ABBV-319 for Systemic Lupus Erythematosus, Sjogren's Disease, and RA
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), Sjogren's Disease (SjD) and Rheumatoid Arthritis (RA)
Recruiting
Phase 1Interventional Study
Dry Eye SyndromeSystemic Lupus Erythematosus
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
36 (estimated)
Sponsor
AbbVie · Industry
Who this trial is looking for
This trial is looking for adults with systemic lupus erythematosus, Sjogren's disease, or rheumatoid arthritis. Participants will receive two doses of an investigational drug called ABBV-319 and will be monitored for about a year.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with systemic lupus erythematosus for at least 6 months.
I have elevated antinuclear antibodies.
I have been diagnosed with Sjogren's disease for at least 6 months.
I have active symptoms of Sjogren's disease.
I have been diagnosed with rheumatoid arthritis.
I have elevated rheumatoid factor or ACPA.
I have moderate disease activity in rheumatoid arthritis.
You may not be able to join if
I have a history of significant infections.
I have any of the medical diseases listed in the protocol.
I have had drug or alcohol abuse in the last 6 months.
I have any planned surgeries that could affect this study.
I have significant heart problems shown by my ECG.
I have a history of RA overlap syndromes.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Systemic lupus erythematosus (SLE) is a chronic, systemic autoimmune disease characterized by B cell hyperactivity. Sjorgren's disease (SjD) is a chronic, multisystem autoimmune disease characterized by lacrimal and salivary gland inflammation, with resultant dryness of the eyes and mouth and occasional glandular enlargement and Rheumatoid arthritis (RA) is a long-lasting autoimmune disease that c…
Systemic lupus erythematosus (SLE) is a chronic, systemic autoimmune disease characterized by B cell hyperactivity. Sjorgren's disease (SjD) is a chronic, multisystem autoimmune disease characterized by lacrimal and salivary gland inflammation, with resultant dryness of the eyes and mouth and occasional glandular enlargement and Rheumatoid arthritis (RA) is a long-lasting autoimmune disease that causes the body's immune system to attack itself. RA targets the body's joints, causing inflammation (swelling, pain, and redness). ABBV-319 exhibits potential B cell depletion in SLE, SjD and RA which are characterized by B cell hyperactivity. The purpose of this study is to assess the pharmacokinetics, safety, and efficacy of ABBV-319 in adult participants with SLE, SjD and RA.
ABBV-319 is an investigational drug being developed for the treatment of SLE , SjD and RA. Participants are placed in 1 of 8 groups called treatment arms. Each group receives a different dose of ABBV-319 depending on whether they have SLE, SjD or RA. Around 48 adult participants with SLE, SjD or RA will be enrolled at approximately up to 17 sites worldwide.
Participants will receive 2 doses of IV ABBV-319 21 days apart and will be followed for up to 343 days.
There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
* Systemic Lupus Erythematosus (SLE) Population - Clinical diagnosis of SLE at least 6 months prior to Screening as defined by the 2019 European Alliance of Associations for Rheumatology (EULAR)/American College Of Rheumatology (ACR) classification criteria for SLE and a positiv…
Inclusion Criteria:
* Systemic Lupus Erythematosus (SLE) Population - Clinical diagnosis of SLE at least 6 months prior to Screening as defined by the 2019 European Alliance of Associations for Rheumatology (EULAR)/American College Of Rheumatology (ACR) classification criteria for SLE and a positive antinuclear antibody (ANA) \>= 1:80 drawn at Screening.
* SLE Population - Anti-double stranded DNA (dsDNA), anti-Smith (Sm), anti-ribonucleoprotein (RNP), or anti-Sjogren's syndrome Ag A (SSA) Abs above the upper limit of normal (ULN).
* Sjogren's Disease (SjD) Population - Primary diagnosis of SjD at least 6 months prior to Screening as defined by the ACR/EULAR 2016 Criteria.
* SjD Population - EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) \>= 5 at Screening.
* SjD Population - EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) \>= 5 at Screening.
* Rheumatoid Arthritis (RA) Population - Clinical diagnosis of RA and fulfilling the 2010 ACR/EULAR classification criteria for RA.
* RA Population - Rheumatoid Factor (RF) or ACPA above the ULN at Screening.
* RA Population - Confirmation of at least moderate disease activity at Screening, defined by both of the following disease activity criteria:
* Presence of at least 6 swollen and 6 tender joints at Screening using the 68 (tender)/66 (swollen) joint count.
* hs-CRP ≥3 mg/L.
Exclusion Criteria:
* History of infection as defined in the protocol.
* Any of the medical diseases or disorders listed in the protocol.
* History of clinically significant (per investigator's judgment) drug or alcohol abuse within the 6 months prior to Screening.
* Any planned elective surgery that would impact study procedures or assessments through the completion of the Day 365 assessments.
* Any clinically significant ECG abnormalities at Screening.
* RA-Specific Exclusion Criteria - History of RA overlap syndromes, including but not limited to, SLE, SjD, scleroderma, mixed connective tissue disease, or polymyositis.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.
