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

Phase 3

Recruiting

• Conditions: Primary Sjögren’s Disease
• Interventions: Biological: Efgartigimod PH20 SC; Other: Placebo PH20 SC

• Registration Number: 2024-516609-22-00
• Lead Sponsor: Argenx

Brief Summary

To evaluate the efficacy of efgartigimod PH20 SC compared with placebo PH20 SC on systemic disease activity as measured by clinESSDAI.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2025-03-25
• Last Update Posted: 2025-06-06

Recruitment & Eligibility

• Status: Authorised, recruiting
• Sex: Not specified
• Target Recruitment: 208

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Double-blinded treatment period: Efgartigimod PH20 SC	Efgartigimod PH20 SC	Participants receiving efgartigimod PH20 SC during the double-blinded treatment period
Double-blinded treatment period: Placebo PH20 SC	Placebo PH20 SC	Participants receiving placebo PH20 SC during the double-blinded treatment period
Open-label treatment period	Efgartigimod PH20 SC	Participants receiving efgartigimod PH20 SC during the open-label treatment period

Primary Outcome Measures

Name	Time	Method
Change from baseline in clinESSDAI score at week 48		Change from baseline in clinESSDAI score at week 48

Secondary Outcome Measures

Name	Time	Method
Change from baseline in ESSDAI score at week 48		Change from baseline in ESSDAI score at week 48
Proportion of participants with low disease activity (clinESSDAI < 5) at week 48		Proportion of participants with low disease activity (clinESSDAI < 5) at week 48
Proportion of responders on STAR (defined as ≥ 5 points) at week 48		Proportion of responders on STAR (defined as ≥ 5 points) at week 48
Change from baseline in DiSSA joint pain item at week 48		Change from baseline in DiSSA joint pain item at week 48
Change from baseline in DiSSA total score at week 48		Change from baseline in DiSSA total score at week 48
Change from baseline in DiSSA sicca domain at week 48		Change from baseline in DiSSA sicca domain at week 48
Proportion of participants with MCII (minimal clinically important improvement) in ESSDAI (defined as improvement of ≥ 3 points) at week 48		Proportion of participants with MCII (minimal clinically important improvement) in ESSDAI (defined as improvement of ≥ 3 points) at week 48
Change from baseline in clinESSDAI score at week 24		Change from baseline in clinESSDAI score at week 24

Trial Locations

Locations (96)

Universitair Ziekenhuis Gent; 🇧🇪 Gent, Belgium

CHU Saint Pierre; 🇧🇪 Brussels, Belgium

Reumaclinic; 🇧🇪 Genk, Belgium

Hopital Erasme; 🇧🇪 Anderlecht, Belgium

Universitair Ziekenhuis Antwerpen; 🇧🇪 Edegem, Belgium

UZ Leuven; 🇧🇪 Leuven, Belgium

Diagnostic-Consultative Center Alexandrovska EOOD; 🇧🇬 Sofiya, Bulgaria

MBAL Dr. Ivan Seliminski - Sliven AD; 🇧🇬 Sliven, Bulgaria

Medical Center Artmed Ltd.; 🇧🇬 Plovdiv, Bulgaria

University Multiprofile Hospital For Active Treatment Pulmed Ltd.; 🇧🇬 Plovdiv, Bulgaria

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Universitair Ziekenhuis Gent

🇧🇪Gent, Belgium

Isabelle Peene

Site contact

+3293322261

isabelle.peene@uzgent.be