A Study to Evaluate the Efficacy and Safety of Abiprubart in Participants With Sjögren's Disease

May 16, 2025 updated by: Kiniksa Pharmaceuticals International, plc

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Menifee, California, United States, 92586
        • Medvin Clinical Research
      • Poway, California, United States, 92064
        • BioSolutions Clinical Research Center
      • Whittier, California, United States, 90602
        • Medvin Clinical Research
    • Florida
      • Daytona Beach, Florida, United States, 32117
        • International Medical Research
      • DeBary, Florida, United States, 32713
        • Omega Research Debary, LLC
    • Illinois
      • Schaumburg, Illinois, United States, 60195
        • Greater Chicago Specialty Physicians/ Clinical Investigation Specialists
      • Skokie, Illinois, United States, 60076
        • Clinic of Robert Hozman, MD/Clinical Investigation Specialists, Inc.
      • Springfield, Illinois, United States, 62702
        • Springfield Clinic Rheumatology
    • Louisiana
      • Lake Charles, Louisiana, United States, 70605
        • Accurate Clinical Research, Inc
    • North Carolina
      • Salisbury, North Carolina, United States, 28144
        • Accellacare (Salisbury)
      • Wilmington, North Carolina, United States, 28401
        • Carolina Arthritis Associates
    • Texas
      • Allen, Texas, United States, 75013
        • Arthritis and Rheumatology Research Institute, PLLC
      • Corpus Christi, Texas, United States, 78415
        • Arthritis Care of Texas
      • Plano, Texas, United States, 75024
        • Trinity Universal Research Associates, Inc.
      • San Antonio, Texas, United States, 78215
        • Sun Research Institute
      • Waco, Texas, United States, 76710
        • Arthritis & Osteoporosis Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Abiprubart 400mg SC q2wk

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.
Drug: Abiprubart
humanized monoclonal antibody
Other Names:
  • KPL-404
Experimental: Abiprubart 400mg SC q4wk

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.
Drug: Abiprubart
humanized monoclonal antibody
Other Names:
  • KPL-404
Drug: Placebo
sterile preservative-free solution
Placebo Comparator: Placebo

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.
Drug: Abiprubart
humanized monoclonal antibody
Other Names:
  • KPL-404
Drug: Placebo
sterile preservative-free solution

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change From Baseline in European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) at Week 24
Time Frame: Baseline, Week 24
Baseline, Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Proportion of Sjögren's Tool for Assessing Response (STAR) Responders (≥ 5 points) at Week 24
Time Frame: Week 24
Week 24
Proportion of STAR Responders (≥ 5 points) Over Time
Time Frame: Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kiniksa Pharmaceuticals International, plc

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Kiniksa Pharmaceuticals, GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 17, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 6, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 21, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KPL-404-C221
  • 2024-512986-15-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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