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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

TREATMENT

Phase

PHASE3

Trial ID

NCT06104124

Intervention or treatment

DRUG: Dazodalibep

DRUG: Placebo

Conditions

• Sjogren's Syndrome

Condition: Sjogren's Syndrome
DRUG: Dazodalibep and other drugs
Woodville South, South Australia, Australia
Sponsor: Amgen

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Find a site

Closest Location:

The Queen Elizabeth Hospital

Research sites nearby

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The Queen Elizabeth Hospital
Woodville South, South Australia, Australia

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/Arm	Intervention/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 Measure	Primary Outcome Description	Primary Outcome Time Frame
Change from baseline in European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index (ESSDAI) Score	Not Specified	At Week 48

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Proportion of participants achieving ESSDAI response	Not Specified	At Week 48
Change from baseline in Diary for Assessing Sjogren's Patient-Reported Outcome Index (DASPRI) dryness domain score	Not Specified	At Week 48
Change from baseline in ESSPRI dryness domain score	Not Specified	At Week 48
Change from baseline in DASPRI dryness domain score	Not Specified	At Week 48
Change from baseline in tender and swollen joint counts	Not Specified	At Week 48
Change from baseline in Patient-Reported Outcomes Measurement Information System Fatigue-Short Form 10a (PROMIS-Fatigue-SF-10a)	Not Specified	At Week 48
Change from baseline in ESSDAI score	Not Specified	Week 12 and Week 24
Change from baseline in DASPRI total score	Not Specified	At Week 48
Change from baseline in ESSPRI total score	Not Specified	At Week 48
Change from baseline in total stimulated salivary flow	Not Specified	At Week 48
Number of participants With Treatment Emergent Adverse Events (TEAEs)	Not Specified	Baseline (Day 1) to Week 56
Number of participants With Treatment Emergent Serious Adverse Events (TESAEs)	Not Specified	Up to Week 56
Number of participants With Adverse Events of Special Interest (AESIs)	Not Specified	Up to Week 56

Frequently Asked Questions

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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