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Submitted by: Kristal Ann Placido 2018-07-19 00:00:00 Last Updated by: Kristal Ann Placido 2020-03-02 11:35:12


A Randomized, Controlled, Double-blind, Continuation Study Comparing the Long-term Safety and Efficacy of Orelvo (voclosporin) (23.7 mg Twice Daily) with Placebo in Subjects with Lupus Nephritis

PHRR180727-001869

2018-CT0443

2018-CT0443

A Randomized, Controlled, Double-blind, Continuation Study Comparing the Long-term Safety and Efficacy of Orelvo (voclosporin) (23.7 mg Twice Daily) with Placebo in Subjects with Lupus Nephritis

The aim of the Phase 3 continuation study (AURORA 2) is to assess the long-term safety and tolerability of voclosporin, added to the standard of care treatment in LN, for an additional 24 months, following a treatment period of 52 weeks in the AURORA 1 study (AUR-VCS-2016-01). All subjects will continue to receive background therapy of MMF and/or oral corticosteroids starting at the same dose as at the end of the AURORA 1 study. Subjects with LN, who have completed 52 weeks of treatment with study drug in the AURORA 1 study, will be eligible to enter the study. The long-term safety and tolerability of the drug combination will be assessed from its safety profile while demonstrating the continued ability to achieve and maintain long-term renal response.

Start Date Duration in Months Target Completion Date Actual Completion Date
2018-12-07 24 2020-12-07 0000-00-00

Ongoing

Institution Classification Region LTO #
Aurinia Pharmaceuticals Inc. Private Business Canada CDRR-NCR-CRO-25
Institution Classification Region LTO #
CMIC Asia-Pacific (Philippines), Inc. Private Business NCR CDRR-NCR-CRO-25
Institution Region
Aurinia Pharmaceuticals Inc. Canada
Name E-Mail Institution and Institution Address
Kristal Ann M. Placido kristalann.placido@cmicgroup.com Blk 1 Lot 5 Cerritos Terraces Daang Hari Bacoor Cavite 1402 Philippines
Name E-Mail Institution and Institution Address
Dr. Eteri Tsetskhladze Eteri.Tsetskhladze@wwctrials.com 5, Chavchavadze Avenue, Tbilisi, Georgia, 0179
Name Expertise Affiliation
Allan E. Lanzon, MD Rheumatologist Mary Mediatrix Medical Center
Bernadette Heizel Manapat-Reyes, MD Rheumatologist Philippine General Hospital
Edgar Ramiterre, MD Rheumatologist Southern Philippines Medical Center
Eric Jason Amante, MD Rheumatologist Manila Doctors Hospital
Harold Michael P. Gomez, MD Rheumatologist Angeles University Foundation Medical Center
Juan Javier T. Lichauco, MD Rheumatologist St. Luke's Medical Center - Quezon City
Linda Charmaine D. Roberto, MD Rheumatologist Jose R. Reyes Memorial Medical Center
Llewellyn T. Hao, MD Rheumatologist Davao Doctors Hospital
Michael L. Tee, MD Rheumatologist Medical Center Manila
Sandra Teresa V. Navarra, MD Rheumatologist St. Luke's Medical Center - Quezon City
Project Location Institutional Ethics Review Board
Mary Mediatrix Medical Center Mary Mediatrix Medical Center Research Ethics Review Committee
Philippine General Hospital Philippine General Hospital Ethics Review Board
Southern Philippines Medical Center DOH XI Cluster Ethics Review Committee
Manila Doctors Hospital Manila Doctors Hospital Institutional Review Board
Angeles University Foundation Medical Center Angeles University Foundation Medical Center Institutional Ethics Review Committee
St. Luke's Medical Center - Quezon City St. Luke's Medical Center Institutional Ethics Review Board
Jose R. Reyes Memorial Medical Center Jose R. Reyes Memorial Medical Center Ethics Review Committee
Davao Doctors Hospital Davao Doctors Hospital Ethics Review Committee
Medical Center Manila Manila Medical Ethics Review Committee
St. Luke's Medical Center - Quezon City St. Luke's Medical Center Institutional Ethics Review Board

Active lupus nephritis

To assess the long-term safety and tolerability of Orelvo compared with placebo for up to an additional 24 months following completion of treatment in the AURORA 1 study in subjects with lupus nephritis (LN).

To assess the long-term efficacy of Orelvo compared with placebo for up to an additional 24 months following completion of treatment in the AURORA 1 study in subjects with LN.

Recruiting

  • Argentina
  • Belarus
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • Colombia
  • Costa Rica
  • Croatia
  • Dominican Republic
  • Guatemala
  • Japan
  • Macedonia
  • Malaysia
  • Mexico
  • Netherlands
  • Peru
  • Philippines
  • Poland
  • Russia
  • Serbia and Montenegro
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Turkey
  • Ukraine
  • United States
  • Vietnam

Clinical Trial

2018-CT0443

20180302164931

2018-06-25

0000-00-00

23

Unspecified

AURORA 2 has not started in Philippines

07 Dec 2018

Inclusion Criteria:

1. Subjects who have completed 52 weeks of treatment with study drug in the AURORA 1 study. Subjects who had a temporary interruption and successfully restarted study drug during the AURORA 1 study will be allowed with Medical Monitor approval.
2. Women of childbearing potential must continue to use effective contraception and have a negative urine pregnancy test at Month 12.
3. Subject is willing to continue taking oral MMF for the duration of the study.

Exclusion Criteria:
1. Currently taking or known need for any of the medications or food items listed in Section 7.8, Prohibited Therapy and Concomitant Treatment during the study.
2. Subjects currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
3. A planned kidney transplant within study treatment period.
4. Subjects with any medical condition which, in the Investigator's judgment, may be associated with increased risk to the subject or may interfere with study assessments or outcomes.
5. Subjects who are pregnant, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions.
6. Vaccines using live organisms, virus or bacterial, while taking the study treatment.

Interventional

Voclosporin 7.9 mg soft gel capsules or matching placebo capsules. 23.7 mg BID

Orelvo (Voclosporin) softgel capsules and matching Placebo capsules will be supplied in cartons containing
168 capsules in 4 wallets of 42 capsules each

None

Randomized

Double Blind

All study personnel and subjects will be blinded to the study treatment administered during the study. Voclosporin and placebo will be identical in taste, smell, and appearance. The site staff, monitors, and study subjects will remain blinded until the end of the study.

Parallel

The purpose of this study is assess the long-term safety and tolerability of voclosporin compared with placebo for up to an additional 24 months following completion of treatment in the AURORA 1 study in subjects with lupus nephritis (LN).

Phase III

Utilization Utilization Info
Publication
Oral Presentation
Drug Literature
Posters
Others
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