What side effects are associated with this type of intervention?

Common side effects of treatments targeting B cell activity, such as obexelimab, often include infusion-related reactions, infections due to immunosuppression, and hematologic toxicities like thrombocytopenia and leukopenia. Patients may also experience fatigue, headache, and gastrointestinal symptoms. It is important to monitor for severe infections and manage any adverse effects promptly.

What prior FDA approvals exist?

The FDA has approved several treatments that target B cell activity through CD19, similar to obexelimab. Rituximab, a monoclonal antibody that targets CD20 on B cells, is one such drug and has been approved for various autoimmune diseases and certain types of cancer. Another example is brexucabtagene autoleucel, a CAR-T cell therapy targeting CD19, approved for relapsed or refractory mantle cell lymphoma. These treatments highlight the therapeutic potential of targeting B cells in managing autoimmune and related diseases.

What other types of research exist?

Promising, novel alternatives to Obexelimab for IgG4-Related Disease patients in 2024 may include therapies such as Rituximab, which targets CD20 on B cells, and Belimumab, which inhibits B cell activating factor (BAFF). These therapies have shown efficacy in other autoimmune conditions and could be considered as potential alternatives.

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Monoclonal Antibodies

Obexelimab for IgG4-Related Disease (INDIGO Trial)

Phase 3

Recruiting

Research Sponsored by Zenas BioPharma (USA), LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up randomization to week 52

Awards & highlights

Pivotal Trial

Summary

This trial is testing obexelimab, a medication given through injections, to see if it can prevent flare-ups in patients with IgG4-related disease. These patients have active symptoms that need steroid treatment. Obexelimab works by calming the immune system to stop it from causing inflammation and other symptoms.

Who is the study for?

Adults diagnosed with IgG4-Related Disease showing active symptoms needing treatment can join this trial. They must meet specific criteria for the disease's classification. Excluded are those with only one affected organ system, high-dose steroid use in the last month, recent other treatments or live vaccines, and certain infections or use of B cell targeting drugs within six months.

What is being tested?

The trial is testing Obexelimab against a placebo to see if it prevents flare-ups of IgG4-Related Disease when added to standard therapy. Participants will be randomly assigned to receive either Obexelimab or a placebo alongside their usual treatment.

What are the potential side effects?

While not specified here, potential side effects may include reactions at the injection site, increased risk of infections due to immune system suppression, and possible allergic reactions among others typically associated with immunomodulatory therapies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ randomization to week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~randomization to week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization to week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

measure

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ZB012Experimental Treatment1 Intervention

Obexelimab administered as an SC injection.

Group II: PlaceboPlacebo Group1 Intervention

Placebo administered as an SC injection.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Obexelimab works by inhibiting B cell activity through targeting CD19, a protein found on the surface of B cells. This mechanism is crucial for patients with IgG4-Related Disease (IgG4-RD) because B cells play a significant role in the pathogenesis of the disease by producing IgG4 antibodies, which contribute to inflammation and tissue damage. By targeting CD19 and reducing B cell activity, obexelimab can potentially decrease the production of harmful IgG4 antibodies, thereby reducing disease flares and improving patient outcomes.