CTIS2022-502546-26-00
Recruiting
Phase 1
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) - BO42452
ConditionsSickle Cell DiseaseMedDRA version: 21.0Level: PTClassification code: 10040644Term: Sickle cell disease Class: 100000004850MedDRA version: 20.0Level: LLTClassification code: 10072397Term: Vaso-occlusive crisis Class: 10005329Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Sickle Cell Disease
- Sponsor
- F. Hoffmann-La Roche AG
- Enrollment
- 53
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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,, and vaccinations against H. influenzae type B and S. pneumoniae, 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, Participants receiving sickle cell therapies must be on a stable dose for \>\=28 days
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, and pain atypical of an acute uncomplicated VOE, Transfusion or receipt of blood products within 3 months or current participation in a chronic transfusion protocol, 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
Outcomes
Primary Outcomes
Not specified
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