Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment (LUNA 4)

Sanofi

Status and phase

Begins enrollment in 1 month

Phase 3

Conditions

Immune Thrombocytopenia

Treatments

Drug: rilzabrutinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT07007962

LPS18573

U1111-1320-4669 (Registry Identifier)

Details and patient eligibility

About

This is a multinational, open label, single arm study that will evaluate the impact of early multi-immune modulation with rilzabrutinib in adult ITP patients who failed first-line treatment. The study includes a screening period (up to 8 weeks), a primary analysis period (up to 28 weeks), a long-term extension period for selected participants (28 weeks) and a 24-week follow-up period only for eligible participants.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

Male or female participants aged 18 years and older with primary ITP
Participant received at least a first line therapy and had a history of response while on treatment
Participant has loss of response, relapse or steroid dependency

Key Exclusion Criteria:

Participants with Secondary ITP
Participants with Evans syndrome or history of myelodysplastic syndrome
Participants with history of lymphoma, leukemia, or any malignancy within the past 5 years except for non-melanoma skin malignancy.
Participants with history of solid organ transplant
Participants with history of coagulation or bleeding disorders other than ITP
Participant received advanced therapy for ITP or was splenectomized
Pregnancy or nursing The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.