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Monoclonal Antibodies
SAR445088 for Thrombocytopenic Purpura
Phase 2
Waitlist Available
Research Sponsored by Bioverativ, a Sanofi company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmed diagnosis of primary ITP; for participants who previously received sutimlimab in study TDR16218 (NCT03275454), a response to sutimlimab must have been obtained, as defined by platelet count ≥30 × 10^9/L on 2 visits at least 7 days apart
Platelet count ≤30 × 10^9/L on 2 occasions at least 5 days apart during the Screening Period;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-hour post-dose on day 1, on days 8, 15, 29, 43, at weeks 12, 16, 24, 32, 40, 48, 56, 64, 72, 80 and eos visit, up to 103 weeks
Awards & highlights
Study Summary
This trial is looking at a new drug, BIVV020, for people with a chronic condition called ITP, which causes low platelet counts. The study will evaluate how well the drug works and how safe it is.
Eligible Conditions
- Idiopathic Thrombocytopenic Purpura (ITP)
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-hour post-dose on day 1, on days 8, 15, 29, 43, at weeks 12, 16, 24, 32, 40, 48, 56, 64, 72, 80 and eos visit, up to 103 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-hour post-dose on day 1, on days 8, 15, 29, 43, at weeks 12, 16, 24, 32, 40, 48, 56, 64, 72, 80 and eos visit, up to 103 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants With a Durable Platelet Response
Secondary outcome measures
Number of Participants With Anti-Drug Antibody (ADAs) Response to SAR445088 (BIVV020)
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Clinical Chemistry
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Coagulation
+7 moreSide effects data
From 2023 Phase 2 trial • 12 Patients • NCT0466960025%
Covid-19
25%
Fatigue
17%
Diarrhoea
8%
Blood Cholesterol Increased
8%
Lymphadenopathy
8%
Abdominal Pain Upper
8%
Cerebrovascular Accident
8%
Aphasia
8%
Dizziness
8%
Psoriasis
8%
Myalgia
8%
Influenza
8%
Arthralgia
8%
Injection Site Bruising
8%
Appendicitis
8%
Post-Acute Covid-19 Syndrome
8%
Arthritis
8%
Hyperglycaemia
8%
Decreased Appetite
8%
Tinnitus
8%
Abdominal Pain
8%
Constipation
8%
Back Pain
8%
Oedema Peripheral
8%
Dermatitis Contact
8%
Sinusitis
8%
Cholecystitis Chronic
8%
Pain In Extremity
8%
Hypertension
8%
Dyspepsia
8%
Burning Sensation
8%
Eye Irritation
8%
Syncope
8%
Cough
8%
Sinus Congestion
100%
80%
60%
40%
20%
0%
Study treatment Arm
SAR445088
Trial Design
1Treatment groups
Experimental Treatment
Group I: SAR445088Experimental Treatment1 Intervention
Participants received SAR445088 (BIVV020).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SAR445088 (BIVV020)
2021
Completed Phase 2
~20
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Who is running the clinical trial?
Bioverativ, a Sanofi companyLead Sponsor
17 Previous Clinical Trials
1,024 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,018,944 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How reliable is BIVV020 in ensuring the health of patients?
"Our experts at Power rate BIVV020's safety as a 2 based on the fact that it is in Phase 2 trials and thus only has limited data to support its protective effects."
Answered by AI
Is enrollment in this study currently open?
"Clinicaltrials.gov reports that this particular trial, which was initially posted on February 4th 2021 and edited most recently on May 3rd 2022, is no longer accepting patients. However, there exist 133 other medical trials currently recruiting participants at the moment."
Answered by AI
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