A Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Crovalimab for the Management of Acute Uncomplicated Vaso-Occlusive Episodes (VOE) in Participants With Sickle Cell Disease (SCD). (CROSSWALK-a)

Phase 1

Recruiting

• Conditions: Haematological Disorders

• Registration Number: PACTR202308825367505
• Lead Sponsor: Roche

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-07-24
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Body weight >=40 kg.
-Confirmed diagnosis of HbSS (SCD genotype of sickle cell anemia) or HbSß0 (SCD genotype of sickle cell beta zero thalassemia).
--Vaccination against Neisseria Meningitidis serotypes A, C, W, and Y.
Vaccinations against H. influenzae type B and S. pneumoniae.
-Participants vaccinated against SARS-CoV-2 are eligible, as long as it has been 3 days or more after inoculation with the vaccine.
-Diagnosis of an acute uncomplicated VOE, that requires admission to a hospital/acute medical facility and treatment with parenteral opioid analgesics.
-Adequate hepatic and renal function.
-Hemoglobin >=5 grams/deciliter (g/dL)
-Platelet count >=100,000/microliter (µL)
-Participants receiving sickle cell therapies must be on a stable dose for >=28 days.
-For female participants of childbearing potential, an agreement to remain abstinent or use contraception for 322 days (approximately 10.5 months) after the dose of study treatment.

Exclusion Criteria

-More than 10 VOEs within the last 12 months prior to presentation, that have required a medical facility visit.
-Pain related to the current VOE ongoing for >48 hours.
-Acute pain related to avascular necrosis, hepatic or splenic sequestration, or priapism.
-Pain atypical of an acute uncomplicated VOE.
-Evidence of or suspicion of ACS.
-Evidence or high suspicion of a severe systemic infection.
-Major surgery and/or hospitalization for any reason within 30 days.
-History of Neisseria meningitidis infection within 6 months prior.
-Known HIV infection with a documented CD4 count <200 cells/µL.
-Transfusion or receipt of blood products within 3 months or current participation in a chronic transfusion protocol.
-Immunized with a live attenuated vaccine within 30 days.
-History of hematopoietic stem cell transplant.
-Known or suspected hereditary complement deficiency.
-Pregnant or breastfeeding, or intending to become pregnant during the study or within 322 days (approximately 10.5 months) after the study drug administration.
-Participation in another interventional treatment study with an investigational agent or use of any experimental therapy within the prior 28 days or within five half-lives of that investigational product, whichever was greater.

Study & Design

• Study Type: Interventional
• Study Design: Not specified