JAK1 Inhibitor Ivarmacitinib for Improving Pancreatic Islet Function in T1D (INSPIRE-T1D)
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).
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 2
Kontakter och platser
Studiekontakt
- Namn: jingjing jiang, PhD
- Telefonnummer: 13402003919
- E-post: jiang.jingjing@zs-hospital.sh.cn
Studieorter
-
-
Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200032
- Zhongshan Hospital, Fudan University
-
Kontakt:
- jingjing jiang, phD
- Telefonnummer: 86-021-64041990
- E-post: jiang.jingjing@zs-hospital.sh.cn
-
Huvudutredare:
- Huijie Zhang, phD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- 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 Criteria:
- 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.
- 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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Placebo-jämförare: Placebokontrollgrupp
|
Oral tablet matching active Ivarmacitinib in appearance and scheduling, without active ingredients, taken once daily for 52 weeks. |
|
Experimentell: Ivarmacitinib 8 mg group
|
Oral tablet, administered at a fixed dose of 8mg once daily for 52 weeks. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from baseline in MMTT-stimulated C-peptide AUC at Week 52
Tidsram: 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. |
From Baseline to Week 52
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from baseline in MMTT-stimulated C-peptide AUC at Week 26
Tidsram: From Baseline to 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. |
From Baseline to Week 26
|
|
Change from baseline in HbA1c at Week 52
Tidsram: From Baseline to Week 52
|
Change from baseline in glycated hemoglobin (HbA1c) after 52 weeks of treatment. |
From Baseline to Week 52
|
|
Change from baseline in daily insulin dose at Week 52
Tidsram: From Baseline to Week 52
|
Change from baseline in daily insulin dose after 52 weeks of treatment |
From Baseline to Week 52
|
|
Change from baseline in TIR assessed by CGM at Week 52
Tidsram: From Baseline to Week 52
|
Change from baseline in time-in-range (TIR) assessed by continuous glucose monitoring (CGM) after 52 weeks of treatment. |
From Baseline to Week 52
|
|
Cumulative severe hypoglycemic events from baseline to Week 52
Tidsram: From Baseline to Week 52
|
Total number of severe hypoglycemic events that occurred during 52 weeks of treatment. |
From Baseline to Week 52
|
|
Change from baseline in lymphocyte subpopulation quantified by flow cytometry at week 52
Tidsram: From Baseline to Week 52
|
Peripheral Blood Mononuclear Cell (PBMC) will be isolated and lymphocyte subpopulation will be quantified at baseline and Week 52 |
From Baseline to Week 52
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Huijie Zhang, Fudan University
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- B2026-427R
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
All IPD that underlie results in a publication.
Tidsram för IPD-delning
After publication.
Kriterier för IPD Sharing Access
IPD and supporting information will be available to researchers upon reasonable request (e.g. with a practical and meaningful research proposal).
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
Läkemedels- och apparatinformation, studiedokument
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