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Tests treatment safety and results for Sickle Cell Disease
Official title Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD)
ClinicalTrials.gov ID: NCT07224360
What this study is testing
What is Anumigilimab?
Anumigilimab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for sickle cell disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- HU Regimen:
- a. On stable and well-tolerated Hydroxyurea (HU) regimen for at least 30 days before Screening.
You likely can't join if
- 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.
See the full eligibility 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.
- b. HU was discontinued or refused (eg, due to concern of side effects or lack of effect).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Hollywood, Florida, United States
- Bethesda, Maryland, United States
- Flowood, Mississippi, United States
- The Bronx, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; Hollywood, Florida, United States; Bethesda, Maryland, United States; Flowood, Mississippi, United States; The Bronx, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.