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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
argenx
Study ID
NCT06655155
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Systemic Sclerosis (SSc)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Efgartigimod PH20 SC — COMBINATION_PRODUCT
    Subcutaneous efgartigimod PH20 SC given by prefilled syringe
  • Placebo PH20 SC — OTHER
    Subcutaneous placebo PH20 SC given by prefilled syringe

Study Details

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

Key Dates

Start date
Nov 11, 2024
Status verified
Apr 2026
Primary completion
Feb 28, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
81 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Efgartigimod PH20 SC
    Participants receiving efgartigimod PH20 SC
  • Placebo Comparator: Placebo PH20 SC
    Participants receiving placebo PH20 SC

Primary Outcome Measure

Change from baseline in mRSS at week 24 [ Time Frame: Up to 24 weeks ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Arizona Arthritis and Rheumatology AssociatesPhoenixArizona85032-9306
Saima Chohan, MD
[email protected]
480-626-6637
UCLA Ronald Reagan University of California Los Angeles Medical CenterLos AngelesCalifornia90095
Suzanne Kafaja, MD
[email protected]
310-825-9682
IRIS Research and Development LLCPlantationFlorida33324
Guillermo Valenzuela, MD
[email protected]
954-476-2338
University of Illinois Health Outpatient Care CenterChicagoIllinois60612
Nadera Sweiss, MD
[email protected]
312-355-6167
DelRicht Research, LLCNew OrleansLouisiana70112
Lesley Saketkoo, MD
[email protected]
504-336-2667
Johns Hopkins Asthma and Allergy CenterBaltimoreMaryland21224
Ami Shah, MD
[email protected]
410-550-8582
Thomas Jefferson UniversityColumbiaMaryland21044
Fabian Mendoza-Ballesteros, MD
[email protected]
215-955-3823
University of Michigan HospitalAnn ArborMichigan48109
Erica Mulcaire-Jones, MD
[email protected]
888-229-3065
Perelman Center for Advanced MedicinePhiladelphiaPennsylvania19104
Nora Sandorfi, MD
[email protected]
215-614-4407

Find similar trials in Phoenix, AZ

By research site
Arizona Arthritis and Rheumatology Associates· Phoenix, AZUCLA Ronald Reagan University of California Los Angeles Medical Center· Los Angeles, CAIRIS Research and Development LLC· Plantation, FLUniversity of Illinois Health Outpatient Care Center· Chicago, ILDelRicht Research, LLC· New Orleans, LAJohns Hopkins Asthma and Allergy Center· Baltimore, MD

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