Recruiting
Phase 2

Efgartigimod PH20 SC

Sponsor:

argenx

Code:

NCT06655155

Conditions

Systemic Sclerosis (SSc)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Efgartigimod PH20 SC

Placebo PH20 SC

Study Details

Brief summary:

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

Conditions

Systemic Sclerosis (SSc)

Study ID

NCT06655155

Start date

Nov 11, 2024

Status verified date

Aug, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

81 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Efgartigimod PH20 SC

Participants receiving efgartigimod PH20 SC

placebo comparator: Placebo PH20 SC

Participants receiving placebo PH20 SC

Interventions

Efgartigimod PH20 SC

Subcutaneous efgartigimod PH20 SC given by prefilled syringe

Placebo PH20 SC

Subcutaneous placebo PH20 SC given by prefilled syringe

Primary outcome measure

  • Change from baseline in mRSS at week 24 [ Time Frame: Up to 24 weeks ]

Central Contacts and Locations

Central contacts

Sabine Coppieters, MD

857-350-4834clinicaltrials@argenx.com

Locations

Arizona Arthritis and Rheumatology Associates

Recruiting

Phoenix, Arizona, United States, 85032-9306

Contacts

Saima Chohan, MD

480-626-6637mandee.lochridge@aaracr.com

UCLA Ronald Reagan University of California Los Angeles Medical Center

Recruiting

Los Angeles, California, United States, 90095

Contacts

Suzanne Kafaja, MD

310-825-9682lnam@mednet.ucla.edu

IRIS Research and Development LLC

Recruiting

Plantation, Florida, United States, 33324

Contacts

Guillermo Valenzuela, MD

954-476-2338jgalindo@irisrheumatology.com

University of Illinois Health Outpatient Care Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Nadera Sweiss, MD

312-355-6167nsweiss@uic.edu

DelRicht Research, LLC

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Lesley Saketkoo, MD

504-336-2667no_recruitment@delricht.com

Johns Hopkins Asthma and Allergy Center

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Ami Shah, MD

410-550-8582gleathe1@jh.edu

Thomas Jefferson University

Recruiting

Columbia, Maryland, United States, 21044

Contacts

Fabian Mendoza-Ballesteros, MD

215-955-3823atmroseline.atchori@jefferson.edu

University of Michigan Hospital

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Carleigh Zahn, MD

857-350-4834clinicaltrials@argenx.com

Perelman Center for Advanced Medicine

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Nora Sandorfi, MD

215-614-4407lauren.baker@pennmedicine.upenn.edu

More Information

Sponsor

argenx

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by argenx on 2026-08-21.