Dry Eye SyndromePhase 1NCT06977724
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)
A Phase 1 study testing ABBV-319 in people with Dry Eye Syndrome and Systemic Lupus Erythematosus, run by AbbVie at 11 sites in 3 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dry Eye Syndrome, Systemic Lupus Erythematosus
- What is being tested?
- ABBV-319
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 26 Aug 2025to Mar 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
11 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 3 countries
United States7 sites, 7 recruiting
- Not yet recruiting
Highlands Advanced Rheumatology And Arthritis Center - Avon Park /ID# 278239
Avon Park, Florida, 33825
- Not yet recruiting
Clinical Research Of West Florida - Phase I Unit /ID# 275834
Clearwater, Florida, 33765
- Recruiting
Integrative Rheumatology of South Texas - Harlingen /ID# 276458
Harlingen, Texas, 78550
Site Coordinator, 956-423-1112
- Recruiting
Life Clinical Trials - Colonial Drive - Margate /ID# 276050
Margate, Florida, 33063
- Recruiting
Private Practice - Dr. Ramesh C. Gupta /ID# 275826
Memphis, Tennessee, 38119
Site Coordinator, 901-681-9670
- Recruiting
Advanced Quality Medical Research /ID# 278462
Orland Park, Illinois, 60462
- Recruiting
Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 275836
Tampa, Florida, 33606
France2 sites, 2 recruiting
- Recruiting
CHU de Montpellier - Hopital Lapeyronie /ID# 279892
Montpellier, Herault, 34090
- Recruiting
Les Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre /ID# 272692
Strasbourg, Alsace, 67200
Netherlands2 sites, 2 recruiting
- Recruiting
Amsterdam University Medical Center /ID# 274286
Amsterdam, North Holland, 1105 AZ
- Recruiting
Universitair Medisch Centrum Utrecht /ID# 273398
Utrecht, 3584 CX
About this study
Official title: A Phase1b, Multiple Ascending Dose, Open-label, Non-randomized Study Evaluating the Pharmacokinetics, Safety, and Efficacy of ABBV-319 in Subjects With Systemic Lupus Erythematosus (SLE), Sjogren's Disease (SjD) and Rheumatoid Arthritis (RA)
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.
Read more
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.
- Conditions
- Dry Eye Syndrome, Systemic Lupus Erythematosus
- Being tested
- ABBV-319
- Keywords
- Dry Eye Syndrome, Systemic Lupus Erythematosus, ABBV-319
- Medical subject headings
- Dry Eye Syndromes, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-319Drug
Intravenous (IV) Infusion
| Study group | Role | What they receive |
|---|---|---|
| ABBV-319 Group 1: SLE Participants | Experimental | Systemic Lupus Erythematosus (SLE) participants will receive 2 doses of ABBV-319 Dose A 21 days apart. Receives: Drug: ABBV-319 |
| ABBV-319 Group 2: SLE Participants | Experimental | SLE participants will receive 2 doses of ABBV-319 Dose B 21 days apart. Receives: Drug: ABBV-319 |
| ABBV-319 Group 3: SLE Participants | Experimental | SLE participants will receive 2 doses of ABBV-319 Dose C 21 days apart. Receives: Drug: ABBV-319 |
| ABBV-319 Group 4: SLE Participants | Experimental | SLE participants will receive 2 doses of ABBV-319 Dose D 21 days apart. Receives: Drug: ABBV-319 |
| ABBV-319 Group 5: SjD Participants | Experimental | Sjogren's disease (SjD) participants will receive 2 doses of ABBV-319 Dose TBD 21 days apart. Receives: Drug: ABBV-319 |
| ABBV-319 Group 6: SjD Participants | Experimental | SjD participants will receive 2 doses of ABBV-319 Dose TBD 21 days apart. Receives: Drug: ABBV-319 |
| ABBV-319 Group 7: RA Participants | Experimental | Rheumatoid Arthritis (RA) participants will receive 2 doses of ABBV-319 Dose TBD 21 days apart. Receives: Drug: ABBV-319 |
| ABBV-319 Group 8: RA Participants | Experimental | RA participants will receive 2 doses of ABBV-319 Dose TBD 21 days apart. Receives: Drug: ABBV-319 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Measured: Up to approximately 400 days
Change from Baseline in B Cells in Blood and Tissue
Change from baseline in B cells in blood and tissue.
Measured: Up to approximately 400 days
Maximum Plasma Concentration (Cmax) of ABBV-319
Cmax of ABBV-319.
Measured: Up to approximately 400 days
Time to Cmax (Tmax) of ABBV-319
Tmax of ABBV-319.
