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

Sponsor

Horizon Therapeutics Ireland DAC (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06104124

Collaborator

(none)

510

Enrollment

Arms

30.3

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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:

To evaluate the effect of dazodalibep on patient reported outcomes (PROs) in participants with SS.
To evaluate the safety and tolerability of dazodalibep in participants with SS

Condition or Disease	Intervention/Treatment	Phase
Sjogren's Syndrome	Drug: Dazodalibep Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

510 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome With Moderate-to-severe Systemic Disease Activity

Anticipated Study Start Date :

Oct 30, 2023

Anticipated Primary Completion Date :

Feb 13, 2026

Anticipated Study Completion Date :

May 8, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dazodalibep Dose 1 Participants will be administered dose 1 of dazodalibep by intravenous (IV) infusion.	Drug: Dazodalibep IV infusion Other Names: VIB 4920 MEDI 4920
Experimental: Dazodalibep Dose 2 Participants will be administered dose 2 of dazodalibep by IV infusion.	Drug: Dazodalibep IV infusion Other Names: VIB 4920 MEDI 4920
Placebo Comparator: Placebo Participants will be administered placebo by IV infusion.	Drug: Placebo IV infusion

Arm

Intervention/Treatment

Experimental: Dazodalibep Dose 1

Participants will be administered dose 1 of dazodalibep by intravenous (IV) infusion.

Drug: Dazodalibep

IV infusion

Other Names:

VIB 4920

MEDI 4920

Experimental: Dazodalibep Dose 2

Participants will be administered dose 2 of dazodalibep by IV infusion.

Drug: Dazodalibep

IV infusion

Other Names:

VIB 4920

MEDI 4920

Placebo Comparator: Placebo

Participants will be administered placebo by IV infusion.

Drug: Placebo

IV infusion

Outcome Measures

Primary Outcome Measures

Change from baseline in European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index (ESSDAI) Score [At Week 48]

Secondary Outcome Measures

Proportion of participants achieving ESSDAI response [At Week 48]
Change from baseline in Diary for Assessing Sjogren's Patient-Reported Outcome Index (DASPRI) dryness domain score [At Week 48]
Change from baseline in ESSPRI dryness domain score [At Week 48]
Change from baseline in tender and swollen joint counts [At Week 48]
Change from baseline in Patient-Reported Outcomes Measurement Information System Fatigue-Short Form 10a (PROMIS-Fatigue-SF-10a) [At Week 48]
Change from baseline in ESSDAI score [Week 12 and Week 24]
Change from baseline in DASPRI total score [At Week 48]
Change from baseline in ESSPRI total score [At Week 48]
Change from baseline in total stimulated salivary flow [At Week 48]
Number of participants With Treatment Emergent Adverse Events (TEAEs) [Baseline (Day 1) to Week 56]
Number of participants With Treatment Emergent Serious Adverse Events (TESAEs) [Up to Week 56]
Number of participants With Adverse Events of Special Interest (AESIs) [Up to Week 56]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key 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).

Key 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, or have been treated for, hepatitis B, hepatitis C (unless they have undergone hepatitis C antiviral treatment and have undetectable viral level of hepatitis C RNA at least 24 weeks following completion of therapy) or human immunodeficiency virus (HIV) infection.
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.