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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Have active disease and are thyroid-stimulating hormone receptor antibodies (TRAb) positive, defined as:

‣ Free thyroxine (FT4) and free triiodothyronine (FT3), within the reference range,

⁃ suppressed thyroid-stimulating hormone (TSH)

⁃ TRAb levels \> upper limit of normal (ULN)

• Participants must be receiving stable dose of anti-thyroid drugs (ATD) for at least 12 weeks prior to randomization.

• Must agree to refrain from blood product donation from Screening through end of study. If a participant terminates early from the study, they must refrain from blood product donation for 90 days following the last dose of study drug.

Locations
United States
Arizona
Sun City Clinical Research
RECRUITING
Glendale
California
AME Clinical Research
RECRUITING
Los Angeles
Florida
DM Clinical Research
RECRUITING
Doral
Floridian Clinical Research - Clinitiative
RECRUITING
Miami
North Carolina
Asheville Clinical Research
RECRUITING
Asheville
Texas
M3 Wake Research - Dallas
RECRUITING
Dallas
Other Locations
Puerto Rico
Solace Clinical Research - Puerto Rico
RECRUITING
Bayamón
Contact Information
Primary
US Biogen Clinical Trial Center
clinicaltrials@biogen.com
866-633-4636
Backup
Global Biogen Clinical Trial Center
clinicaltrials@biogen.com
Time Frame
Start Date: 2026-07-30
Estimated Completion Date: 2028-03-31
Participants
Target number of participants: 60
Treatments
Placebo_comparator: Placebo
Participants will receive multiple IV doses of placebo.
Experimental: Felzartamab or Placebo
Participants will receive multiple IV doses of felzartamab or placebo.
Experimental: Felzartamab
Participants will receive multiple IV doses of felzartamab.
Related Therapeutic Areas
Sponsors
Leads: Biogen

This content was sourced from clinicaltrials.gov

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