A Study Evaluating The Safety, Pharmacokinetics, and Efficacy Of Crovalimab Versus Eculizumab In Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors

a study on Paroxysmal Nocturnal Hemoglobinuria

Summary

Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Caspian Oliai (ucla)

Description

Summary

A study designed to evaluate the safety of crovalimab with eculizumab in participants with PNH currently treated with complement inhibitors. This study will enroll approximately 190 participants.

Official Title

A Phase III, Randomized, Open-Label, Active-Controlled, Multicenter Study Evaluating The Safety, Pharmacokinetics, Pharmacodynamic And Efficacy of Crovalimab Versus Eculizumab In Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors

Keywords

Paroxysmal Nocturnal Hemoglobinuria, Hemoglobinuria, Paroxysmal Hemoglobinuria, Eculizumab, Crovalimab, Crovalimab) (Exploratory

Eligibility

You can join if…

  • Body weight >= 40 kg at screening.
  • Treated with eculizumab or ravulizumab for PNH for at least 3 months prior to Day 1.
  • Lactate Dehydrogenase Levels =< 2x the upper limit of normal (ULN) at screening.
  • Willingness and ability to comply with all study visits and procedures.
  • Documented diagnosis of PNH, confirmed by high sensitivity flow cytometry.
  • Vaccination against Neisseria meningitidis serotypes A, C, W, and Y < 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 (refrain from heterosexual intercourse) or use contraception during the treatment period and for 10.5 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...

  • History of allogeneic bone marrow transplantation.
  • History of myelodysplastic syndrome with Revised International Prognostic Scoring System (IPSS-R) prognostic risk categories of intermediate, high and very high.
  • Pregnant or breastfeeding, or intending to become pregnant during the study, within 10.5 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 was greater: participants enrolled in an eculizumab or ravulizumab interventional study are eligible provided they fulfill eligibility (e.g., are willing and able to comply with the study assessments) and stop their participation in current trial before randomisation/enrolment.
  • Positive for Active Hepatitis B and C infection (HBV/HCV).
  • 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.
  • History of or ongoing cryoglobulinemia at screening.

Locations

  • David Geffen School of Medicine UCLA accepting new patients
    Los Angeles California 90095 United States
  • The Oncology Institute of Hope and Innovation in progress, not accepting new patients
    Anaheim California 92801 United States
  • University of Texas Health Science Center at San Antonio accepting new patients
    San Antonio Texas 78229 United States

Lead Scientist at University of California Health

  • Caspian Oliai (ucla)
    HS Assistant Clinical Professor, Medicine. Authored (or co-authored) 23 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT04432584
Phase
Phase 3 Paroxysmal Nocturnal Hemoglobinuria Research Study
Study Type
Interventional
Participants
Expecting 190 study participants
Last Updated