A Safety and Efficacy Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-Severe Symptom State

Conditions

• Sjögren's Syndrome (SS)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dazodalibep — DRUG
  IV infusion
• Placebo — DRUG
  IV infusion

Study Details

Primary Objective: To evaluate the effect of dazodalibep on patient-reported symptoms of SS in participants with moderate-to-severe symptom state Secondary Objectives: 1. To evaluate the effect of dazodalibep on patient-reported outcomes (PROs) in participants with SS. 2. To evaluate the effect of dazodalibep on measures of systemic activity, PROs, and salivary flow in participants with SS 3. To evaluate the safety and tolerability of multiple doses of dazodalibep in participants with SS

Key Dates

Start date

Apr 8, 2024

Status verified

Dec 2025

Primary completion

Oct 22, 2026

Completion

Dec 17, 2026

Study Design

Enrollment

434 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Dazodalibep Dose 1
  Participants will be administered dose 1 of dazodalibep by intravenous (IV) infusion.
• Experimental: Dazodalibep Dose 2
  Participants will be administered dose 2 of dazodalibep by IV infusion.
• Placebo Comparator: Placebo
  Participants will be administered placebo by IV infusion.

Primary Outcome Measure

Change from baseline in ESSPRI score [ Time Frame: At Week 48 ]

Locations (41)

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