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

Study acronym: eSScape
StatusRecruiting
PhasePhase 2
Sponsorargenx
Started2024-11-11
View on ClinicalTrials.gov ↗

Amendment history

2026-08-20
Study Status, Contacts/Locations v13
Study sites76→77
2026-07-20
Study Status, Contacts/Locations v12
Study sites74→76
2026-04-22
Study Status, Contacts/Locations v11
Trial sites expanded: 69 → 74 locations
2026-04-17
Study Status, Contacts/Locations v10
Primary completion pushed: 2026-08-17 → 2027-02
Completion pushed: 2027-06-14 → 2027-09
Study sitescontacts updated at 43 of 69 sites
2026-03-09
Study Status, Study Description, References v9
Show 8 earlier versions
2026-01-29
Study Status, Contacts/Locations v8
Study sites58→69
2025-11-03
Study Status, Oversight, Contacts/Locations v7
Study sites50→58
2025-09-30
Study Status, Contacts/Locations v6
Study sites28→50
2025-08-22
Study Status, Contacts/Locations v5
Study sites19→28
2025-07-22
Study Status, Contacts/Locations v4
Study sites4→19
2025-06-13
Study Status, Contacts/Locations v3
Study sites3→4
2025-04-01
Study Identification, Study Status, Contacts/Locations v2
Study sites1→3
Study titlerevised
A Study to Assess the Efficacy and Safety of Efgartigimod PH20 SC in Adults withWith Systemic Sclerosis
2024-12-05
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-11-18→confirmed 2024-11-11
Study sites0→1
2024-10-22
Original filing
Argenx
56 trials monitored
See 2 trials at risk
Scleroderma
302 trials monitored
See 9 trials at risk
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
Trial Details
NCT Number NCT06655155
Lead Sponsor argenx
Conditions Systemic Sclerosis (SSc)
Enrollment 81 participants
Start Date 2024-11-11
Primary Completion 2027-02 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2026-09-24