Health TrialsbyHealthPanel

VIBRANT: VIB4920 for Active Lupus Nephritis

ConditionLupus Nephritis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

About this trial

This is a multi-center double-blind placebo controlled clinical trial evaluating the efficacy of VIB4920 combined with mycophenolate mofetil (MMF) and prednisone in achieving a renal response in participants with active lupus nephritis (LN).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older.

Classification of Systemic Lupus Erythematosus (SLE) by any of the following criteria: the 1997 update of the 1982 American College of Rheumatology (ACR) criteria, the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria, or the 2019 European League Against Rheumatism (EULAR)/ACR criteria.

UPCR ≥ 1.0 based on a 24-hour urine collection at Visit -1 or within 14 days prior to Visit -1.

Class III, Class IV, or Class V in combination with Class III or IV, and

Disqualifiers

Inability or unwillingness to give written informed consent or comply with study protocol.

Contraindication to treatment with MMF or mycophenolate sodium; or treatment with MMF or mycophenolate sodium is inappropriate in the opinion of the investigator.

Treatment with a biologic agent, except belimumab, or investigational agent within 90 days or 5 half-lives prior to Visit 0, whichever is longer.

Rituximab or other B cell depleting agent within 6 months prior to Visit 0.

Trial design

Design model

Parallel

Treatments tested in this trial

  • VIB4920

    Drug

    Participants will receive 1500 mg of VIB4920 at Weeks 0, 2, 4, 8, 12, 16, 20, and 24 while continuing on MMF and prednisone

  • Placebo for VIB4920

    Drug

    Participants will receive placebo for VIB4920 at Weeks 0, 2, 4, 8, 12, 16, 20, and 24 while continuing on MMF and prednisone

Treatment groups

74 Participants
are divided into 2 treatment groups
Group A: VIB4920Experimental treatment 1 intervention
Group B: VIB4920 PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of participants achieving a complete renal response at week 36

Complete renal response is defined as all of the following: 1. Urine protein-to-creatinine ratio (UPCR) \<= 0.5, based on a 24-hour urine collection 2. Estimated glomerular filtration rate (eGFR) \>= 120 ml/min/1.73 m\^2 or, if \< 120 ml/min/1.73 m\^2, then \>= 80 percent of the eGFR at baseline 3. Prednisone \<= 5 mg/day from Week 8, according to the prednisone dosing restrictions

Time frame
Week 36

Secondary outcomes

1

Proportion of participants who achieve a complete renal response

Complete renal response is defined as all of the following: 1. Urine protein-to-creatinine ratio (UPCR) \<= 0.5, based on a 24-hour urine collection 2. Estimated glomerular filtration rate (eGFR) \>= 120 ml/min/1.73 m\^2 or, if \< 120 ml/min/1.73 m\^2, then \> 80 percent of the eGFR at Week 0 3. Prednisone tapered to \<= 5 mg/day by Week 8, and adherence to the prednisone dosing restrictions

Time frame
Weeks 12, 24, 48, and 60
2

Proportion of participants who achieve an overall renal response

Overall renal response is defined as all of the following: 1. \>= 50 percent improvement in the urine protein-to-creatinine ratio (UPCR) compared to baseline, based on a 24-hour urine collection 2. Estimated glomerular filtration rate (eGFR) \>= 120 ml/min/1.73 m\^2, or if \< 120 ml/min/1.73 m\^2, then \> 80 percent of the eGFR at baseline, and 3. Prednisone \<= 5 mg/day from Week 8, according to the prednisone dosing restrictions

Time frame
Weeks 12, 24, 36, 48 and 60
3

Proportion of participants who achieve a BLISS-LN primary efficacy renal response (PERR)

BLISS-LN primary efficacy renal response (PERR) defined as all of the following: 1. UPCR ≤ 0.7, and 2. eGFR ≥ 60 ml/min/1.73m2, or if \< 60 ml/min/1.73m2, then ≥ 80% of the eGFR at baseline, and 3. no receipt of a prohibited immunosuppressive or immunomodulatory medication

Time frame
Weeks 12, 24, 36, 48, and 60
4

Urine Protein-to-Creatinine Ratio (UPCR)

Based on 24-hour urine collection

Time frame
Weeks 12, 24, 36, 48, and 60

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Institute of Allergy and Infectious Diseases (NIAID)

Lead sponsor

Source ClinicalTrials.gov
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