RecruitingPhase 2NCT07722546

A Study to Learn About The Effects of Felzartamab on Thyroid Function and Its Safety in Adults With Graves' Disease Ages 18 to 75 Years Old

A Placebo-Controlled, Multicenter, Randomized Phase 2 Trial Evaluating the Efficacy and Safety of Felzartamab Compared to Placebo in Adult Participants With Graves' Disease


Sponsor

Biogen

Enrollment

60 participants

Start Date

Jul 30, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

In this study, researchers will learn more about the use of felzartamab in participants with Graves' Disease, also known as GD. GD is an autoimmune disease, which means the body's immune system attacks its own healthy cells. In people with GD, the immune system produces abnormal antibodies, called thyroid-stimulating hormone receptor antibodies (TRAb), that attack the thyroid gland. This causes the thyroid to become too active and produce too much hormone, a condition called hyperthyroidism. Participants with GD are often treated with anti-thyroid drugs, or ATDs, which are medicines that help bring thyroid hormone levels back to normal. Felzartamab is designed to target certain immune cells that produce the abnormal TRAb antibodies. The main goal of the study is to learn whether felzartamab can help bring thyroid hormone levels back to normal and allow participants to stop taking ATDs. Participants will receive either felzartamab or placebo during the study. A placebo looks like the study drug but contains no real medicine. The main question that researchers want to answer is: • How many participants have normal thyroid levels without receiving any ATD medicine at Week 24? Researchers will also learn more about the safety of felzartamab and how the body processes the drug. The study will be done as follows: * Participants will be screened to check if they can join the study. * This is a double-blind study, which means neither the participants, study doctor, or site staff will know if participants are receiving felzartamab or a placebo. * Participants will be placed into 1 of 3 groups. Two groups will receive felzartamab while the other receives placebo. * Participants will receive felzartamab or placebo as intravenous (IV) infusions, which are slow injections into a vein using a needle. The Treatment Period will last 20 weeks. * During the Treatment Period, the study doctor may gradually lower the dose of the ATD if a participant's thyroid levels become normal. * Afterwards, participants will enter a follow-up period which will last 12 weeks. * In total, participants will have 22 study visits. Participants will stay in the study for about 9 months (up to 36 weeks).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Felzartamab and a drug called Placebo for people with graves disease. The study is currently recruiting participants at 3 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFelzartamab

Administered IV

DRUGPlacebo

Administered IV


Locations(7)

Sun City Clinical Research

Glendale, Arizona, United States

AME Clinical Research

Los Angeles, California, United States

DM Clinical Research

Doral, Florida, United States

Floridian Clinical Research - Clinitiative

Miami, Florida, United States

Asheville Clinical Research

Asheville, North Carolina, United States

M3 Wake Research - Dallas

Dallas, Texas, United States

Solace Clinical Research - Puerto Rico

Bayamón, Puerto Rico

View Full Details on ClinicalTrials.gov

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NCT07722546


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