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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.