IgG4-Related Disease Clinical Trials

• Participants must have an adjudicated clinical diagnosis of IgG4-RD

• Participants meeting Step 1 Entry criteria of 2019 ACR/EULAR classification criteria for IgG4-RD and Total inclusion points are ≥20

• Participants with active disease at screening in at least one organ system, excluding lymph nodes, as an IgG4-RD Responder Index total activity score ≥ 2

• Participants with history or current involvement of at least 1 organ/site (excluding lymph nodes) affected with IgG4-RD.

• Participants with active IgG4-RD controlled for at least 2 weeks while on a stable dose of GC.

• Participants willing to taper off GC after starting IMP.

• Participants willing and able to participate in repeated study protocol mandated or clinically indicated imaging procedures to assess IgG4-RD such as computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), or ultrasound.

• Participants who have an up-to-date vaccination status as per local guidelines. The last dose of live vaccines should be received at least 30 days before Day 1.

• Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.