Sjögrens DiseasePhase 2NCT06531395
A Study to Evaluate the Efficacy and Safety of Abiprubart in Participants With Sjögren's Disease
A Phase 2 study testing Abiprubart in people with Sjögrens Disease, run by Kiniksa Pharmaceuticals International, plc at 16 sites in United States.
Trial summary
Primary objective of the study is to evaluate the effect of abiprubart on an established systemic disease activity measure for Sjögren's Disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sjögrens Disease
- What is being tested?
- Abiprubart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 16 sitesUnited States
- Study dates
- 17 Jul 2024to 1 May 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has a diagnosis of Sjögren's Disease according to 2016 American College or Rheumatology (ACR)-EULAR Classification Criteria.
- Has ESSDAI value ≥ 5, counting only the biological, hematological, articular, cutaneous, glandular, lymphadenopathy, and constitutional organ domains at Screening.
- Is seropositive at Screening for anti-Sjögren's-syndrome-related antigen A autoantibodies (SSA) antibodies tested at a central laboratory.
- Has stimulated whole salivary flow rate at Screening of ≥ 0.05 mL/min
- Weighs at least 40 kg and no more than 150 kg and has a body mass index (BMI) within the range of 18-40 kg/m2.
Who cannot join
- Prior exposure to any other anti-CD40/CD154 agent.
- Diagnosis of Sjögren's Disease overlap syndromes where another autoimmune rheumatic disease constitutes the principal illness, including fibromyalgia with currently active, inadequately controlled symptoms.
- Has received cataract surgery, Lasik, or other ophthalmologic surgery procedure (e.g., lachrymal plug) in the 6 months prior to Screening.
- Injectable corticosteroids (including intra-articular) within 8 weeks prior to randomization.
- Has started, stopped or adjusted dose/regimen of medications for treatment of, or known to cause dry mouth/eyes within the 30 days prior to screening or is anticipating change to these treatment regimens during the study.
- Has history of immunodeficiency (e.g., immune disorders or disorders that result in decreased immunity), including human immunodeficiency virus (HIV).
- History of thromboembolic event or a significant risk of future thromboembolic events.
- Has a known high risk of infection; Has a history of chronic or recurrent infectious disease; Has any known or suspected active infection, or has had a serious infection requiring hospitalization, or has been treated with IV/IM antibiotics for an infection within 8 weeks prior to first dose of study drug or treatment with oral antibiotics for an infection within 2 weeks prior to first dose of study drug.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Arthritis and Rheumatology Research Institute, PLLC
Allen, Texas, 75013
Arthritis Care of Texas
Corpus Christi, Texas, 78415
International Medical Research
Daytona Beach, Florida, 32117
Omega Research Debary, LLC
DeBary, Florida, 32713
Accurate Clinical Research, Inc
Lake Charles, Louisiana, 70605
Medvin Clinical Research
Menifee, California, 92586
Trinity Universal Research Associates, Inc.
Plano, Texas, 75024
BioSolutions Clinical Research Center
Poway, California, 92064
Accellacare (Salisbury)
Salisbury, North Carolina, 28144
Sun Research Institute
San Antonio, Texas, 78215
Greater Chicago Specialty Physicians/ Clinical Investigation Specialists
Schaumburg, Illinois, 60195
Clinic of Robert Hozman, MD/Clinical Investigation Specialists, Inc.
Skokie, Illinois, 60076
Springfield Clinic Rheumatology
Springfield, Illinois, 62702
Arthritis & Osteoporosis Clinic
Waco, Texas, 76710
Medvin Clinical Research
Whittier, California, 90602
Carolina Arthritis Associates
Wilmington, North Carolina, 28401
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of Abiprubart in Participants With Sjögren's Disease
Primary objective of the study is to evaluate the effect of abiprubart on an established systemic disease activity measure for Sjögren's Disease.
Read the detailed description
This is a 56-week (24-week randomized double-blind period, 24-week active treatment period, and 8-week safety follow-up period) multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of abiprubart in participants with Sjögren's Disease with moderate or high systemic disease activity according to the European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI). The objectives of the study are to evaluate efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of abiprubart compared with placebo across the estimated therapeutic range using different dosing regimens of abiprubart.
- Conditions
- Sjögrens Disease
- Being tested
- Abiprubart, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbiprubartDrug
Also called KPL-404
humanized monoclonal antibody
PlaceboDrug
sterile preservative-free solution
| Study group | Role | What they receive |
|---|---|---|
| Abiprubart 400mg SC q2wk | Experimental | Part A: Loading dose of abiprubart 800 mg subcutaneous (SC) followed by abiprubart 400 mg SC every 2 weeks (q2wk) through Week 22.
