Abiprubart for Sjögren's Syndrome

Recruiting in Palo Alto (17 mi)

+15 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Kiniksa Pharmaceuticals International, plc

Must not be taking: Injectable corticosteroids

Disqualifiers: Fibromyalgia, Immunodeficiency, Thromboembolic, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Primary objective of the study is to evaluate the effect of abiprubart on an established systemic disease activity measure for Sjögren's Disease.

Will I have to stop taking my current medications?

The trial does not specify if you must stop all current medications, but you cannot change medications for dry mouth/eyes within 30 days before the trial or during it. Injectable corticosteroids must be stopped 8 weeks before joining.

How is the drug Abiprubart different from other treatments for Sjögren's syndrome?

Abiprubart (KPL-404) is unique because it targets a specific immune pathway, potentially offering a new approach to treating Sjögren's syndrome, which currently lacks standard treatments that effectively address both symptoms and organ involvement.

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Eligibility Criteria

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.

Inclusion Criteria

Has stimulated whole salivary flow rate at Screening of ≥ 0.05 mL/min

I tested positive for SSA antibodies.

I have been diagnosed with Sjögren's Disease.

Exclusion Criteria

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

Has history of immunodeficiency, including human immunodeficiency virus (HIV)

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

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomized Double-blind Treatment

Participants receive either abiprubart or placebo in a double-blind manner for 24 weeks

24 weeks

Bi-weekly visits for subcutaneous injections

Active Treatment

Participants receive active abiprubart treatment for an additional 24 weeks

24 weeks

Bi-weekly or monthly visits for subcutaneous injections

Safety Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Participant Groups

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).

Group I: Abiprubart 400mg SC q4wk Experimental Treatment 2 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 q2wk Experimental Treatment 1 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: Placebo Placebo Group 2 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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Medvin Clinical Research Menifee, CA

Medvin Clinical Research Whittier, CA

Carolina Arthritis Associates Wilmington, NC

Sun Research Institute San Antonio, TX

More Trial Locations

Who Is Running the Clinical Trial?

Kiniksa Pharmaceuticals International, plc Lead Sponsor

Kiniksa Pharmaceuticals, GmbH Industry Sponsor

References

1. China pubmed.ncbi.nlm.nih.gov

Effect of Oral Pilocarpine in Treating Severe Dry Eye in Patients With Sjögren Syndrome. [2017] The aim of this study is to evaluate the efficacy and safety of oral pilocarpine in treating severe dry eye unresponsive to conventional conservative treatment in patients with Sjögren syndrome.

2. England pubmed.ncbi.nlm.nih.gov

Oral pilocarpine for the treatment of ocular symptoms in patients with Sjögren's syndrome: a randomised 12 week controlled study. [2019] To evaluate the efficacy and side effects of oral pilocarpine for the treatment of ocular symptoms in patients with primary Sjögren's syndrome (SS).

3. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of telitacicept in primary Sjögren's syndrome: a randomized, double-blind, placebo-controlled, phase 2 trial. [2023] To evaluate the efficacy and safety of telitacicept in adult patients with primary Sjögren's syndrome (pSS) in a phase II randomized double-blind placebo-controlled trial.

4. England pubmed.ncbi.nlm.nih.gov

Effect of rituximab on a salivary gland ultrasound score in primary Sjögren's syndrome: results of the TRACTISS randomised double-blind multicentre substudy. [2021] To compare the effects of rituximab versus placebo on salivary gland ultrasound (SGUS) in primary Sjögren's syndrome (PSS) in a multicentre, multiobserver phase III trial substudy.

5. England pubmed.ncbi.nlm.nih.gov

Emerging treatment for Sjögren's disease: a review of recent phase II and III trials. [2023] Sjögren's Disease, SjD, is a systemic autoimmune disorder characterized by reduced function of the salivary and lacrimal glands. Patients suffer from dryness, fatigue, and pain and may present with or without extra-glandular organ involvement. Symptoms limit SjD patients' quality of life and are the most difficult to improve with therapy. SjD patients are heterogeneous and clustering them into biologically similar subgroups might improve the efficacy of therapies. The need for therapies that address both the symptoms and extra glandular organ involvement of SjD presents an unmet opportunity that has recently attracted a growing interest in the pharmaceutical industry.