Felzartamab for Graves’ Disease: See if it helps control thyroids and reduce need for ATDs

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial enrolls adults with active Graves’ disease who are TRAb positive and on stable ATD therapy. Participants receive either felzartamab or a placebo to evaluate its effect on thyroid hormone levels, safety, and how the drug behaves in the body. The study compares outcomes with a control group and also examines pharmacokinetics and tolerability. Primary goal is to determine whether felzartamab can normalize thyroid hormones and reduce dependence on ATDs. Safety monitoring and PK analyses are included as secondary objectives.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* 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.

Key Exclusion Criteria:

* History of thyroidectomy or radioactive iodine therapy.
* ATD dose change within 12 weeks prior to Day1, or anticipated need for dose adjustment prior to randomization (except for protocol-defined safety management).
* Active, moderate-to-severe, or sight threatening thyroid eye disease (TED) (as assessed by the clinical activity score \[CAS\]), or requirement for imminent or ongoing TED-directed therapy (e.g., systemic glucocorticoids, biologic therapy, orbital radiation, surgery).
* Any history of malignancy within 5 years prior to Screening except for adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer.
* History of hyperthyroidism not caused by GD (e.g. toxic multinodular goiter, autonomous thyroid nodule, acute inflammatory thyroiditis) and/or history or presence of thyroid storm.
* Type 1 diabetes and type 2 diabetes mellitus with hemoglobin A1c (HbA1c) \> 8%.
* Known or suspected history of hypersensitivity to felzartamab or its excipients.
* Use of immunosuppressive therapy within 5 half-lives/12 weeks of Screening.
* Co-existing autoimmune diseases that require systemic immunosuppressants (e.g., cyclosporine, methotrexate, biologics, monoclonals).
* Prior use of an anti-Neonatal Fragment Crystallizable Receptor (FcRn) therapy or intravenous immunoglobulin (IVIg) within 6 months of the last dose prior to Screening.
* Any condition that requires chronic use of high-dose steroids.

NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.

Where it's running

• Sun City Clinical Research
  Glendale, Arizona, United States Recruiting
• AME Clinical Research
  Los Angeles, California, United States Recruiting
• San Jose Clinical Trials
  San Jose, California, United States Recruiting
• DM Clinical Research
  Doral, Florida, United States Recruiting
• Floridian Clinical Research - Clinitiative
  Miami, Florida, United States Recruiting
• Bioluminux Clinical Research
  Naperville, Illinois, United States Recruiting

Study contacts

• Study coordinator: US Biogen Clinical Trial Center
• Email: clinicaltrials@biogen.com
• Phone: 866-633-4636

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.