Efficacy and Safety of IPG11406 in Moderately to Severely Active Ulcerative Colitis (Phase 2)
Phase 2 · Testing IPG11406 · 1 site · Nanjing Immunophage Biotech Co., Ltd
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing IPG11406 (a drug) as a possible treatment. Condition(s) listed: Moderately to Severely Active Ulcerative Colitis (UC).
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 to 70
- Any sex
Some of the main requirements, copied from the record:
- See the official record.
There are also 15 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 144 participants are expected to take part.
- Start date: 2026-07-07 (planned).
- Main results expected around 2028-12-01 (estimate from the record).
- 1 study site listed in China.
Main thing being measured
- Proportion of participants achieving clinical remission at Week 12, as assessed by the modified Mayo Score (mMS) (week 12)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Moderately to Severely Active Ulcerative Colitis (UC) |
| Lead sponsor | Nanjing Immunophage Biotech Co., Ltd |
| Collaborators | Peking Union Medical College |
| Enrollment | 144 (estimated) |
| Start date | 2026-07-07 |
| Primary completion (est.) | 2028-12-01 |
| First posted | 2026-04-17 |
| Last updated | 2026-04-17 |
| Official title | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of IPG11406 Tablets in Adult Patients With Moderately to Severely Active Ulcerative Colitis |
| ClinicalTrials.gov ID | NCT07535489 |
Interventions
- IPG11406 (Drug)
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, w… - Placebo (Drug)
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 sche…
Full eligibility criteria (from the record)
Inclusion Criteria:1.Males and females aged ≥18 and ≤70 years at randomization 2.Diagnosis of moderately to severely active UC with mMS 5-9, mMES 2-3, SF ≥1, RB ≥1 3.Documented UC diagnosis for ≥3 months prior to screening 4.Inadequate response, loss of response, or intolerance to conventional or advanced therapies 5.Stable background UC therapy for specified intervals before baseline 6.Willingness to use effective contraception throughout the study and for 1 month after last dose 7.Ability to comply with study visits and procedures 8.Signed informed consent Exclusion Criteria: 1. Diagnosis of indeterminate colitis or Crohn's disease 2. History of bowel surgery for UC or likely requiring surgery during study 3. Ulcerative proctitis only (distal ≤15 cm) 4. History of colonic dysplasia or adenomatous polyps not completely removed 5. Active intestinal infection (including C. difficile) within 30 days 6. HBV, HCV, HIV, or untreated latent/active TB 7. Significant cardiovascular disease or uncontrolled hypertension 8. Clinically significant abnormal ECG or QTcF prolongation 9. Treatment with prohibited medications within specified windows 10. Abnormal laboratory values at screening 11. History of malignancy (except non-melanoma skin cancer or in situ cervical cancer) 12. Pregnancy, breastfeeding, or plan to become pregnant 13. Alcohol or drug abuse within 6 months 14. Prior participation in an IPG11406 study 15. Other conditions deemed inappropriate by the investigator
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital Chinese Academy of Medical Sciences | Beijing | China |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.