VIBRANT: VIB4920 for Active Lupus Nephritis

Conditions

• Lupus Nephritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

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).

Key Dates

First listed

Jan 21, 2022

Start date

Dec 15, 2022

Status verified

Sep 2026

Primary completion

Jun 30, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

74 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: VIB4920
  Participants will receive VIB4920 1500 mg intravenously at Weeks 0, 2, 4, 8, 12, 16, 20, and 24. Participants who previously received 1000 mg of methylprednisolone IV within 42 days of Visit 0 will not receive additional methylprednisolone IV on Day 0. Participants who previously received less than 1000 mg of methylprednisolone IV within 42 days of Visit 0 will receive an additional dose of methylprednisolone IV at Day 0, according to the following formula, where X is the intravenous dose previously received and Y is the intravenous dose administered on Day 0: 1000 mg - X = Y. Participants will begin MMF 2-3 g per day and prednisone 25 mg per day, tapered to 5 mg per day by Week 8. The prednisone dose may be tapered more rapidly and to a dose lower than 5 mg/d, at the discretion of the site investigator. Prednisone of no more than 5 mg/d will be continued until Week 60.
• Placebo Comparator: VIB4920 Placebo
  Participants will receive VIB4920 placebo intravenously at Weeks 0, 2, 4, 8, 12, 16, 20, and 24. Participants who previously received 1000 mg of methylprednisolone IV within 42 days of Visit 0 will not receive additional methylprednisolone IV on Day 0. Participants who previously received less than 1000 mg of methylprednisolone IV within 42 days of Visit 0 will receive an additional dose of methylprednisolone IV at Day 0, according to the following formula, where X is the intravenous dose previously received and Y is the intravenous dose administered on Day 0: 1000 mg - X = Y. Participants will begin MMF 2-3 g per day and prednisone 25 mg per day, tapered to 5 mg per day by Week 8. The prednisone dose may be tapered more rapidly and to a dose lower than 5 mg/d, at the discretion of the site investigator. Prednisone of no more than 5 mg/d will be continued until Week 60.

Primary Outcome Measure

Proportion of participants achieving a complete renal response at week 36 [ Time Frame: Week 36 ]

Locations (17)

Find similar trials in La Jolla, CA

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