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

NCT07172022 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2026-03-02

No results posted yet for this study

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

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).

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-16
Primary Completion
2030-03-11
Completion
2030-12-02
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07172022 on ClinicalTrials.gov