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Crovalimab for Sickle Cell Disease (CROSSWALK-c Trial)

Phase 2
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
If receiving erythropoietin, the participant must have been prescribed this medication for the preceding 3 months and be dose-stabilised for at least 3 months prior to study enrollment
Body weight >=40 kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 91 weeks
Awards & highlights

CROSSWALK-c Trial Summary

This trial will compare the effectiveness of crovalimab versus placebo at preventing vascular occlusive events (VOEs) in people with sickle cell disease.

Who is the study for?
Adults with Sickle Cell Disease who weigh at least 40 kg, have had 2-10 vaso-occlusive episodes in the past year, and are on a stable dose of current SCD treatments. They must be vaccinated against certain infections and women must agree to use contraception or remain abstinent.Check my eligibility
What is being tested?
The trial is testing Crovalimab's effectiveness as an additional treatment to prevent vaso-occlusive episodes compared to a placebo in people with Sickle Cell Disease.See study design
What are the potential side effects?
Possible side effects of Crovalimab may include allergic reactions, potential increased risk of infections due to immune system effects, and other unspecified drug-related adverse events.

CROSSWALK-c Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been on a stable dose of erythropoietin for at least 3 months.
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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.
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I am vaccinated against meningitis, Hib, and pneumonia.
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I've been on a stable dose of my current sickle cell disease treatment for at least 3 months.

CROSSWALK-c Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 91 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 91 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Annualized rate of medical facility VOEs (AVR)
Secondary outcome measures
Annualized rate of Acute Chest Syndrome (ACS)
Annualized rate of days hospitalized for medical facility VOE
Annualized rate of days hospitalized for treatment of non-VOE complications of SCD
+10 more

CROSSWALK-c Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CrovalimabExperimental Treatment1 Intervention
Participants will receive a loading series of Crovalimab comprised of an intravenous (IV) loading dose on Day 1, followed by weekly Crovalimab subcutaneous (SC) doses for 4 weeks on Week 1 Day 2, then on Weeks 2, 3 and 4. Maintenance SC dosing will begin at Week 5 and will continue every 4 weeks (Q4W) thereafter for a total of 48 weeks of treatment.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive matching Placebo administered by IV infusion and SC injection over the same duration as Crovalimab, for a total of 48 weeks of treatment.

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,427 Previous Clinical Trials
1,089,061 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,198 Previous Clinical Trials
888,501 Total Patients Enrolled

Media Library

Crovalimab Clinical Trial Eligibility Overview. Trial Name: NCT05075824 — Phase 2
Sickle Cell Disease Research Study Groups: Crovalimab, Placebo
Sickle Cell Disease Clinical Trial 2023: Crovalimab Highlights & Side Effects. Trial Name: NCT05075824 — Phase 2
Crovalimab 2023 Treatment Timeline for Medical Study. Trial Name: NCT05075824 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age restriction for this medical experiment permit individuals under 35?

"The enrollment criteria for this trial requires participants to be between 12 and 55 years of age."

Answered by AI

Are there any safety concerns related to Crovalimab utilization?

"Our team at Power has ranked the safety of Crovalimab as a 2, indicating that there is evidence pointing to its safety, but no data yet affirming its efficacy."

Answered by AI

How many participants have enrolled in this trial thus far?

"Indeed, the information posted on clinicaltrials.gov confirms that this medical trial is presently recruiting participants. It was first listed on March 9th 2022 and has been recently updated as of November 8th 2022; it requires 90 individuals to be recruited from 5 different sites."

Answered by AI

What prior experiments have involved Crovalimab?

"Crovalimab was initially researched in 2016 at Tokyo Medical University Hospital, with a total of 18321 completed studies. There are 8 currently active clinical trials being conducted, many of which take place out of Greenville, North carolina."

Answered by AI

Are there any vacancies for participants in this experiment?

"Per the data published on clinicaltrials.gov, this ongoing medical investigation is still searching for trial participants. It was initially posted on March 9th 2022 and most recently updated in November 8th of the same year."

Answered by AI

How unprecedented is this clinical experiment?

"Presently, 8 Crovalimab trials are running in 90 cities and 41 countries. Hoffmann-La Roche was the first to trial this drug back in 2016 with 59 participants; a Phase 1 & 2 approval stage followed suit immediately after. Since then, 18,321 studies have been completed concerning this medication."

Answered by AI

Who is eligible to partake in this research trial?

"This clinical trial is actively seeking 90 individuals between the ages of 12 and 55, with a confirmed diagnosis of sickle cell anemia. Furthermore, these patients must not be undergoing any alterations to their medication dosage other than for safety reasons; have been vaccinated against N. meningitides serotypes A, C, W and Y as well as H. influenza type B and S. pneumonia.; demonstrate adequate hepatic and renal function; agree to abstain from or use contraception during treatment period 10 months after final dose; weigh 40 kg or more; have experienced two to ten documented vaso-occlusive episodes in the twelve months prior to"

Answered by AI

How many sites are involved in the implementation of this trial?

"As of now, there are 5 sites that are currently enrolling patients. These locations include Greenville, Detroit, and New Hyde Park alongside other cities in the vicinity. If you do decide to join this trial it is recommended to choose the closest site so as to reduce travelling demands."

Answered by AI
~10 spots leftby Jul 2024