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JAK1 Inhibitor Ivarmacitinib for Improving Pancreatic Islet Function in T1D

ConditionT1DM - Type 1 Diabetes Mellitus
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age10-40
SponsorHuijie Zhang

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ivarmacitinib

    Drug

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

  • Placebo

    Drug

    Oral tablet matching active Ivarmacitinib in appearance and scheduling, without active ingredients, taken once daily for 52 weeks.

Treatment groups

132 Participants
are divided into 2 treatment groups
Group A: Ivarmacitinib 8 mg groupExperimental treatment 1 intervention
Group B: Placebo control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Huijie Zhang

Lead sponsor

Shanghai Zhongshan Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: