NCT06655155 A Study to Assess the Efficacy and Safety of Efgartigimod PH20 SC in Adults With Systemic Sclerosis
| NCT ID | NCT06655155 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | argenx |
| Condition | Systemic Sclerosis (SSc) |
| Study Type | INTERVENTIONAL |
| Enrollment | 81 participants |
| Start Date | 2024-11-11 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 81 participants in total. It began in 2024-11-11 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06655155 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Systemic Sclerosis (SSc). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06655155 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06655155 currently recruiting?
Yes, NCT06655155 is actively recruiting participants. Contact the research team at clinicaltrials@argenx.com for enrollment information.
Where is the NCT06655155 trial being conducted?
This trial is being conducted at Phoenix, United States, Los Angeles, United States, Plantation, United States, Chicago, United States and 11 additional locations.
Who is sponsoring the NCT06655155 clinical trial?
NCT06655155 is sponsored by argenx. The trial plans to enroll 81 participants.