A Phase IB, Randomized, Placebo-Controlled Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Crovalimab for the Management of Acute Uncomplicated Vaso‑Occlusive Episodes (VOE) in Patients With Sickle Cell Disease (SCD)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502546-26-00

Acronym

BO42452

Enrollment

Registered

2023-07-21

Start date

2023-09-11

Completion date

2025-05-26

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle Cell Disease

Brief summary

Incidence and severity of adverse events, with severity determined according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0), Change from baseline in targeted vital signs and clinical laboratory test results, Incidence and severity of infusion-related reactions and hypersensitivity

Detailed description

Serum concentrations of crovalimab over time, Relationships between drug exposure and pharmacodynamics, efficacy, or safety endpoints of crovalimab (patients randomized to crovalimab), Change over time in PD biomarkers (CH50, free C5, sC5b-9), Time to improvement of the primary acute uncomplicated VOE from baseline, Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study

Interventions

DRUGCrovalimab Placebo

DRUGCrovalimab

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Incidence and severity of adverse events, with severity determined according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0), Change from baseline in targeted vital signs and clinical laboratory test results, Incidence and severity of infusion-related reactions and hypersensitivity	—

Secondary

Measure	Time frame
Serum concentrations of crovalimab over time, Relationships between drug exposure and pharmacodynamics, efficacy, or safety endpoints of crovalimab (patients randomized to crovalimab), Change over time in PD biomarkers (CH50, free C5, sC5b-9), Time to improvement of the primary acute uncomplicated VOE from baseline, Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study	—

Measure

Time frame

—

Countries

France, Italy, Netherlands, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026