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NCT Number: NCT06684847

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Primary Sjogrens Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centro Medico Arsema, CABA, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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: fulfilled ACR/EULAR classification criteria 2016 PSjD criteria before screening; clinESSDAI ≥ 6 at screening; Anti-Ro/SS-A positive at central laboratory; Unstimulated residual salivary flow (≥ 0.01 mL/min)

Exclusion criteria

  • Secondary (also referred to as associated) Sjögren's disease, defined as overlap with another autoimmune rheumatic or systemic inflammatory condition (eg, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, or idiopathic inflammatory myopathy
  • 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 screening or 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

Treatment and study plan

efgartigimod PH20 SC

Biological

subcutaneous efgartigimod PH20 SC given by prefilled syringe

Placebo PH20 SC

Other

subcutaneous placebo PH20 SC given by prefilled syringe

Primary outcomes

  1. Change from baseline in clinESSDAI score at week 48

    Time frame: Up to 48 weeks

    The ESSDAI was designed to measure systemic disease activity in patients with PSjD and consists of 12 domains. The score varies between 0 (no disease activity) and 123 (max disease activity). The clinESSDAI includes all ESSDAI domains except the biological domain.

Secondary outcomes

  1. Change from baseline in ESSDAI score at week 48

    Time frame: Up to 48 weeks

    The ESSDAI was designed to measure systemic disease activity in patients with PSjD and consists of 12 domains. The score varies between 0 (no disease activity) and 123 (max disease activity).

  2. Proportion of participants with low disease activity (clinESSDAI < 5) at week 48

    Time frame: Up to 48 weeks

    The ESSDAI was designed to measure systemic disease activity in patients with PSjD and consists of 12 domains. The score varies between 0 (no disease activity) and 123 (max disease activity). The clinESSDAI includes all ESSDAI domains except the biological domain.

  3. Proportion of responders on STAR (defined as ≥ 5 points) at week 48

    Time frame: Up to 48 weeks

    Sjögren's Tool for Assessing Response ( STAR) has been developed as a composite score to assess the efficacy of treatments for PSjD in 5 domains. Patients are classified as STAR responders when they reach ≥ 5 of 9 points.

  4. Change from baseline in DiSSA joint pain item at week 48

    Time frame: Up to 48 weeks

    Diary of Sjögren's Symptoms Assessment (DiSSA) is a patient-reported symptom severity diary that includes 6 PSjD symptoms. Each symptom is rated from 0 (no symptoms) to 10 (worst).

  5. Change from baseline in DiSSA total score at week 48

    Time frame: Up to 48 weeks

    Diary of Sjögren's Symptoms Assessment (DiSSA) is a patient-reported symptom severity diary that includes 6 PSjD symptoms. Each symptom is rated from 0 (no symptoms) to 10 (worst).

  6. Change from baseline in DiSSA sicca domain at week 48

    Time frame: Up to 48 weeks

    Diary of Sjögren's Symptoms Assessment (DiSSA) is a patient-reported symptom severity diary that includes 6 PSjD symptoms. Each symptom is rated from 0 (no symptoms) to 10 (worst).

  7. Proportion of participants with MCII (minimal clinically important improvement) in ESSDAI (defined as improvement of ≥ 3 points) at week 48

    Time frame: Up to 48 weeks

    The ESSDAI was designed to measure systemic disease activity in patients with PSjD and consists of 12 domains. The score varies between 0 (no disease activity) and 123 (max disease activity).

  8. Change from baseline in clinESSDAI score at week 24

    Time frame: Up to 24 weeks

    The ESSDAI was designed to measure systemic disease activity in patients with PSjD and consists of 12 domains. The score varies between 0 (no disease activity) and 123 (max disease activity). The clinESSDAI includes all ESSDAI domains except the biological domain.

Sponsors and collaborators

Lead sponsor

argenx

Industry

Registry information

Official study title

A Phase 3 Randomized, Double-Blinded, Placebo-Controlled Multicenter Trial With Open-Label Extension to Evaluate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 Subcutaneous Administered by Prefilled Syringe in Adult Patients With Primary Sjögren's Disease

Acronym: Unity

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Nov 12, 2024
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.