NCT00962832

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

Completed Phase 2 Last updated 10 August 2016

What this trial tests

Phase 2 trial testing Placebo in Systemic Lupus Erythematosus in 238 participants. Completed in 1 August 2013.

Timeline

1 September 2009

Primary endpoint
1 January 2012

1 August 2013

Quick facts

Lead sponsor	Genentech, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	238
Start date	1 September 2009
Primary completion	1 January 2012
Estimated completion	1 August 2013
Sites	79 locations across United States, Argentina, Colombia, Mexico, Poland, Russia

Drugs / interventions tested

• Placebo
• Rontalizumab — full drug profile →

Conditions studied

• Systemic Lupus Erythematosus — all drugs for Systemic Lupus Erythematosus →

Sponsor

Genentech, Inc. — full company profile →

Who can join

Adults 18 to 65, any sex, with Systemic Lupus Erythematosus. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Proportion of responders at Week 24
  Time frame: Until study discontinuation or up to 24 weeks

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. A Phase II study of the efficacy and safety of rontalizumab (rhuMAb interferon-α) in patients with systemic lupus erythematosus (ROSE).
   Kalunian KC, Merrill JT, Maciuca R, McBride JM, et al · · 2016 · cited 267× · PMID 26038091 · DOI 10.1136/annrheumdis-2014-206090
2. Lupus nephritis: current update.
   Saxena R, Mahajan T, Mohan C. · · 2011 · cited 112× · PMID 22078716 · DOI 10.1186/ar3378
3. Association of the interferon signature metric with serological disease manifestations but not global activity scores in multiple cohorts of patients with SLE.
   Kennedy WP, Maciuca R, Wolslegel K, Tew W, et al · · 2015 · cited 111× · PMID 25861459 · DOI 10.1136/lupus-2014-000080
4. Systemic lupus erythematosus: updated insights on the pathogenesis, diagnosis, prevention and therapeutics.
   Dai X, Fan Y, Zhao X. · · 2025 · cited 78× · PMID 40097390 · DOI 10.1038/s41392-025-02168-0
5. Lupus nephritis: the evolving role of novel therapeutics.
   Rovin BH, Parikh SV. · · 2014 · cited 74× · PMID 24411715 · DOI 10.1053/j.ajkd.2013.11.023
6. Signaling Pathways of Type I and Type III Interferons and Targeted Therapies in Systemic Lupus Erythematosus.
   Chyuan IT, Tzeng HT, Chen JY. · · 2019 · cited 62× · PMID 31450787 · DOI 10.3390/cells8090963
7. Systemic lupus erythematosus biomarkers: the challenging quest.
   Arriens C, Wren JD, Munroe ME, Mohan C. · · 2017 · cited 52× · PMID 28013203 · DOI 10.1093/rheumatology/kew407
8. Cytokines as Biomarkers in Systemic Lupus Erythematosus: Value for Diagnosis and Drug Therapy.
   Idborg H, Oke V. · · 2021 · cited 40× · PMID 34768756 · DOI 10.3390/ijms222111327