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 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 |
|
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.