T1DM - Type 1 Diabetes MellitusPhase 2INSPIRE-T1DNCT07845955
JAK1 Inhibitor Ivarmacitinib for Improving Pancreatic Islet Function in T1D
A Phase 2 study testing Ivarmacitinib in people with T1DM - Type 1 Diabetes Mellitus, run by Huijie Zhang at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 40 years
- Conditions the study is for
- T1DM - Type 1 Diabetes Mellitus
- What is being tested?
- Ivarmacitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2026to 31 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 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).
- 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.
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- Severe cardiovascular disease such as angina pectoris, myocardial infarction, or stroke within the previous 6 months.
- Severe gastrointestinal disease.
- Surgical procedure performed within the past 6 months.
- Medical, psychological, or social conditions that, in the opinion of the investigator, may interfere with trial safety or proper completion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
jingjing jiang, phD, 86-021-64041990, jiang.jingjing@zs-hospital.sh.cn
Huijie Zhang, phD
About this study
Official title: 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).
- Conditions
- T1DM - Type 1 Diabetes Mellitus
- Being tested
- Ivarmacitinib, Placebo
- Keywords
- Type 1 Diabetes Mellitus, JAK1 Inhibitor, Ivarmacitinib
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvarmacitinibDrug
Oral tablet, administered at a fixed dose of 8mg once daily for 52 weeks.
PlaceboDrug
Oral tablet matching active Ivarmacitinib in appearance and scheduling, without active ingredients, taken once daily for 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Ivarmacitinib 8 mg group | Experimental | Not described Receives: Drug: Ivarmacitinib |
| Placebo control group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Baseline to Week 52
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: From Baseline to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T1DM - Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huijie Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Huijie Zhang, Shanghai Zhongshan Hospital
- Investigators
- Huijie Zhang, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845955
- Sponsor's protocol ID
- B2026-427R
- Acronym
- INSPIRE-T1D
- Status last verified
- Sep 2026
- First submitted
- 13 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INhibiting JAK1 to Save Pancreatic Islet Function in Recently Established T1D(INSPIRE-T1D)
- ClinicalTrials.gov ID
- NCT07845955
- Acronym / sponsor ID
- INSPIRE-T1D / B2026-427R
- Conditions
- T1DM - Type 1 Diabetes Mellitus
- Keywords
- Type 1 Diabetes Mellitus, JAK1 Inhibitor, Ivarmacitinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Huijie ZhangUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ivarmacitinib 8 mg group | Experimental | Drug: Ivarmacitinib |
| Placebo control group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 10 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IvarmacitinibOral tablet, administered at a fixed dose of 8mg once daily for 52 weeks. | Drug | Ivarmacitinib 8 mg group |
| PlaceboOral tablet matching active Ivarmacitinib in appearance and scheduling, without active ingredients, taken once daily for 52 weeks. | Drug | Placebo control group |
Primary outcome
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.
6 secondary outcomes
Change from baseline in MMTT-stimulated C-peptide AUC at Week 26
Time frame: From Baseline to Week 26
Change from baseline in HbA1c at Week 52
Time frame: 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 TIR assessed by CGM at Week 52
Time frame: From Baseline to Week 52
Cumulative severe hypoglycemic events from baseline to Week 52
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Huijie Zhang principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ivarmacitinib in people with T1DM - Type 1 Diabetes Mellitus, run by Huijie Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact jingjing jiang, PhD (13402003919, jiang.jingjing@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in MMTT-stimulated C-peptide AUC at Week 52 (time frame: From Baseline to Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.