Study on the Effectiveness and Safety of Efgartigimod PH20 SC for Adults with Systemic Sclerosis

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What is this study about?

This clinical trial is focused on studying a condition known as Systemic Sclerosis, a disease that causes the skin and connective tissues to harden and tighten. The study will evaluate a treatment called efgartigimod PH20 SC, which is a solution for injection. This treatment is being compared to a placebo to see how effective it is in reducing skin thickening in people with Systemic Sclerosis.

The purpose of the study is to assess the effectiveness and safety of efgartigimod PH20 SC. Participants in the study will receive either the treatment or a placebo. The study will monitor changes in skin condition over a period of time, specifically looking at improvements in skin thickness and overall health. Participants will be observed for any side effects or changes in their health during the study.

The study will last for several months, with regular check-ups to track progress. Participants will have their skin condition assessed at different points in time to see how well the treatment is working. The study aims to provide valuable information on whether efgartigimod PH20 SC can be a beneficial treatment for those living with Systemic Sclerosis.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, a healthcare professional will confirm your eligibility based on specific criteria, such as age and medical history related to systemic sclerosis.

You will undergo a series of assessments, including a skin examination to measure the thickness of your skin, and a blood test to check for specific antibodies.

2 randomization

After the initial assessments, you will be randomly assigned to one of two groups. One group will receive the investigational medication, efgartigimod PH20 SC, and the other group will receive a placebo.

This process is double-blinded, meaning neither you nor the study team will know which group you are in.

3 medication administration

You will receive the assigned medication as a subcutaneous injection, which means it will be injected under the skin using a pre-filled syringe.

The frequency and dosage of the injections will be determined by the study protocol, and you will be informed about the schedule during your visits.

4 follow-up visits

You will have regular follow-up visits with the study team. These visits will occur at specific intervals to monitor your health and the effects of the medication.

During these visits, you will undergo various assessments, including skin examinations, blood tests, and questionnaires about your health and any symptoms you may experience.

5 midpoint assessment

At approximately 24 weeks into the study, a detailed assessment will be conducted to evaluate changes in your skin condition and overall health.

This assessment will help determine the effectiveness of the medication in reducing skin sclerosis.

6 final assessment

At the end of the study period, around 48 weeks, a final assessment will be conducted. This will include a comprehensive evaluation of your skin condition and any changes in your health.

The study team will also review any side effects or adverse events you may have experienced during the trial.

7 study completion

After the final assessment, your participation in the study will conclude. The study team will provide you with information about the results and any next steps regarding your health care.

You will have the opportunity to discuss your experience and any concerns with the study team.

Who Can Join the Study?

Must be at least 18 years old and meet the legal age of consent for clinical studies in your area.
Must have a diagnosis of either diffuse or limited Systemic Sclerosis (SSc) and meet the 2013 ACR/EULAR classification criteria.
Must have a positive result on an antinuclear antibodies (ANA) test with a titer of at least 1:160. This test checks for certain antibodies in your blood.
Must have 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. These scores help measure your health and how you feel about it.
Must have a modified Rodnan Skin Score (mRSS) between 15 and 35. This score measures the thickness of your skin.
If you are anti-RNA polymerase III autoantibody negative, your first non-Raynaud’s phenomenon symptom must have appeared less than 5 years before screening. If you are anti-RNA polymerase III autoantibody positive, your first non-Raynaud’s phenomenon symptom must have appeared less than 2 years before screening. These antibodies are proteins in your blood that can affect your immune system.
Must have an area of skin that is either not affected or only mildly thickened at at least one injection site.

Who Cannot Join the Study?

