Sickle Cell DiseasePhase 2CROSSWALK-cNCT05075824
A Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab as Adjunct Treatment in Prevention of Vaso-Occlusive Episodes (VOE) in Sickle Cell Disease (SCD)
A Phase 2 study testing Crovalimab in people with Sickle Cell Disease, run by Hoffmann-La Roche at 27 sites in 11 countries.
Trial summary
This study is designed to evaluate the efficacy, safety and pharmacokinetics of crovalimab compared with placebo as adjunct therapy in the prevention of VOEs in participants with SCD. Read more about this study
- Who is it for?
- Ages 12 to 55 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Crovalimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 27 sitesin 11 countries
- Study dates
- 9 Mar 2022to 9 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Body weight >=40 kg.
- Male or female with confirmed diagnosis of HbSS (SCD genotype of sickle cell anemia) or HbSβ0 (SCD genotype of sickle cell beta zero thalassemia).
- Two or more (>=2) to <=10 documented VOEs in the 12 months prior to randomisation.
- If receiving concurrent SCD-directed therapy, the participant must have been on a stable dose for a minimum of 3 months prior to study enrollment. There should be no plans to modify the participants' dosing throughout the study duration, other than for safety reasons.
- 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.
- Vaccination against N. meningitides serotypes A, C, W, and Y and Vaccinations against H. influenza type B and S. pneumonia.
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- Participants who have been vaccinated (partially or in full) against SARS-CoV-2 with a locally approved vaccine are eligible to be enrolled in the study, 3 days or longer after inoculation.
- Adequate hepatic and renal function.
- For women of childbearing potential: agreement to remain abstinent or use contraception during the treatment period and for 10.5 months after the final dose of study treatment.
Who cannot join
- History of hematopoietic stem cell transplant.
- Participating in a chronic transfusion program and/or planning on undergoing an exchange transfusion during the duration of the study.
- History of hypersensitivity, allergic, or anaphylactic reactions to any ingredient contained in the study treatment.
- Received active treatment on another investigational trial within 28 days (or within five half-lives of that agent, whichever is greater) prior to screening visit, or plans to participate in another investigational drug trial.
- Hemoglobin <6 g/dL.
- Known or suspected hereditary complement deficiency.
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- Active systemic bacterial, viral, or fungal infection within 14 days before first drug administration.
- Presence of fever (>=38 degrees Celsius) within 7 days before the first drug administration.
- Immunised with a live attenuated vaccine within 1 month before first drug administration.
- Pregnant or breastfeeding, or intending to become pregnant during the study or within 10.5 months after the final dose of study treatment.
- Known HIV infection with documented CD4 count <200 cells/microliter within 24 weeks prior to screening.
- History of N. meningitidis infection within the prior 6 months.
Trial locations and contacts
27 sites in 11 countries.
27 sites in 11 countries
Brazil8 sites
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
Botucatu, São Paulo, 18618-970
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul
Hospital das Clínicas Faculdades Médicas de Ribeirão Preto
Ribeirão Preto, São Paulo, 14051-140
HEMORIO
Rio de Janeiro, 20211-030
Hospital Sao Rafael - HSR
Salvador, Estado de Bahia, 41253-190
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, 15090-000
Beneficencia Portuguesa de Sao Paulo
São Paulo, São Paulo, 01323-900
Hospital Samaritano
São Paulo, 01232-010
United States4 sites
Children's Hospital of Michigan
Detroit, Michigan, 48201
East Carolina University
Greenville, North Carolina, 27834
Mississippi Center for Advanced Medicine
Madison, Mississippi, 39110
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Turkey (Türkiye)3 sites
Adana Acibadem Hospital; Pediatric Hematology
Adana, 01130
Cukurova University Medical Faculty Balcali Hospital
Adana, 1330
Mersin Universitesi Tip Fakultesi Hastanesi
Mersin, 33343
Italy2 sites
Università degli Studi della Campania Luigi Vanvitelli
Naples, Campania, 80138
Azienda Ospedaliera di Verona-Policlinico G.B. Rossi
Verona, Veneto, 37134
Kenya2 sites
International Cancer Institute (ICI)
Eldoret, 30100
Gertrude's Children Hospital
Nairobi
Spain2 sites
Hospital General Univ. Gregorio Maranon
Madrid, 28009
Hospital Universitario Miguel Servet
Zaragoza, 50009
United Kingdom2 sites
Central Middlesex Hospital
London, NW10 7NS
Hammersmith Hospital
London, W12 0HS
South Africa1 site
Charlotte Maxeke Johannesburg Hospital
Johannesburg, 2193
About this study
Official title: A Randomized Double-Blind Phase IIA Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab as Adjunct Treatment in Prevention of Vaso-Occlusive Episodes (VOE) in Sickle Cell Disease (SCD)
This study is designed to evaluate the efficacy, safety and pharmacokinetics of crovalimab compared with placebo as adjunct therapy in the prevention of VOEs in participants with SCD.
