An open-label Phase 2 study to investigate the efficacy and safety of rilzabrutinib in adult participants with Graves’ disease

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-521023-75-00

Acronym

PDY18663

Enrollment

Registered

2025-07-16

Start date

2025-10-03

Completion date

Unknown

Last updated

2025-08-14

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

Conditions

Immune system diseases

Brief summary

Percent change from baseline in FT4 levels

Detailed description

Percent change from baseline in FT3 levels, Proportion of participants with FT4 levels within normal limits, Proportion of participants with FT3 levels within normal limits, Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs) and withdrawals due to TEAEs during the study period

Interventions

DRUGRilzabrutinib

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percent change from baseline in FT4 levels	—

Secondary

Measure	Time frame
Percent change from baseline in FT3 levels, Proportion of participants with FT4 levels within normal limits, Proportion of participants with FT3 levels within normal limits, Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs) and withdrawals due to TEAEs during the study period	—

Countries

Germany, Italy, Spain

Outcome results

None listed

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