Patients with any other serious health condition that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial within the last 30 days.
Patients with a history of severe allergic reactions to any of the study medications.
Patients with active infections that require treatment.
Patients who have received certain medications that might interfere with the study results.
Patients with a history of drug or alcohol abuse within the past year.
Patients who have had a major surgery within the last 3 months.
Patients with unstable or uncontrolled medical conditions.
Patients who are unable to comply with the study procedures.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Unidade Local De Saude De Lisboa Ocidental E.P.E.	Carnaxide	Portugal
IRCCS Humanitas Research Hospital	Rozzano	Italy
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal

Other Sites

Site Name	City	Country
Revmatologicky Ustav	Prague	Czechia
Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o	Wroclaw	Poland
Diagnostics And Consultation Center Convex Ltd.	Sofia	Bulgaria
Opca Bolnica Zadar	Zadar	Croatia
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Ospedale San Raffaele S.r.l.	Milan	Italy
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
General University Hospital Of Patras	Patras	Greece
Rigshospitalet	Copenhagen	Denmark
Klaipedos universiteto ligonine VšĮ	Klaipeda	Lithuania
KBC Split	Split	Croatia
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Universitair Ziekenhuis Gent	Gent	Belgium
Saint Maria Hospital	Bucharest	Romania
Hospital Del Mar	Barcelona	Spain
Unidade Local De Saude De Gaia/Espinho E.P.E.	Vila Nova De Gaia	Portugal
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos	Kaunas	Lithuania
Johannes Wesling Klinikum Minden	Minden	Germany
Reumed Sp. z o.o.	Lublin	Poland
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.	Nowa Sol	Poland
Malopolskie Badania Kliniczne Sp. z o.o.	Cracow	Poland
Klinikum Bad Bramstedt GmbH	Bad Bramstedt	Germany
Clinical Medical Center Osijek	Osijek	Croatia
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Vrije Universiteit Brussel	Jette	Belgium
University Of Pecs	Pecs	Hungary
Hopital Beaujon	Clichy	France
Hopital Huriez	Lille	France
Olympion Therapeftirio General Clinic Of Patras S.A.	Patras	Greece
MICS Centrum Medyczne Warszawa	Warsaw	Poland
Pqdo Tqeiv Hxiiveve Ukyvmznojldb	Sabadell	Spain
Echmldiahp Kbgkhfu Szajxsf	Thessaloniki	Greece
Lhcia Uxtuykrfkila Mkhillm Cutgzfc (ovwkz	Leiden	The Netherlands
Stawcanu Ckujon &aoztkdorc Im Cyfmwgeijgtlpooubb	Bucharest	Romania
Hjukvohw Uoaeuxtenstybo Sfqqprutej &acfawo Hynqpbw de Hlzvfgvhqzf	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	01.03.2025
Bulgaria	Recruiting	01.03.2025
Croatia	Recruiting	01.03.2025
Czechia	Recruiting	01.03.2025
Denmark	Recruiting	01.03.2025
France	Recruiting	01.03.2025
Germany	Recruiting	01.03.2025
Greece	Recruiting	01.03.2025
Hungary	Recruiting	01.03.2025
Italy	Recruiting	01.03.2025
Lithuania	Recruiting	01.03.2025
Poland	Recruiting	01.03.2025
Portugal	Recruiting	01.03.2025
Romania	Recruiting	01.03.2025
Spain	Recruiting	01.03.2025
The Netherlands	Recruiting	01.03.2025

Trial locations

Investigated drugs:

Efgartigimod Alfa

Efgartigimod PH20 SC is a medication being tested in this clinical trial for its potential to help people with systemic sclerosis, a condition that causes hardening and tightening of the skin. This medication is a combination of efgartigimod and rHuPH20, which is designed to be given under the skin. Efgartigimod works by targeting and reducing certain proteins in the body that may be involved in the disease process, potentially leading to an improvement in skin symptoms.

Investigated diseases:

Systemic scleroderma

Systemic Sclerosis – Systemic Sclerosis is a chronic connective tissue disease characterized by the hardening and tightening of the skin and connective tissues. It progresses with the overproduction and accumulation of collagen in the skin and other organs. This leads to skin thickening, which can limit movement and flexibility. As the disease advances, it may affect internal organs such as the lungs, heart, and kidneys, causing further complications. The progression varies among individuals, with some experiencing only skin involvement, while others may have more widespread organ involvement. The exact cause of Systemic Sclerosis is unknown, but it is believed to involve an autoimmune response.

Trial ID:

2024-514539-67-00

Protocol code:

ARGX-113-2317

NCT ID:

NCT06655155

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness and Safety of Efgartigimod PH20 SC for Adults with Systemic Sclerosis

What is this study about?

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