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NCT06655155 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Efficacy and Safety of Efgartigimod PH20 SC in Adults With Systemic Sclerosis
A Phase 2 study of Systemic Sclerosis (SSc), sponsored by argenx.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 81
- Enrollment target
- 20
- Study locations
NCT06655155: Recruiting Phase 2 study of Systemic Sclerosis (SSc), sponsored by argenx.
NCT06655155 is a Phase 2 study of Systemic Sclerosis (SSc) that is actively recruiting participants, run by argenx. The registered enrollment target is 81 participants, below the 92-participant average among 8 other Systemic Sclerosis (SSc) trials with a reported enrollment target (12% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06655155, a Phase 2 study of Systemic Sclerosis (SSc), is actively recruiting participants, sponsored by argenx.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 81 participants
- Enrollment target
- 20
- Study locations
Study 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
Primary Outcome
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.
Conditions Studied
Interventions
- COMBINATION_PRODUCT Efgartigimod PH20 SC
- OTHER Placebo PH20 SC
Study Locations (20)
Other
- Aprillus Asistencia e Investigacion - Buenos Aires
- Instituto de Investigación Clínica TyT - Buenos Aires
- Consultorios Médicos Dr. Doreski - Fundacion Respirar - Buenos Aires
- Hospital General de Agudos Dr. José María Ramos Mejia - Buenos Aires
- Sanatorio Allende S.A. - Córdoba
- Clínica Mayo de U.M.C.B. S.R.L - San Miguel de Tucumán
- Centro de Investigaciones Médicas Tucumán - San Miguel de Tucumán
- UZ Gent - Ghent
- UZ Brussel - Jette
- Medical Center Artmed OOD - Plovdiv
- Diagnostic Consultative Center Convex EOOD - Sofia
Maryland
- Johns Hopkins Asthma and Allergy Center - Baltimore
- Thomas Jefferson University - Columbia
Arizona
- Arizona Arthritis and Rheumatology Associates - Phoenix
California
- UCLA Ronald Reagan University of California Los Angeles Medical Center - Los Angeles
Florida
- IRIS Research and Development LLC - Plantation
Illinois
- University of Illinois Health Outpatient Care Center - Chicago
Louisiana
- DelRicht Research, LLC - New Orleans
Michigan
- University of Michigan Hospital - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2024-11-11 |
| Est. Completion | 2027-06-14 |
| Phase | Phase 2 |
What NCT06655155 shows while recruiting
NCT06655155 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 92-participant average among 8 other Systemic Sclerosis (SSc) trials with a reported enrollment target (12% lower).
The record links to 1 condition, with Systemic Sclerosis (SSc) appearing as the primary indexed condition, and to 2 interventions - of which Efgartigimod PH20 SC is the first listed.
NCT06655155 names 20 study sites across 9 states, led by Other, Maryland, Arizona.
Frequently Asked Questions
What is clinical trial NCT06655155 about?
NCT06655155 is a clinical study titled "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 partic...
What is the current status of trial NCT06655155?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 81 participants. The study started on 2024-11-11. Estimated completion is 2027-06-14.
What conditions does trial NCT06655155 study?
This clinical trial studies the following conditions: Systemic Sclerosis (SSc).
What interventions are being tested in trial NCT06655155?
The interventions under investigation include: Efgartigimod PH20 SC (COMBINATION_PRODUCT), Placebo PH20 SC (OTHER).
Who is sponsoring clinical trial NCT06655155?
This trial is sponsored by argenx, which has 49 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06655155 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Illinois, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Systemic Sclerosis (SSc)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06655155's enrollment target sits among peer trials
81 4th of 8 higher than 5 of 8 other Systemic Sclerosis (SSc) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Systemic Sclerosis (SSc) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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