IPG11406의 중등도에서 중증 활동성 궤양성 대장염에 대한 유효성 및 안전성 (2상)
중등도에서 중증 활동성 궤양성 대장염 성인 환자를 대상으로 IPG11406 정제의 유효성 및 안전성을 평가하기 위한 제2상, 다기관, 무작위, 이중 맹검, 위약 대조, 용량 탐색 연구
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 2 단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Filipe Huang
- 전화번호: +86-21-34782827
- 이메일: yfhuang@immunophage.com.cn
연구 장소
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Beijing, 중국
- 모병
- Peking Union Medical College Hospital Chinese Academy of Medical Sciences
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연락하다:
- Hong Yang
- 전화번호: +86-010-69154016
- 이메일: hongy72@163.com
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: 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. |
|
실험적: 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. |
|
실험적: 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. |
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위약 비교기: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of participants achieving clinical remission at Week 12, as assessed by the modified Mayo Score (mMS)
기간: week 12
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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
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2차 결과 측정
2차 결과 측정
결과 측정 |
기간 |
|---|---|
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12주차 mMS 기준 임상 반응을 달성한 참가자 비율
기간: 12주차
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12주차
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제12주차 전체 메이요 점수 기준 임상 반응 달성 참가자 비율
기간: 12주차
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12주차
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12주차 전체 Mayo 점수를 기준으로 임상 관해를 달성한 참가자 비율
기간: 12주차
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12주차
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12주차에 PRO2 완화와 내시경적 완화를 동시에 달성한 참가자의 비율
기간: 12주
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12주
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12주차에 내시경적 관해를 달성한 참가자 비율
기간: 12주차
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12주차
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공동 작업자 및 조사자
협력자
협력자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- IPG11406-C003
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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