Measured: Up to approximately 400 days
Terminal Phase Elimination Half-Life (t1/2) of ABBV-319
t1/2 of ABBV-319.
Measured: Up to approximately 400 days
Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-319
AUCt of ABBV-319.
Measured: Up to approximately 400 days
Percentage of Participants with Detection of Anti-Drug Antibodies (ADAs) for ABBV-319
Percentage of participants with detection of ADAs for ABBV-319.
Measured: Up to approximately 400 days
Percentage of Participants with Detection of Neutralizing Antibodies (nAbs) for ABBV-319
Percentage of participants with detection of nAbs for ABBV-319.
Measured: Up to approximately 400 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start26 Aug 2025
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromeStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977724
- Sponsor's protocol ID
- M25-433
- Other IDs
- 2024-519157-10, 2024-519157-10-00
- Status last verified
- Aug 2026
- First submitted
- 12 May 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase1b, Multiple Ascending Dose, Open-label, Non-randomized Study Evaluating the Pharmacokinetics, Safety, and Efficacy of ABBV-319 in Subjects With Systemic Lupus Erythematosus (SLE), Sjogren's Disease (SjD) and Rheumatoid Arthritis (RA)
- ClinicalTrials.gov ID
- NCT06977724
- Acronym / sponsor ID
- M25-433
- Conditions
- Dry Eye Syndrome, Systemic Lupus Erythematosus
- Keywords
- Dry Eye Syndrome, Systemic Lupus Erythematosus, ABBV-319
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2025 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| ABBV-319 Group 1: SLE Participants | Experimental | Drug: ABBV-319Systemic Lupus Erythematosus (SLE) participants will receive 2 doses of ABBV-319 Dose A 21 days apart. |
| ABBV-319 Group 2: SLE Participants | Experimental | Drug: ABBV-319SLE participants will receive 2 doses of ABBV-319 Dose B 21 days apart. |
| ABBV-319 Group 3: SLE Participants | Experimental | Drug: ABBV-319SLE participants will receive 2 doses of ABBV-319 Dose C 21 days apart. |
| ABBV-319 Group 4: SLE Participants | Experimental | Drug: ABBV-319SLE participants will receive 2 doses of ABBV-319 Dose D 21 days apart. |
| ABBV-319 Group 5: SjD Participants | Experimental | Drug: ABBV-319Sjogren's disease (SjD) participants will receive 2 doses of ABBV-319 Dose TBD 21 days apart. |
| ABBV-319 Group 6: SjD Participants | Experimental | Drug: ABBV-319SjD participants will receive 2 doses of ABBV-319 Dose TBD 21 days apart. |
| ABBV-319 Group 7: RA Participants | Experimental | Drug: ABBV-319Rheumatoid Arthritis (RA) participants will receive 2 doses of ABBV-319 Dose TBD 21 days apart. |
| ABBV-319 Group 8: RA Participants | Experimental | Drug: ABBV-319RA participants will receive 2 doses of ABBV-319 Dose TBD 21 days apart. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABBV-319Intravenous (IV) Infusion | Drug | ABBV-319 Group 1: SLE Participants, ABBV-319 Group 2: SLE Participants, ABBV-319 Group 3: SLE Participants, ABBV-319 Group 4: SLE Participants, ABBV-319 Group 5: SjD Participants, ABBV-319 Group 6: SjD Participants, ABBV-319 Group 7: RA Participants, ABBV-319 Group 8: RA Participants |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: Up to approximately 400 days
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Change from Baseline in B Cells in Blood and Tissue
Time frame: Up to approximately 400 days
Change from baseline in B cells in blood and tissue.
Maximum Plasma Concentration (Cmax) of ABBV-319
Time frame: Up to approximately 400 days
Cmax of ABBV-319.
Time to Cmax (Tmax) of ABBV-319
Time frame: Up to approximately 400 days
Tmax of ABBV-319.
Terminal Phase Elimination Half-Life (t1/2) of ABBV-319
Time frame: Up to approximately 400 days
t1/2 of ABBV-319.
Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-319
Time frame: Up to approximately 400 days
AUCt of ABBV-319.
Percentage of Participants with Detection of Anti-Drug Antibodies (ADAs) for ABBV-319
Time frame: Up to approximately 400 days
Percentage of participants with detection of ADAs for ABBV-319.
Percentage of Participants with Detection of Neutralizing Antibodies (nAbs) for ABBV-319
Time frame: Up to approximately 400 days
Percentage of participants with detection of nAbs for ABBV-319.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ABBVIE INC. study director
AbbVie
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABBV-319 in people with Dry Eye Syndrome and Systemic Lupus Erythematosus, run by AbbVie at 11 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, France, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (AEs) (time frame: Up to approximately 400 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.