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

Sponsor
Hoffmann-La Roche
Study ID
NCT07172022
Phase
PHASE2
Status
Withdrawn

Conditions

  • Antiphospholipid Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

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.
  • Placebo — DRUG
    Placebo matching crovalimab will be administered as per the schedule specified in the respective arm.
  • 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).

Study Details

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.

Key Dates

Start date
Mar 16, 2026
Status verified
Feb 2026
Primary completion
Mar 11, 2030
Completion
Dec 2, 2030

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Placebo Comparator: 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.

Primary Outcome Measure

Time From Randomization to First Occurrence of Objectively Confirmed Arterial Thrombosis, Venous Thromboembolism or Cardiovascular Death [ Time Frame: Up to approximately 4.5 years ]

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