Actively Recruiting
Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment
Led by Sanofi · Updated on 2026-05-01
60
Participants Needed
24
Research Sites
166 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 24 locations
1
Tulane University Health Sciences Center - Tulane Avenue-Investigational Site Number: 8400011
New Orleans, Louisiana, United States, 70112
Actively Recruiting
2
University of Michigan Health - Michigan Medicine - University Hospital-Investigational Site Number: 8400001
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
3
Mayo Clinic_Investigational Site Number: 8400009
Rochester, Minnesota, United States, 55905
Actively Recruiting
4
New York Oncology Hematology-Investigational Site Number: 8400010
Albany, New York, United States, 12208
Actively Recruiting
5
Montefiore Medical Center-Investigational Site Number: 8400012
The Bronx, New York, United States, 10467
Actively Recruiting
6
Community Cancer Trials of Utah-Investigational Site Number: 8400002
Ogden, Utah, United States, 84405
Actively Recruiting
7
Investigational Site Number : 0400001
Vienna, Austria, 1140
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8
Investigational Site Number: 2500003
Créteil, France, 94000
Actively Recruiting
9
Investigational Site Number : 2500001
Dijon, France, 21079
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10
Investigational Site Number : 2500002
Pessac, France, 33604
Actively Recruiting
11
Investigational Site Number : 2500004
Toulouse, France, 31059
Actively Recruiting
12
Investigational Site Number : 3480002
Kaposvár, Hungary, 7400
Actively Recruiting
13
Investigational Site Number : 3800006
Naples, Italy, 80131
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14
Investigational Site Number : 3800007
Torino, Italy, 10126
Actively Recruiting
15
Investigational Site Number : 3800003
Vicenza, Italy, 36100
Actively Recruiting
16
Investigational Site Number : 6160002
Gdansk, Poland, 80-219
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17
Investigational Site Number : 6160003
Skorzewo, Poland, 60-185
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18
Investigational Site Number : 6160004
Słupsk, Poland, 76-200
Actively Recruiting
19
Investigational Site Number : 7240001
Barcelona, Spain, 8003
Actively Recruiting
20
Investigational Site Number : 7240002
Burgos, Spain, 9006
Actively Recruiting
21
Investigational Site Number : 7240007
Madrid, Spain, 28007
Actively Recruiting
22
Investigational Site Number : 7240008
Madrid, Spain, 28046
Actively Recruiting
23
Investigational Site Number : 7240005
Murcia, Spain, 30008
Actively Recruiting
24
Investigational Site Number : 7240004
Seville, Spain, 41013
Actively Recruiting
Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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