Testing Anumigilimab (CSL324) safety in adults with sickle cell disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled phase 2a trial that gives Anumigilimab or placebo by subcutaneous injection at multiple international sites. Participants enter a 12-week dose-escalation period to reach an individual maximum tolerated dose (MTD), followed by 52 weeks of maintenance dosing at that MTD, for a total of 64 weeks on treatment. The primary focus is on safety and tolerability in adults with any genotype of sickle cell disease who have had recent vaso-occlusive crises. Study procedures will include regular clinical visits, laboratory monitoring, and recording of adverse events.

Why it matters

Who can join: the full rules

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.

Where it's running

• UAMS Medical Center
  Little Rock, Arkansas, United States Recruiting
• University of California Irvine
  Orange, California, United States Recruiting
• The Foundation for Sickle Cell Disease
  Hollywood, Florida, United States Recruiting
• Arthur M. Blank Hospital- Children's Healthcare of Atlanta
  Atlanta, Georgia, United States Recruiting
• Center for Cancer and Blood Disorders
  Bethesda, Maryland, United States Recruiting
• Boston Medical Center
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Trial Registration Coordinator
• Email: clinicaltrials@cslbehring.com
• Phone: +1 610-878-4697

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.