RecruitingPhase 2NCT07035041

A Phase 2 Study of D-2570 in Subjects With Moderately to Severely Active Ulcerative Colitis

A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of D-2570 as Induction Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis


Sponsor

InventisBio Co., Ltd

Enrollment

120 participants

Start Date

May 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial. The target population is patients with moderately to severely active ulcerative colitis. A total of 120 subjects are planned to be included.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called D-2570 in people with moderately to severely active ulcerative colitis (UC) — a chronic inflammatory bowel disease that causes the lining of the colon to become inflamed and develop ulcers. **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with ulcerative colitis for at least 3 months, confirmed by endoscopy and biopsy - Your disease is moderately to severely active - You understand and agree to the study protocol **You may NOT be eligible if...** - You have had ulcerative colitis for less than 3 months - You have only mild disease activity - You have serious other health conditions that could interfere with the study drug - You have not given informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGD-2570

Subjects will then be randomized in a 1:1:1 ratio to D-2570 or placebo . They will enter the study treatment period and take the assigned investigational product once daily for 12 consecutive weeks.

DRUGPlacebo

Subjects will then be randomized in a 1:1:1 ratio to D-2570 or placebo . They will enter the study treatment period and take the assigned investigational product once daily for 12 consecutive weeks.


Locations(1)

Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT07035041


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