- Conditions
- Sickle Cell Disease
- Being tested
- Crovalimab, Placebo
- Keywords
- Vaso-occlusive episodes, Pain crisis
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrovalimabDrug
Crovalimab will be administered at a dose of 1000 mg IV (for participants with body weight between 40 kg and 100 kg) or 1500 mg IV (for participants with body weight >= 100 kg) on Week 1 Day 1. On Week 1 Day 2 and on Weeks 2, 3 and 4, crovalimab will be administered at a dose of 340 mg SC. For Week 5 and Q4W thereafter, crovalimab will be administered at a dose of 680 mg SC (for participants with body weight between 40 kg and 100 kg) or 1020 mg SC (for participants with body weight >= 100 kg). Dosing schedule will be as per Arm Description.
PlaceboDrug
Matching Placebo will be administered with the same dosing schedule and equivalent IV and SC volume as weight-based Crovalimab.
| Study group | Role | What they receive |
|---|---|---|
| Crovalimab | Experimental | 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. Receives: Drug: Crovalimab |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized rate of medical facility VOEs (AVR)
Measured: Baseline up to Week 49
Secondary outcomes (13)
Annualized rate of home VOE
Measured: Baseline up to Week 49
Annualized rate of uncomplicated medical facility VOE
Measured: Baseline up to Week 49
Annualized rate of Acute Chest Syndrome (ACS)
Measured: Baseline to up Week 49
Annualized rate of days hospitalized for medical facility VOE
Measured: Baseline up to Week 49
Annualized rate of days hospitalized for treatment of non-VOE complications of SCD
Measured: Baseline up to Week 49
Time to first medical facility VOE from randomization
Measured: Baseline up to Week 49
Change in urinary albumin-creatinine ratio
Measured: Baseline up to Week 49
Change in Tricuspid Regurgitant Jet Velocity (TRV)
Measured: Baseline up to Week 49
Percentage of Participants with TRV >2.5 m/s
Measured: Week 49
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue Score in Adults
Measured: Baseline up to Week 49
Percentage of Participants with Adverse Events (AEs)
Measured: Up to 91 weeks
Serum Concentrations of Crovalimab over time
Measured: Baseline up to Week 49
Percentage of Participants with Anti-Drug Antibodies to Crovalimab
Measured: Baseline up to Week 49
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start9 Mar 2022
- Primary completion11 Jun 2025
- Study completion9 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05075824
- Sponsor's protocol ID
- BO42451
- Other IDs
- 2020-004839-25, 2022-502542-28-00
- Acronym
- CROSSWALK-c
- Status last verified
- Apr 2026
- First submitted
- 20 Sep 2021
- Last updated
- 30 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind Phase IIA Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab as Adjunct Treatment in Prevention of Vaso-Occlusive Episodes (VOE) in Sickle Cell Disease (SCD)
- ClinicalTrials.gov ID
- NCT05075824
- Acronym / sponsor ID
- CROSSWALK-c / BO42451
- Conditions
- Sickle Cell Disease
- Keywords
- Vaso-occlusive episodes, Pain crisis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 11 Jun 2025 (actual)
- Study completion
- 9 Apr 2026 (actual)
- First posted
- 13 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the efficacy, safety and pharmacokinetics of crovalimab compared with placebo as adjunct therapy in the prevention of VOEs in participants with SCD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crovalimab | Experimental | Drug: CrovalimabParticipants 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. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 12 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Body weight >=40 kg.
