IPG11406 Phase 2 UC Trial, 144 Patients, 12 Weeks
Summary
NIH has registered a Phase 2 clinical trial (NCT07535489) for IPG11406, an investigational oral drug targeting the GPR183 receptor for ulcerative colitis. The randomized, double-blind, placebo-controlled study will enroll 144 adult patients across three active dose groups (10 mg, 20 mg, 40 mg twice daily) and one placebo arm over 12 weeks. The primary endpoint is clinical remission measured by modified Mayo Score at week 12, with secondary endpoints including clinical response, endoscopic remission, histological improvement, and safety evaluation.
What changed
The NIH ClinicalTrials.gov registry has posted a Phase 2 clinical trial for IPG11406, an investigational oral therapy targeting GPR183 receptor for treatment of moderately to severely active ulcerative colitis. The trial is designed as a multicenter, randomized, double-blind, placebo-controlled study with four treatment arms and a 12-week treatment period.
Pharmaceutical companies conducting or sponsoring clinical trials and clinical investigators should note this trial registration for competitive intelligence and patient recruitment purposes. Healthcare providers treating ulcerative colitis patients may identify potential enrollment opportunities for appropriate candidates.
Archived snapshot
Apr 17, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Efficacy and Safety of IPG11406 in Moderately to Severely Active Ulcerative Colitis (Phase 2)
Phase 2 NCT07535489 Kind: PHASE2 Apr 17, 2026
Abstract
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 stu...
Conditions: Moderately to Severely Active Ulcerative Colitis (UC)
Interventions: IPG11406, Placebo
Related changes
Get daily alerts for ClinicalTrials.gov Studies
Daily digest delivered to your inbox.
Free. Unsubscribe anytime.
Source
About this page
Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission
Source document text, dates, docket IDs, and authority are extracted directly from NIH.
The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.
Classification
Who this affects
Taxonomy
Browse Categories
Get alerts for this source
We'll email you when ClinicalTrials.gov Studies publishes new changes.
Subscribed!
Optional. Filters your digest to exactly the updates that matter to you.