JAK1 Inhibitor Ivarmacitinib for Improving Pancreatic Islet Function in T1D (INSPIRE-T1D)
INhibiting JAK1 to Save Pancreatic Islet Function in Recently Established T1D(INSPIRE-T1D)
This is a double-blind, randomized, placebo-parallel-controlled, multicenter study. The objective is to evaluate the efficacy and safety of Ivarmacitinib 8 mg administered for 52 weeks in preserving pancreatic β cell function in subjects with newly-onset type 1 diabetes mellitus. The study consists of a screening period (V1, up to 2 weeks), a 52-week double-blind treatment period (V2 to V14), and a 4-week safety follow-up period (V15).
연구 개요
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: jingjing jiang, PhD
- 전화번호: 13402003919
- 이메일: jiang.jingjing@zs-hospital.sh.cn
연구 장소
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Shanghai Municipality
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Shanghai, Shanghai Municipality, 중국, 200032
- Zhongshan Hospital, Fudan University
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연락하다:
- jingjing jiang, phD
- 전화번호: 86-021-64041990
- 이메일: jiang.jingjing@zs-hospital.sh.cn
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수석 연구원:
- Huijie Zhang, phD
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Confirmed diagnosis of type 1 diabetes mellitus.
- Able to complete randomization and initiate treatment with the study drug within 100 days of being formally diagnosed with type 1 diabetes.
- Peak stimulated C-peptide level ≥ 0.2 pmol/mL during the mixed-meal tolerance test performed in the screening period.
- Tested positive for at least one type 1 diabetes-associated autoantibody.
Exclusion Criteria:
- Presence of any autoimmune disease other than type 1 diabetes mellitus, except for stable autoimmune thyroid disease.
- Presence of active infection and/or fever.
- Known current or prior infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV), or serological evidence of such infection at screening.
- Active pulmonary tuberculosis, malignancy, etc.
- Severe hepatic impairment (AST or ALT >3 × upper limit of normal), or severe renal impairment or end-stage renal disease (eGFR < 30 mL/min/1.73 m²).
- Prior exposure to immunomodulatory agents, including baricitinib, ivarmacitinib, IL-1 receptor antagonists, tocilizumab (anti-IL-6 monoclonal antibody), infliximab (anti-TNF-α monoclonal antibody), interferons, etc.
- Severe cardiovascular disease such as angina pectoris, myocardial infarction, or stroke within the previous 6 months.
- Severe gastrointestinal disease.
- Surgical procedure performed within the past 6 months.
- Medical, psychological, or social conditions that, in the opinion of the investigator, may interfere with trial safety or proper completion.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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위약 비교기: 위약 대조군
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Oral tablet matching active Ivarmacitinib in appearance and scheduling, without active ingredients, taken once daily for 52 weeks. |
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실험적: Ivarmacitinib 8 mg group
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Oral tablet, administered at a fixed dose of 8mg once daily for 52 weeks. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from baseline in MMTT-stimulated C-peptide AUC at Week 52
기간: From Baseline to Week 52
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Change from baseline in C-peptide area under the curve (AUC) during a mixed-meal tolerance test (MMTT) after 52 weeks of treatment. |
From Baseline to Week 52
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from baseline in MMTT-stimulated C-peptide AUC at Week 26
기간: From Baseline to Week 26
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Change from baseline in C-peptide area under the curve (AUC) during a mixed-meal tolerance test (MMTT) after 26 weeks of treatment. |
From Baseline to Week 26
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Change from baseline in HbA1c at Week 52
기간: From Baseline to Week 52
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Change from baseline in glycated hemoglobin (HbA1c) after 52 weeks of treatment. |
From Baseline to Week 52
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Change from baseline in daily insulin dose at Week 52
기간: From Baseline to Week 52
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Change from baseline in daily insulin dose after 52 weeks of treatment |
From Baseline to Week 52
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Change from baseline in TIR assessed by CGM at Week 52
기간: From Baseline to Week 52
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Change from baseline in time-in-range (TIR) assessed by continuous glucose monitoring (CGM) after 52 weeks of treatment. |
From Baseline to Week 52
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Cumulative severe hypoglycemic events from baseline to Week 52
기간: From Baseline to Week 52
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Total number of severe hypoglycemic events that occurred during 52 weeks of treatment. |
From Baseline to Week 52
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Change from baseline in lymphocyte subpopulation quantified by flow cytometry at week 52
기간: From Baseline to Week 52
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Peripheral Blood Mononuclear Cell (PBMC) will be isolated and lymphocyte subpopulation will be quantified at baseline and Week 52 |
From Baseline to Week 52
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Huijie Zhang, Fudan University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- B2026-427R
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
All IPD that underlie results in a publication.
IPD 공유 기간
After publication.
IPD 공유 액세스 기준
IPD and supporting information will be available to researchers upon reasonable request (e.g. with a practical and meaningful research proposal).
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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