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NCT Number: NCT06655155

A Study to Assess the Efficacy and Safety of Efgartigimod PH20 SC in Adults With Systemic Sclerosis

The main purpose of this study is to evaluate the effect and safety of efgartigimod PH20 SC compared to placebo in adults with systemic sclerosis. The study consists of a screening period, a treatment period of up to 48 weeks and a safety follow-up period. After the screening period, eligible participants will be randomized in a 2:1 ratio to receive either efgartigimod PH20 SC or placebo. The total study duration can be up to approximately 15 months.

More information can be found on: https://clinicaltrials.argenx.com/esscape

Recruiting

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Key information

Conditions

Systemic Sclerosis (SSc) Connective Tissue Diseases Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Aprillus Asistencia e Investigacion, 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 aged ≥18 years and the local legal age of consent for clinical studies
  • Has diffuse or limited SSc diagnosis and fulfills the 2013 ACR/EULAR classification criteria
  • Has a positive antinuclear antibodies (ANA) test result at the central laboratory with titer of at least 1:160
  • Has a Health Assessment Questionnaire-Disability Index (HAQ-DI) score of at least 0.5 OR a Patient Global Assessment (PGA) score of at least 3
  • Has a modified Rodnan Skin Score (mRSS) score between 15 and 35
  • The participant is anti-RNA polymerase III autoantibody negative at central laboratory and had the first non-Raynaud's phenomenon manifestation less than 5 years before screening or the participant is anti-RNA polymerase III autoantibody positive at central laboratory and had the first non-Raynaud's phenomenon manifestation less than 2 years before screening
  • Has uninvolved or mildly thickened skin area in at least 1 injection site

Exclusion criteria

  • Isolated anticentromere antibodies (ACA) seropositivity at the central laboratory
  • Significant Pulmonary Arterial Hypertension
  • Severe digital vasculopathy within the past 3 months
  • Skin thickening due to scleroderma mimics or localized scleroderma
  • Scleroderma renal crisis within the past 6 months of participating to the study
  • Another rheumatic autoimmune disease, except for secondary Sjögren's syndrome or fibromyalgia

Treatment and study plan

Efgartigimod PH20 SC

Combination Product

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 mRSS at week 24

    Time frame: Up to 24 weeks

    The Modified Rodnan Skin Score is a scoring tool to assess skin thickness in 17 cutaneous sites across the body. Each site is rated on a semiquantitative score ranging from 0 (normal) to 3 (severe). The total score is the sum of the individual skin scores and can range from 0 to 51.

Secondary outcomes

  1. Change from baseline in mRSS at week 48

    Time frame: Up to 48 weeks

    The Modified Rodnan Skin Score is a scoring tool to assess skin thickness in 17 cutaneous sites across the body. Each site is rated on a semiquantitative score ranging from 0 (normal) to 3 (severe). The total score is the sum of the individual skin scores and can range from 0 to 51.

  2. Incidence of treatment-emergent (serious) adverse events

    Time frame: Up to 55 weeks

  3. Proportion of participants who improve in at least 2 or at least 3 of the 5 core items of CRISS-25 at weeks 24 and 48 and do not have worsening in >1 component and have no significant SSc-related event(s)

    Time frame: Up to 48 weeks

    Revised Composite Response Index in Systemic Sclerosis (CRISS-25) is a global composite outcome assessment that provides a holistic perspective of the disease. It includes 5 core items: the Modified Rodnan Skin Score, the Clinician's global assessment, the Forced Vital Capacity, the Patient global assessment, and the Health Assessment Questionnaire-Disability Index.

  4. Change from baseline in HAQ-DI at weeks 24 and 48

    Time frame: Up to 48 weeks

    Health Assessment Questionnaire-Disability Index is a tool to assess physical function and disability. It consists of 8 categories with each question scored from 0 (without any difficulty) to 3 (unable to do).

  5. Change from baseline in PGA at weeks 24 and 48

    Time frame: Up to 48 weeks

    Patient's Global Assessment is a tool that measures a participant's global evaluation of their overall health during the previous week using a 10-point numerical scale. The score varies between 0 (excellent overall health) and 10 (extremely poor overall health).

  6. Change from baseline in CGA at weeks 24 and 48

    Time frame: Up to 48 weeks

    Clinician's Global Assessment is a tool that measures a clinician's assessment of the overall health of a participant during the previous week using a 10-point numerical scale. The score varies between 0 (excellent overall health) and 10 (extremely poor overall health).

  7. Annualized rate of decline in FVC (in mL) in participants with interstitial lung disease

    Time frame: Up to 48 weeks

    Forced Vital Capacity is a tool to assess lung function

  8. Efgartigimod serum concentrations over time

    Time frame: Up to 48 weeks

  9. Percent change from baseline in total IgG levels in serum over time

    Time frame: Up to 55 weeks

  10. Incidence of anti-drug antibodies against efgartigimod in serum over time

    Time frame: Up to 55 weeks

  11. Incidence of antibodies against rHuPH20 in plasma over time

    Time frame: Up to 55 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Sabine Coppieters, MD

CONTACT

[email protected]

857-350-4834

Sponsors and collaborators

Lead sponsor

argenx

Industry

Registry information

Official study title

A Randomized, Double-Blinded, Placebo-Controlled, Phase 2, Parallel-Group Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Efgartigimod PH20 SC in Adult Participants With Systemic Sclerosis

Acronym: eSScape

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 23, 2024
Registry last updated
Jul 21, 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.

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