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

NCT05907668 | Completed Phase 2 Results FDA Drug

• 1 other identifier: IMVT-1401-2501
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Graves Disease

Keywords

Graves' Disease; IMVT-1401; Batoclimab; Hyperthyroidism

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved 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 Compared to Baseline

  Antithyroid drug therapy was indicated as a first-line treatment for GD by effectively controlling hyperthyroidism. FT3 and FT4 were prespecified biomarkers of GD. Fasting blood samples were collected to assess the percentage of participants who achieved normalization of FT3 and FT4 or levels below the LLN without increase in ATD dose compared to baseline. The change in the ATD dose was compared only between baseline and Week 24 to determine if there was an increase. Percentages were estimated using the 2-sided Clopper-Pearson Exact method, with corresponding 95% confidence intervals. Participants who, at Week 24, without an increase in ATD dose compared with baseline, had achieved normalization of FT3 and FT4, or had FT3 and/or FT4 below the lower limit of normal (LLN), were considered responders. Participants with missing Week 24 assessments were considered nonresponders.

  At Week 24

Secondary Outcomes (2)

• Percentage of Participants Who Achieved Normalization of FT3 and FT4 With ATD Dose ≤50% of the Baseline ATD Dose at Week 24

  At Week 24

• Percentage of Participants Who Are Off ATD Treatment and Achieved Normalization of FT3 and FT4, or Had FT3 and/or FT4 Below the LLN at Week 24

  At Week 24

Study Arms (1)

Batoclimab

EXPERIMENTAL

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)

Interventions

IMVT-1401 (batoclimab) DRUG

Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody.

Also known as: IMVT-1401

Batoclimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Immunovant Sciences GmbH: lead

Study Sites (1)

Site Number - 6505

Mainz, 55131, Germany

Location

MeSH Terms

Conditions

Graves Disease; Hyperthyroidism

Condition Hierarchy (Ancestors)

Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Thyroid Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Central Study Contact
• Organization: Immunovant Sciences GmbH

clinicaltrials@immunovant.com

18007970414

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: June 18, 2023
• Study Start: May 15, 2023
• Primary Completion: July 25, 2025
• Study Completion: July 25, 2025
• Last Updated: August 13, 2026
• Results First Posted: August 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)