Moderately to Severely Active Ulcerative Colitis (UC)Phase 2NCT07535489
Efficacy and Safety of IPG11406 in Moderately to Severely Active Ulcerative Colitis (Phase 2)
A Phase 2 study testing IPG11406 in people with Moderately to Severely Active Ulcerative Colitis (UC), run by Nanjing Immunophage Biotech Co., Ltd at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Moderately to Severely Active Ulcerative Colitis (UC)
- What is being tested?
- IPG11406
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 7 Jul 2026to 1 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Diagnosis of indeterminate colitis or Crohn's disease
- History of bowel surgery for UC or likely requiring surgery during study
- Ulcerative proctitis only (distal ≤15 cm)
- History of colonic dysplasia or adenomatous polyps not completely removed
- Active intestinal infection (including C. difficile) within 30 days
- HBV, HCV, HIV, or untreated latent/active TB
Show all 15Show fewer
- Significant cardiovascular disease or uncontrolled hypertension
- Clinically significant abnormal ECG or QTcF prolongation
- Treatment with prohibited medications within specified windows
- Abnormal laboratory values at screening
- History of malignancy (except non-melanoma skin cancer or in situ cervical cancer)
- Pregnancy, breastfeeding, or plan to become pregnant
- Alcohol or drug abuse within 6 months
- Prior participation in an IPG11406 study
- Other conditions deemed inappropriate by the investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking Union Medical College Hospital Chinese Academy of Medical Sciences
Beijing
Hong Yang, +86-010-69154016, hongy72@163.com
About this study
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
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.
Read more
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.
- Being tested
- IPG11406, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPG11406Drug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| IPG11406 10 mg BID | Experimental | Participants in this arm receive IPG11406 10 mg oral tablets twice daily (BID) for 12 weeks, in a double-blind, placebo-controlled design. Receives: Drug: IPG11406 |
| IPG11406 20 mg BID | Experimental | Participants in this arm receive IPG11406 20 mg oral tablets twice daily (BID) for 12 weeks, in a double-blind, placebo-controlled design. Receives: Drug: IPG11406 |
| IPG11406 40 mg BID | Experimental | Participants in this arm receive IPG11406 40 mg oral tablets twice daily (BID) for 12 weeks, in a double-blind, placebo-controlled design. Receives: Drug: IPG11406 |
| Placebo | Placebo comparator | Participants in this arm receive matching placebo oral tablets twice daily (BID) for 12 weeks, identical in appearance to IPG11406, to maintain the double-blind study design. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving clinical remission at Week 12, as assessed by the modified Mayo Score (mMS)
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)
Measured: week 12
Secondary outcomes (5)
Proportion of participants achieving clinical response based on mMS at Week 12
Measured: Week 12
Proportion of participants achieving clinical response based on full Mayo Score at Week 12
Measured: Week 12
Proportion of participants achieving clinical remission based on full Mayo Score at Week 12
Measured: Week 12
Proportion of participants achieving combined PRO2 remission and endoscopic remission at Week 12
Measured: Week 12
Proportion of participants achieving endoscopic remission at Week 12
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start7 Jul 2026 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderately to Severely Active Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Immunophage Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking Union Medical College
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07535489
- Sponsor's protocol ID
- IPG11406-C003
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- IPG11406-C003
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Nanjing Immunophage Biotech Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Peking Union Medical College
- Study start
- 7 Jul 2026 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IPG11406 10 mg BID | Experimental | Drug: IPG11406Participants in this arm receive IPG11406 10 mg oral tablets twice daily (BID) for 12 weeks, in a double-blind, placebo-controlled design. |
| IPG11406 20 mg BID | Experimental | Drug: IPG11406Participants in this arm receive IPG11406 20 mg oral tablets twice daily (BID) for 12 weeks, in a double-blind, placebo-controlled design. |
| IPG11406 40 mg BID | Experimental | Drug: IPG11406Participants in this arm receive IPG11406 40 mg oral tablets twice daily (BID) for 12 weeks, in a double-blind, placebo-controlled design. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants in this arm receive matching placebo oral tablets twice daily (BID) for 12 weeks, identical in appearance to IPG11406, to maintain the double-blind study design. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (15 listed)
- Diagnosis of indeterminate colitis or Crohn's disease
- History of bowel surgery for UC or likely requiring surgery during study
- Ulcerative proctitis only (distal ≤15 cm)
- History of colonic dysplasia or adenomatous polyps not completely removed
- Active intestinal infection (including C. difficile) within 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPG11406This 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 | IPG11406 10 mg BID, IPG11406 20 mg BID, IPG11406 40 mg BID |
| PlaceboThis 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. | Drug | Placebo |
Primary outcome
Proportion of participants achieving clinical remission at Week 12, as assessed by the modified Mayo Score (mMS)
Time frame: 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)
5 secondary outcomes
Proportion of participants achieving clinical response based on mMS at Week 12
Time frame: Week 12
Proportion of participants achieving clinical response based on full Mayo Score at Week 12
Time frame: Week 12
Proportion of participants achieving clinical remission based on full Mayo Score at Week 12
Time frame: Week 12
Proportion of participants achieving combined PRO2 remission and endoscopic remission at Week 12
Time frame: Week 12
Proportion of participants achieving endoscopic remission at Week 12
Time frame: Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IPG11406 in people with Moderately to Severely Active Ulcerative Colitis (UC), run by Nanjing Immunophage Biotech Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Filipe Huang (+86-21-34782827, yfhuang@immunophage.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving clinical remission at Week 12, as assessed by the modified Mayo Score (mMS) (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.