Clinical trial NCT06928142: A Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Participants With Sjögren's
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Participants With Sjögren's
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Sjogren Disease
Keywords: Sibeprenlimab
Autoimmune Diseases
Immune System Diseases
Dry Mouth
Dry Eyes
Salivary Gland Disorders
Lacrimal Gland Disorders
Immunoglobulin G
EnVISage
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2025-04-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase 2 study to evaluate the effects of sibeprenlimab 400 mg administered subcutaneously (SC) every 4 (Q4) weeks as an add-on to background treatment in participants with Sjögren's disease.

Detailed description: This is a multicenter, randomized, double-blind, placebo-controlled, proof-of-concept study followed by an optional open-label extension to evaluate the efficacy and safety of sibeprenlimab 400 mg administered SC Q4 weeks as an add-on to background treatment in participants with Sjögren's disease.

The primary objective is to compare the effect of sibeprenlimab versus placebo added to background treatment on European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) scores at 28 weeks.

The key secondary objective is to compare the effect of sibeprenlimab versus placebo added to background treatment on European League Against Rheumatism Sjögren's Syndrome Patient-Reported Index (ESSPRI) at 28 weeks.

Approximately 80 participants who have a diagnosis of Sjögren's disease according to the 2016 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria will be randomized with approximately 40 participants in the sibeprenlimab group and 40 participants in the placebo group.

Eligibility criteria: Key Inclusion Criteria:

* Diagnosed with Sjögren's disease.
* ESSDAI score (which measures disease activity) must be 5 or higher.
* Salivary flow rate must be at least 0.05 mL/min.
* Serum IgG level must be higher than 900 mg/dL.
* Must be able to communicate well with the investigator and agree to follow the trial requirements.
* Participants can continue certain medications (hydroxychloroquine, methotrexate, leflunomide, or azathioprine) if they have been on a stable dose for at least 30 days.
* Corticosteroid dose must be stable and no more than 10 mg/day for at least 30 days.
* Test positive for anti-Ro52 and/or anti-Ro60 antibodies.

Key Exclusion Criteria:

* Another active autoimmune rheumatic disease.
* Prior use of B-cell depleting therapy or prohibited immunosuppressants.
* Significant comorbidities including uncontrolled type 2 diabetes, malignancy, and chronic and/or acute infections.
* Suicidal ideation or behavior based on the Patient Health Questionnaire-9 (PHQ-9).

Primary outcomes:
measure: Change from baseline in European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) score
timeFrame: 28 weeks
Secondary outcomes:
measure: Change from baseline in European League Against Rheumatism Sjögren's Syndrome Patient-Reported Index (ESSPRI) score
timeFrame: 28 weeks
measure: Incidence of treatment-emergent adverse events (TEAEs)
timeFrame: 28 weeks
measure: Incidence of treatment-emergent adverse events (TEAEs) by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade
timeFrame: 28 weeks
measure: Incidence of treatment-emergent adverse events (TEAEs) with an outcome of death
timeFrame: 28 weeks
measure: Incidence of serious treatment-emergent adverse events (TEAEs)
timeFrame: 28 weeks
measure: Incidence of treatment-emergent adverse events (TEAEs) leading to discontinuation of the investigational medicinal product (IMP)
timeFrame: 28 weeks
measure: Proportion of participants with minimal clinical improvement defined as European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) reduction ≥ 3 points from baseline
timeFrame: At 28 weeks
measure: Proportion of participants with minimal clinical improvement defined as European League Against Rheumatism Sjögren's Syndrome Patient-Reported Index (ESSPRI) reduction ≥ 1 point from baseline
timeFrame: At 28 weeks
measure: Change from baseline in individual European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) domains
timeFrame: At 28 weeks
measure: Change from baseline in salivary flow rate
timeFrame: At 28 weeks
measure: Change from baseline in tear flow rate
timeFrame: At 28 weeks
measure: Change from baseline in Clinical European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ClinESSDAI) score
timeFrame: At 28 weeks
measure: Change from baseline in Physician Global Assessment (PhGA) score
timeFrame: At 28 weeks
measure: Change from baseline in Patient Global Assessment (PaGA) score of participant outcomes
timeFrame: At 28 weeks
measure: Change from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) score
timeFrame: At 28 weeks
measure: Change from baseline in 36 Item Short-Form Survey Version 2 (SF-36v2) Physical Component Summary Scale score and Mental Component Summary Scale score
timeFrame: At 28 weeks
measure: Change from baseline in patient-reported Sjögren's disease diary score
timeFrame: At 28 weeks
measure: Proportion of participants with minimal clinical improvement, defined as Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) score increase of ≥ 4 from baseline
timeFrame: At 28 weeks
measure: Time to the first occurrence of minimal clinical improvement in ESSDAI
timeFrame: Week 28
measure: Time to the first occurrence of minimal clinical improvement in ESSPRI
timeFrame: Week 28
measure: Percent change from baseline in total serum IgA
timeFrame: Week 28
measure: Percent change from baseline in total serum IgG
timeFrame: Week 28
measure: Percent change from baseline in total serum IgM
timeFrame: Week 28
measure: Percent change from baseline in total serum free APRIL (a proliferation-inducing ligand) concentrations
timeFrame: Week 28
measure: Cmax of sibeprenlimab
timeFrame: 28 weeks
measure: Tmax of sibeprenlimab
timeFrame: 28 weeks
measure: Area Under the Curve (AUC) of sibeprenlimab
timeFrame: 28 weeks
measure: Serum concentration of sibeprenlimab
timeFrame: 28 weeks
measure: Presence or absence of serum antidrug antibody (ADA) to sibeprenlimiab
timeFrame: 28 weeks
Other outcomes:
Locations:
city: Riverside
country: United States
facility: Medvin Clinical Research - Riverside
state: California
city: Tujunga
country: United States
facility: Medvin Clinical Research - Tujunga
state: California
city: Brandon
country: United States
facility: Bay Area Arthritis and Osteoporosis
state: Florida
city: Clearwater
country: United States
facility: Clinical Research of West Florida Inc
state: Florida
city: Fort Lauderdale
country: United States
facility: GNP Research - Florida
state: Florida
city: Tampa
country: United States
facility: Vantage Clinical Trials - Tampa - ClinEdge - PPDS
state: Florida
city: Rockford
country: United States
facility: OrthoIllinois, LTD
state: Illinois
city: Baton Rouge
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Boston
country: United States
facility: Tufts University School of Dental Medicine
state: Massachusetts
city: Albuquerque
country: United States
facility: Albuquerque Center for Rheumatology
state: New Mexico
city: Charlotte
country: United States
facility: DJL Clinical Research PLLC
state: North Carolina
city: Dayton
country: United States
facility: STAT Research
state: Ohio
city: Austin
country: United States
facility: Tekton Research, LLC
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Research - Houston
state: Texas
city: Houston
country: United States
facility: Prolato Clinical Research Center
state: Texas
city: Katy
country: United States
facility: R & H Clinical Research
state: Texas
city: Kingwood
country: United States
facility: Accurate Clinical Management, LLC
state: Texas
city: The Woodlands
country: United States
facility: Advanced Rheumatology of Houston
state: Texas
Study officials:
References: