A Phase 2 interventional study of Efgartigimod PH20 SC and Placebo PH20 SC in Systemic Sclerosis (SSc), sponsored by argenx. Active, not recruiting at 79 sites in 24 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by argenx · Phase 2, Interventional, and Treatment
Among 165 studies in Scleroderma, Systemic with a site in United States — 40 open to participants now, 52 under way, 6 of them phase 3. Scleroderma, Systemic · United States.
Among the 165 studies in Scleroderma, Systemic with a site in United States, this one is the 41st largest by enrollment of the 142 interventional ones, is one of 10 that started in 2024, is one of 54 in phase 2, reaches primary completion later than 7 of the 51 other live ones, and was the 135th registered.
610 studies on the registry are indexed under Scleroderma, Systemic; 218 are open to participants now.
This study's enrollment of 87 is above the median of 37 across 446 interventional studies indexed under Scleroderma, Systemic.
Browse Scleroderma, Systemic studies →40 of the 165 studies in Scleroderma, Systemic with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 144 Scleroderma, Systemic studies recruiting now, 82 (57%) set no upper age limit and 49 (34%) stop at 75 or younger; 19 take children under 18; 16 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →165 studies; the count open now beside each. This study's row is marked.
First in 1992; this study’s year is marked. 10 started in 2024.
Median enrollment 34 across the 142 interventional studies, 67 across the 22 observational. Of the 104 that completed or were terminated, 56 (54%) have results posted.
69 of 165 have an industry lead sponsor. The 10 most frequent:
argenx is the lead sponsor of 87 studies on the registry; 29 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 16 (73%) have results posted.
argenx has 1 study filed under Scleroderma, Systemic — fewer than ten, so there is no comparison to draw.
15 of the studies in Scleroderma, Systemic with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05925803Phase 3AstraZenecaDetermine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY) | 2027-01-06 |
| NCT06195072Scleroderma Research Foundation, Inc.Platform Clinical Study for Conquering Scleroderma | 2026-11 |
| NCT06375993Adicet TherapeuticsA Phase 1 Study of Prulacabtagene Leucel (Prula-cel, Formerly ADI-001) in Autoimmune Disease | 2026-12 |
| NCT04380831City of Hope Medical CenterTBI Using IMRT and Cyclophosphamide Prior to Stem Cell Transplant for the Treatment of Severe Systemic Sclerosis | 2026-12-22 |
| NCT06655155argenxA Study to Assess the Efficacy and Safety of Efgartigimod PH20 SC in Adults With Systemic Sclerosis | 2027-03 |
Among the 165 studies in Scleroderma, Systemic with a site in United States, from their registry updates:
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receiving efgartigimod PH20 SC
Combination Product: Efgartigimod PH20 SC
Participants receiving placebo PH20 SC
Other: Placebo PH20 SC
Drug pages: Efgartigimod alfa · Hyaluronidase (human recombinant)
Subcutaneous efgartigimod PH20 SC given by prefilled syringe
Subcutaneous placebo PH20 SC given by prefilled syringe
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.
Time frame: Up to 24 weeks
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.
Time frame: Up to 48 weeks
Incidence of treatment-emergent (serious) adverse events
Time frame: Up to 55 weeks
Proportion of participants who improve in at least 2 or at least 3 of the 5 core items of CRISS-25 at weeks 24 and 48 and do not have worsening in >1 component and have no significant SSc-related event(s)
Revised Composite Response Index in Systemic Sclerosis (CRISS-25) is a global composite outcome assessment that provides a holistic perspective of the disease. It includes 5 core items: the Modified Rodnan Skin Score, the Clinician's global assessment, the Forced Vital Capacity, the Patient global assessment, and the Health Assessment Questionnaire-Disability Index.
Time frame: Up to 48 weeks
Change from baseline in HAQ-DI at weeks 24 and 48
Health Assessment Questionnaire-Disability Index is a tool to assess physical function and disability. It consists of 8 categories with each question scored from 0 (without any difficulty) to 3 (unable to do).
Time frame: Up to 48 weeks
Change from baseline in PGA at weeks 24 and 48
Patient's Global Assessment is a tool that measures a participant's global evaluation of their overall health during the previous week using a 10-point numerical scale. The score varies between 0 (excellent overall health) and 10 (extremely poor overall health).
Time frame: Up to 48 weeks
Change from baseline in CGA at weeks 24 and 48
Clinician's Global Assessment is a tool that measures a clinician's assessment of the overall health of a participant during the previous week using a 10-point numerical scale. The score varies between 0 (excellent overall health) and 10 (extremely poor overall health).
Time frame: Up to 48 weeks
Annualized rate of decline in FVC (in mL) in participants with interstitial lung disease
Forced Vital Capacity is a tool to assess lung function
Time frame: Up to 48 weeks
Efgartigimod serum concentrations over time
Time frame: Up to 48 weeks
Percent change from baseline in total IgG levels in serum over time
Time frame: Up to 55 weeks
Incidence of anti-drug antibodies against efgartigimod in serum over time
Time frame: Up to 55 weeks
Incidence of antibodies against rHuPH20 in plasma over time
Time frame: Up to 55 weeks
Plan to share: No
Started Nov 2024 (actual). Primary completion is estimated for Mar 2027, 28 months after the start.
Of 48 phase 2 interventional studies under Scleroderma, Systemic, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 83. This study's planned 28 months is below that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 16, 2026: primary completion Feb 2027 → Mar 2027 and completion Sep 2027 → Oct 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Efgartigimod alfa · Hyaluronidase (human recombinant)