A Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Crovalimab for the Management of Acute Uncomplicated Vaso-Occlusive Episodes (VOE) in Participants With Sickle Cell Disease (SCD). (CROSSWALK-a)

August 25, 2025 updated by: Hoffmann-La Roche

A Phase IB Randomized, Placebo-Controlled Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Crovalimab for the Management of Acute Uncomplicated Vaso-Occlusive Episodes (VOE) in Patients With Sickle Cell Disease (SCD)

The purpose of this study is to evaluate crovalimab for the treatment of a sickle cell pain crisis (also known as a VOE) that requires hospitalisation in adult and adolescent participants with SCD. The primary objective of this study is safety and will additionally evaluate pharmacokinetics (how crovalimab is processed by your body), pharmacodynamics (how your body reacts to crovalimab) and the preliminary efficacy of crovalimab compared with placebo.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Brazil
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 41253-190
        • Hospital Sao Rafael - HSR
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil
        • Hospital das Clinicas - UFRGS
  • France
      • Créteil, France, 64010
        • CHU Henri Mondor
  • Italy
    • Veneto
      • Verona, Veneto, Italy, 37134
        • Azienda Ospedaliera di Verona-Policlinico G.B. Rossi
  • Kenya
      • Eldoret, Kenya, 30100
        • International Cancer Institute (ICI)
      • Nairobi, Kenya
        • Gertrude's Children Hospital
  • Lebanon
      • Beirut, Lebanon, 1107 2020
        • American University of Beirut - Medical Center
      • Tripoli, Lebanon
        • Hopital Nini
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • Amsterdam UMC location VUMC
  • South Africa
      • Johannesburg, South Africa, 2193
        • Charlotte Maxeke Johannesburg Hospital
  • Spain
      • Madrid, Spain, 28009
        • Hospital General Univ. Gregorio Marañón
      • Seville, Spain, 41013
        • Hospital Universitario Virgen del Rocío
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet
  • United Kingdom
      • London, United Kingdom, W12 OHS
        • Hammersmith Hospital
  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Children's Healthcare of Atlanta
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 55 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Body weight >=40 kg.
  • Confirmed diagnosis of HbSS (SCD genotype of sickle cell anemia) or HbSβ0 (SCD genotype of sickle cell beta zero thalassemia).
  • Vaccination against Neisseria Meningitidis serotypes A, C, W, and Y.
  • Vaccinations against H. influenzae type B and S. pneumoniae.
  • Participants vaccinated against SARS-CoV-2 are eligible, as long as it has been 3 days or more after inoculation with the vaccine.
  • Diagnosis of an acute uncomplicated VOE, that requires admission to a hospital/acute medical facility and treatment with parenteral opioid analgesics.
  • Adequate hepatic and renal function.
  • Hemoglobin >=5 grams/deciliter (g/dL)
  • Platelet count >=100,000/microliter (µL)
  • Participants receiving SCD-directed therapies must be on a stable dose for >=28 days.
  • For female participants of childbearing potential, an agreement to remain abstinent or use contraception for 322 days (approximately 10.5 months) after the dose of study treatment.

Exclusion Criteria:

  • 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 >36 hours.
  • Acute pain related to avascular necrosis, hepatic or splenic sequestration, or priapism.
  • Pain atypical of an acute uncomplicated VOE.
  • Evidence of or suspicion of ACS.
  • Evidence or high suspicion of a severe systemic infection.
  • Major surgery and/or hospitalization for any reason within 30 days.
  • History of Neisseria meningitidis infection within 6 months prior.
  • Known HIV infection with a documented CD4 count <200 cells/µL.
  • Transfusion or receipt of blood products within 3 months or current participation in a chronic transfusion protocol.
  • Immunized with a live attenuated vaccine within 30 days.
  • History of hematopoietic stem cell transplant.
  • Known or suspected hereditary complement deficiency.
  • Pregnant or breastfeeding, or intending to become pregnant during the study or within 322 days (approximately 10.5 months) after the study drug administration.
  • Participation in another interventional treatment study with an investigational agent or use of any experimental therapy within the prior 28 days or within five half-lives of that investigational product, whichever was greater.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Crovalimab
Participants will receive a single intravenous (IV) infusion of Crovalimab based on body weight.
Drug: Crovalimab
Crovalimab will be administered as a single dose of 1000 milligrams (mg) IV (for participants with a body weight between 40 kilograms (kg) and 100 kg) or 1500 mg IV (for participants with a body weight >=100 kg).
Placebo Comparator: Placebo
Participants will receive a single IV infusion of matching Placebo.
Drug: Placebo
Placebo will be administered as a single IV infusion, with an equal volume and over the same duration as weight- based crovalimab

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage of Participants with Infusion-Related Reactions and Hypersensitivity
Time Frame: Baseline up to Day 84
Baseline up to Day 84
Percentage of Participants With Adverse Events (AEs)
Time Frame: Baseline up to Day 84
Baseline up to Day 84

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants with Anti-Drug Antibodies to Crovalimab
Time Frame: Baseline up to Day 84
Baseline up to Day 84
Time to Improvement of the Primary Acute Uncomplicated VOE From Baseline
Time Frame: Baseline up to Day 84
Baseline up to Day 84
Total Cumulative Opioid Dose From Baseline
Time Frame: Baseline up to Day 84
Baseline up to Day 84
Time to Discontinuation of all Parenteral Opioids From Baseline
Time Frame: Baseline up to Day 84
Baseline up to Day 84
Time to Readiness For Hospital Discharge From Baseline
Time Frame: Baseline up to Day 84
Baseline up to Day 84
Time to Hospital Discharge From Baseline
Time Frame: Baseline up to Day 84
Baseline up to Day 84
Time to a Confirmed Decrease in Pain Score of at Least 2 Points From the Maximal Pre-dose Pain Score
Time Frame: Baseline up to Day 84
Baseline up to Day 84
Change in Pain Score From the Maximal Pre-dose Pain Score to the Score at Hospital Discharge
Time Frame: Baseline up to Day 84
Baseline up to Day 84
Percentage of Participants who Develop Acute Chest Syndrome (ACS)
Time Frame: Baseline up to Day 28
Baseline up to Day 28
Percentage of Participants Requiring Intensive Care Unit (ICU)/Critical Care Admission for SCD-related Complications
Time Frame: Baseline up to Day 84
Baseline up to Day 84
Percentage of Participants Requiring Blood Transfusion for SCD-related Complications
Time Frame: Baseline up to Day 84
Baseline up to Day 84
Readmission Rate for a VOE or VOE-related Event Within 28 days of Discharge of the Primary Acute Uncomplicated VOE
Time Frame: Baseline up to Day 84
Baseline up to Day 84
Serum Concentrations of Crovalimab Over Time
Time Frame: Baseline up to Day 84
Baseline up to Day 84
Change in PD Biomarkers Including Complement Activity (CH50) Over Time
Time Frame: Baseline up to Day 84
Assessed by a Liposome Immunoassay (LIA)
Baseline up to Day 84
Change Over Time in Free C5 Concentration
Time Frame: Baseline up to Day 84
Baseline up to Day 84
Change Over Time in Soluble Complement 5b 9 (sC5b-9) Concentration
Time Frame: Baseline up to Day 84
Baseline up to Day 84

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 26, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 23, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 3, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BO42452
  • 2020-004840-27 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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