Moderately to Severely Active Ulcerative Colitis (UC)
Conditions
Brief 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.
Interventions
DRUGIPG11406
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.
DRUGPlacebo
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
Nanjing Immunophage Biotech Co., Ltd
Peking Union Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants achieving clinical remission at Week 12, as assessed by the modified Mayo Score (mMS) | week 12 | Clinical remission: mMS ≤2 with all subscores ≤1; stool frequency subscore 0 or 1 and ≥1 point decrease from baseline; rectal bleeding subscore 0; modified Mayo endoscopic subscore 0 or 1 (without friability for score 1) |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants achieving clinical response based on mMS at Week 12 | Week 12 |
| Proportion of participants achieving clinical response based on full Mayo Score at Week 12 | Week 12 |
| Proportion of participants achieving clinical remission based on full Mayo Score at Week 12 | Week 12 |
| Proportion of participants achieving combined PRO2 remission and endoscopic remission at Week 12 | Week 12 |
| Proportion of participants achieving endoscopic remission at Week 12 | Week 12 |
Countries
China
Contacts
CONTACTFilipe Huang
Outcome results
None listed