JAK1 Inhibitor Ivarmacitinib for Improving Pancreatic Islet Function in T1D (INSPIRE-T1D)

September 27, 2026 updated by: Huijie Zhang

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

132

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Zhongshan Hospital, Fudan University
        • Contact:
        • Principal Investigator:
          • Huijie Zhang, phD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Confirmed diagnosis of type 1 diabetes mellitus.
  2. Able to complete randomization and initiate treatment with the study drug within 100 days of being formally diagnosed with type 1 diabetes.
  3. Peak stimulated C-peptide level ≥ 0.2 pmol/mL during the mixed-meal tolerance test performed in the screening period.
  4. Tested positive for at least one type 1 diabetes-associated autoantibody.

Exclusion Criteria:

  1. Presence of any autoimmune disease other than type 1 diabetes mellitus, except for stable autoimmune thyroid disease.
  2. Presence of active infection and/or fever.
  3. 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.
  4. Active pulmonary tuberculosis, malignancy, etc.
  5. 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).
  6. 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.
  7. Severe cardiovascular disease such as angina pectoris, myocardial infarction, or stroke within the previous 6 months.
  8. Severe gastrointestinal disease.
  9. Surgical procedure performed within the past 6 months.
  10. Medical, psychological, or social conditions that, in the opinion of the investigator, may interfere with trial safety or proper completion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo control group
Drug: Placebo

Oral tablet matching active Ivarmacitinib in appearance and scheduling, without active ingredients, taken once daily for 52 weeks.
Experimental: Ivarmacitinib 8 mg group
Drug: Ivarmacitinib

Oral tablet, administered at a fixed dose of 8mg once daily for 52 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in MMTT-stimulated C-peptide AUC at Week 52
Time Frame: From Baseline to Week 52

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in MMTT-stimulated C-peptide AUC at Week 26
Time Frame: From Baseline to Week 26

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
Change from baseline in HbA1c at Week 52
Time Frame: From Baseline to Week 52

Change from baseline in glycated hemoglobin (HbA1c) after 52 weeks of treatment.
From Baseline to Week 52
Change from baseline in daily insulin dose at Week 52
Time Frame: From Baseline to Week 52

Change from baseline in daily insulin dose after 52 weeks of treatment
From Baseline to Week 52
Change from baseline in TIR assessed by CGM at Week 52
Time Frame: From Baseline to Week 52

Change from baseline in time-in-range (TIR) assessed by continuous glucose monitoring (CGM) after 52 weeks of treatment.
From Baseline to Week 52
Cumulative severe hypoglycemic events from baseline to Week 52
Time Frame: From Baseline to Week 52

Total number of severe hypoglycemic events that occurred during 52 weeks of treatment.
From Baseline to Week 52
Change from baseline in lymphocyte subpopulation quantified by flow cytometry at week 52
Time Frame: From Baseline to Week 52

Peripheral Blood Mononuclear Cell (PBMC) will be isolated and lymphocyte subpopulation will be quantified at baseline and Week 52
From Baseline to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huijie Zhang

Investigators

  • Principal Investigator: Huijie Zhang, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 30, 2026

Primary Completion (Estimated)

August 31, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

September 13, 2026

First Submitted That Met QC Criteria

September 27, 2026

First Posted (Actual)

September 29, 2026

Study Record Updates

Last Update Posted (Actual)

September 29, 2026

Last Update Submitted That Met QC Criteria

September 27, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2026-427R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication.

IPD Sharing Time Frame

After publication.

IPD Sharing Access Criteria

IPD and supporting information will be available to researchers upon reasonable request (e.g. with a practical and meaningful research proposal).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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