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Monoclonal Antibodies

A Phase 2a Study Evaluating BIVV020 in Adults With Persistent/Chronic Immune Thrombocytopenia (ITP)

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
Be older than 18 years old
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
No Placebo-Only Group

Summary

This trial is testing BIVV020, a new medication, in people with a condition where the immune system destroys platelets. The goal is to see if it can help increase platelet counts by preventing this destruction.

Eligible Conditions
  • Idiopathic Thrombocytopenic Purpura (ITP)

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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants With a Durable Platelet Response
Secondary study objectives
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 more

Side effects data

From 2023 Phase 2 trial • 12 Patients • NCT04669600
25%
Fatigue
25%
Covid-19
17%
Diarrhoea
8%
Aphasia
8%
Dyspepsia
8%
Burning Sensation
8%
Dizziness
8%
Syncope
8%
Eye Irritation
8%
Cholecystitis Chronic
8%
Dermatitis Contact
8%
Tinnitus
8%
Back Pain
8%
Injection Site Bruising
8%
Blood Cholesterol Increased
8%
Hypertension
8%
Psoriasis
8%
Arthritis
8%
Pain In Extremity
8%
Arthralgia
8%
Myalgia
8%
Oedema Peripheral
8%
Appendicitis
8%
Cerebrovascular Accident
8%
Abdominal Pain Upper
8%
Influenza
8%
Post-Acute Covid-19 Syndrome
8%
Sinusitis
8%
Lymphadenopathy
8%
Decreased Appetite
8%
Hyperglycaemia
8%
Cough
8%
Sinus Congestion
8%
Abdominal Pain
8%
Constipation
100%
80%
60%
40%
20%
0%
Study treatment Arm
SAR445088

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

Bioverativ, a Sanofi companyLead Sponsor
17 Previous Clinical Trials
1,024 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
876 Previous Clinical Trials
2,021,658 Total Patients Enrolled
~2 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
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