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

Purpose

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.

Condition

  • Immune Thrombocytopenia

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Male or female participants aged 18 years and older with a documented diagnosis of primary ITP in the medical history - Participant received at least one course of first-line therapy and had a history of response while on treatment - Participant has loss of response, relapse, or steroid dependency

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, including genetic conditions, 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
rilzabrutinib 		400 mg BID
  • Drug: rilzabrutinib
    Pharmaceutical form:Tablet-Route of administration:Oral
    Other names:
    • SAR444671

Recruiting Locations

University of Michigan Health - Michigan Medicine - University Hospital-Investigational Site Number: 8400001
Ann Arbor, Michigan 48109

Mayo Clinic_Investigational Site Number: 8400009
Rochester, Minnesota 55905

New York Oncology Hematology_Investigational Site Number: 8400010
Albany, New York 12208

Montefiore Medical Center-Investigational Site Number: 8400012
The Bronx, New York 10467

Community Cancer Trials of Utah_Investigational Site Number: 8400002
Ogden, Utah 84405

More Details

Status
Recruiting
Sponsor
Sanofi

Study Contact

Trial Transparency email recommended (Toll free for US & Canada)
800-633-1610
contact-us@sanofi.com