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A Study of IMM0306 in IgG4-Related Disease

1. juni 2026 opdateret af: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

A Phase II/III Clinical Study to Evaluate the Efficacy and Safety of IMM0306 in Participants With IgG4-Related Disease (IgG4-RD)

The goal of this clinical trial is to learn if IMM0306 works to reduce the risk of disease relapse in participants with IgG4-related disease (IgG4-RD). It will also learn about the safety and tolerability of IMM0306. The main questions it aims to answer are:

  • Does IMM0306 reduce the risk of disease relapse in participants with IgG4-RD?
  • What medical problems do participants have when receiving IMM0306?
  • How does IMM0306 behave in the body, and does the body develop anti-drug antibodies against IMM0306? In the Phase II part, all participants will receive IMM0306. In the Phase III part, researchers will compare IMM0306 with placebo to evaluate whether IMM0306 reduces the risk of disease relapse in participants with IgG4-RD.

Participants will:

  • Receive IMM0306 or placebo by intravenous infusion once weekly for 4 consecutive weeks, with the same treatment repeated 6 months later
  • Start a planned glucocorticoid taper from Day 1 and gradually reduce oral prednisone or equivalent until complete discontinuation after 8 weeks
  • Visit the study site for efficacy and safety assessments, including disease relapse assessment, IgG4-RD responder index assessment, laboratory tests, imaging examinations, electrocardiograms, pharmacokinetic sampling, immunogenicity sampling, biomarker sampling, and adverse event assessment.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

125

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Clinical diagnosis of IgG4-RD;
  • Meeting 2019 ACR/EULAR classification criteria with an inclusion score ≥20;
  • At least two organs/sites involved during the disease course;
  • Prior or recent IgG4-RD flare requiring initiation or continuation of GC treatment at informed consent.

Exclusion Criteria:

  • Fibrotic manifestation as the only clinical manifestation of the current relapse;
  • Significant hematologic or hepatic abnormalities;
  • Recent B-cell-depleting therapy, alkylating agents, DMARDs or immunosuppressants;
  • Other chronic active immune diseases requiring long-term use of immunosuppressants;
  • Active malignancy or active malignancy within 10 years;
  • Significant cardiac disease;
  • Active infection or active TB;
  • Severe pulmonary disease;
  • Recent opportunistic infection;
  • Alcohol/drug abuse;
  • Pregnancy, lactation or failure to meet contraception requirements.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Phase II single arm
Medicin: IMM0306
1.6mg/kg by intravenous infusion once weekly for 4 consecutive weeks, with the same treatment repeated 6 months later
Eksperimentel: Phase III treatment arm
Medicin: IMM0306
1.6mg/kg by intravenous infusion once weekly for 4 consecutive weeks, with the same treatment repeated 6 months later
Placebo komparator: Phase III control arm
Medicin: Placebo
1.6 mg/kg by intravenous infusion once weekly for 4 consecutive weeks, with the same treatment repeated 6 months later

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Time to disease relapse
Tidsramme: From Day 1 to the end of Week 26/52
From Day 1 to the end of Week 26/52

Sekundære resultatmål

Resultatmål
Tidsramme
Annualized relapse rate
Tidsramme: From Day 1 to the end of Week 26/52
From Day 1 to the end of Week 26/52
Cumulative glucocorticoid dose
Tidsramme: From Day 1 to the end of Week 52
From Day 1 to the end of Week 52
Proportion of relapse-free and glucocorticoid-free complete remission
Tidsramme: At Week 26/52
At Week 26/52
Incidence of AEs
Tidsramme: From Day 1 to the end of Week 52
From Day 1 to the end of Week 52
Incidence of ADA
Tidsramme: From Day 1 to the end of Week 38
From Day 1 to the end of Week 38
Cmax
Tidsramme: From Day 1 to the end of Week 29
From Day 1 to the end of Week 29
Cmin
Tidsramme: From Day 1 to the end of Week 29
From Day 1 to the end of Week 29

Andre resultatmål

Resultatmål
Tidsramme
Change from baseline in B-cell subsets
Tidsramme: From Day 1 to the end of Week 52
From Day 1 to the end of Week 52
Change from baseline in complement levels
Tidsramme: From screening to the end of Week 52
From screening to the end of Week 52

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. maj 2030

Studieafslutning (Anslået)

1. maj 2030

Datoer for studieregistrering

Først indsendt

17. maj 2026

Først indsendt, der opfyldte QC-kriterier

1. juni 2026

Først opslået (Faktiske)

2. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IMM0306-IgG4RD-301

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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