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Completed

NCT Number: NCT05770609

A Study of SPH3127 in the Treatment of Mild to Moderate Ulcerative Colitis

To preliminarily evaluate the clinical efficacy of the renin inhibitor SPH3127 Tablets in patients with mild to moderate ulcerative colitis with placebo as a control and determine the recommended dose.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Affiliated Hospital,Sun Yat-sen University, Guangzhou, Guangdong, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 - 75 years, male or female;
  • Subjects who have been diagnosed with ulcerative colitis;
  • Subjects who agree to take effective contraceptive measures with their spouses throughout the study period and for up to 12 weeks after the last dose;
  • Subjects who thoroughly learn about the nature, significance, possible benefits, possible inconvenience and potential risks of the trial, understand the study procedures and voluntarily sign the informed consent form prior to their participation in the trial.

Exclusion criteria

  • Subjects who are diagnosed with Crohn's disease or indeterminate colitis;
  • Subjects with active infections at screening which may, as evaluated by the investigator, cause increased risks for subjects;
  • Subjects who had surgery that might impact the absorption of oral drugs, subjects who will undergo surgery during the study period, subjects who have undergone major surgery before screening, or subjects who have a plan of surgery during the study period;
  • Subjects and lactating women and those who will become pregnant within 6 months after the trial starts;
  • Subjects with a history of drug abuse with clinical significance within 1 year prior to screening;
  • Subjects with other diseases or conditions that the investigator considers unsuitable for this trial.

Treatment and study plan

SPH3127 Tablets with Dose A

Drug

See Arm description

SPH3127 Tablets with Dose B

Drug

See Arm description

SPH3127 Tablets placebo

Drug

See Arm description

Primary outcomes

  1. Symptom remission rate

    Time frame: Week8

    Symptom remission rate

  2. Endoscopic remission rate

    Time frame: Week8

    Endoscopic remission rate

Secondary outcomes

  1. Clinical remission rate

    Time frame: Week8

    Clinical remission rate

  2. Symptom remission rate

    Time frame: Week2、Week4

    Symptom remission rate

  3. Safety and tolerability since the start of any study treatment.

    Time frame: Approximately 3 months

    Incidence of adverse event and serious adverse event

    , correlation with study drug

Sponsors and collaborators

Lead sponsor

Shanghai Pharmaceuticals Holding Co., Ltd

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel, Dose-finding Phase II Clinical Study to Evaluate the Efficacy and Safety of SPH3127 Tablets in the Treatment of Mild to Moderate Ulcerative Colitis

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 15, 2023
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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