Efficacy and Safety of IPG11406 in Moderately to Severely Active Ulcerative Colitis (Phase 2)

Summary

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and pharmacokinetics of IPG11406, an investigational oral drug, in adult patients with moderately to severely active ulcerative colitis (UC).

UC is a chronic inflammatory bowel disease that causes long-term inflammation and ulcers in the colon, leading to symptoms like frequent diarrhea, rectal bleeding, abdominal pain, and urgent bowel movements. IPG11406 works by targeting the GPR183 receptor, which helps reduce immune cell migration to the inflamed colon, potentially easing UC symptoms and promoting mucosal healing.

In this study, 144 eligible adult patients will be randomly assigned (1:1:1:1) to receive one of three doses of IPG11406 (10 mg, 20 mg, or 40 mg, taken twice daily by mouth) or a matching placebo for 12 weeks. Neither the patients nor their study doctors will know who is receiving the active drug or placebo to ensure unbiased results.

The main goal of the study is to see how well IPG11406 works to achieve clinical remission (reduced or no UC symptoms) at 12 weeks, measured by the modified Mayo Score. Additional goals include evaluating other efficacy measures (such as clinical response, endoscopic remission, and histological improvement), long-term safety, how the drug is absorbed and processed in the body (pharmacokinetics), and changes in inflammatory biomarkers like fecal calprotectin and hsCRP.

All participants will undergo regular study visits for safety assessments, including physical exams, laboratory tests, colonoscopies, and monitoring for any side effects throughout the 12-week treatment period and a 2-week follow-up. This study will help determine the optimal dose of IPG11406 for future larger clinical trials in UC patients.

Conditions

• Moderately to Severely Active Ulcerative Colitis (UC)

Interventions

DRUG

IPG11406

This intervention refers to IPG11406, an investigational oral tablet being evaluated in a Phase 2, randomized, double-blind, placebo-controlled, dose-ranging study in adult patients with moderately to severely active ulcerative colitis (UC). IPG11406 is administered twice daily (BID) at three dose levels (10 mg, 20 mg, or 40 mg) for 12 weeks. The formulation is intended for oral administration, with matching placebo used as the control. The primary objective is to assess clinical remission based on the modified Mayo Score at Week 12. Secondary and exploratory endpoints include clinical response, endoscopic/histologic improvement, pharmacokinetics, safety, and changes in inflammatory biomarkers.

DRUG

Placebo

This intervention refers to matching placebo oral tablets, identical in appearance, shape, size, and color to the IPG11406 investigational product, used as the control in this Phase 2, randomized, double-blind, placebo-controlled study in adult patients with moderately to severely active ulcerative colitis. The placebo is administered twice daily (BID) for 12 weeks, following the same dosing schedule as the active IPG11406 treatment arms, to maintain the double-blind study design. It contains no active pharmaceutical ingredient (API) and is formulated to be indistinguishable from IPG11406 tablets for participants, investigators, and study staff.

Sponsors & Collaborators

• Peking Union Medical College

  collaborator OTHER

• Nanjing Immunophage Biotech Co., Ltd

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-07

Primary Completion

2028-12-01

Completion

2029-12-01

FDA Drug

Yes

Countries

• China

Study Locations