ABBV-319 for Lupus and Dry Eye Syndrome

Recruiting at 3 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Disqualifiers: Infection, Drug or alcohol abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, ABBV-319, to determine its effectiveness for two specific autoimmune diseases: systemic lupus erythematosus (SLE) and Sjogren’s disease (SjD). The trial seeks to understand the drug's movement through the body, its safety, and its efficacy in reducing symptoms by targeting and reducing overactive immune cells. Participants are divided into groups based on their condition and receive varying doses of the drug. Individuals diagnosed with SLE or SjD for at least six months, who experience symptoms impacting daily life, might be suitable for this trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research shows that ABBV-319 is being tested for safety in people with systemic lupus erythematosus (SLE) and Sjogren's disease (SjD). This early-phase trial primarily aims to assess how well participants tolerate this new treatment. Although extensive safety data may not yet be available, ensuring safety remains a top priority in the trial.

Earlier studies have shown that ABBV-319 targets B cells, which contribute to the overactivity in these autoimmune diseases. This suggests potential effectiveness, but researchers are still learning about its safety in humans.

Participants in this trial will receive two doses of ABBV-319, with their health closely monitored for any side effects. This includes regular medical check-ups and tests. As this is an early-phase trial, not all side effects may be known, but participants will be carefully observed to ensure their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about ABBV-319 because it offers a potentially novel approach for treating Systemic Lupus Erythematosus (SLE) and Sjogren's disease (SjD), conditions often managed with immunosuppressants and corticosteroids. Unlike these standard treatments, ABBV-319 is designed to work with a new mechanism, possibly targeting specific pathways involved in the diseases' progression. This targeted approach could mean fewer side effects and improved efficacy. Additionally, ABBV-319 is delivered in just two doses, 21 days apart, which might offer a more convenient and quicker therapeutic effect compared to ongoing daily treatments.

What evidence suggests that this trial's treatments could be effective for SLE and SjD?

Research suggests that ABBV-319, the investigational treatment being studied in this trial, might help treat conditions like systemic lupus erythematosus (SLE) and Sjogren's disease (SjD) by calming overactive B cells. Early laboratory studies have shown that ABBV-319 can significantly reduce disease symptoms in SLE models. For SjD, ABBV-319 has outperformed other treatments by effectively reducing the number of troublesome B cells. These B cells are often too active in both SLE and SjD, causing symptoms like inflammation and dryness. While information from human studies is still being collected, these early results indicate that ABBV-319 has the potential to improve health outcomes for people with these autoimmune conditions. ^{1 4 6 7 8}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

Adults with a confirmed diagnosis of Systemic Lupus Erythematosus (SLE) or Sjogren's Disease (SjD) for at least 6 months can join. They must meet specific disease activity levels and have certain antibodies present for SLE, or report a certain level of symptoms and disease activity for SjD.

Inclusion Criteria

I have been diagnosed with SLE for at least 6 months and have a positive ANA test.

I have SLE and my blood tests show high levels of specific antibodies.

My Sjogren's symptoms are moderately severe.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 2 doses of IV ABBV-319 21 days apart

6 weeks

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 343 days

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-319

Trial Overview The trial is testing ABBV-319, an experimental drug that may reduce B cell activity in patients with SLE or SjD. Participants are divided into six groups to receive varying doses via IV infusions twice, 21 days apart, followed up to nearly a year.

How Is the Trial Designed?

Group I: ABBV-319 Group 6: SjD Participants Experimental Treatment 1 Intervention

SjD participants will receive 2 doses of ABBV-319 Dose TBD 21 days apart.

Group II: ABBV-319 Group 5: SjD Participants Experimental Treatment 1 Intervention

Sjogren's disease (SjD) participants will receive 2 doses of ABBV-319 Dose TBD 21 days apart.

Group III: ABBV-319 Group 4: SLE Participants Experimental Treatment 1 Intervention

SLE participants will receive 2 doses of ABBV-319 Dose D 21 days apart.

Group IV: ABBV-319 Group 3: SLE Participants Experimental Treatment 1 Intervention

SLE participants will receive 2 doses of ABBV-319 Dose C 21 days apart.

Group V: ABBV-319 Group 2: SLE Participants Experimental Treatment 1 Intervention

SLE participants will receive 2 doses of ABBV-319 Dose B 21 days apart.

Group VI: ABBV-319 Group 1: SLE Participants Experimental Treatment 1 Intervention

Systemic Lupus Erythematosus (SLE) participants will receive 2 doses of ABBV-319 Dose A 21 days apart.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06977724

NCT06977724 | A Study to Assess Adverse Events, How ... The purpose of this study is to assess the pharmacokinetics, safety, and efficacy of ABBV-319 in adult participants with SLE or SjD.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10561476/

Safety and efficacy of biological agents in the treatment ... Multiple biologic agents are shown in high quality studies to have a significant therapeutic impact on outcomes in SLE.

3. synapse.patsnap.com synapse.patsnap.com/drug/f0db804ab2c94ee29ff301c196921f67

ABBV-319 - Drug Targets, Indications, Patents Remarkably, a single dose of ABBV-319 induced sustained tumor regression and enhanced antitumor activity compared with repeated dosing of systemic prednisolone ...

4. ctv.veeva.com ctv.veeva.com/study/clinical-study-of-a-319-in-the-treatment-of-active-refractory-systemic-lupus-erythematosus

Clinical Study of A-319 in the Treatment of Active/Refractory ... Preclinical studies have shown the efficacy of A-319 in SLE. The aim of this study is to investigate the safety, tolerability, pharmacokinetics ...

5. researchgate.net researchgate.net/publication/380323046_ABBV-319_A_CD19-targeting_glucocorticoid_receptor_modulator_antibody-drug_conjugate_therapy_for_B-cell_malignancies

ABBV-319: A CD19-targeting glucocorticoid receptor ... Conclusion: ABBV-319 has potent anti-tumor activity from three distinct MoA and exhibits safety improvements compared to systemic glucocorticoids, supporting ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06977724/a-study-to-assess-adverse-events-how-the-drug-moves-through-the-body-and-effectiveness-of-intravenous-infusions-of-abbv-319-in-adult-participants-with-systemic-lupus-erythematosus-sle-and-sjogrens-disease-sjd?activelyRecruiting=false&page=107&id=749&slug=cutaneous-lupus-erythematosus

A Study to Assess Adverse Events, How the Drug Moves ... The purpose of this study is to assess the pharmacokinetics, safety, and efficacy of ABBV-319 in adult participants with SLE or SjD. ABBV ...

7. delta.larvol.com delta.larvol.com/Products/?ProductId=377638e6-6f34-4e83-be6b-857ed47bb212

ABBV-319 / AbbVie Adverse events • New P1 trial • Dry Eye Disease • Immunology • Inflammatory Arthritis • Lupus • Ophthalmology • Sjogren's Syndrome • Systemic Lupus ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S156899722500117X

Exploring vaccine safety and adverse events in major ... This study evaluates post-vaccination adverse events by analyzing a large dataset of patients with major autoimmune diseases, ...