Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at Irvine, California and other locations
Dates
study started
estimated completion

Description

Summary

This study will enroll participants aged 12 years or older with a body weight >= 40 kg diagnosed with PNH who have not been previously treated with complement inhibitor therapy. Approximately 200 participants will be randomized in a 2:1 ratio into the following regimens: [1] Crovalimab; [2] Eculizumab.

Official Title

A Phase III, Randomized, Open-Label, Active-Controlled, Multicenter Study Evaluating The Efficacy And Safety Of Crovalimab Versus Eculizumab In Adult And Adolescent Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors.

Keywords

Paroxysmal Nocturnal Hemoglobinuria Hemoglobinuria Hemoglobinuria, Paroxysmal Crovalimab Eculizumab

Eligibility

You can join if…

Open to people ages 12 years and up

  • Body weight >= 40 kg at screening.
  • Willingness and ability to comply with all study visits and procedures.
  • Documented diagnosis of PNH, confirmed by high sensitivity flow cytometry.
  • LDH level >= 2x ULN at screening (as per local assessment).
  • Vaccination against Neisseria meningitidis < 3 years prior to initiation of study treatment.
  • Women of childbearing potential: agreement to remain abstinent or use contraception.

You CAN'T join if...

  • Current or previous treatment with a complement inhibitor.
  • History of allogeneic bone marrow transplantation.
  • History of Neisseria meningitidis infection within 6 months prior to screening and up to first study drug administration.
  • Pregnant or breastfeeding, or intention of becoming pregnant during the study or within 6 months after the final dose of the study treatment.
  • Participation in another interventional treatment study with an investigational agent or use of any experimental therapy within 28 days of screening or within 5 half-lives of that investigational product, whichever is greater.
  • Concurrent disease, treatment, procedure or surgery, or abnormality in clinical laboratory tests that could interfere with the conduct of the study, may pose any additional risk for the participant, or would, in the opinion of the Investigator, preclude the participant's safe participation in and completion of the study.
  • Splenectomy < 6 months before screening.
  • Positive for Active Hepatitis B and C infection (HBV/HCV).
  • History of or ongoing cryoglobulinemia at screening.

Locations

  • University of California Irvine
    Irvine California 92697 United States
  • Innovative Clinical Research Institute
    Whittier California 90603 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT04434092
Phase
Phase 3
Study Type
Interventional
Last Updated