Effekt og sikkerhed af IPG11406 ved moderat til svært aktiv ulcerøs colitis (fase 2)
En fase 2, multicenter, randomiseret, dobbeltblind, placebokontrolleret, dosisundersøgende undersøgelse til evaluering af effektivitet og sikkerhed af IPG11406-tabletter hos voksne patienter med moderat til svært aktiv ulcerøs 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.
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
- Navn: Filipe Huang
- Telefonnummer: +86-21-34782827
- E-mail: yfhuang@immunophage.com.cn
Studiesteder
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-
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Beijing, Kina
- Rekruttering
- Peking Union Medical College Hospital Chinese Academy of Medical Sciences
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Kontakt:
- Hong Yang
- Telefonnummer: +86-010-69154016
- E-mail: hongy72@163.com
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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:
- 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
- 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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: IPG11406 10 mg BID
Participants in this arm receive IPG11406 10 mg oral tablets twice daily (BID) for 12 weeks, in a double-blind, placebo-controlled design. |
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. |
|
Eksperimentel: IPG11406 20 mg BID
Participants in this arm receive IPG11406 20 mg oral tablets twice daily (BID) for 12 weeks, in a double-blind, placebo-controlled design. |
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. |
|
Eksperimentel: IPG11406 40 mg BID
Participants in this arm receive IPG11406 40 mg oral tablets twice daily (BID) for 12 weeks, in a double-blind, placebo-controlled design. |
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. |
|
Placebo komparator: Placebo
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. |
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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of participants achieving clinical remission at Week 12, as assessed by the modified Mayo Score (mMS)
Tidsramme: 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) |
week 12
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Andel af deltagere, der opnår klinisk respons baseret på mMS i uge 12
Tidsramme: Uge 12
|
Uge 12
|
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Andel af deltagere, der opnår klinisk respons baseret på fuld Mayo-score i uge 12
Tidsramme: Uge 12
|
Uge 12
|
|
Andel af deltagere, der opnår klinisk remission baseret på fuld Mayo Score i uge 12
Tidsramme: Uge 12
|
Uge 12
|
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Andel af deltagere, der opnår kombineret PRO2-remission og endoskopisk remission i uge 12
Tidsramme: Uge 12
|
Uge 12
|
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Andel af deltagere, der opnår endoskopisk remission i uge 12
Tidsramme: Uge 12
|
Uge 12
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- IPG11406-C003
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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