relevant abnormalities detected on ECG regarding either rhythm orconduction (e.g., QTcF > 450 ms or a known long QT syndrome). A first-degree heartblock or sinus arrhythmia will not be considered a significant abnormality.
  5. Low blood pressure at screening (i.e., SBP < 90 mmHg or DBP < 60 mmHg).
  6. Clinically relevant abnormalities detected on vital signs prior to dosing.
  7. Significant blood loss (including blood donation > 500 mL) or transfusion of any bloodproduct within 12 weeks prior to the IP administration or scheduled transfusion within 4 weeks after the end of the trial.
  8. Treatment with any drug known to have a well-defined potential for toxicity to a majororgan in the last 3 months preceding the initial investigational product (IP)administration.
  9. Concurrent participation, or participation within 30 days prior to the IPadministration or 5 half-lives of the investigational drug (whichever is longer), inany drug/device or biologic investigational research trial.
  10. Women who are breastfeeding.
  11. Vaccination (including influenza and COVID-19) within the last 4 weeks prior torandomization.
  12. History of drug or alcohol abuse.
  13. Is an investigator, sub-investigator, research assistant, pharmacist, trialcoordinator, or other staff of a relative who is directly involved in the conduct ofthe trial.
  14. Any condition or circumstances that in the opinion of the investigator may make asubject unlikely or unable to complete the trial or comply with trial procedures andrequirements.

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
March 21, 2022
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Clinical Research Associates, LLC

    Huntsville, Alabama 35801
    United States

    Active - Recruiting

  • Southern California Research Institute Medical Group, Inc.

    Los Angeles, California 90045
    United States

    Active - Recruiting

  • Facey Medical Group at Facey Medical Foundation

    Mission Hills, California 91345
    United States

    Active - Recruiting

  • Precision Research Institute

    San Diego, California 92114
    United States

    Active - Recruiting

  • Ventura Clinical Trials

    Ventura, California 93003
    United States

    Active - Recruiting

  • Clinical Research of West Florida

    Clearwater, Florida 33765
    United States

    Active - Recruiting

  • Velocity Clinical Research

    Edgewater, Florida 32132
    United States

    Active - Recruiting

  • Homestead Research Institute, Inc.

    Homestead, Florida 33030
    United States

    Active - Recruiting

  • IHS Health

    Kissimmee, Florida 34741
    United States

    Active - Recruiting

  • Bayside Clinical Research LLC

    Trinity, Florida 34655
    United States

    Active - Recruiting

  • Atlanta Center for Gastroenterology, P.C.

    Decatur, Georgia 30033
    United States

    Active - Recruiting

  • Gastroenterology Associates of Western Michigan, PLC

    Wyoming, Michigan 49519
    United States

    Active - Recruiting

  • NY Scientific

    Brooklyn, New York 11235
    United States

    Active - Recruiting

  • Southern Star Research Institute, LLC

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Gastro Health & Nutrition - Victoria

    Victoria, Texas 77904
    United States

    Active - Recruiting

  • Velocity Clinical Research

    Spokane, Washington 99202
    United States

    Active - Recruiting

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