Image

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

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

Non Recruiting
18-75 years
All
Phase 2

Powered by AI

Overview

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.

Eligibility

Inclusion Criteria:

  1. Aged 18 - 75 years, male or female;
  2. Subjects who have been diagnosed with ulcerative colitis;
  3. 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;
  4. 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:

  1. Subjects who are diagnosed with Crohn's disease or indeterminate colitis;
  2. Subjects with active infections at screening which may, as evaluated by the investigator, cause increased risks for subjects;
  3. 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;
  4. Subjects and lactating women and those who will become pregnant within 6 months after the trial starts;
  5. Subjects with a history of drug abuse with clinical significance within 1 year prior to screening;
  6. Subjects with other diseases or conditions that the investigator considers unsuitable for this trial.

Study details
    Mild to Moderate Ulcerative Colitis

NCT05770609

Shanghai Pharmaceuticals Holding Co., Ltd

20 August 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.