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Active, Not Recruiting

NCT Number: NCT06928142

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Sjogren Disease Autoimmune Diseases Dry Eye Syndromes Eye Diseases Immune System Diseases Lacrimal Apparatus Diseases Mouth Diseases Salivary Gland Diseases Stomatognathic Diseases Xerostomia

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Sibeprenlimab

Biological

400 mg administered SC Q4 weeks

Placebo

Other

Administered SC Q4 weeks

Primary outcomes

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

    Time frame: 28 weeks

    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.

Secondary outcomes

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

    Time frame: 28 weeks

    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.

  2. Incidence of treatment-emergent adverse events (TEAEs)

    Time frame: 28 weeks

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

    Time frame: 28 weeks

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

    Time frame: 28 weeks

  5. Incidence of serious treatment-emergent adverse events (TEAEs)

    Time frame: 28 weeks

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

    Time frame: 28 weeks

  7. 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

    Time frame: At 28 weeks

    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.

  8. 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

    Time frame: At 28 weeks

    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.

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

    Time frame: At 28 weeks

    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.

  10. Change from baseline in salivary flow rate

    Time frame: At 28 weeks

  11. Change from baseline in tear flow rate

    Time frame: At 28 weeks

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

    Time frame: At 28 weeks

    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.

  13. Change from baseline in Physician Global Assessment (PhGA) score

    Time frame: At 28 weeks

    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.

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

    Time frame: At 28 weeks

    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.

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

    Time frame: At 28 weeks

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

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

    Time frame: At 28 weeks

    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.

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

    Time frame: At 28 weeks

    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.

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

    Time frame: At 28 weeks

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

  19. Time to the first occurrence of minimal clinical improvement in ESSDAI

    Time frame: Week 28

  20. Time to the first occurrence of minimal clinical improvement in ESSPRI

    Time frame: Week 28

  21. Percent change from baseline in total serum IgA

    Time frame: Week 28

  22. Percent change from baseline in total serum IgG

    Time frame: Week 28

  23. Percent change from baseline in total serum IgM

    Time frame: Week 28

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

    Time frame: Week 28

  25. Cmax of sibeprenlimab

    Time frame: 28 weeks

  26. Tmax of sibeprenlimab

    Time frame: 28 weeks

  27. Area Under the Curve (AUC) of sibeprenlimab

    Time frame: 28 weeks

  28. Serum concentration of sibeprenlimab

    Time frame: 28 weeks

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

    Time frame: 28 weeks

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Industry

Registry information

Official study 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

Acronym: EnVISage

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 15, 2025
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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