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A Study to Investigate the Efficacy and Safety of Rilzabrutinib in Adult Participants With Graves' Disease

NCT06984627 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-22

No results posted yet for this study

Summary

This is a parallel group, Phase 2, 2-arm study to measure the treatment effect and safety of rilzabrutinib dose 1 or rilzabrutinib dose 2 in participants with Graves' disease, with and without Graves' orbitopathy, aged 18 years or older.

Study details include:

* Screening period (up to 4 weeks).
* Treatment period (up to 16 weeks).
* Follow-up period (4 weeks). The number of visits will be up to 13.

Conditions

  • Graves' Disease

Interventions

DRUG

Rilzabrutinib dose 1

Pharmaceutical form:Tablet-Route of administration:Oral

DRUG

Rilzabrutinib dose 2

Pharmaceutical form:Tablet-Route of administration:Oral

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-02
Primary Completion
2026-08-25
Completion
2026-09-23
FDA Drug
Yes

Countries

  • Canada
  • Germany
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06984627 on ClinicalTrials.gov