Eficácia e Segurança do IPG11406 na Colite Ulcerosa Moderada a Severamente Ativa (Fase 2)
Estudo de Fase 2, Multicêntrico, Randomizado, Duplamente-Cego, Controlado por Placebo, de Variação de Dose para Avaliar a Eficácia e Segurança dos Comprimidos IPG11406 em Doentes Adultos com Colite Ulcerosa Ativa Moderada a Grave
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.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 2
Contactos e Locais
Contato de estudo
- Nome: Filipe Huang
- Número de telefone: +86-21-34782827
- E-mail: yfhuang@immunophage.com.cn
Locais de estudo
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-
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Beijing, China
- Recrutamento
- Peking Union Medical College Hospital Chinese Academy of Medical Sciences
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Contato:
- Hong Yang
- Número de telefone: +86-010-69154016
- E-mail: hongy72@163.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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. |
|
Experimental: 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. |
|
Experimental: 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. |
|
Comparador de Placebo: 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Proportion of participants achieving clinical remission at Week 12, as assessed by the modified Mayo Score (mMS)
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Proporção de participantes com resposta clínica com base no mMS na Semana 12
Prazo: Semana 12
|
Semana 12
|
|
Proporção de participantes que atingiram resposta clínica com base na pontuação completa de Mayo na Semana 12
Prazo: Semana 12
|
Semana 12
|
|
Proporção de participantes que atingiram remissão clínica com base na pontuação completa de Mayo na Semana 12
Prazo: Semana 12
|
Semana 12
|
|
Proporção de participantes que atingiram remissão PRO2 combinada e remissão endoscópica na Semana 12
Prazo: Semana 12
|
Semana 12
|
|
Proporção de participantes que alcançaram remissão endoscópica na Semana 12
Prazo: Semana 12
|
Semana 12
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- IPG11406-C003
Plano para dados de participantes individuais (IPD)
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