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).
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiekontakt
- Navn: jingjing jiang, PhD
- Telefonnummer: 13402003919
- E-post: jiang.jingjing@zs-hospital.sh.cn
Studiesteder
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Kina, 200032
- Zhongshan Hospital, Fudan University
-
Ta kontakt med:
- jingjing jiang, phD
- Telefonnummer: 86-021-64041990
- E-post: jiang.jingjing@zs-hospital.sh.cn
-
Hovedetterforsker:
- Huijie Zhang, phD
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: Placebo kontrollgruppe
|
Oral tablet matching active Ivarmacitinib in appearance and scheduling, without active ingredients, taken once daily for 52 weeks. |
|
Eksperimentell: Ivarmacitinib 8 mg group
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Oral tablet, administered at a fixed dose of 8mg once daily for 52 weeks. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in MMTT-stimulated C-peptide AUC at Week 52
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in MMTT-stimulated C-peptide AUC at Week 26
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Huijie Zhang, Fudan University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- B2026-427R
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
All IPD that underlie results in a publication.
IPD-delingstidsramme
After publication.
Tilgangskriterier for IPD-deling
IPD and supporting information will be available to researchers upon reasonable request (e.g. with a practical and meaningful research proposal).
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
Legemiddel- og utstyrsinformasjon, studiedokumenter
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