Crovalimab for Sickle Cell Disease

(CROSSWALK-c Trial)

Recruiting at 46 trial locations

Overseen By Reference Study ID Number: BO42451 https://forpatients.roche.com/

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Hoffmann-La Roche

Disqualifiers: Stem cell transplant, Chronic transfusion, HIV, others

Stay on Your Current Meds You can continue your current medications while participating

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

90 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing crovalimab to see if it can safely and effectively prevent painful episodes in people with Sickle Cell Disease by stopping the immune system from causing blood vessel blockages.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on SCD-directed therapy or erythropoietin, you must have been on a stable dose for at least 3 months before joining the study and should not change the dose during the study unless for safety reasons.

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

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.

Inclusion Criteria

I have been on a stable dose of erythropoietin for at least 3 months.

I have been vaccinated against COVID-19 with an approved vaccine at least 3 days ago.

I weigh at least 40 kg.

Exclusion Criteria

I have not had a serious infection in the last 14 days.

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

I have had a fever of 38°C or higher in the past week.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Crovalimab or placebo for a total of 48 weeks. Initial loading dose followed by weekly subcutaneous doses for 4 weeks, then maintenance dosing every 4 weeks.

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Crovalimab

Trial Overview 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.

Participant Groups

Group I: Crovalimab Experimental Treatment 1 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: Placebo Placebo Group 1 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.

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University