A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus

August 10, 2016 updated by: Genentech, Inc.

A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rontalizumab (rhuMAb IFNalpha) in Patients With Moderately to Severely Active Systemic Lupus Erythematosus

This is a Phase II, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of rontalizumab compared with placebo in patients with moderately to severely active systemic lupus erythematosus (SLE).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will be conducted in 3 parts. Parts 1 and 2 of the study will include a double-blind treatment period of 24 weeks and a safety follow-up period of 48 weeks for participants who do not continue onto Part 3. Patients meeting the eligibility criteria for enrollment in Part 3, will enter Part 3 after completion of the Week 24 visit but prior to completion of the Week 72 visit. In Part 1, participants will be randomized in a 2:1 ratio (active drug:placebo) to receive either rontalizumab 750 mg or matching placebo intravenously every 4 weeks for 24 weeks. Part 2 was will be initiated upon the completion of recruitment for Part 1. In Part 2, participants will be randomized in a 2:1 ratio (active drug:placebo) to receive either rontalizumab 300 mg or matching placebo subcutaneously every 2 weeks for 24 weeks. After Week 24, patients will enter a 48-week safety follow-up period, or, after the open label extension became available via protocol amendment, will have the option of entering Part 3 of the study, if eligible. In Part 3, all participants will receive rontalizumab 750 mg intravenously every 4 weeks for 120 weeks (up to 144 weeks total).

Study Type

Interventional

Enrollment (Actual)

238

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1015ABO
      • Buenos Aires, Argentina, C1181ACH
      • Ciudad Autonoma Buenos A., Argentina, C1284AEB
      • Rosario, Argentina, S2000DSV
      • San Miguel de Tucuman, Argentina, T4000AXL
  • Colombia
      • Barranquilla, Colombia
      • Barranquilla-Atlantico, Colombia
      • Bogota D.C., Colombia
      • Bogotá, Colombia
      • Bucaramanga, Colombia
      • Chia-Cundinamarca, Colombia
      • Medellin-Antioquia, Colombia
  • Mexico
      • Guadalajara, Mexico, 44280
      • Mexico, Mexico, 06726
      • Mexico Ctiy, Mexico, 07760
      • Mexico D.F., Mexico, 14000
      • Miexico City, Mexico, 06700
      • Morelia, Mexico, 58070
      • San Luis Potosi S.L.P., Mexico, 78240
  • Poland
      • Bydgoszcz, Poland, 85-168
      • Elblag, Poland, 82-300
      • Konskie, Poland, 26-200
      • Koscian, Poland, 64-000
      • Krakow, Poland, 30-510
      • Poznan, Poland, 60-218
      • Warszawa, Poland, 02-637
  • Russian Federation
      • Kazan, Russian Federation, 420064
      • Moscow, Russian Federation, 115522
      • Tomsk, Russian Federation, 634063
      • Yaroslavl, Russian Federation, 150030
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
      • Birmingham, Alabama, United States, 35294
    • Arizona
      • Tucson, Arizona, United States, 85724
    • California
      • La Jolla, California, United States, 92037
      • Long Beach, California, United States, 90806
      • Los Angeles, California, United States, 90048
      • Palo Alto, California, United States, 94304
      • San Leandro, California, United States, 94578
      • Upland, California, United States, 91786
    • Florida
      • Aventura, Florida, United States, 33180
      • Clearwater, Florida, United States, 33765
      • Orlando, Florida, United States, 32806
    • Georgia
      • Atlanta, Georgia, United States, 30303
    • Idaho
      • Coeur D'alene, Idaho, United States, 83814
    • Illinois
      • Chicago, Illinois, United States, 60637
      • Chicago, Illinois, United States, 60612
    • Kansas
      • Kansas City, Kansas, United States, 66160
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
    • Maryland
      • Cumberland, Maryland, United States, 21502
      • Hagerstown, Maryland, United States, 21740
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
    • New York
      • Brooklyn, New York, United States, 11203
      • Great Neck, New York, United States, 11020
      • Manhasset, New York, United States, 11030
      • New York, New York, United States, 10016
      • New York, New York, United States, 10021
      • Rochester, New York, United States, 14618
      • Roslyn, New York, United States, 11576
    • North Carolina
      • Chapel HIll, North Carolina, United States, 27599
      • Charlotte, North Carolina, United States, 28210
      • Greenville, North Carolina, United States, 27834
      • Winston-Salem, North Carolina, United States, 27157
    • Ohio
      • Cleveland, Ohio, United States, 44109
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
      • Tulsa, Oklahoma, United States, 74104
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
      • Philadelphia, Pennsylvania, United States, 19141
      • Pittsburgh, Pennsylvania, United States, 15213
    • South Carolina
      • Charleston, South Carolina, United States, 29406
      • Charleston, South Carolina, United States, 29425
    • Texas
      • Dallas, Texas, United States, 75231
      • Dallas, Texas, United States, 75390
      • Houston, Texas, United States, 77004
      • Houston, Texas, United States, 77034
      • Houston, Texas, United States, 77074
      • Sugar Land, Texas, United States, 77479
    • Virginia
      • Arlington, Virginia, United States, 22205
    • Washington
      • Spokane, Washington, United States, 99204

