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

Amgen

Status and phase: Enrolling; Phase 3

Conditions: Sjogren's Syndrome

Treatments: Drug: Dazodalibep; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06104124

HZNP-DAZ-301

2023-503904-10-00 (Registry Identifier)

Details and patient eligibility

About

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

Full description

Acquired from Horizon in 2024.

Enrollment: 621 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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621 participants in 3 patient groups, including a placebo group

Dazodalibep Dose 1

Experimental group

Description:

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

Treatment:

Drug: Dazodalibep

Dazodalibep Dose 2

Experimental group

Description:

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

Treatment:

Drug: Dazodalibep

Placebo

Placebo Comparator group

Description:

Participants will be administered placebo by IV infusion.

Treatment:

Drug: Placebo