Study of VIB7734 for the Treatment of Moderate to Severely Active SLE

(RECAST SLE Trial)

Recruiting at 94 trial locations

Overseen By Horizon Therapeutics

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Viela Bio

Must be taking: DMARDs, Immunosuppressants, OGC

Must not be taking: Immunosuppressants, Biologics, DMARDs

Disqualifiers: Active LN, Neuropsychiatric SLE, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

214 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called VIB7734 to help people with severe lupus. The drug aims to reduce the harmful activity of the immune system that causes damage in lupus patients. The study will include nearly 200 participants.

Will I have to stop taking my current medications?

The trial requires that you stay on your current SLE medications at a stable dose for a certain period before starting the study. There are specific washout periods for certain medications, so you may need to adjust your treatment plan accordingly.

Research Team

MD

Principal Investigator

Amgen

Nisha Jain, MD

Principal Investigator

Horizon Therapeutics

Eligibility Criteria

Inclusion Criteria

At least one of the following BILAG 2004 Index levels of disease at Screening: BILAG A disease in ≥ 1 organ system BILAG B disease in ≥ 2 organ systems d. PGA score ≥ 1 on a 0 to 3 visual analog scale (VAS) at Screening

Fulfill the 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for SLE

Willing and able to understand and provide written informed consent.

Exclusion Criteria

Major surgery within 8 weeks prior to Screening or elective surgery planned from Screening through Day 393.

You have had a miscarriage, abortion, stillbirth, or gave birth within the last 4 weeks.

Known history of a primary immunodeficiency or an underlying condition such as known human immunodeficiency virus (HIV) infection

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive VIB7734 or placebo in a double-blind, placebo-controlled setting for the treatment of systemic lupus erythematosus

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Treatment Details

Interventions

• VIB7734

Participant Groups

Group I: VIB7734 SC (dosing interval 2) Experimental Treatment 1 Intervention

Group II: VIB7734 SC (dosing interval 1) Experimental Treatment 1 Intervention

Group III: Placebo SC (dosing interval 3) Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Viela Bio

Lead Sponsor

Trials

13

Recruited

1,100+

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Viela Bio (acquired by Horizon Therapeutics)

Lead Sponsor

Trials

7

Recruited

950+