A Proof-of-Concept Study to Assess Batoclimab in Participants With Graves' Disease

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy and safety of 24 weeks of treatment with batoclimab in adult participants with biochemically documented hyperthyroidism due to GD who have failed to achieve euthyroidism on antithyroid drugs (ATDs).

Official Title
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IMVT-1401-2501: A Proof-of-Concept, Open-label Study to Assess the Safety and Efficacy of Batoclimab in Participants With Graves' Disease (GD)

Conditions
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Graves Disease

Intervention / Treatment
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* Drug: IMVT-1401 (batoclimab)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have serologically confirmed GD as documented by presence of elevated stimulatory thyrotropin receptor antibody (TSH-R-Ab) level (i.e., > specimen-to-reference ratio of 140%) at the Screening Visit. Have active hyperthyroidism due to GD with the following laboratory values at the Screening Visit: TSH < LLN FT3 > upper limit of normal (ULN) and <=5 * ULN FT4 > ULN and <=5 * ULN Note: Participants who have T3 thyrotoxicosis (i.e TSH <LLN, FT3 > ULN and ≤5× ULN, but FT4 within normal range) at the Screening Visit may be enrolled, if they have serologically confirmed GD as per Inclusion Criterion 1. Are willing and capable of giving written informed consent, which includes being able to comply with all aspects of the study treatment and testing schedule. Exclusion Criteria: History of hyperthyroidism not caused by GD (e.g., toxic adenoma or toxic multinodular goiter), and/or history or presence of thyroid storm. History of treatment with radioactive iodine or thyroid surgery. Total immunoglobulin G (IgG) level <6 grams per liter (g/L) at the Screening Visit. Albumin level <3.5 grams per deciliter (g/dL) (<35 g/L) at the Screening Visit. Absolute neutrophil count <1000 cells per cubic millimeter (cells/mm^3) at the Screening Visit. Other, more specific exclusion criteria are defined in the protocol.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Batoclimab<br>Participants will receive batoclimab 680 milligrams (mg) subcutaneously (SC) weekly (QW) injection for 12 weeks followed by 340 mg SC QW for 12 weeks. | Drug: IMVT-1401 (batoclimab)<br>* Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody.<br>* Other names: IMVT-1401;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants who achieve normalization of free triiodothyronine (FT3) and free thyroxine (FT4), or have FT3 and/or FT4 below the lower limit of normal (LLN) at week 24 without increase in ATD dose |  | At Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants who achieve normalization of FT3 and FT4 at Week 24 with ATD dose <= 50% of the ATD dose at Week 24 |  | At Week 24 | 
| Percentage of participants who are off ATD treatment and achieve normalization of FT3 and FT4, or have FT3 and/or FT4 below the LLN at Week 24 |  | At Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Graves' Disease, IMVT-1401, Batoclimab, Hyperthyroidism