Sickle Cell DiseasePhase 1CROSSWALK-aNCT04912869
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).
A Phase 1 study testing Crovalimab in people with Sickle Cell Disease, run by Hoffmann-La Roche at 16 sites in 10 countries.
Trial summary
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. 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
- 30 participants
- Where
- 16 sitesin 10 countries
- Study dates
- 26 Mar 2022to 15 Aug 2025
- Phase
- Phase 1
- 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.
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
16 sites in 10 countries.
16 sites in 10 countries
Spain3 sites
Hospital General Univ. Gregorio Maranon
Madrid, 28009
Hospital Universitario Virgen del Rocio
Seville, 41013
Hospital Universitario Miguel Servet
Zaragoza, 50009
United States2 sites
Children'S Healthcare of Atlanta
Atlanta, Georgia, 30329
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Brazil2 sites
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul
Hospital Sao Rafael - HSR
Salvador, Estado de Bahia, 41253-190
Kenya2 sites
International Cancer Institute (ICI)
Eldoret, 30100
Gertrude's Children Hospital
Nairobi
Lebanon2 sites
American University of Beirut - Medical Center
Beirut, 1107 2020
Hopital Nini
Tripoli
Italy1 site
Azienda Ospedaliera di Verona-Policlinico G.B. Rossi
Verona, Veneto, 37134
South Africa1 site
Charlotte Maxeke Johannesburg Hospital
Johannesburg, 2193
About this study
Official title: 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.
- 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 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).
PlaceboDrug
Placebo will be administered as a single IV infusion, with an equal volume and over the same duration as weight- based crovalimab
| Study group | Role | What they receive |
|---|---|---|
| Crovalimab | Experimental | Participants will receive a single intravenous (IV) infusion of Crovalimab based on body weight. Receives: Drug: Crovalimab |
| Placebo | Placebo comparator | Participants will receive a single IV infusion of matching Placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events (AEs)
Measured: Baseline up to Day 84
Percentage of Participants with Infusion-Related Reactions and Hypersensitivity
Measured: Baseline up to Day 84
Secondary outcomes (16)
Time to Improvement of the Primary Acute Uncomplicated VOE From Baseline
Measured: Baseline up to Day 84
Total Cumulative Opioid Dose From Baseline
Measured: Baseline up to Day 84
Time to Discontinuation of all Parenteral Opioids From Baseline
Measured: Baseline up to Day 84
Time to Readiness For Hospital Discharge From Baseline
Measured: Baseline up to Day 84
Time to Hospital Discharge From Baseline
Measured: 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
Measured: Baseline up to Day 84
Change in Pain Score From the Maximal Pre-dose Pain Score to the Score at Hospital Discharge
Measured: Baseline up to Day 84
Percentage of Participants who Develop Acute Chest Syndrome (ACS)
Measured: Baseline up to Day 28
Percentage of Participants Requiring Intensive Care Unit (ICU)/Critical Care Admission for SCD-related Complications
Measured: Baseline up to Day 84
Percentage of Participants Requiring Blood Transfusion for SCD-related Complications
Measured: 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
Measured: Baseline up to Day 84
Serum Concentrations of Crovalimab Over Time
Measured: Baseline up to Day 84
Change in PD Biomarkers Including Complement Activity (CH50) Over Time
Assessed by a Liposome Immunoassay (LIA)
Measured: Baseline up to Day 84
Change Over Time in Free C5 Concentration
Measured: Baseline up to Day 84
Change Over Time in Soluble Complement 5b 9 (sC5b-9) Concentration
Measured: Baseline up to Day 84
Percentage of Participants with Anti-Drug Antibodies to Crovalimab
Measured: Baseline up to Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start26 Mar 2022
- Primary completion23 Dec 2024
- Study completion15 Aug 2025
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 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
- NCT04912869
- Sponsor's protocol ID
- BO42452
- Other IDs
- 2020-004840-27
- Acronym
- CROSSWALK-a
- Status last verified
- Aug 2025
- First submitted
- 2 Jun 2021
- Last updated
- 26 Aug 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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).
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04912869
- Acronym / sponsor ID
- CROSSWALK-a / BO42452
- Conditions
- Sickle Cell Disease
- Keywords
- Vaso-occlusive episodes, Pain crisis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2022 (actual)
- Primary completion
- 23 Dec 2024 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 3 Jun 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.
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 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 single intravenous (IV) infusion of Crovalimab based on body weight. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a single IV infusion of matching Placebo. |
Who may qualify
- Ages
- 12 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
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 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). | Drug | Crovalimab |
| PlaceboPlacebo will be administered as a single IV infusion, with an equal volume and over the same duration as weight- based crovalimab | Drug | Placebo |
Primary outcome
Percentage of Participants With Adverse Events (AEs)
Time frame: Baseline up to Day 84
Percentage of Participants with Infusion-Related Reactions and Hypersensitivity
Time frame: Baseline up to Day 84
16 secondary outcomes
Time to Improvement of the Primary Acute Uncomplicated VOE From Baseline
Time frame: Baseline up to Day 84
Total Cumulative Opioid Dose From Baseline
Time frame: Baseline up to Day 84
Time to Discontinuation of all Parenteral Opioids From Baseline
Time frame: Baseline up to Day 84
Time to Readiness For Hospital Discharge From Baseline
Time frame: Baseline up to Day 84
Time to Hospital Discharge From Baseline
Time frame: 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
Change in Pain Score From the Maximal Pre-dose Pain Score to the Score at Hospital Discharge
Time frame: Baseline up to Day 84
Percentage of Participants who Develop Acute Chest Syndrome (ACS)
Time frame: 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
Percentage of Participants Requiring Blood Transfusion for SCD-related Complications
Time frame: 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
Serum Concentrations of Crovalimab Over Time
Time frame: Baseline up to Day 84
Change in PD Biomarkers Including Complement Activity (CH50) Over Time
Time frame: Baseline up to Day 84
Change Over Time in Free C5 Concentration
Time frame: Baseline up to Day 84
Change Over Time in Soluble Complement 5b 9 (sC5b-9) Concentration
Time frame: Baseline up to Day 84
Percentage of Participants with Anti-Drug Antibodies to Crovalimab
Time frame: Baseline up to Day 84
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 26 Aug 2025.
- Individual participant dataSharing planned: No. 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).
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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
16 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Crovalimab in people with Sickle Cell Disease, run by Hoffmann-La Roche at 16 sites in 10 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 11 inclusion and 15 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 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Spain, United States, Brazil, Kenya, Lebanon and 5 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Percentage of Participants With Adverse Events (AEs) (time frame: Baseline up to Day 84). The study lists 2 primary outcomes in all. 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 26 Aug 2025.