Recruiting INTERVENTIONAL NCT06655155

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

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

Sponsor: argenx

Conditions Systemic Sclerosis (SSc)

Interventions Efgartigimod PH20 SC Placebo PH20 SC

Updated 11 times since 2024 Last updated: Apr 22, 2026 Started: Nov 11, 2024 Primary completion: Feb 1, 2027 Completion: Sep 1, 2027

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This observational or N/A phase trial investigates Systemic Sclerosis (SSc) and is currently actively recruiting participants. argenx leads this study, which shows 11 recorded versions since 2024 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

11 versions recorded

Apr 28, 2026 — Present [daily]

Recruiting

Phase: PHASE2 → None
Mar 2026 — Apr 2026 [monthly]

Recruiting PHASE2
Feb 2026 — Mar 2026 [monthly]

Recruiting PHASE2
Dec 2025 — Feb 2026 [monthly]

Recruiting PHASE2
Nov 2025 — Dec 2025 [monthly]

Recruiting PHASE2

▶ Show 6 earlier versions

Sep 2025 — Nov 2025 [monthly]

Recruiting PHASE2
Aug 2025 — Sep 2025 [monthly]

Recruiting PHASE2
Jul 2025 — Aug 2025 [monthly]

Recruiting PHASE2
May 2025 — Jul 2025 [monthly]

Recruiting PHASE2
Jan 2025 — May 2025 [monthly]

Recruiting PHASE2

Status: Not Yet Recruiting → Recruiting
Nov 2024 — Jan 2025 [monthly]

Not Yet Recruiting PHASE2

First recorded

Eligibility 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

Contact Information

Sponsor contact:

argenx

Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Ann Arbor, United States , Baltimore, United States , Barcelona, Spain , Belgrade, Serbia , Belgrade, Serbia , Bordeaux, France , Bucharest, Romania , Bucharest, Romania , Buenos Aires, Argentina , Buenos Aires, Argentina and 64 more locations