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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to day 322
Awards & highlights

CROSSWALK-a Trial Summary

This trial is testing a new drug, crovalimab, to see if it is safe and effective for treating sickle cell pain crises in adults and adolescents.

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.Check my eligibility
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.See study design
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.

CROSSWALK-a Trial 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.

CROSSWALK-a Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to day 322
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to day 322 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Adverse Events (AEs)
Percentage of Participants with Infusion-Related Reactions and Hypersensitivity
Secondary outcome measures
Change in PD biomarkers including complement activity (CH50) over time
Change in pain score from the maximal pre-dose pain score to the score at hospital discharge
Change over time in free C5 concentration
+13 more

CROSSWALK-a 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.

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,427 Previous Clinical Trials
1,089,121 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,198 Previous Clinical Trials
888,561 Total Patients Enrolled

Media Library

Crovalimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04912869 — Phase 1
Sickle Cell Disease Research Study Groups: Crovalimab, Placebo
Sickle Cell Disease Clinical Trial 2023: Crovalimab Highlights & Side Effects. Trial Name: NCT04912869 — Phase 1
Crovalimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04912869 — Phase 1

Frequently Asked Questions

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

How many participants are engaged in this experiment?

"The sponsor, Hoffmann-La Roche is looking to enrol 30 eligible patients from two medical centres - Icahn School of Medicine at Mount Sinai in New york and Children's Hospital of Michigan Pediatrics."

Answered by AI

How widely is this trial being administered throughout the state?

"Participants in this trial are being recruited from Icahn School of Medicine at Mount Sinai (New york, NY), Children's Hospital of Michigan; Pediatrics (Detroit, MI), East Carolina University; Brody School of Medicine (Greenville, NC) and 4 other medical centres."

Answered by AI

Has Crovalimab obtained authorization from the FDA?

"Crovalimab's safety is rated as a 1 on the scale because this clinical trial is in its early stages, meaning that there are limited data points to support both efficacy and protection from risks."

Answered by AI

Are additional participants being sought out for this experiment?

"Affirmative. According to the information hosted on clinicaltrials.gov, this medical trial, which was initially posted on March 26th 2022 is currently recruiting patients for participation. A total of 30 individuals are being sought from 4 different sites."

Answered by AI

Who has the qualifications to be considered a participant in this clinical trial?

"This clinical trial aims to enroll 30 individuals suffering from anemia and sickle cell, aged between 12 and 55. Applicants must have a confirmed diagnosis of HbSS or HbSβ0 (SCD genotype), as well as satisfactory renal/hepatic functions, hemoglobin over 5g/dL, platelet count greater than 100k µL, body weight at least 40 kgs. Furthermore, they should be vaccinated against Neisseria Meningitidis serotypes A-Y, SARS-CoV-2 (if administered more than 3 days prior) and Hib + Pneumococcal vaccines."

Answered by AI

Is there a precedent of Crovalimab being used in previous research investigations?

"Crovalimab was initially studied in 2016 at Tokyo Medical University Hospital, and since then there have been 18327 separate clinical trials. Currently, 8 of these studies are active with a majority based out of New york City."

Answered by AI

Does this trial represent a pioneering effort in its field?

"At the moment, Hoffmann-La Roche's Crovalimab has 8 active trials being conducted in 90 municipalities and 41 nations. This drug was first introduced for human testing back in 2016 with 59 subjects enrolled; since then, 18,327 studies have been completed up to Phase 1 & 2 approval status."

Answered by AI

Could individuals younger than 35 years old partake in this trial?

"According to the age restrictions outlined in this medical trial, participants must be at least 12 years old and no older than 55."

Answered by AI
~8 spots leftby Jan 2025