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A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab as Adjunct Treatment in Prevention of Vaso-Occlusive Episodes (VOE) in Sickle Cell Disease (SCD)
EU CTIS ID: 2022-502542-28-00
What this study is testing
To evaluate the efficacy of crovalimab compared with placebo
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Body weight >=40 kg
- Male or female with confirmed diagnosis of HbSS (SCD genotype of sickle cell anemia) or HbSβ0 (SCD genotype of sickle cell beta zero thalassemia)
- Two or more (>=2) to <=10 documented VOEs in the 12 months prior to randomisation
- If receiving concurrent SCD-directed therapy, the participant must have been on a stable dose for a minimum of 3 months prior to study enrollment. There should be no plans to modify the participants' dosing throughout the study duration, other than for safety reasons
- Vaccination against N. meningitides serotypes A, C, W, and Y, and vaccinations against H. influenza type B and S. pneumonia
- Adequate hepatic and renal function
You likely can't join if
- History of hematopoietic stem cell transplant
- Participating in a chronic transfusion program and/or planning on undergoing an exchange transfusion during the duration of the study
- History of hypersensitivity, allergic, or anaphylactic reactions to any ingredient contained in the study treatment
- Hemoglobin <6 g/dL
- Active systemic bacterial, viral, or fungal infection within 14 days before first drug administration
- Presence of fever (>=38 degrees Celsius) within 7 days before the first drug administration
The study team makes the final eligibility decision.
Where it's taking place
- Lebanon
- Turkey
- United Kingdom
- United States
- Kenya
- Brazil
- Canada
- South Africa
- Ghana
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lebanon; Turkey; United Kingdom; United States; Kenya; Brazil and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.