NCT07035041

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: InventisBio Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study is divided into two parts, Part A and Part B. Part A will include 30 subjects, while Part B will include 90 subjects. The primary difference between Part A and Part B is that Part A includes a single-dose pharmacokinetic (PK) study period. Other aspects, such as population selection, randomization and blinding, dosing regimens, and outcome assessments (safety and efficacy), are consistent between Part A and Part B.

Conditions

• UC - Ulcerative Colitis
• Moderately to Severely Active Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	D-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.
DRUG	Placebo	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.

Timeline

• Start date: 2025-05-22
• Primary completion: 2026-07-30
• Completion: 2026-12-31
• First posted: 2025-06-24
• Last updated: 2025-06-24

Locations

1 site across 1 country: China