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A Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-severe Systemic Disease Activity

PHASE3RECRUITING

Primary Objective: To evaluate the effect of dazodalibep on systemic manifestations of Sjögren's Syndrome (SS) in participants with moderate-to-severe systemic disease activity. Secondary Objectives: 1. To evaluate the effect of dazodalibep on patient reported outcomes (PROs) in participants with SS.

2. To evaluate the safety and tolerability of dazodalibep in participants with SS.

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Study details:

Acquired from Horizon in 2024.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  • Diagnosed with Sjögren's syndrome (SS) by meeting the 2016 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) Classification Criteria.
  • Have an European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index (ESSDAI) score of >= 5 despite symptomatic or local therapy at screening.
  • Positive for either anti-Ro autoantibodies or rheumatoid factor (RF), or both at screening (as per the central laboratory test).
  • Exclusion criteria

  • Medical history of confirmed deep vein thrombosis, pulmonary embolism, or arterial thromboembolism within 2 years of screening.
  • Active malignancy or history of malignancy within the last 5 years, except in situ carcinoma of cervix treated with apparent success with curative therapy > 12 months prior to screening OR cutaneous basal cell carcinoma following presumed curative therapy.
  • Individuals with any severe or life-threatening cardiovascular (including vasculitis), respiratory, endocrine, gastrointestinal, hematological, psychiatric, or systemic disorder or any other condition that would place the individual at unacceptable risk of complications, interfere with evaluation of the IP, or confound the interpretation of participant safety or study results.
  • Individuals who have a positive test for hepatitis B, hepatitis C, or HIV infection. A positive test for hepatitis B at screening is defined as: (1) positive for HBsAg OR (2) positive for either HBcAb or HBsAb and HBV DNA detected above the LLOQ by reflex testing by the central laboratory at screening.
  • Active TB or untreated (per local guidelines) latent TB
  • Individuals with a history of more than one episode of herpes zoster and/or any opportunistic infection in the last 12 months, and active infection requiring systemic treatment at the time of screening or through randomization, or history of more than 2 infections requiring intravenous (IV) antibiotics within 12 months prior to screening.
  • Individuals who have received a live (attenuated) vaccine within the 4 weeks prior to randomization or plan to receive a live vaccine during their participation in the study.
  • Last administration of experimental or investigational biologic or oral agents < 6 months prior to screening.
  • Individuals who have had previous treatment with any biologic B-cell-depleting therapy (eg, rituximab, ocrelizumab, inebilizumab, ofatumumab, or ianalumab) within 12 months or other B-cell-targeting therapy (eg, belimumab) < 3 months prior to screening.
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2024-01-24

    Primary completion: 2026-07-29

    Study completion finish: 2026-07-29

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE3

    trial

    Trial ID

    NCT06104124

    Intervention or treatment

    DRUG: Dazodalibep

    DRUG: Placebo

    Conditions

    • Sjogren's Syndrome

    Find a site

    Closest Location:

    The Queen Elizabeth Hospital

    Research sites nearby

    Select from list below to view details:

    • The Queen Elizabeth Hospital

      Woodville South, South Australia, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: Dazodalibep Dose 1
    • Participants will be administered dose 1 of dazodalibep by intravenous (IV) infusion.
    DRUG: Dazodalibep
    • IV infusion
    EXPERIMENTAL: Dazodalibep Dose 2
    • Participants will be administered dose 2 of dazodalibep by IV infusion.
    DRUG: Dazodalibep
    • IV infusion
    PLACEBO_COMPARATOR: Placebo
    • Participants will be administered placebo by IV infusion.
    DRUG: Placebo
    • IV infusion

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Change from baseline in European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index (ESSDAI) ScoreNot SpecifiedAt Week 48

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Proportion of participants achieving ESSDAI responseNot SpecifiedAt Week 48
    Change from baseline in Diary for Assessing Sjogren's Patient-Reported Outcome Index (DASPRI) dryness domain scoreNot SpecifiedAt Week 48
    Change from baseline in ESSPRI dryness domain scoreNot SpecifiedAt Week 48
    Change from baseline in DASPRI dryness domain scoreNot SpecifiedAt Week 48
    Change from baseline in tender and swollen joint countsNot SpecifiedAt Week 48
    Change from baseline in Patient-Reported Outcomes Measurement Information System Fatigue-Short Form 10a (PROMIS-Fatigue-SF-10a)Not SpecifiedAt Week 48
    Change from baseline in ESSDAI scoreNot SpecifiedWeek 12 and Week 24
    Change from baseline in DASPRI total scoreNot SpecifiedAt Week 48
    Change from baseline in ESSPRI total scoreNot SpecifiedAt Week 48
    Change from baseline in total stimulated salivary flowNot SpecifiedAt Week 48
    Number of participants With Treatment Emergent Adverse Events (TEAEs)Not SpecifiedBaseline (Day 1) to Week 56
    Number of participants With Treatment Emergent Serious Adverse Events (TESAEs)Not SpecifiedUp to Week 56
    Number of participants With Adverse Events of Special Interest (AESIs)Not SpecifiedUp to Week 56

    Frequently Asked Questions

    Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

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    References

    Clinical Trials Gov: A Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-severe Systemic Disease Activity

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