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

Part of paid clinical trials in Clovis, California.

Sponsor
Sanofi
Study ID
NCT07007962
Phase
PHASE3
Status
Recruiting
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Conditions

  • Immune Thrombocytopenia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • rilzabrutinib — DRUG
    Pharmaceutical form:Tablet-Route of administration:Oral

Study Details

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.

Key Dates

Start date
Oct 24, 2025
Status verified
May 2026
Primary completion
Nov 5, 2027
Completion
Dec 30, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: rilzabrutinib
    400 mg BID

Primary Outcome Measure

Durable platelet response [ Time Frame: Until Week 28 ]

Central Contacts

  • Trial Transparency email recommended (Toll free for US & Canada)
    800-633-1610
    [email protected]

Locations (9)

FacilityCityStateZIPSite coordinators
Community Health Partners (CHP) - Community Medical Oncology Specialists (University Oncology Associates)ClovisCalifornia93611-
Tulane University Health Sciences Center - Tulane Avenue-Investigational Site Number: 8400011New OrleansLouisiana70112-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114-
University of Michigan Health - Michigan Medicine - University Hospital-Investigational Site Number: 8400001Ann ArborMichigan48109-
Mayo Clinic_Investigational Site Number: 8400009RochesterMinnesota55905-
New York Oncology Hematology-Investigational Site Number: 8400010AlbanyNew York12208-
Montefiore Medical Center-Investigational Site Number: 8400012The BronxNew York10467-
Community Cancer Trials of Utah-Investigational Site Number: 8400002OgdenUtah84405-

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Community Health Partners (CHP) - Community Medical Oncology Specialists (University Oncology Associates)· Clovis, CATulane University Health Sciences Center - Tulane Avenue-Investigational· New Orleans, LABeth Israel Deaconess Medical Center· Boston, MAMassachusetts General Hospital Cancer Center· Boston, MAUniversity of Michigan Health - Michigan Medicine - University Hospital-Investigational· Ann Arbor, MIMayo Clinic_Investigational· Rochester, MN

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