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A Phase 3 Study of Obexelimab in Patients With IgG4-Related Disease

Join our Phase 3 study on Obexelimab for IgG4-related disease.

Recruiting
18 years and older
All
Phase 3

Study Objective: This research checks how well a drug called obexelimab works to stop flare-ups in people with IgG4-related disease, a condition where the immune system attacks the body's own tissues.

Study Length: The study lasts up to 116 weeks, including screening and follow-up periods. Initial treatment lasts 1 year, followed by an optional extra year.

Study Process: Participants will be randomly given either obexelimab or a placebo (a harmless, inactive substance) through injections. All participants will taper off steroid medication by the 8th week. Regular clinic visits will monitor any flares, which are sudden worsening of symptoms.

Inclusion Criteria: Adults 18+ with diagnosed IgG4-RD, showing active symptoms needing steroid treatment.

  • Participation may last over 2 years.
  • Regular clinic visits are required.
  • Medication and health monitoring are part of the study process.

Exclusion Criteria: Individuals with certain conditions or recent treatments, like high steroid use or recent vaccinations, may not participate.

Study details
    IgG4 Related Disease

NCT05662241

Zenas BioPharma (USA), LLC

13 December 2024

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What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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