A Study of the Efficacy and Safety of Efgartigimod in Patients with Primary Sjögren's Syndrome (Unity)

argenx

Status and phase: Enrolling; Phase 3

Conditions: Primary Sjogrens Disease

Treatments: Biological: Efgartigimod PH20 SC; Other: Placebo PH20 SC

Study type: Interventional

Funder types: Industry

Identifiers

NCT06684847

ARGX-113-2306

2024-516609-22-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 580 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Is at least 18 years of age and the local legal age of consent for clinical studies when signing the ICF.
• Meets the following criteria at screening: ACR/EULAR classification criteria 2016 PSjD; clinESSDAI ≥ 6; Anti-Ro/SS-A positive at central laboratory; Unstimulated residual salivary flow (≥ 0.01 mL/min)

Exclusion criteria

• Secondary Sjögren's disease where another confirmed autoimmune rheumatic or systemic inflammatory condition (eg, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, and inflammatory bowel disease) is the primary diagnosis.
• Active fibromyalgia which is not adequately controlled in the judgment of the investigator, or participant is receiving fibromyalgia treatment that has not been stable treatment for at least 12 weeks before screening.
• Any severe systemic PSjD manifestation that is not adequately controlled at baseline that may put the participant at undue risk based on the investigator's opinion.
• Use of cyclophosphamide ≤ 24 weeks prior to screening
• Anti-CD20 or anti-CD19 antibody received < 6 months before screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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580 participants in 3 patient groups, including a placebo group

Double-blinded treatment period: Efgartigimod PH20 SC

Experimental group

Description:

Participants receiving efgartigimod PH20 SC during the double-blinded treatment period

Treatment:

Biological: Efgartigimod PH20 SC

Double-blinded treatment period: Placebo PH20 SC

Placebo Comparator group

Description:

Participants receiving placebo PH20 SC during the double-blinded treatment period

Treatment:

Other: Placebo PH20 SC

Open-label treatment period

Experimental group

Description:

Participants receiving efgartigimod PH20 SC during the open-label treatment period

Treatment:

Biological: Efgartigimod PH20 SC