- Male or female with confirmed diagnosis of HbSS (SCD genotype of sickle cell anemia) or HbSβ0 (SCD genotype of sickle cell beta zero thalassemia).
- Two or more (>=2) to <=10 documented VOEs in the 12 months prior to randomisation.
- If receiving concurrent SCD-directed therapy, the participant must have been on a stable dose for a minimum of 3 months prior to study enrollment. There should be no plans to modify the participants' dosing throughout the study duration, other than for safety reasons.
- 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.
Key exclusion criteria (12 listed)
- History of hematopoietic stem cell transplant.
- Participating in a chronic transfusion program and/or planning on undergoing an exchange transfusion during the duration of the study.
- History of hypersensitivity, allergic, or anaphylactic reactions to any ingredient contained in the study treatment.
- Received active treatment on another investigational trial within 28 days (or within five half-lives of that agent, whichever is greater) prior to screening visit, or plans to participate in another investigational drug trial.
- Hemoglobin <6 g/dL.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CrovalimabCrovalimab will be administered at a dose of 1000 mg IV (for participants with body weight between 40 kg and 100 kg) or 1500 mg IV (for participants with body weight >= 100 kg) on Week 1 Day 1. On Week 1 Day 2 and on Weeks 2, 3 and 4, crovalimab will be administered at a dose of 340 mg SC. For Week 5 and Q4W thereafter, crovalimab will be administered at a dose of 680 mg SC (for participants with body weight between 40 kg and 100 kg) or 1020 mg SC (for participants with body weight >= 100 kg). Dosing schedule will be as per Arm Description. | Drug | Crovalimab |
| PlaceboMatching Placebo will be administered with the same dosing schedule and equivalent IV and SC volume as weight-based Crovalimab. | Drug | Placebo |
Primary outcome
Annualized rate of medical facility VOEs (AVR)
Time frame: Baseline up to Week 49
13 secondary outcomes
Annualized rate of home VOE
Time frame: Baseline up to Week 49
Annualized rate of uncomplicated medical facility VOE
Time frame: Baseline up to Week 49
Annualized rate of Acute Chest Syndrome (ACS)
Time frame: Baseline to up Week 49
Annualized rate of days hospitalized for medical facility VOE
Time frame: Baseline up to Week 49
Annualized rate of days hospitalized for treatment of non-VOE complications of SCD
Time frame: Baseline up to Week 49
Time to first medical facility VOE from randomization
Time frame: Baseline up to Week 49
Change in urinary albumin-creatinine ratio
Time frame: Baseline up to Week 49
Change in Tricuspid Regurgitant Jet Velocity (TRV)
Time frame: Baseline up to Week 49
Percentage of Participants with TRV >2.5 m/s
Time frame: Week 49
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue Score in Adults
Time frame: Baseline up to Week 49
Percentage of Participants with Adverse Events (AEs)
Time frame: Up to 91 weeks
Serum Concentrations of Crovalimab over time
Time frame: Baseline up to Week 49
Percentage of Participants with Anti-Drug Antibodies to Crovalimab
Time frame: Baseline up to Week 49
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: Yes. For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
27 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Crovalimab in people with Sickle Cell Disease, run by Hoffmann-La Roche at 27 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Brazil, United States, Turkey (Türkiye), Italy, Kenya and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annualized rate of medical facility VOEs (AVR) (time frame: Baseline up to Week 49). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.