Felzartamab compared with placebo for adults with Graves' disease
Tests felzartamab against placebo in adults with Graves' disease, an overactive thyroid condition.
Key facts
- Who runs it
- Biogen
- Where
- Asheville, Dallas, Doral, Glendale, Hamilton, Hialeah, Houston, Humble, Los Angeles, Lutherville, Miami, Naperville, Richmond, and San Jose, United StatesSee the 14 sitesAlso in 3 other countries, 9 sites
- Trial code
- Registry title
- 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
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 60 people, planned
- Started
- 30 Jul 2026
- Expected to end
- 31 Mar 2028
- Type of study
- Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Felzartamab
- Placebo
- Record updated
- 12 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with active Graves' disease who are taking anti-thyroid drugs. It tests felzartamab against a placebo.
- Age
- 18 Years to 75 Years
- Sex
- All sexes can join
- Disease stage
- Active Graves' disease. FT4 and FT3 are within the reference range, and TSH is suppressed.
- Earlier treatment
- People must be on a stable dose of anti-thyroid drugs (ATD) for at least 12 weeks before being placed in a group. People who had thyroid surgery (thyroidectomy) or radioactive iodine therapy cannot join.
- Biomarker or test result
- TRAb positive: TRAb levels above the upper limit of normal (ULN).
Main reasons for not taking part
- Active, moderate-to-severe or sight-threatening thyroid eye disease, or needing treatment for it
- Cancer within 5 years before screening, apart from some treated skin or cervix cancers
- Overactive thyroid not caused by Graves' disease, or a past or current thyroid storm
- Type 1 diabetes, or type 2 diabetes with HbA1c > 8% (64 mmol/mol)
- Immunosuppressive therapy within 5 half-lives/12 weeks of screening, or anti-FcRn therapy or IVIg within 6 months
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- ATD dose change within 12 weeks prior to Day1, or anticipated need for dose adjustment prior to randomization (except for protocol-defined safety management)
- Use of immunosuppressive therapy within 5 half-lives/12 weeks of Screening
- 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
- History of thyroidectomy or radioactive iodine therapy
- 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
- Known or suspected history of hypersensitivity to felzartamab or its excipients
- Co-existing autoimmune diseases that require systemic immunosuppressants (e.g., cyclosporine, methotrexate, biologics, monoclonals)
- Any condition that requires chronic use of high-dose steroids; NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply
- Type 1 diabetes and type 2 diabetes mellitus with hemoglobin A1c (HbA1c) > 8%
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in United States
Also in 3 other countries, 9 sites
- Asheville Clinical ResearchAsheville, United StatesContact: Lauren Bernstein (principal investigator)Taking people
- M3 Wake Research-DallasDallas, United StatesContact: Carlos Arauz-Pacheco (principal investigator)Taking people
- DM Clinical ResearchDoral, United StatesContact: Noreen Shaaban (principal investigator)Taking people
- Sun City Clinical ResearchGlendale, United StatesContact: Rohit Dwivedi (principal investigator)Taking people
- Bioluminux Clinical ResearchHamilton, United StatesContact: Matthew Adasofunjo (principal investigator)Taking people
- LAMK Research and HealthHialeah, United StatesContact: Lysette Iglesias (principal investigator)Taking people
- Gulf Coast Clinical ResearchHouston, United StatesContact: Anjani Pandya (principal investigator)Taking people
- Accurate Clinical Research, IncHumble, United StatesContact: Brian Chou (principal investigator)Taking people
- AME Clinical ResearchLos Angeles, United StatesContact: Chris Tsimerekis (principal investigator)Taking people
- Patient First Clinical Trials (PFCTRIALS)Lutherville, United StatesContact: Greg Tampus (principal investigator)Taking people
- Floridian Clinical Research - ClinitiativeMiami, United StatesContact: Marco Fiore (principal investigator)Taking people
- Bioluminux Clinical ResearchNaperville, United StatesContact: Adeshola Ezeokoli (principal investigator)Taking people
- Patient First Clinical Trials (PFCTrials)Richmond, United StatesContact: Ritu Madan (principal investigator)Taking people
- San Jose Clinical TrialsSan Jose, United StatesContact: Richard Cherlin (principal investigator)Taking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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).
The 3 groups in the trial
- PlaceboPlacebo, for comparison
Participants will receive multiple IV doses of placebo.
- Felzartamab or PlaceboTreatment being tested
Participants will receive multiple IV doses of felzartamab or placebo.
Treatment: Felzartamab and Placebo
- FelzartamabTreatment being tested
Participants will receive multiple IV doses of felzartamab.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Placebo-Controlled, Multicenter, Randomized Phase 2 Trial Evaluating the Efficacy and Safety of Felzartamab Compared to Placebo in Adult Participants With Graves' Disease
- Plain-language title
- Felzartamab compared with placebo for adults with Graves' diseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT07722546, who can take part
- Record updated
- 12 November 2026