What side effects are associated with this type of intervention?

Common treatments for Sickle Cell Disease include hydroxyurea, crizanlizumab, and regular blood transfusions. Hydroxyurea can cause bone marrow suppression, gastrointestinal symptoms, and potential long-term risks like secondary malignancies. Crizanlizumab may lead to infusion-related reactions, nausea, and joint pain. Regular blood transfusions carry risks of iron overload, alloimmunization, and transfusion reactions.

What prior FDA approvals exist?

The FDA has approved several treatments for Sickle Cell Disease, including hydroxyurea, which reduces the frequency of pain crises, and crizanlizumab, which targets P-selectin to prevent vaso-occlusive episodes. Voxelotor, another approved drug, works by increasing hemoglobin's affinity for oxygen, thus reducing sickling. While Crovalimab, which inhibits the complement system, is still under study, these existing treatments highlight the diverse mechanisms being explored to manage SCD.

What other types of research exist?

Promising novel alternatives to Crovalimab for Sickle Cell Disease patients include Canakinumab, which blocks IL-1β and has shown reductions in inflammation, SCD-related adverse events, and hospitalizations. Another option is Hydroxyurea, which is recommended as the first-line therapy for reducing vaso-occlusive pain and other complications in SCD patients. Both treatments have demonstrated potential therapeutic benefits and safety in clinical studies.

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Monoclonal Antibodies

Crovalimab for Sickle Cell Disease (CROSSWALK-a Trial)

Phase 1

Recruiting

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of an acute uncomplicated VOE, that requires admission to a hospital/acute medical facility and treatment with parenteral opioid analgesics

Vaccinations against H. influenzae type B and S. pneumoniae

Must not have

More than 10 VOEs within the last 12 months prior to presentation, that have required a medical facility visit

Pain related to the current VOE ongoing for >48 hours

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to day 84

Summary

This trial is testing crovalimab, a medication, to see if it can help treat severe pain crises in people with sickle cell disease. The study focuses on adults and adolescents who need hospital care for their pain. Researchers will check how the body handles crovalimab and its effects to ensure it is safe and effective.

Who is the study for?

This trial is for adults and teens with Sickle Cell Disease who weigh at least 40 kg, have had certain vaccinations, stable sickle cell therapies if any, good liver/kidney function, and not pregnant. They must be hospitalized for a pain crisis but can't join if they've had recent surgeries, severe infections, many pain crises in the past year or are on other experimental treatments.

What is being tested?

The study tests Crovalimab against a placebo to manage acute uncomplicated Vaso-Occlusive Episodes (VOE) requiring hospital care in Sickle Cell Disease patients. It focuses on safety while also checking how the body processes and responds to Crovalimab and its initial effectiveness.

What are the potential side effects?

While specific side effects of Crovalimab aren't listed here, common ones may include reactions at the injection site, headaches, nausea or fever. Since it's being tested for safety as well as efficacy in this trial, monitoring for any adverse effects will be a primary concern.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am hospitalized for a painful sickle cell crisis needing strong pain medication.

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I am vaccinated against H. influenzae type B and S. pneumoniae.

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I am vaccinated against meningitis ACWY.

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I weigh at least 40 kg.

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I have been diagnosed with either sickle cell anemia or sickle cell beta zero thalassemia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I've had over 10 pain crises needing hospital visits in the last year.

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My pain from the current episode has lasted more than 48 hours.

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I have had a stem cell transplant.

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I might have a severe infection throughout my body.

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I have not had major surgery or been hospitalized in the last 30 days.

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I might have or am suspected to have acute coronary syndrome.

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I have a known or suspected genetic issue with my immune system.

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I have not had a blood transfusion or received blood products in the last 3 months.

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I have acute pain due to bone death, liver or spleen issues, or prolonged erection.

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I have not received a live vaccine in the last 30 days.

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I have not been in a drug study or taken experimental therapy in the last 28 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to day 84

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to day 84

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to day 84 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change in PD Biomarkers Including Complement Activity (CH50) Over Time

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CrovalimabExperimental Treatment1 Intervention

Participants will receive a single intravenous (IV) infusion of Crovalimab based on body weight.

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive a single IV infusion of matching Placebo.

0 / 16Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Hydroxyurea increases fetal hemoglobin (Hb F) production, which reduces the sickling of red blood cells and decreases vaso-occlusive episodes. Red blood cell transfusions reduce the proportion of sickled cells, improving oxygen delivery and reducing complications. Crovalimab, an investigational therapy, inhibits the complement system, potentially reducing inflammation and hemolysis associated with SCD. These treatments are crucial as they address different aspects of the disease's pathophysiology, aiming to reduce pain, prevent complications, and improve the quality of life for SCD patients.

Role of complement in alloimmunization and hyperhemolysis.