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Monoclonal Antibodies

Abiprubart for Sjögren's Syndrome

Phase 2

Recruiting

Research Sponsored by Kiniksa Pharmaceuticals International, plc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Is seropositive at Screening for anti-Sjögren's-syndrome-related antigen A autoantibodies (SSA) antibodies tested at a central laboratory

Has a diagnosis of Sjögren's Disease according to 2016 American College of Rheumatology (ACR)-EULAR Classification Criteria

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

"This trial aims to see how well abiprubart works on measuring the disease activity of Sjögren's Disease."

Who is the study for?

This trial is for individuals with Sjögren's Disease, a condition where the immune system attacks glands that make tears and saliva. The eligibility criteria are not fully listed here, but typically include having a diagnosis of Sjögren's Syndrome and meeting certain health standards.

What is being tested?

The study aims to test the effectiveness and safety of Abiprubart compared to a placebo in managing Sjögren's Disease. Participants will be randomly assigned to receive either Abiprubart or an inactive substance (placebo).

What are the potential side effects?

Specific side effects of Abiprubart are not provided here, but common drug-related side effects may include allergic reactions, gastrointestinal issues, fatigue, or headaches. Placebos generally have no direct side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I tested positive for SSA antibodies.

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I have been diagnosed with Sjögren's Disease.

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My ESSDAI score is 5 or higher, considering specific organs.

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I weigh between 40 and 150 kg and my BMI is between 18 and 40.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with a drug targeting CD40 or CD154 before.

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My main illness is an autoimmune disease, not just Sjögren's, and includes uncontrolled fibromyalgia symptoms.

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I have had eye surgery, like cataract or Lasik, in the last 6 months.

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I have not had injectable corticosteroids in the last 8 weeks.

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I have a high risk of infection or have had a serious infection recently.

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I have had blood clots or am at high risk for them.

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I have recently changed my medication that affects or is for dry mouth/eyes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Abiprubart 400mg SC q4wkExperimental Treatment2 Interventions

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.

Group II: Abiprubart 400mg SC q2wkExperimental Treatment1 Intervention

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.

Group III: PlaceboPlacebo Group2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

0 / 11Eligibility criteria met