Upstate Active Clinical Trials

Study Title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care. 230LE303

What is the purpose of the study? (in Layman's terms, please describe the study)

The primary objective of this study is to evaluate the long-term safety and tolerability of litifilimab in participants with active systemic lupus erythematosus (SLE).

The secondary objectives of this study are to evaluate the long-term effect of litifilimab on disease activity in participants with SLE, to evaluate the long-term effect of litifilimab in participants with SLE in maintaining low disease activity, to evaluate the effect of litifilimab in participants with active SLE in preventing irreversible organ damage, to assess long-term use of oral corticosteroid (OCS) with participants receiving litifilimab treatment, to assess the impact of litifilimab on participant-reported Health-Related Quality-of-Life Questionnaire (HRQoL), symptoms, and impacts of SLE, to evaluate long-term effect of litifilimab on laboratory parameters, and to evaluate immunogenicity of litifilimab.

Upstate Institutional Review Board (IRB) Number:

1826645

Study/Protocol ID:

230LE303

Study Phase:

Phase 3

Patient Age Group:

Adults

Principal Investigator:

Andras Perl, MD, PhD

What is involved if I participate?

• How long is the study?
  N/A
• Is transportation provided or reimbursed?
  Yes
• Is parking provided or reimbursed?
  Yes
• What tests and procedures are involved?
  N/A

Where will the study take place?

The Hill Medical Center - 1000 E Genesee St, Syracuse, NY 13210

Other Information:

N/A

ClinicalTrials.Gov ID:

NCT05352919

For more information about this trial go to ClinicalTrials.Gov

Who can I contact for more information?

Name: Bryan Blaker
Phone: 315-464-6481
Email: blakerb@upstate.edu

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