Part B: Abiprubart 400 mg SC q2wk: abiprubart 400 mg SC q2wk up to and including Week 46. Receives: Drug: Abiprubart |
| Abiprubart 400mg SC q4wk | Experimental | Part A: Loading dose of abiprubart 800 mg SC followed by abiprubart 400 mg SC q2wk through Week 22 which will alternately administer placebo or abiprubart to provide active drug every 4 weeks (q4wk) while maintaining treatment concealment.
Part B: Abiprubart 400 mg SC q4wk: abiprubart 400 mg SC q2wk up to and including Week 46 which will alternately administer placebo or abiprubart to provide active drug q4wk while maintaining treatment concealment. Receives: Drug: Abiprubart; Drug: Placebo |
| Placebo | Placebo comparator | Part A: A matched volume placebo loading dose followed by placebo SC injections q2wk through Week 22.
Part B: Participants assigned to placebo in Part A will transition to active abiprubart treatment, according to randomized assignment, with either abiprubart 400 mg SC q2wk or abiprubart 400 mg SC q4wk. Receives: Drug: Abiprubart; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) at Week 24
Measured: Baseline, Week 24
Secondary outcomes (16)
Proportion of Sjögren's Tool for Assessing Response (STAR) Responders (≥ 5 points) at Week 24
Measured: Week 24
Proportion of STAR Responders (≥ 5 points) Over Time
Measured: Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56
Change From Baseline in Stimulated Salivary Flow Rate (mL/min) at Week 24
Measured: Baseline, Week 24
Change From Baseline in Stimulated Salivary Flow Rate (mL/min) Over Time
Measured: Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56
Change From Baseline in Unstimulated Salivary Flow Rate (mL/min) at Week 24
Measured: Baseline, Week 24
Change From Baseline in Unstimulated Salivary Flow Rate (mL/min) Over Time
Measured: Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56
Change From Baseline in EULAR Sjögren's Syndrome Disease Patient Reported Index (ESSPRI) at Week 24
Measured: Baseline, Week 24
Change From Baseline in ESSPRI Over Time
Measured: Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56
Change From Baseline in Schirmer's Test at Week 24
Measured: Baseline, Week 24
Change From Baseline in Schirmer's Test Over Time
Measured: Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56
Change From Baseline in Clinical EULAR Sjögren's Syndrome Disease Activity Index (clinESSDAI) at Week 24
Measured: Baseline, Week 24
Change From Baseline in clinESSDAI Over Time
Measured: Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) at Week 24
Measured: Baseline, Week 24
Change From Baseline in FACIT-Fatigue Over Time
Measured: Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D 5L) at Week 24
Measured: Baseline, Week 24
Change From Baseline in EQ-5D 5L Over Time
Measured: Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start17 Jul 2024
- Primary completion6 Mar 2025
- Study completion1 May 2025
Why it stopped: Terminated due to strategic business decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjögrens DiseaseStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kiniksa Pharmaceuticals International, plc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kiniksa Pharmaceuticals, GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531395
- Sponsor's protocol ID
- KPL-404-C221
- Other IDs
- 2024-512986-15-00
- Status last verified
- May 2025
- First submitted
- 25 Jul 2024
- Last updated
- 21 May 2025
- 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 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of Abiprubart in Participants With Sjögren's Disease
- ClinicalTrials.gov ID
- NCT06531395
- Acronym / sponsor ID
- KPL-404-C221
- Conditions
- Sjögrens Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to strategic business decision.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Kiniksa Pharmaceuticals International, plcIndustry (pharma, biotech, devices)
- Collaborators
- Kiniksa Pharmaceuticals, GmbH
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- 6 Mar 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 1 Aug 2024 (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.
Primary objective of the study is to evaluate the effect of abiprubart on an established systemic disease activity measure for Sjögren's Disease.
