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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 belowSelect...
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:Select...
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
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.
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.
Role of complement in alloimmunization and hyperhemolysis.
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,450 Previous Clinical Trials
1,095,503 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,220 Previous Clinical Trials
895,410 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had over 10 pain crises needing hospital visits in the last year.My liver and kidneys are working well.I have been on a stable dose of my sickle cell treatment for at least 28 days.I am hospitalized for a painful sickle cell crisis needing strong pain medication.My pain from the current episode has lasted more than 48 hours.I have had a stem cell transplant.I am vaccinated against H. influenzae type B and S. pneumoniae.I am vaccinated against meningitis ACWY.My pain does not match typical sickle cell crisis pain.I had a Neisseria meningitidis infection in the last 6 months.I weigh at least 40 kg.I might have a severe infection throughout my body.I have not had major surgery or been hospitalized in the last 30 days.I have been diagnosed with either sickle cell anemia or sickle cell beta zero thalassemia.I have been vaccinated against COVID-19 and it's been over 3 days since my last shot.I might have or am suspected to have acute coronary syndrome.I have a known or suspected genetic issue with my immune system.I have not had a blood transfusion or received blood products in the last 3 months.I have acute pain due to bone death, liver or spleen issues, or prolonged erection.I have not received a live vaccine in the last 30 days.I have not been in a drug study or taken experimental therapy in the last 28 days.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Crovalimab
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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