Extension Study to Assess Batoclimab in Participants with TED

An Open-label Extension Study for Participants who Completed Study IMVT-1401-3201 or Study IMVT-1401-3202 to Assess the Efficacy and Safety of Batoclimab for the Treatment of Thyroid Eye Disease (TED)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-002839-66-SK

Enrollment

180

Registered

2023-01-03

Start date

2023-05-06

Completion date

Unknown

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Eye Disease (TED) MedDRA version: 23.1 Level: LLT Classification code 10084358 Term: Thyroid eye disease System Organ Class: 10015919 - Eye disorders

Interventions

Product Name: Batoclimab Product Code: IMVT-1401 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Batoclimab CAS Number: 2187430-05-1 Current Sponsor code: IMVT-1

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: For all participants: 1. Have completed the Week 24 visit of the feeder study. For participants assigned to the Open-label Treatment Cohort: 1. Do not require immediate surgical intervention and is not planning corrective surgery/irradiation or medical therapy for TED during the course of the study. 2. Did not permanently discontinue study drug Additional inclusion criteria are defined in the protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 162 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 18

Exclusion criteria

Exclusion criteria: For all participants: 1. In the Investigator's judgement, the benefits of entry in the study do not outweigh the risk.

Design outcomes

Primary

Measure	Time frame
Main Objective: To describe batoclimab maintenance of efficacy as assessed by proptosis;Secondary Objective: • To describe the efficacy of batoclimab in participants previously treated with placebo and did not achieve proptosis response in the feeder studies • To describe the treatment effect of batoclimab in participants previously treated with batoclimab but did not achieve proptosis response in the feeder studies;Primary end point(s): Duration of proptosis response off treatment in study eye in participants who were batoclimab responders in the feeder studies.;Timepoint(s) of evaluation of this end point: Week 24	—

Measure

Time frame

Main Objective: To describe batoclimab maintenance of efficacy as assessed by proptosis;Secondary Objective: • To describe the efficacy of batoclimab in participants previously treated with placebo and did not achieve proptosis response in the feeder studies • To describe the treatment effect of batoclimab in participants previously treated with batoclimab but did not achieve proptosis response in the feeder studies;Primary end point(s): Duration of proptosis response off treatment in study eye in participants who were batoclimab responders in the feeder studies.;Timepoint(s) of evaluation of this end point: Week 24

—

Secondary

Measure	Time frame
Secondary end point(s): • Proportion of proptosis responders at Week 24 in study eye in participants who were placebo non-responders in the feeder studies. • Proportion of proptosis responders at Week 24 in study eye in participants who were batoclimab non-responders in the feeder studies.;Timepoint(s) of evaluation of this end point: Week 24	—

Countries

Australia, Belgium, Canada, Georgia, Germany, Hungary, Israel, Italy, Japan, Latvia, New Zealand, Poland, Slovakia, Spain, Turkey, United Kingdom, United States

Contacts

Public ContactCentral Study Contact

Immunovant Sciences GmbH

clinicaltrials@immunovant.com18007970414

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026