Detailed description
This is a 56-week (24-week randomized double-blind period, 24-week active treatment period, and 8-week safety follow-up period) multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of abiprubart in participants with Sjögren's Disease with moderate or high systemic disease activity according to the European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI). The objectives of the study are to evaluate efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of abiprubart compared with placebo across the estimated therapeutic range using different dosing regimens of abiprubart.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Abiprubart 400mg SC q2wk | Experimental | Drug: AbiprubartPart A: Loading dose of abiprubart 800 mg subcutaneous (SC) followed by abiprubart 400 mg SC every 2 weeks (q2wk) through Week 22. Part B: Abiprubart 400 mg SC q2wk: abiprubart 400 mg SC q2wk up to and including Week 46. |
| Abiprubart 400mg SC q4wk | Experimental | Drug: Abiprubart, Drug: PlaceboPart A: Loading dose of abiprubart 800 mg SC followed by abiprubart 400 mg SC q2wk through Week 22 which will alternately administer placebo or abiprubart to provide active drug every 4 weeks (q4wk) while maintaining treatment concealment. Part B: Abiprubart 400 mg SC q4wk: abiprubart 400 mg SC q2wk up to and including Week 46 which will alternately administer placebo or abiprubart to provide active drug q4wk while maintaining treatment concealment. |
| Placebo | Placebo comparator | Drug: Abiprubart, Drug: PlaceboPart A: A matched volume placebo loading dose followed by placebo SC injections q2wk through Week 22. Part B: Participants assigned to placebo in Part A will transition to active abiprubart treatment, according to randomized assignment, with either abiprubart 400 mg SC q2wk or abiprubart 400 mg SC q4wk. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Has a diagnosis of Sjögren's Disease according to 2016 American College or Rheumatology (ACR)-EULAR Classification Criteria.
- Has ESSDAI value ≥ 5, counting only the biological, hematological, articular, cutaneous, glandular, lymphadenopathy, and constitutional organ domains at Screening.
- Is seropositive at Screening for anti-Sjögren's-syndrome-related antigen A autoantibodies (SSA) antibodies tested at a central laboratory.
- Has stimulated whole salivary flow rate at Screening of ≥ 0.05 mL/min
- Weighs at least 40 kg and no more than 150 kg and has a body mass index (BMI) within the range of 18-40 kg/m2.
Key exclusion criteria (8 listed)
- Prior exposure to any other anti-CD40/CD154 agent.
- Diagnosis of Sjögren's Disease overlap syndromes where another autoimmune rheumatic disease constitutes the principal illness, including fibromyalgia with currently active, inadequately controlled symptoms.
- Has received cataract surgery, Lasik, or other ophthalmologic surgery procedure (e.g., lachrymal plug) in the 6 months prior to Screening.
- Injectable corticosteroids (including intra-articular) within 8 weeks prior to randomization.
- Has started, stopped or adjusted dose/regimen of medications for treatment of, or known to cause dry mouth/eyes within the 30 days prior to screening or is anticipating change to these treatment regimens during the study.
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 |
|---|---|---|
| AbiprubartAlso: KPL-404humanized monoclonal antibody | Drug | Abiprubart 400mg SC q2wk, Abiprubart 400mg SC q4wk, Placebo |
| Placebosterile preservative-free solution | Drug | Abiprubart 400mg SC q4wk, Placebo |
Primary outcome
Change From Baseline in European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) at Week 24
Time frame: Baseline, Week 24
16 secondary outcomes
Proportion of Sjögren's Tool for Assessing Response (STAR) Responders (≥ 5 points) at Week 24
Time frame: Week 24
Proportion of STAR Responders (≥ 5 points) Over Time
Time frame: Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56
Change From Baseline in Stimulated Salivary Flow Rate (mL/min) at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Stimulated Salivary Flow Rate (mL/min) Over Time
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56
Change From Baseline in Unstimulated Salivary Flow Rate (mL/min) at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Unstimulated Salivary Flow Rate (mL/min) Over Time
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56
Change From Baseline in EULAR Sjögren's Syndrome Disease Patient Reported Index (ESSPRI) at Week 24
Time frame: Baseline, Week 24
Change From Baseline in ESSPRI Over Time
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56
Change From Baseline in Schirmer's Test at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Schirmer's Test Over Time
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56
Change From Baseline in Clinical EULAR Sjögren's Syndrome Disease Activity Index (clinESSDAI) at Week 24
Time frame: Baseline, Week 24
Change From Baseline in clinESSDAI Over Time
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) at Week 24
Time frame: Baseline, Week 24
Change From Baseline in FACIT-Fatigue Over Time
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D 5L) at Week 24
Time frame: Baseline, Week 24
Change From Baseline in EQ-5D 5L Over Time
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56
Results and safety
The study was stopped early (reason given: Terminated due to strategic business decision.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abiprubart in people with Sjögrens Disease, run by Kiniksa Pharmaceuticals International, plc at 16 sites in United States.
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 5 inclusion and 8 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: stopped early, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Terminated due to strategic business decision.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) at Week 24 (time frame: Baseline, Week 24). 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 21 May 2025.