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Lupus flare prevention drug trial halted early

NCT ID NCT05087628

Disease control Sponsor: Provention Bio, a Sanofi Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called PRV-3279 to see if it could prevent lupus flares in people with active systemic lupus erythematosus (SLE). The trial included 28 adults with moderate to severe lupus who had improved after steroid treatment. The study was terminated early, so results are limited, but the goal was to keep disease activity under control without needing more steroids.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

28 people

The number who actually took part.

Started

Jan 2022

Finished

Jun 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. A diagnosis of SLE for at least 6 months prior to the Screening visit 2. Meet the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) criteria for SLE at Screening 3. Have moderate to severe disease activity despite stable standard-of-care medication defined as: At screening: hSLEDAI score ≥6 (≥4 points of which must come from non-serological finding), OR at least one BILAG A or one B score; At randomization: ≥4-point drop in hSLEDAI, OR one BILAG letter grade improvement in at least one A or B score present at Screening, and investigator or central adjudication committee (CAC) rating of definite improvement or major or complete improvement 4. Able and willing to stop all lupus treatments, except antimalarials, corticosteroids (prednisone equivalent ≤ 10 mg), and NSAIDs Exclusion Criteria: 1. Active lupus nephritis or active central nervous system manifestations of SLE 2. Other inflammatory or autoimmune diseases that, in the opinion of the Investigator or CAC, may confound efficacy evaluations 3. Common variable immunodeficiency syndrome or any other clinically significant immunodeficiency 4. Known COVID-19 infection in the 4 weeks before Screening or positive SARS-CoV-2 RNA test 5. Received a live attenuated vaccine within 2 months of Screening, received a non-live or mRNA vaccine within 2 weeks of Screening, or expecting to receive any vaccine during the study period 6. Any recent infection requiring antibiotics within two weeks of Screening or any recent infection requiring IV antibiotics or hospitalization within 1 month of Screening 7. Any condition for which, in the opinion of the Investigator or CAC, participation in the study would not be in the best interest of the patient (e.g., compromise their well-being) or that could prevent, limit, or confound the protocol-specified assessments 8. Participated in any interventional clinical trial within 42 days prior to Screening or within five half-lives of the investigational product, whichever is longer 9. Received rituximab or equivalent treatment that depletes B cells within 6 months of Screening unless return of B cells to pre-treatment value or normal range can be demonstrated. 10. Received tumor necrosis factor inhibitors, interleukin antagonists, or other biologics, including belimumab, within 42 days or five half-lives of the agent, whichever is longer. 11. Received IV immunoglobulin (IVIG) or IV cyclophosphamide within 2 months, prednisone ≥ 100 mg/day for more than 30 days within 2 months, or plasmapheresis within two months of the Screening visit.

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Conditions

The condition(s) this trial relates to.

systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Systemic lupus erythematosus

Contacts and locations

Locations

  • Accurate Clinical Management - Greenhouse Road- Site Number : 104

    Houston, Texas, 77084, United States

  • Accurate Clinical Research - Houston Resource Parkway- Site Number : 105

    Houston, Texas, 77089, United States

  • BCR Medical Center Inc.- Site Number : 129

    San Juan, 909, Puerto Rico

  • Center for Rheumatology, Immunology and Arthritis- Site Number : 109

    Fort Lauderdale, Florida, 33309, United States

  • Centro Reumatologico de Caguas- Site Number : 112

    Caguas, 00725, Puerto Rico

  • D&H Tamarac Research Center- Site Number : 123

    Tamarac, Florida, 33321, United States

  • Desert Medical Advances- Site Number : 114

    Rancho Mirage, California, 92270, United States

  • Facey Medical Group - Los Angeles- Site Number : 126

    Los Angeles, California, 91345, United States

  • Florida Hospital Tampa- Site Number : 107

    Tampa, Florida, 33613, United States

  • Grapevine Rheumatology Clinic- Site Number : 103

    Grapevine, Texas, 76051, United States

  • Highlands Advanced Rheumatology & Arthritis Center- Site Number : 116

    Avon Park, Florida, 33825, United States

  • Investigational Site Number : 201

    Tuenmen, 999077, Hong Kong

  • Investigational Site Number : 202

    Pok Fu Lam, 999077, Hong Kong

  • Investigational Site Number : 301

    Beijing, 100730, China

  • Investigational Site Number : 302

    Guangzhou, 510080, China

  • Investigational Site Number : 303

    Nanchang, 330006, China

  • Investigational Site Number : 304

    Wuhan, 430030, China

  • Investigational Site Number : 305

    Tianjin, 300052, China

  • Investigational Site Number : 306

    Shanghai, 200127, China

  • Investigational Site Number : 307

    Nanjing, 210008, China

  • Investigational Site Number : 309

    Changchun, 130021, China

  • Investigational Site Number : 310

    Beijing, 100050, China

  • Medvin Clinical Research - Apple Valley- Site Number : 133

    Apple Valley, California, 92307, United States

  • Medvin Clinical Research - Covina - West San Bernardino Road- Site Number : 106

    Covina, California, 91722, United States

  • Medvin Clinical Research - Tujunga- Site Number : 119

    Tujunga, California, 91042, United States

  • Medvin Clinical Research - Whittier- Site Number : 118

    Whittier, California, 90602, United States

  • Millennium Research- Site Number : 111

    Ormond Beach, Florida, 32174, United States

  • Ochsner Medical Center - Jefferson Highway- Site Number : 113

    New Orleans, Louisiana, 70121, United States

  • Private Practice - Dr. Karina Vila Rivera- Site Number : 117

    San Juan, 00917, Puerto Rico

  • Revival Research Corporation - Michigan - ClinEdge - PPDS- Site Number : 124

    Troy, Michigan, 48084, United States

  • Sun Research Institute- Site Number : 121

    San Antonio, Texas, 78215, United States

  • University of California Los Angeles Medical Center- Site Number : 122

    Los Angeles, California, 90095, United States

  • University of California San Diego - La Jolla- Site Number : 108

    La Jolla, California, 92037, United States

  • University of Toledo Medical Center- Site Number : 110

    Toledo, Ohio, 43614, United States

  • Vernon Hills Medical Associates- Site Number : 128

    Vernon Hills, Illinois, 60061, United States

  • Yale University School of Medicine- Site Number : 125

    Pittsburgh, Pennsylvania, 15213-2536, United States

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