Clinical Trial Finder

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06655155
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 argenx
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Systemic Sclerosis (SSc)
Arms & Interventions

Arms

Experimental: Efgartigimod PH20 SC

Participants receiving efgartigimod PH20 SC

Placebo Comparator: Placebo PH20 SC

Participants receiving placebo PH20 SC

Interventions

Combination Product: - Efgartigimod PH20 SC

Subcutaneous efgartigimod PH20 SC given by prefilled syringe

Other: - Placebo PH20 SC

Subcutaneous placebo PH20 SC given by prefilled syringe

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Phoenix, Arizona

Status

Recruiting

Address

Arizona Arthritis and Rheumatology Associates

Phoenix, Arizona, 85032-9306

Site Contact

Saima Chohan, MD

[email protected]

857-350-4834

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