NCT07845955Not yet recruitingPhase 2
JAK1 Inhibitor Ivarmacitinib for Improving Pancreatic Islet Function in T1D
INhibiting JAK1 to Save Pancreatic Islet Function in Recently Established T1D(INSPIRE-T1D)
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 132 (estimated)
- First submitted
- 13 Sept 2026
- Start date
- 30 Sept 2026
- Primary completion date
- 31 Aug 2029
- Lead sponsor
- Huijie Zhang
- Diseases
- Type 1 diabetes
- NCT number
- NCT07845955
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 132
- From 30 Sept 2026 to the primary completion date, 31 Aug 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
- Surgical procedure performed within the past 6 months.
Other illness
- Presence of any autoimmune disease other than type 1 diabetes mellitus, except for stable autoimmune thyroid disease.
- Presence of active infection and/or fever.
- Active pulmonary tuberculosis, malignancy, etc.
- Severe gastrointestinal disease.
- Medical, psychological, or social conditions that, in the opinion of the investigator, may interfere with trial safety or proper completion.
Lab values
- 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).
Who the study is looking for
- 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.
Age in the registry: 10 years to 40 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongshan Hospital,Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.