Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD)

Purpose

This is a phase 2a, global, multicenter, randomized, double-blind, placebo-controlled study investigating the safety of anumigilimab administered subcutaneously (SC) at the maximum tolerated dose (MTD) in adult participants with SCD. The primary aim of the study is to assess the safety of anumigilimab in participants with SCD. Participants will be treated for 64 weeks: for 12 weeks in the dose escalation period, where the dose will be escalated to each participant's individual MTD; and for 52 weeks at the MTD in the maintenance period.

Condition

  • Sickle Cell Disease

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • • Adults aged greater than or equal to (>=) 18 years on the day of signing the informed consent form. - • Confirmed diagnosis of SCD of any genotype. - • Experienced 1 to 12 VOCs requiring a visit to a medical facility and treatment with parenteral opioids or a parenteral nonsteroidal anti-inflammatory drug within the 12 months before Screening. - • HU Regimen: - a. On stable and well-tolerated Hydroxyurea (HU) regimen for at least 30 days before Screening. - or - b. HU was discontinued or refused (eg, due to concern of side effects or lack of effect).

Exclusion Criteria

  • • Absolute neutrophil count less than (<) 2.5 ×10^9 cells/Litre at Screening or Baseline (Week 1 Day 1). - • If on SCD preventive medication, dose is not stable in the 30 days before Screening.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
This is a double blind, placebo controlled study.
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Anumigilimab 		Safety of Anumigilimab (CSL324) in Adults with Sickle Cell Disease (SCD)
  • Biological: Anumigilimab
    Participants will receive anumigilimab, escalated to a maximum dose guided by absolute neutrophil count (ANC) and safety concerns.
Placebo Comparator
Placebo 		Participants will receive matching volume of placebo.
  • Drug: Placebo
    Volume matched saline will be administered SC.

Recruiting Locations

UAMS Medical Center
Little Rock, Arkansas 72202

The Foundation for Sickle Cell Disease
Hollywood, Florida 33023-6703

Center for Cancer and Blood Disorders
Bethesda, Maryland 20817

Southern Specialty Research
Flowood, Mississippi 39232

Jacobi Medical Center
The Bronx, New York 10461

More Details

Status
Recruiting
Sponsor
CSL Behring

Study Contact

Trial Registration Coordinator
+1 610-878-4697
clinicaltrials@cslbehring.com