VIB7734 for SLE

(RECAST SLE Trial)

No longer recruiting at 113 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called VIB7734 for individuals with moderate to severely active systemic lupus erythematosus (SLE), a condition where the immune system attacks the body. The researchers aim to determine if VIB7734 can safely and effectively reduce symptoms. Participants will be divided into three groups: two will receive different doses of VIB7734, and one will receive a placebo, a harmless pill resembling the treatment. Those with active SLE for at least six months, while undergoing ongoing treatment, may be suitable for this study. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that VIB7734 was safe in earlier studies. In two previous studies involving patients with autoimmune diseases, VIB7734 proved to be as safe as a placebo, causing no more side effects than a non-active substance. This suggests that VIB7734 is generally well-tolerated by patients. While these results are promising, the current study will help confirm its safety for people with systemic lupus erythematosus (SLE). ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about VIB7734 for treating moderate to severely active systemic lupus erythematosus (SLE) because it offers a novel approach compared to current treatments like corticosteroids, antimalarials, and immunosuppressants. Unlike these standard options, which mainly suppress the immune system broadly, VIB7734 specifically targets the plasmacytoid dendritic cells, which are believed to play a key role in the inflammation and autoimmunity seen in SLE. This targeted mechanism could mean fewer side effects and more effective symptom management. Additionally, VIB7734 is administered subcutaneously, which could provide a more convenient and potentially quicker onset of action than some traditional treatments.

What evidence suggests that this trial's treatments could be effective for systemic lupus erythematosus?

Research suggests that VIB7734 might help treat Systemic Lupus Erythematosus (SLE) by reducing certain immune cells called plasmacytoid dendritic cells (pDCs). These cells likely play a key role in causing the inflammation seen in lupus. An earlier study showed that VIB7734 lowered the number of these cells in the blood and skin of patients with a type of lupus affecting the skin. While these results are encouraging for SLE, further research is needed to confirm its effectiveness for this condition. Participants in this trial will receive VIB7734 at different dosing intervals or a placebo to further evaluate its potential benefits. ^{1 2 5 6 7}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Nisha Jain, MD

Principal Investigator

Horizon Therapeutics

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• VIB7734

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04925934

NCT04925934 | Study of VIB7734 for the Treatment ... A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of VIB7734 for the Treatment of Moderate to Severely Active Systemic Lupus ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03817424

NCT03817424 | A Study to Evaluate VIB7734 in ... The purpose of this study is to evaluate the safety and tolerability of escalating, multiple subcutaneous (SC) doses of VIB7734 in participants with Systemic ...

3. biospace.com biospace.com/viela-bio-announces-final-results-from-phase-1b-trial-of-vib7734-in-patients-with-cutaneous-lupus-erythematosus

Viela Bio Announces Final Results from Phase 1b Trial of ... In this trial, treatment with VIB7734 was shown to potently deplete pDC, both in blood and in CLE skin lesions.

4. amgentrials.com amgentrials.com/study/?id=VIB7734.P2.S1

Study of VIB7734 for the Treatment of Moderate to Severely ... A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of VIB7734 for the Treatment of Moderate to Severely Active Systemic Lupus ...

5. firstwordpharma.com firstwordpharma.com/story/5016213

Viela Bio Announces Positive Interim Results from a Phase ... Viela Bio Announces Positive Interim Results from a Phase 1b Study of VIB7734 in Patients with Cutaneous Lupus Erythematosus · Study Details:

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/34/NCT04925934/Prot_000.pdf

Controlled Efficacy and Safety Study of VIB7734 for the ... ... VIB7734 has the potential to decrease SLE disease activity. In addition, based on data currently available, VIB7734 presents an acceptable ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34039741/

Depleting plasmacytoid dendritic cells reduces local type I ... In two phase 1 studies in patients with autoimmune diseases, VIB7734 demonstrated an acceptable safety profile, comparable to that of placebo.