A Phase 2 interventional study of Ivarmacitinib and Placebo in T1DM - Type 1 Diabetes Mellitus, sponsored by Huijie Zhang. Not yet recruiting at 1 site in China. Open to participants aged 10 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Huijie Zhang · Phase 2, Interventional, and Treatment
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).
Exclusion Criteria:
Drug: Ivarmacitinib
Drug: Placebo
Oral tablet, administered at a fixed dose of 8mg once daily for 52 weeks.
Oral tablet matching active Ivarmacitinib in appearance and scheduling, without active ingredients, taken once daily for 52 weeks.
Change from baseline in MMTT-stimulated C-peptide AUC at 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.
Time frame: From Baseline to Week 52
Change from baseline in MMTT-stimulated C-peptide AUC at 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.
Time frame: From Baseline to Week 26
Change from baseline in HbA1c at Week 52
Change from baseline in glycated hemoglobin (HbA1c) after 52 weeks of treatment.
Time frame: From Baseline to Week 52
Change from baseline in daily insulin dose at Week 52
Change from baseline in daily insulin dose after 52 weeks of treatment
Time frame: From Baseline to Week 52
Change from baseline in TIR assessed by CGM at Week 52
Change from baseline in time-in-range (TIR) assessed by continuous glucose monitoring (CGM) after 52 weeks of treatment.
Time frame: From Baseline to Week 52
Cumulative severe hypoglycemic events from baseline to Week 52
Total number of severe hypoglycemic events that occurred during 52 weeks of treatment.
Time frame: From Baseline to Week 52
Change from baseline in lymphocyte subpopulation quantified by flow cytometry at week 52
Peripheral Blood Mononuclear Cell (PBMC) will be isolated and lymphocyte subpopulation will be quantified at baseline and Week 52
Time frame: From Baseline to Week 52
Plan to share: Yes — All IPD that underlie results in a publication.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Huijie Zhang