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

NCT07172022 | Withdrawn Phase 2 FDA Drug

• 2 other identifiers: BO461072025-522980-14-00
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Time From Randomization to First Occurrence of Objectively Confirmed Arterial Thrombosis, Venous Thromboembolism or Cardiovascular Death

  Up to approximately 4.5 years

Secondary Outcomes (7)

• Time From Randomization to the First Occurrence of Objectively Confirmed Venous Thromboembolism

  Up to approximately 4.5 years

• Time From Randomization to the First Occurrence of Objectively Confirmed Arterial Thrombosis

  Up to approximately 4.5 years

• Percentage of Participants With Adverse Events (AEs) With Severity Determined According to the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)

  Up to approximately 4.5 years

• Percentage of Participants With Injection Site Reactions and Hypersensitivity

  Up to approximately 4.5 years

• Percentage of Participants With Infections and Severity of Infection

  Up to approximately 4.5 years

Study Arms (2)

Crovalimab + VKA

EXPERIMENTAL

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.

Drug: Crovalimab; Drug: VKA

Placebo + VKA

PLACEBO COMPARATOR

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.

Drug: Placebo; Drug: VKA

Interventions

Crovalimab 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.

Also known as: RO7112689; SKY59; PIASKY

Crovalimab + VKA

Placebo DRUG

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

Placebo + VKA

VKA 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).

Crovalimab + VKA; Placebo + VKA

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

MeSH Terms

Conditions

Antiphospholipid Syndrome

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 15, 2025
• Study Start: March 16, 2026
• Primary Completion (Estimated): March 11, 2030
• Study Completion (Estimated): December 2, 2030
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share