A Long-term Extension Study of Dazodalibep in Participants With Sjögren's Syndrome (SS)

Conditions

• Sjögren's Syndrome

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dazodalibep — DRUG
  Dazodalibep will be given intravenously (IV).

Study Details

The primary objective of this study is to evaluate the long-term safety and tolerability of dazodalibep.

Key Dates

Start date

Feb 25, 2025

Status verified

Apr 2026

Primary completion

Dec 11, 2029

Completion

Dec 11, 2029

Study Design

Enrollment

844 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Dazodalibep
  Participants who completed the 48-week dazodalibep or placebo treatment in trials HZNP-DAZ-301 or HZNP-DAZ-303 will receive assigned dose Dose A of dazodalibep for an additional 132 weeks.

Primary Outcome Measure

Number of Participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to 152 weeks ]

Central Contacts

• Amgen Call Center
  866-572-6436
  [email protected]

Locations (31)

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