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New treatment option for Graves Disease
Official title NEXUS Study: A Study to Test Single and Multiple Doses of MER511 Given to Adults With Graves' Disease
ClinicalTrials.gov ID: NCT07305818
What this study is testing
What is MER511 (IV)?
MER511 (IV) is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for graves disease.
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 purpose of this study is to evaluate how well MER511 is tolerated and what side effects may occur in adults who have Graves' disease. The study drug will be administered either intravenously (into a vein in the arm) or subcutaneously (under the skin).
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
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 55
You may be able to join if
- Adults 18 to 65 years of age, inclusive, at the time of signing the ICF
- Documented GD diagnosis,
- Receiving stable dose of ATD (Antithyroid drug)
- Body weight at least 50 kg (110 lb) and body mass index (BMI) 18.0-35.0 kg/m2, inclusive
- Women of childbearing potential must agree to use highly effective contraceptive methods
You likely can't join if
- History of:
- total thyroidectomy.
- History of hyperthyroidism not caused by GD (eg, toxic adenoma, toxic multinodular goiter).
- History of thyroid storm.
- History of agranulocytosis, anemia, leukopenia, thrombocytopenia, vasculitis, or liver toxicity due to prior ATD therapy Treatment with RAI therapy...
- Likely to require definitive treatment for GD (RAI therapy or thyroidectomy) during the study, based on GD history and anticipated prognosis.
See the full eligibility criteria
- Adults 18 to 65 years of age, inclusive, at the time of signing the ICF
- Documented GD diagnosis,
- Receiving stable dose of ATD (Antithyroid drug)
- Body weight at least 50 kg (110 lb) and body mass index (BMI) 18.0-35.0 kg/m2, inclusive
- Women of childbearing potential must agree to use highly effective contraceptive methods
- Men with partners of childbearing potential or who are pregnant must agree to use a condom or strict abstinence
- Signed informed consent to participate in the study
- Willingness and ability, in the opinion of the investigator, to comply with protocol requirements and restrictions (eg, dosing, schedule of assessments).
- History of:
- total thyroidectomy.
- History of hyperthyroidism not caused by GD (eg, toxic adenoma, toxic multinodular goiter).
- History of thyroid storm.
- History of agranulocytosis, anemia, leukopenia, thrombocytopenia, vasculitis, or liver toxicity due to prior ATD therapy Treatment with RAI therapy within 12 months prior to Screening
- Likely to require definitive treatment for GD (RAI therapy or thyroidectomy) during the study, based on GD history and anticipated prognosis.
- Use of levothyroxine, desiccated thyroid extract, or T3 at any dose within 6 weeks prior to Screening.
- Current active or chronic moderate-to-severe TED per EUropean Group On Graves' Orbitopathy (EUGOGO) criteria as judged by the investigator at Screening
- History of TED-directed medical treatment (including IV/oral steroids, immunosuppressants, or teprotumumab), surgical treatment, and/or orbital radiation within 3 months prior to Screening, or per required prohibited...
- Major surgery or use of iodinated contrast within 3 months prior to planned IMP dosing.
- Active systemic autoimmune disease requiring treatment that causes undue risk in the opinion of the investigator.
- History of cardiovascular, respiratory, renal, gastrointestinal, endocrinological (other than GD), hematological, immunodeficiency, or neurological disorders that may constitute a risk when taking the IMP or interfere...
- History of liver disease
- Pregnant, breastfeeding, or planning to become pregnant during the study
- Treatment with prohibited medications prior to planned IMP dosing or likely to require prohibited concomitant therapy during the study
- Live vaccine(s) or mRNA vaccine(s) within 1 month prior to IMP dosing, or plans to receive such vaccines during the study
- Treatment with any investigational drug within within 3 months or 5 half-lives (whichever is longer) prior to enrollment
- Total IgG level \<700 mg/dL at Screening
- Any of the following at Screening (confirmed by single repeat measurement, if deemed necessary):
- ALT or AST \>1.5 × ULN
- Total bilirubin \>1.5 × ULN
- Estimated glomerular filtration rate (eGFR) \<75 mL/min/1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation
- Positive result for HIV antibody, HBsAg, or hepatitis C antibody with detectable viral RNA levels at Screening
- Positive drug screen or positive test for alcohol
- 12-lead ECG demonstrating any of the following at Screening:
- QTcF interval \>450 ms
- QRS interval \>120 ms
- PR interval \>220 ms
- Blood pressure measurements demonstrating any of the following at Screening:
- Systolic blood pressure ≥140 mmHg
- Diastolic blood pressure ≥90 mmHg
- Heart rate \ 100 bpm
- Donated more than 500 mL of blood in the 2 months prior to signing the ICF
- Current enrollment or past participation within 3 months or 5 half-lives (whichever is longer) prior to signing the ICF in any other clinical trial involving an IMP
- Refusal to adhere to lifestyle considerations as defined in the protocol
- Employee of the investigator, clinic, or sponsor with direct involvement in the proposed study or other studies under the direction of the investigator or clinic, as well as family members of the employee or investigator
- Any other conditions that, in the opinion of the investigator or the sponsor, could interfere with participation in or completion of the study
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Hollywood, Florida, United States
- Miami, Florida, United States
- Wesley Chapel, Florida, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Webster, Texas, United States
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 - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Hollywood, Florida, United States; Miami, Florida, United States; Wesley Chapel, Florida, United States; Boston, Massachusetts, United States; Rochester, Minnesota, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.