A Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Participants With Sjögren's

Phase 2RecruitingNCT06928142

Otsuka Pharmaceutical Development & Commercialization, Inc.80 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Sjogren Disease

Interventions

SibeprenlimabBIOLOGICAL

400 mg administered SC Q4 weeks

PlaceboOTHER

Administered SC Q4 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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).

Locations (73)

Outcomes

Primary Outcomes

Change from baseline in European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) score

Higher scores on the ESSDAI indicate a worse outcome, as they reflect higher disease activity. Minimum value is 0 and the maximum value is 123.

Time frame: 28 weeks

Secondary Outcomes

Change from baseline in European League Against Rheumatism Sjögren's Syndrome Patient-Reported Index (ESSPRI) score

Higher scores on the ESSPRI indicate a worse outcome, as they reflect higher levels of patient-reported symptoms. Minimum value is 0, maximum value is 10.

Time frame: 28 weeks

Incidence of treatment-emergent adverse events (TEAEs)

Time frame: 28 weeks

Incidence of treatment-emergent adverse events (TEAEs) by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade

Time frame: 28 weeks

Incidence of treatment-emergent adverse events (TEAEs) with an outcome of death

Time frame: 28 weeks

Incidence of serious treatment-emergent adverse events (TEAEs)

Time frame: 28 weeks

Incidence of treatment-emergent adverse events (TEAEs) leading to discontinuation of the investigational medicinal product (IMP)

Time frame: 28 weeks

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

Higher scores on the ESSDAI indicate a worse outcome, as they reflect higher disease activity. Minimum value is 0 and the maximum value is 123.

Central Contacts

Otsuka Call Center

CONTACT

844-687-8522 Otsuka-ProfessionalServices@otsuka-us.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Medvin Clinical Research - Riverside

Riverside, California, United States

RECRUITING

Medvin Clinical Research - Tujunga

Tujunga, California, United States

RECRUITING

Bay Area Arthritis and Osteoporosis

Brandon, Florida, United States

RECRUITING

Clinical Research of West Florida Inc

Clearwater, Florida, United States

RECRUITING

GNP Research - Florida

Cooper City, Florida, United States

RECRUITING

Vantage Clinical Trials - Tampa - ClinEdge - PPDS

Tampa, Florida, United States

RECRUITING

OrthoIllinois, LTD

Rockford, Illinois, United States

RECRUITING

Arnold Arthritis and Rheumatology

Skokie, Illinois, United States

NOT_YET_RECRUITING

Ochsner Clinic Foundation

Baton Rouge, Louisiana, United States

RECRUITING

Tufts University School of Dental Medicine

Boston, Massachusetts, United States

NOT_YET_RECRUITING

...and 63 more locations

Time frame: At 28 weeks

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

Higher scores on the ESSPRI indicate a worse outcome, as they reflect higher levels of patient-reported symptoms. Minimum value is 0, maximum value is 10.

Time frame: At 28 weeks

Change from baseline in individual European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) domains

Higher scores on the ESSDAI indicate a worse outcome, as they reflect higher disease activity. Minimum value is 0 and the maximum value is 123.

Time frame: At 28 weeks

Change from baseline in salivary flow rate

Time frame: At 28 weeks

Change from baseline in tear flow rate

Time frame: At 28 weeks

Change from baseline in Clinical European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ClinESSDAI) score

Higher scores on the ClinESSDAI indicate a worse outcome, as they reflect higher disease activity. Minimum value is 0 and the maximum value is 123.

Time frame: At 28 weeks

Change from baseline in Physician Global Assessment (PhGA) score

Higher scores on the PhGA indicate a worse outcome, as they reflect a higher assessment of disease activity or severity by the physician. Minimum value is 0 and the maximum value is 10.

Time frame: At 28 weeks

Change from baseline in Patient Global Assessment (PaGA) score of participant outcomes

Higher scores on the PaGA indicate a worse outcome, as they reflect a higher assessment of disease severity or impact by the patient. Minimum value is 0 and the maximum value is 10.

Time frame: At 28 weeks

Change from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) score

Higher FACIT-Fatigue scores indicate a better outcome, as they reflect less fatigue. Minimum value is 0 and the maximum value is 52.

Time frame: At 28 weeks

Change from baseline in 36 Item Short-Form Survey Version 2 (SF-36v2) Physical Component Summary Scale score and Mental Component Summary Scale score

Higher scores on the SF-36v2 indicate a better outcome, as they reflect better health status and quality of life. Minimum value is 0 and the maximum value is 100.

Time frame: At 28 weeks

Change from baseline in patient-reported Sjögren's disease diary score

Higher diary score indicates more severe symptoms and greater impact on the patient's daily life. Minimum value is 0 and the maximum value is 10.

Time frame: At 28 weeks

Proportion of participants with minimal clinical improvement, defined as Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) score increase of ≥ 4 from baseline

Higher FACIT-Fatigue scores indicate a better outcome, as they reflect less fatigue. Minimum value is 0 and the maximum value is 52.

Time frame: At 28 weeks

Time to the first occurrence of minimal clinical improvement in ESSDAI

Time frame: Week 28

Time to the first occurrence of minimal clinical improvement in ESSPRI

Time frame: Week 28

Percent change from baseline in total serum IgA

Time frame: Week 28

Percent change from baseline in total serum IgG

Time frame: Week 28

Percent change from baseline in total serum IgM

Time frame: Week 28

Percent change from baseline in total serum free APRIL (a proliferation-inducing ligand) concentrations

Time frame: Week 28

Cmax of sibeprenlimab

Time frame: 28 weeks

Tmax of sibeprenlimab

Time frame: 28 weeks

Area Under the Curve (AUC) of sibeprenlimab

Time frame: 28 weeks

Serum concentration of sibeprenlimab

Time frame: 28 weeks

Presence or absence of serum antidrug antibody (ADA) to sibeprenlimiab

Time frame: 28 weeks