Graves' DiseasePhase 2GRAVITATENCT07722546
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 Phase 2 study testing Felzartamab in people with Graves' Disease, run by Biogen at 12 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Graves' Disease
- What is being tested?
- Felzartamab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 30 Jul 2026to 31 Mar 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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%.
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- 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.
Trial locations and contacts
12 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Global Biogen Clinical Trial Center contact
12 sites in 2 countries
United States11 sites, 11 recruiting
- Recruiting
Asheville Clinical Research
Asheville, North Carolina, 28803
828-579-2273
Lauren Bernstein
- Recruiting
M3 Wake Research - Dallas
Dallas, Texas, 75246
469-297-3074
Carlos Arauz-Pacheco
- Recruiting
DM Clinical Research
Doral, Florida, 33166
786-789-1036
Noreen Shaaban
- Recruiting
Sun City Clinical Research
Glendale, Arizona, 85304
623-253-9777
Rohit Dwivedi
- Recruiting
Bioluminux Clinical Research
Hamilton, New Jersey, 08690
609-613-6859
Matthew Adasofunjo
- Recruiting
Gulf Coast Clinical Research
Houston, Texas, 77070
281-640-2940
Anjani Pandya
- Recruiting
Accurate Clinical Research, Inc
Humble, Texas, 77346
281-760-3930
Brian Chou
- Recruiting
AME Clinical Research
Los Angeles, California, 92647
714-375-5970
Chris Tsimerekis
- Recruiting
Patient First Clinical Trials (PFCTrials)
Lutherville, Maryland, 21093
410-832-3968
Greg Tampus
- Recruiting
Floridian Clinical Research - Clinitiative
Miami, Florida, 33016
305-330-9977
Marco Fiore
- Recruiting
Patient First Clinical Trials (PFCTrials)
Richmond, Virginia, 23229
804-613-5079
Ritu Madan
Puerto Rico1 site, 1 recruiting
- Recruiting
Solace Clinical Research - Puerto Rico
Bayamón, 00959
787-425-4881
Carmen Pizarro
About this study
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
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.
Read more
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).
Read the detailed description
The primary objective of the study is to evaluate the efficacy of felzartamab compared to placebo in participants with Grave's disease (GD). The secondary objectives of the study are to evaluate the safety, efficacy and pharmacokinetics (PK) of felzartamab in participants with GD.
- Conditions
- Graves' Disease
- Being tested
- Felzartamab, Placebo
- Keywords
- Hyperthyroidism
- Medical subject headings
- Graves Disease, Hyperthyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FelzartamabDrug
Also called BIIB148, MOR202, MOR03087, TJ202
Administered IV
PlaceboDrug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants will receive multiple IV doses of placebo. Receives: Drug: Placebo |
| Felzartamab or Placebo | Experimental | Participants will receive multiple IV doses of felzartamab or placebo. Receives: Drug: Felzartamab; Drug: Placebo |
| Felzartamab | Experimental | Participants will receive multiple IV doses of felzartamab. Receives: Drug: Felzartamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants who are Euthyroid and off Anti-Thyroid Drugs (ATD) at Week 24
Measured: At Week 24
Secondary outcomes (9)
Percentage of Participants who Have Down-Titrated to ≤ 50% of Their Baseline ATD and are Euthyroid at Week 12 and Week 24
Measured: At Weeks 12 and 24
Percentage of Participants who are Euthyroid at Week 12 and Week 24
Measured: At Weeks 12 and 24
Change From Baseline in Free Triiodothyronine (FT3)
Measured: Baseline up to Week 32
Change From Baseline in Free Thyroxine (FT4)
Measured: Baseline up to Week 32
Change From Baseline in Thyroid-Stimulating Hormone (TSH)
Measured: Baseline up to Week 32
Change From Baseline in ATD Levels
Measured: Up to Week 24
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)
Measured: From first dose of study drug up to end of study follow-up (Up to Week 32)
Felzartamab Serum Concentrations Over Time
Measured: Predose and at multiple timepoints postdose up to Week 24
Number of Participants with Anti-drug Antibodies (ADAs) Against Felzartamab
Measured: Baseline up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start30 Jul 2026
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves' DiseaseStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722546
- Sponsor's protocol ID
- 299GD201
- Other IDs
- 2026-526482-19-00
- Acronym
- GRAVITATE
- Status last verified
- Oct 2026
- First submitted
- 20 Jul 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/