A Study of the Efficacy and Safety of Efgartigimod in Patients With Primary Sjögren's Syndrome

Conditions

• Primary Sjogrens Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Efgartigimod PH20 SC — BIOLOGICAL
  subcutaneous efgartigimod PH20 SC given by prefilled syringe
• Placebo PH20 SC — OTHER
  subcutaneous placebo PH20 SC given by prefilled syringe

Study Details

The main purpose of the proposed study is to evaluate the efficacy of efgartigimod PH20 SC in patients with moderate-to-severe Primary Sjögren's Disease (pSjD). The study consists of a double-blinded placebo-controlled treatment period and an open-label treatment period. The maximum study duration for participants in both study parts is approximately 105 weeks.

Key Dates

Start date

Jan 15, 2025

Status verified

Apr 2026

Primary completion

Jul 31, 2027

Completion

Jul 31, 2028

Study Design

Enrollment

631 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Double-blinded treatment period: Efgartigimod PH20 SC
  Participants receiving efgartigimod PH20 SC during the double-blinded treatment period
• Placebo Comparator: Double-blinded treatment period: Placebo PH20 SC
  Participants receiving placebo PH20 SC during the double-blinded treatment period
• Experimental: Open-label treatment period
  Participants receiving efgartigimod PH20 SC during the open-label treatment period

Primary Outcome Measure

Change from baseline in clinESSDAI score at week 48 [ Time Frame: Up to 48 weeks ]

Locations (42)

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