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

• ClinicalTrials.gov Identifier: NCT05907668
• Recruitment Status: Recruiting
• First Posted: June 18, 2023
• Last Update Posted: September 5, 2023
• Sponsor: Immunovant Sciences GmbH
• Information provided by (Responsible Party): Immunovant Sciences GmbH

Tracking Information

• First Submitted Date: May 15, 2023
• First Posted Date: June 18, 2023
• Last Update Posted Date: September 5, 2023
• Actual Study Start Date: May 15, 2023
• Estimated Primary Completion Date: November 2024 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 7, 2023): 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 [ Time Frame: At Week 24 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 7, 2023)

• Percentage of participants who achieve normalization of FT3 and FT4 at Week 24 with ATD dose <= 50% of the ATD dose at Week 24 [ Time Frame: 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 [ Time Frame: At Week 24 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Proof-of-Concept Study to Assess Batoclimab in Participants With Graves' Disease
• Official Title: IMVT-1401-2501: A Proof-of-Concept, Open-label Study to Assess the Safety and Efficacy of Batoclimab in Participants With Graves' Disease (GD)
• 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Graves Disease

Intervention

Drug: IMVT-1401 (batoclimab)

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

Other Name: IMVT-1401

Study Arms

Experimental: Batoclimab

Participants will receive batoclimab 680 milligrams (mg) subcutaneously (SC) weekly (QW) injection for 12 weeks followed by 340 mg SC QW for 12 weeks.

Intervention: Drug: IMVT-1401 (batoclimab)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 7, 2023): 45
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 2025
• Estimated Primary Completion Date: November 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Central Study Contact; 18007970414; clinicaltrials@immunovant.com

• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT05907668
• Other Study ID Numbers: IMVT-1401-2501
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Immunovant Sciences GmbH
• Original Responsible Party: Same as current
• Current Study Sponsor: Immunovant Sciences GmbH
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Immunovant Sciences GmbH
• Verification Date: September 2023