It is essential for clinicians to remain informed about emerging clinical trial opportunities and resulting data that may inform therapeutic strategies, affect clinical guidelines, expand treatment options, and ultimately improve patient quality of life.

Today, we have a selection of six Phase 3 trials currently recruiting patients in the United States with systemic lupus erythematosus. Of the six trials, OPUS OLE is the only one that is invite-only. BLOSSOM is limited to pediatric candidates 5–17 years old. Trials are arranged by start date.

Quick View Table of Systemic Lupus Erythematosus Clinical Trials
Study TitleEstimated EnrollmentStart DateEstimated Primary Completion
A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus (GARDENIA)600March 2026December 2028
A Study to Evaluate the Treatment Outcomes of Subcutaneous Anifrolumab in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus (SUNFLOWER)245April 2026January 2029
A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus (PHOENYCS FLY)450November 2024May 2028
Long-term Safety and Tolerability of Cenerimod in Adults With Systemic Lupus Erythematosus (OPUS OLE)680July 2024May 2028
Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension). (SIRIUS-SLE LTE)550May 2024April 2030
An Efficacy and Safety Study of Intravenous Anifrolumab to Treat Systemic Lupus Erythematosus in Pediatric Participants (BLOSSOM)100March 2024October 2028
Featured Phase 3 Clinical Trials

A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus (GARDENIA)

  • Sponsor: Janssen Research & Development
  • Goal: The purpose of this study is to evaluate how well nipocalimab works as compared to placebo in participants with moderate to severe Systemic lupus erythematosus.
  • Interventions: Nipocalimab, placebo, standard of care treatment
  • Primary Outcome Measure: Percentage of participants achieving systemic lupus erythematosus responder index-4 composite response at week 52.
  • Time Frame: Week 52.
  • Study Details
  • Source

A Study to Evaluate the Treatment Outcomes of Subcutaneous Anifrolumab in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus (SUNFLOWER)

  • Sponsor: AstraZeneca
  • Goal: The purpose of the SUNFLOWER study is to describe clinical outcomes, including DORIS remission, achieved following the initiation of anifrolumab 120 mg SC once weekly (QW) as add-on therapy to an anti-malarial, with or without GC; in patients not in LLDAS at enrolment.
  • Intervention: Anifrolumab
  • Primary Outcome Measure: Attainment of DORIS remission.
  • Time Frame: At week 52.
  • Study Details
  • Source

A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus (PHOENYCS FLY)

  • Sponsor: UCB Biopharma
  • Goal: The purpose of this study is to evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease activity.
  • Interventions: DZP, placebo
  • Primary Outcome Measure: Achievement of British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based composite lupus assessment (BICLA) response at week 48.
  • Time Frame: Week 48.
  • Study Details
  • Source

Long-term Safety and Tolerability of Cenerimod in Adults With Systemic Lupus Erythematosus (OPUS OLE)

  • Sponsor: Viatris Innovation
  • Goal: The goal of this clinical study is to learn about the long-term safety and tolerability of cenerimod in adult patients with moderate to severe symptoms of systemic lupus erythematosus.
  • Intervention: Cenerimod 
  • Primary Outcome Measures: Treatment-emergent adverse events; Serious adverse events; Adverse events of special interest.
  • Time Frames: Day 1 (post dose) to a maximum of 3.5 years; Day 1 (post dose) to a maximum of 3.5 years; Day 1 (post dose) to a maximum of 3.5 years.
  • Study Details
  • Source

Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension) (SIRIUS-SLE LTE)

  • Sponsor: Novartis Pharmaceuticals
  • Interventions: Placebo, ianalumab
  • Goal: The purpose of this extension study is to evaluate long-term safety and tolerability of ianalumab administered s.c. monthly or quarterly, compared to monthly placebo, in adolescent and adult participants with anti-nuclear antibody (ANA)-positive systemic lupus erythematosus of moderate-to-severe disease activity, who have completed either CVAY736F12301 (SIRIUS-SLE 1) or CVAY736F12302 (SIRIUS-SLE 2) core studies.
  • Primary Outcome Measure: Number of treatment-emergent Adverse events/Serious Adverse events.
  • Time Frame: Through study completion, up to approximately 91 months.
  • Study Details
  • Source

An Efficacy and Safety Study of Intravenous Anifrolumab to Treat Systemic Lupus Erythematosus in Pediatric Participants (BLOSSOM)

  • Sponsor: AstraZeneca
  • Goal: This study aims to characterize the pharmacokinetics, pharmacodynamics, efficacy, and safety of anifrolumab solution for infusion compared with placebo solution for infusion in pediatric participants with severe active systemic lupus erythematosus who are on background standard of care therapy.
  • Interventions: Anifrolumab, placebo
  • Primary Outcome Measures: Part A- Anifrolumab serum concentration; Part A - Maximum observed serum (peak) drug concentration (Cmax); Part A - Area under the serum concentration curve (AUC); Part A - Minimum observed serum concentration (Cmin); Part B - Number of participants who are British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) responders (yes/no).
  • Time Frames: Pre-dose Day 29; Up to day 29; Up to day 29; Up to day 29; At week 52.
  • Study Details
  • Source
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