Summary

Location
at Irvine, California and other locations
Dates
study started
estimated completion

Description

Summary

A study designed to evaluate the non-inferiority of crovalimab compared with eculizumab in participants with PNH who have not been previously treated with complement inhibitor therapy. This study will enroll approximately 200 participants.

Official Title

A Phase III, Randomized, Open-Label, Active-Controlled, Multicenter Study Evaluating The Efficacy And Safety Of Crovalimab Versus Eculizumab In 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…

  • 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; or, if not previously done, vaccination administered no later than one week after the first drug administration.
  • Women of childbearing potential: agreement to remain abstinent or use contraception during the treatment period and for 6 months after the final dose of crovalimab or for 3 months after the final dose of eculizumab (or longer if required by the local product label).

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 intending to become pregnant during the study, within 6 months after the final dose of crovalimab, or 3 months after the final dose of eculizumab (or longer if required by the local product label).
  • 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 not yet accepting patients
    Irvine California 92697 United States
  • The Oncology Institute of Hope and Innovation accepting new patients
    Glendale California 91204 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT04434092
Phase
Phase 3
Study Type
Interventional
Last Updated