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A study to assess the efficacy and safety of efgartigimod PH20 SC in adults with systemic sclerosis (eSScape)
EU CTIS ID: 2024-514539-67-00
What this study is testing
To evaluate the efficacy of efgartigimod for SC administration coformulated with rHuPH20 (efgartigimod PH20 SC) compared with placebo (placebo PH20 SC) on skin sclerosis in participants with SSc
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Is aged ≥18 years and the local legal age of consent for clinical studies
- 2. Has diffuse or limited SSc diagnosis and fulfills the 2013 ACR/EULAR classification criteria
- 3. Has a positive antinuclear antibodies (ANA) test result at the central laboratory with titer of at least 1:160
- 4. 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
- 5. Has a modified Rodnan Skin Score (mRSS) score between 15 and 35
- 6. 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
You likely can't join if
- 1. Isolated anticentromere antibodies (ACA) seropositivity at the central laboratory
- 10. Positive serum test for active viral infection with any of the following conditions: Hepatitis B virus (HBV); Hepatitis C virus (HCV); HIV
- 11. Disease or any other medical condition that, in the investigator’s opinion, would confound the study results or put the participants at undue risk. Recent major surgery or intention to have major surgery during the study
- 12. History of or current alcohol, drug, or medication abuse
- 13. Pregnant or lactating state or intention to become pregnant during the study
- 14. Severe renal impairment
See the full eligibility criteria
- 1. Is aged ≥18 years and the local legal age of consent for clinical studies
- 2. Has diffuse or limited SSc diagnosis and fulfills the 2013 ACR/EULAR classification criteria
- 3. Has a positive antinuclear antibodies (ANA) test result at the central laboratory with titer of at least 1:160
- 4. 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
- 5. Has a modified Rodnan Skin Score (mRSS) score between 15 and 35
- 6. 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
- 7. Has uninvolved or mildly thickened skin area in at least 1 injection site
- 1. Isolated anticentromere antibodies (ACA) seropositivity at the central laboratory
- 10. Positive serum test for active viral infection with any of the following conditions: Hepatitis B virus (HBV); Hepatitis C virus (HCV); HIV
- 11. Disease or any other medical condition that, in the investigator’s opinion, would confound the study results or put the participants at undue risk. Recent major surgery or intention to have major surgery during the study
- 12. History of or current alcohol, drug, or medication abuse
- 13. Pregnant or lactating state or intention to become pregnant during the study
- 14. Severe renal impairment
- 2. Significant Pulmonary Arterial Hypertension
- 3. Severe digital vasculopathy within the past 3 months
- 4. Skin thickening due to scleroderma mimics or localized scleroderma
- 5. Scleroderma renal crisis within the past 6 months of participating to the study
- 6. Another rheumatic autoimmune disease, except for secondary Sjögren’s syndrome or fibromyalgia
- 7. Another known autoimmune disease or any medical condition that would interfere with an accurate assessment of SSc or puts the participant at undue risk
- 8. History of malignancy unless considered cured by adequate treatment, with no evidence of recurrence for 3 years or more before first IMP administration. Adequately treated participants with the following cancers can be included at any time: Basal cell or squamous cell skin cancer; Carcinoma in situ of the cervix; Carcinoma in situ of the breast; Incidental histological finding of prostate cancer
- 9. Serious or severe active infection that is not sufficiently resolved before baseline OR an active infection that could place the participant at undue risk or confound the study results in the investigator’s opinion
The study team makes the final eligibility decision.
Where it's taking place
- Chile
- United Kingdom
- Argentina
- Mexico
- United States
- Switzerland
- Serbia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chile; United Kingdom; Argentina; Mexico; United States; Switzerland and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.