Graves' Disease study: Felzartamab
Official 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
ClinicalTrials.gov ID: NCT07722546
What this study is testing
What is Felzartamab?
This is an investigational medicine being studied as a potential treatment for Graves' Disease. It is designed to target certain immune cells that produce the abnormal antibodies causing the condition.
Also referred to as BIIB148, MOR202, MOR03087, TJ202.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out if felzartamab can bring thyroid hormone levels back to normal so participants can stop taking anti-thyroid drugs. It also checks for safety and how the body handles the drug.
- Who it's for
- Adults aged 18 to 75 who have Graves' disease, an autoimmune condition that causes the thyroid to become too active.
- What's involved
- Participants will receive slow injections into a vein (IV) of either the study drug or a placebo. They will continue taking their current thyroid medicine, which may be lowered if levels improve.
- Time commitment
- The study lasts about 9 months and requires 22 visits to the clinic.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 9 months
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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.
You likely can't join if
- 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...
- Active, moderate-to-severe, or sight threatening thyroid eye disease (TED) (as assessed by the clinical activity score [CAS]), or requirement for...
- Any history of malignancy within 5 years prior to Screening except for adequately treated in situ carcinoma of the cervix uteri, basal or squamous...
- History of hyperthyroidism not caused by GD (e.g. toxic multinodular goiter, autonomous thyroid nodule, acute inflammatory thyroiditis) and/or...
- Type 1 diabetes and type 2 diabetes mellitus with hemoglobin A1c (HbA1c) \> 8%.
See the full eligibility criteria
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Glendale, Arizona, United States
- Los Angeles, California, United States
- San Jose, California, United States
- Doral, Florida, United States
- Hialeah, Florida, United States
- Miami, Florida, United States
- Naperville, Illinois, United States
- Lutherville, Maryland, United States
- Hamilton, New Jersey, United States
- Asheville, North Carolina, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Humble, Texas, United States
- Richmond, Virginia, United States
- Bayamón, Puerto Rico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 9 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Glendale, Arizona, United States; Los Angeles, California, United States; San Jose, California, United States; Doral, Florida, United States; Hialeah, Florida, United States; Miami, Florida, United States and 9 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.