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).

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Hoffmann-La Roche
Study ID
NCT04912869
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Crovalimab — DRUG
    Crovalimab will be administered as a single dose of 1000 milligrams (mg) IV (for participants with a body weight between 40 kilograms (kg) and 100 kg) or 1500 mg IV (for participants with a body weight \>=100 kg).
  • Placebo — DRUG
    Placebo will be administered as a single IV infusion, with an equal volume and over the same duration as weight- based crovalimab

Study Details

The purpose of this study is to evaluate crovalimab for the treatment of a sickle cell pain crisis (also known as a VOE) that requires hospitalisation in adult and adolescent participants with SCD. The primary objective of this study is safety and will additionally evaluate pharmacokinetics (how crovalimab is processed by your body), pharmacodynamics (how your body reacts to crovalimab) and the preliminary efficacy of crovalimab compared with placebo.

Key Dates

Start date
Mar 26, 2022
Status verified
Aug 2025
Primary completion
Dec 23, 2024
Completion
Aug 15, 2025

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Crovalimab
    Participants will receive a single intravenous (IV) infusion of Crovalimab based on body weight.
  • Placebo Comparator: Placebo
    Participants will receive a single IV infusion of matching Placebo.

Primary Outcome Measure

Percentage of Participants With Adverse Events (AEs) [ Time Frame: Baseline up to Day 84 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Children'S Healthcare of AtlantaAtlantaGeorgia30329-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-

Find similar trials in Atlanta, GA

By condition
Sickle cell disease
By research site
Children'S Healthcare of Atlanta· Atlanta, GAIcahn School of Medicine at Mount Sinai· New York, NY

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