3 Participants Needed

Abiprubart for Sjögren's Syndrome

Recruiting at 15 trial locations
CP
Overseen ByClinical Project Manager
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Kiniksa Pharmaceuticals International, plc
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

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.12345

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.

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.
See 2 more

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.
See 5 more

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

Treatment Details

Interventions

  • Abiprubart
Trial Overview 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).
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kiniksa Pharmaceuticals International, plc

Lead Sponsor

Trials
3
Recruited
1,500+

Kiniksa Pharmaceuticals, GmbH

Industry Sponsor

Trials
1
Recruited
200+

Findings from Research

Oral pilocarpine significantly improved subjective symptoms and objective measures of dry eye in patients with Sjögren syndrome after 1 and 3 months of treatment, indicating its efficacy for severe cases unresponsive to standard treatments.
The study supports the safety of oral pilocarpine as a new treatment option for severe dry eye, although it did not show significant improvement in tear production as measured by Schirmer I testing.
Effect of Oral Pilocarpine in Treating Severe Dry Eye in Patients With Sjögren Syndrome.Kawakita, T., Shimmura, S., Tsubota, K.[2017]
Oral pilocarpine (10 mg daily) significantly improved subjective eye symptoms in patients with primary Sjögren's syndrome, showing a greater than 55 mm improvement on a visual analogue scale compared to artificial tears and inferior puncta occlusion treatments.
While pilocarpine also led to objective improvements in eye condition as measured by the rose bengal test, it did not increase tear production according to the Schirmer's-I test, and common side effects included headache and nausea.
Oral pilocarpine for the treatment of ocular symptoms in patients with Sjögren's syndrome: a randomised 12 week controlled study.Tsifetaki, N., Kitsos, G., Paschides, CA., et al.[2019]
In a phase II trial involving 42 patients with primary Sjögren's syndrome, telitacicept at a dose of 160 mg significantly reduced disease activity (measured by ESSDAI) compared to placebo after 24 weeks, indicating its efficacy in treating this condition.
Telitacicept was well-tolerated with no serious adverse events reported, suggesting it is a safe treatment option for patients with primary Sjögren's syndrome.
Efficacy and safety of telitacicept in primary Sjögren's syndrome: a randomized, double-blind, placebo-controlled, phase 2 trial.Xu, D., Fang, J., Zhang, S., et al.[2023]

References

Effect of Oral Pilocarpine in Treating Severe Dry Eye in Patients With Sjögren Syndrome. [2017]
Oral pilocarpine for the treatment of ocular symptoms in patients with Sjögren's syndrome: a randomised 12 week controlled study. [2019]
Efficacy and safety of telitacicept in primary Sjögren's syndrome: a randomized, double-blind, placebo-controlled, phase 2 trial. [2023]
Effect of rituximab on a salivary gland ultrasound score in primary Sjögren's syndrome: results of the TRACTISS randomised double-blind multicentre substudy. [2021]
Emerging treatment for Sjögren's disease: a review of recent phase II and III trials. [2023]
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