Recruiting
Phase 2

Anumigilimab

Sponsor:

CSL Behring

Code:

NCT07224360

Conditions

Sickle Cell Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Anumigilimab

Placebo

Study Details

Brief summary:

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.

Conditions

Sickle Cell Disease

Study ID

NCT07224360

Start date

Feb 2, 2026

Status verified date

Jul, 2026

Completion date

Jun 29, 2028

Anticipated

Primary completion date

Jun 29, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

63 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Anumigilimab

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

placebo comparator: Placebo

Participants will receive matching volume of placebo.

Interventions

Anumigilimab

Participants will receive anumigilimab, escalated to a maximum dose guided by absolute neutrophil count (ANC) and safety concerns.

Placebo

Volume matched saline will be administered SC.

Primary outcome measure

  • Number of participants with Treatment Emergent Adverse Events (TEAEs), Overall and by severity, seriousness and relationship to Investigational Product (IP) [ Time Frame: From baseline up to Week 75 ]
  • Percentage of participants with TEAEs Overall and by severity, seriousness and relationship to IP [ Time Frame: From baseline up to Week 75 ]
  • Number of participants with Adverse Events of Special Interest (AESI) [ Time Frame: From baseline up to Week 75 ]
  • Percentage of participants with AESI [ Time Frame: From baseline up to Week 75 ]
  • Number of participants with clinically relevant changes from baseline in laboratory assessments and vital signs [ Time Frame: From baseline up to Week 75 ]
  • Percentage of participants with clinically relevant changes from baseline in laboratory assessments and vital signs [ Time Frame: From baseline up to Week 75 ]

Central Contacts and Locations

Central contacts

Trial Registration Coordinator

+1 610-878-4697clinicaltrials@cslbehring.com

Locations

UAMS Medical Center

Recruiting

Little Rock, Arkansas, United States, 72202

University of California Irvine

Recruiting

Orange, California, United States, 92868

The Foundation for Sickle Cell Disease

Recruiting

Hollywood, Florida, United States, 33023-6703

Arthur M. Blank Hospital- Children's Healthcare of Atlanta

Recruiting

Atlanta, Georgia, United States, 30329

Center for Cancer and Blood Disorders

Recruiting

Bethesda, Maryland, United States, 20817

Southern Specialty Research

Recruiting

Flowood, Mississippi, United States, 39232

Jacobi Medical Center

Recruiting

The Bronx, New York, United States, 10461

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

More Information

Sponsor

CSL Behring

Last update posted

Aug 5, 2026

Last verified

Jul, 2026

Keywords

  • Anemia
  • Genetic Disorder
  • Vaso-occlusive Crises

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by CSL Behring on 2026-08-05.