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

• ClinicalTrials.gov Identifier: NCT00962832
• Recruitment Status: Completed
• First Posted: August 20, 2009
• Last Update Posted: August 12, 2016
• Sponsor: Genentech, Inc.
• Information provided by (Responsible Party): Genentech, Inc.

Tracking Information

• First Submitted Date: August 19, 2009
• First Posted Date: August 20, 2009
• Last Update Posted Date: August 12, 2016
• Study Start Date: September 2009
• Actual Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 19, 2009): Proportion of responders at Week 24 [ Time Frame: Until study discontinuation or up to 24 weeks ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 19, 2009)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus
• Official Title: 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
• Brief Summary: 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).
• 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
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Systemic Lupus Erythematosus

Intervention

• Drug: Placebo
  Placebo was supplied as a sterile liquid solution.
• Drug: Rontalizumab
  Rontalizumab was supplied as a sterile liquid solution.

Study Arms

• Placebo Comparator: Part 1 - Placebo intravenously
  Participants received placebo intravenously every 4 weeks for 24 weeks.
  Intervention: Drug: Placebo
• Experimental: Part 1 - Rontalizumab 750 mg intravenously
  Participants received rontalizumab 750 mg intravenously every 4 weeks for 24 weeks.
  Intervention: Drug: Rontalizumab
• Placebo Comparator: Part 2 - Placebo subcutaneously
  Participants received placebo subcutaneously every 2 weeks for 24 weeks.
  Intervention: Drug: Placebo
• Experimental: Part 2 - Rontalizumab 300 mg subcutaneously
  Participants received rontalizumab 300 mg subcutaneously every 2 weeks for 24 weeks.
  Intervention: Drug: Rontalizumab
• Experimental: Part 3 - Rontalizumab 750 mg intravenously
  Participants received rontalizumab 750 mg intravenously every 4 weeks for 120 weeks.
  Intervention: Drug: Rontalizumab

Publications *

• Kalunian KC, Merrill JT, Maciuca R, McBride JM, Townsend MJ, Wei X, Davis JC Jr, Kennedy WP. A Phase II study of the efficacy and safety of rontalizumab (rhuMAb interferon-alpha) in patients with systemic lupus erythematosus (ROSE). Ann Rheum Dis. 2016 Jan;75(1):196-202. doi: 10.1136/annrheumdis-2014-206090. Epub 2015 Jun 2.
• Kennedy WP, Maciuca R, Wolslegel K, Tew W, Abbas AR, Chaivorapol C, Morimoto A, McBride JM, Brunetta P, Richardson BC, Davis JC Jr, Behrens TW, Townsend MJ. Association of the interferon signature metric with serological disease manifestations but not global activity scores in multiple cohorts of patients with SLE. Lupus Sci Med. 2015 Mar 28;2(1):e000080. doi: 10.1136/lupus-2014-000080. eCollection 2015.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 1, 2013): 238
• Original Estimated Enrollment (submitted: August 19, 2009): 210
• Actual Study Completion Date: August 2013
• Actual Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Colombia, Mexico, Poland, Russian Federation, United States
• Removed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT00962832
• Other Study ID Numbers: IFN4575g; GA00806 ( Other Identifier: Hoffmann-La Roche )
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Genentech, Inc.
• Original Responsible Party: Clinical Trials Posting Group, Genentech, Inc.
• Current Study Sponsor: Genentech, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Genentech, Inc.
• Verification Date: August 2016