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of SLE.
  • Active disease at the time of screening.
  • Agreement to use an effective form of contraception for the duration of the study.

Exclusion Criteria:

  • Acutely life- or organ-threatening manifestations of systemic lupus erythematosus (SLE) (eg, proliferative nephritis, unstable neuropsychiatric disease).
  • Pregnancy or breastfeeding.
  • History of severe allergic or anaphylactic reactions to monoclonal antibodies or intravenous (IV) immunoglobulin.
  • Significant, uncontrolled medical disease in any organ system not related to SLE that in the investigator's opinion would preclude patient participation.
  • Concomitant conditions that required systemic corticosteroid use within 1 year prior to screening. Use of topical, intraarticular, or inhaled corticosteroids is not exclusionary.
  • History of cancer within 5 years of screening.
  • Any current or recent (within 4 weeks of screening) signs or symptoms of infection, except for minor infections, fungal infections of the nail beds, or oral or vaginal candidiasis.
  • History of severe systemic bacterial, fungal, viral, or parasitic infections (2 or more hospitalizations or 2 or more courses of IV antibiotics) within 6 months prior to screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Part 1 - Placebo intravenously
Participants received placebo intravenously every 4 weeks for 24 weeks.
Drug: Placebo
Placebo was supplied as a sterile liquid solution.
Experimental: Part 1 - Rontalizumab 750 mg intravenously
Participants received rontalizumab 750 mg intravenously every 4 weeks for 24 weeks.
Drug: Rontalizumab
Rontalizumab was supplied as a sterile liquid solution.
Placebo Comparator: Part 2 - Placebo subcutaneously
Participants received placebo subcutaneously every 2 weeks for 24 weeks.
Drug: Placebo
Placebo was supplied as a sterile liquid solution.
Experimental: Part 2 - Rontalizumab 300 mg subcutaneously
Participants received rontalizumab 300 mg subcutaneously every 2 weeks for 24 weeks.
Drug: Rontalizumab
Rontalizumab was supplied as a sterile liquid solution.
Experimental: Part 3 - Rontalizumab 750 mg intravenously
Participants received rontalizumab 750 mg intravenously every 4 weeks for 120 weeks.
Drug: Rontalizumab
Rontalizumab was supplied as a sterile liquid solution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of responders at Week 24
Time Frame: Until study discontinuation or up to 24 weeks
Until study discontinuation or up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Time-adjusted area under the curve (AUC) of the BILAG index global score
Time Frame: Until study discontinuation or up to 24 weeks
Until study discontinuation or up to 24 weeks
Treatment failure status
Time Frame: Until study discontinuation or up to 24 weeks
Until study discontinuation or up to 24 weeks
Time to treatment failure
Time Frame: Until study discontinuation or up to 24 weeks
Until study discontinuation or up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Investigators

  • Study Director: William Kennedy, M.D., Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

August 19, 2009

First Submitted That Met QC Criteria

August 19, 2009

First Posted (Estimate)

August 20, 2009

Study Record Updates

Last Update Posted (Estimate)

August 12, 2016

Last Update Submitted That Met QC Criteria

August 10, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IFN4575g
  • GA00806 (Other Identifier: Hoffmann-La Roche)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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