A Study to Assess the Efficacy and Safety of Efgartigimod... | NCT06655155

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

NCT06655155

Sponsor

argenx

Status

Recruiting

Last Update Posted

Apr 23, 2026Actual

Enrollment

81Estimated

Phase

Phase 2

Conditions

Systemic Sclerosis (SSc)

Interventions

Efgartigimod PH20 SC
Placebo PH20 SC

Countries

United States
Argentina
Belgium
Bulgaria
Chile
Croatia
Czechia
Denmark
France
Germany
Greece
Hungary
Italy
Lithuania
Mexico
Netherlands
Poland
Portugal
Puerto Rico
Romania
Serbia
Spain
Switzerland
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2024-514539-67-00	EU Trial (CTIS) Number

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 11, 2024Actual

Primary Completion Date

Feb 2027Estimated

Completion Date

Sep 2027Estimated

First Submitted Date

Oct 22, 2024

First Submission Date that Met QC Criteria

Oct 22, 2024

First Posted Date

Oct 23, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2026

Last Update Posted Date

Apr 23, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

81Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Efgartigimod PH20 SC	Experimental	Participants receiving efgartigimod PH20 SC	Combination Product: Efgartigimod PH20 SC
Placebo PH20 SC	Placebo Comparator	Participants receiving placebo PH20 SC	Other: Placebo PH20 SC

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Efgartigimod PH20 SC	Combination Product	Subcutaneous efgartigimod PH20 SC given by prefilled syringe	Efgartigimod PH20 SC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in mRSS at week 24	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.	Up to 24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in mRSS at week 48	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.	Up to 48 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Sabine Coppieters, MD	Contact	857-350-4834		clinicaltrials@argenx.com

Facility	Status	City	State	ZIP	Country	Contacts
Arizona Arthritis and Rheumatology Associates	Recruiting	Phoenix	Arizona	85032-9306	United States

Label	URL
Related Info	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D012871	Skin Diseases