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. 2024 Apr 10;8(2):rkae020. doi: 10.1093/rap/rkae020

Table 3.

Ongoing clinical trials in IgG4-related disease

Trial Design Study arms Primary outcome Follow-up time Results/status
Conventional synthetic DMARDs
NCT05746689 Open-label, single-arm trial Sirolimus + PDN taper Relapse rate 3 months Pre-enrolment
Biologic DMARDs
NCT04918147
  • Part 1: open-label, single-arm trial

  • Part 2: placebo-controlled RCT

  • Part 1a/1b: elotuzumab (various regimens) + PDN taper

  • Part 2: elotuzumab + PDN taper vs placebo + PDN taper

  • Part 1: adverse events

  • Part 2: change in IgG4-RD RI

  • Part 1: up to 48 weeks

  • Part 2: 48 weeks

Part 1 b enrolling
NCT05662241 Placebo-controlled RCT Obexelimab + PDN taper vs placebo + PDN taper Time to relapse 12 months Enrolling
NCT04660565 RCT Belimumab + GC vs GC monotherapy Relapse rate 12 months Enrolling
NCT05728684 Open-label single-arm trial CM310 (anti-IL-4 receptor-α mAb) Response rate 3 months Pre-enrolment
NCT04540497 Placebo-controlled RCT i.v. inebilizumab or placebo followed by optional 3-year open-label treatment period Time to relapse 12 months Active, no longer enrolling
NCT02705638 Open-label single-arm trial Rituximab + lenalidomide Remission 24 months Completed
Targeted synthetic DMARDs
NCT05625581 Non-randomized controlled trial Tofacitinib + GC taper vs CYC + GC taper Remission 6 months Enrolling
NCT04602598 Open-label single-arm trial Zanubrutinib Submandibular and lacrimal gland volume 6 months Enrolling
NCT04520451 Open-label two-arm trial
  • Group 1: rilzabrutinib + 12 week GC taper

  • Group 2: placebo + 12 week GC taper followed by crossover to rilzabrutinib

Relapse 12 months Enrolling
NCT05781516 RCT Baricitinib + GC taper vs GC taper monotherapy Relapse 12 months Enrolling

GC: glucocorticoid; IgG4-RD RI: IgG4-related disease responder index; PDN: prednisone; RCT: randomized controlled trial.