NCT07172022

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

A Phase II, Randomized, Double-blind, Placebo-controlled, Multicenter Study Evaluating Efficacy, Safety, and Pharmacokinetics of Crovalimab in Patients With Antiphospholipid Syndrome (APS)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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.
DRUG	Placebo	Placebo matching crovalimab will be administered as per the schedule specified in the respective arm.
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).

Timeline

• Start date: 2026-03-16
• Primary completion: 2030-03-11
• Completion: 2030-12-02
• First posted: 2025-09-15
• Last updated: 2026-03-02

Regulatory

• FDA-regulated drug study