Sickle Cell Disease study: Anumigilimab
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?
An investigational subcutaneous antibody 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
- The study wants to see how safe anumigilimab is when given under the skin to adults with sickle cell disease.
- Who it's for
- Adults who have sickle cell disease and can receive injections.
- What's involved
- Participants will receive injections of the drug or a placebo, with doses increased over 12 weeks and then kept steady for 52 weeks. They will have regular visits for safety checks and blood tests.
- Time commitment
- The study lasts 64 weeks, with visits throughout the 12‑week dose‑escalation period and the 52‑week maintenance period.
- 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...
- 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).
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.
The study team makes the final eligibility decision.
Where it is enrolling
- Little Rock, Arkansas, United States
- Orange, California, United States
- Hollywood, Florida, United States
- Atlanta, Georgia, United States
- Bethesda, Maryland, United States
- Boston, Massachusetts, United States
- Minneapolis, Minnesota, United States
- Flowood, Mississippi, United States
- Jamaica, New York, United States
- New York, New York, United States
- The Bronx, New York, United States
- Columbus, Ohio, United States
- Houston, Texas, United States
- Richmond, Virginia, United States
- Edegem, Antwerp, Belgium
- Brussels, Belgium
- Marseille, Bouches-du-Rhône, France
- Nantes, France
- Rouen, France
- Toulou, France
+ 14 more site(s).
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, but 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?
This study is enrolling now at Little Rock, Arkansas, United States; Orange, California, United States; Hollywood, Florida, United States; Atlanta, Georgia, United States; Bethesda, Maryland, United States; Boston, Massachusetts, United States and 28 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.