A Study to Evaluate Crovalimab in People With Antiphospholipid Syndrome (APS)

NCT ID: NCT07172022

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-16
• Study Completion Date: 2030-12-02

Brief Summary

The main purpose of this study is to evaluate the efficacy of crovalimab compared with placebo as an add-on therapy to vitamin K antagonist (VKA) in participants with APS.

Conditions

Antiphospholipid Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Crovalimab + VKA

Participants will receive 3 loading doses of crovalimab, 680 milligrams (mg) or 1020 mg, as a subcutaneous (SC) injection based on their body weight (BW) at Weeks 1, 2 and 3 followed by maintenance doses, every 4 weeks (Q4W) from Week 5 until arterial thrombosis, venous thromboembolism or cardiovascular death. Participants will also receive VKA with a target internal normalized ratio (INR) based on investigator's discretion and local guidance.

Group Type: EXPERIMENTAL

Crovalimab

Intervention Type: DRUG

Crovalimab will be administered at a dose of 680 mg (for participants with BW ≥ 40 kilograms \[kg\] to \< 100 kg) or 1020 mg (for participants with BW ≥ 100 kg), as a SC injection, at Weeks 1, 2, and 3 and Q4W from Week 5 onwards.

VKA

Intervention Type: DRUG

Dose administration of VKA will be in accordance with the local prescribing information for the respective product. The VKA regimen will be titrated to a therapeutic target INR based on investigator discretion and local standard of care (SOC).

Placebo + VKA

Participants will receive 3 doses of placebo as a SC injection with equal volume dosing as the weight-based crovalimab at Weeks 1, 2, and 3, followed by Q4W doses, as a SC injection, from Week 5 until arterial thrombosis, venous thromboembolism, or cardiovascular death. Participants will also receive VKA with a target INR based on the investigator's discretion and local guidance.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo matching crovalimab will be administered as per the schedule specified in the respective arm.

VKA

Intervention Type: DRUG

Dose administration of VKA will be in accordance with the local prescribing information for the respective product. The VKA regimen will be titrated to a therapeutic target INR based on investigator discretion and local standard of care (SOC).

Interventions

Crovalimab

Crovalimab will be administered at a dose of 680 mg (for participants with BW ≥ 40 kilograms \[kg\] to \< 100 kg) or 1020 mg (for participants with BW ≥ 100 kg), as a SC injection, at Weeks 1, 2, and 3 and Q4W from Week 5 onwards.

Intervention Type: DRUG

Placebo

Placebo matching crovalimab will be administered as per the schedule specified in the respective arm.

Intervention Type: DRUG

VKA

Dose administration of VKA will be in accordance with the local prescribing information for the respective product. The VKA regimen will be titrated to a therapeutic target INR based on investigator discretion and local standard of care (SOC).

Intervention Type: DRUG

Other Intervention Names

RO7112689; SKY59; PIASKY

Eligibility Criteria

Inclusion Criteria

• Age ≥18 years and ≤70 years, and body weight ≥40 kilograms (kg), at the time of signing Informed Consent Form
• Vaccination against N. meningitidis, H. influenzae type B, and S. pneumoniae
• Participants classified with APS who have experienced at least two prior arterial and/or venous thrombotic events, based on the 2023 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) criteria, positive for at least two of the following: lupus anticoagulant (LAC) test, anticardiolipin antibodies (aCL), anti-β2-glycoprotein 1 antibodies (aβ2GP1)
• Participants receiving corticosteroids, antimalarial treatment, non-biologic disease-modifying rheumatic drugs, statins, and low dose aspirin must be on a stable dose prior to the first dose of study treatment
• Willingness and ability to comply with a VKA regimen titrated to a therapeutic target internal normalized ratio (INR)
• Agreement to adhere to the contraception requirements

Exclusion Criteria

• Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required
• Treatment with investigational therapy, complement inhibitor, and/or other immune-suppressive biologic therapy within 5 half-lives of that agent prior to screening visit, or plans to participate in another investigational trial
• Presence of another systemic autoimmune disease that is unstable and requires additional treatment, and constitutes the principal illness and may impact evaluation of the concurrent APS
• Inadequate renal and hepatic function
• Uncontrolled hyperlipidemia and/or hypertension, known diabetes mellitus, and/or serious infection requiring hospitalization or antibiotics prior to Week 1 Day 1
• History or condition associated with increased bleeding risk

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Central Contacts

Reference Study ID Number: BO46107 https://forpatients.roche.com/

Role: CONTACT

global-roche-genentech-trials@gene.com

888-662-6728 (U.S. Only)

Other Identifiers

2025-522980-14-00

Identifier Type: CTIS

Identifier Source: secondary_id

BO46107

Identifier Type: -

Identifier Source: org_study_id