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A Proof-of-Concept, Open-label Study to Assess the Safety and Efficacy of Batoclimab in Participants with Graves’ Disease (GD)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512647-23-00
Enrollment
35
Registered
2024-09-23
Start date
2023-06-14
Completion date
2025-07-25
Last updated
2025-02-17

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

Conditions

Grave's disease

Brief summary

Proportion of participants who, at Week 24, without increase in ATD dose compared to baseline, have achieved normalization of FT3 and FT4, or have FT3 and/or FT4 below the LLN.

Detailed description

Proportion of participants who achieve normalization of FT3 and FT4 at Week 24 with ATD dose ≤50% of the baseline ATD dose by Week 24., Proportion 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.

Interventions

Sponsors

Immunovant Sciences GmbH
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Proportion of participants who, at Week 24, without increase in ATD dose compared to baseline, have achieved normalization of FT3 and FT4, or have FT3 and/or FT4 below the LLN.

Secondary

MeasureTime frame
Proportion of participants who achieve normalization of FT3 and FT4 at Week 24 with ATD dose ≤50% of the baseline ATD dose by Week 24., Proportion 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.

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026