Ivarmacitinib to Help Preserve Insulin-Making Cells in Newly Diagnosed Type 1 Diabetes
Tests ivarmacitinib against placebo in people recently diagnosed with type 1 diabetes.
Plain-language title generated from the registry record
Registry title: JAK1 Inhibitor Ivarmacitinib for Improving Pancreatic Islet Function in T1D
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 10 and 40 years old?
Source: NCT07845955, who can take part
Where in China
- Zhongshan Hospital,Fudan UniversityShanghai, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Huijie Zhang
- Trial code
- NCT07845955
- Record updated
- 29 September 2026
- Original description
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).Read full original descriptionShow less
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).
Inclusion: 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: 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; 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; 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).