Study on the Effects of Fipaxalparant in Patients with Diffuse Cutaneous Systemic Sclerosis

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What is this study about?

This clinical trial is focused on studying a condition known as Diffuse Cutaneous Systemic Sclerosis, a rare disease that causes the skin and other organs to become thick and hard. The trial will use a medication called Fipaxalparant, also known by its code name HZN-825. This medication is taken in the form of a tablet and works as a selective antagonist of a receptor called LPAR1, which is involved in the disease process.

The purpose of the study is to evaluate how effective, safe, and tolerable HZN-825 is for patients with Diffuse Cutaneous Systemic Sclerosis. Participants in this study will take the medication twice a day for a period of 52 weeks. This study is an extension of a previous trial, meaning it continues the research from an earlier phase to gather more information about the medication’s effects over a longer period.

Throughout the study, participants will be monitored to see how their condition changes, particularly looking at lung function and physical abilities. The study aims to provide valuable insights into the potential benefits and any side effects of using HZN-825 for treating Diffuse Cutaneous Systemic Sclerosis.

1 joining the trial

Participation begins after completing a previous trial phase. Eligibility requires completion of the double-blind treatment period in Trial HZNP-HZN-825-301.

Written informed consent is necessary to proceed.

2 treatment administration

The medication used in this trial is Fipaxalparant, administered in tablet form.

The dosage is taken orally twice a day (BID) for a duration of 52 weeks.

3 monitoring and evaluation

Regular evaluations are conducted to assess the efficacy, safety, and tolerability of the treatment.

Primary evaluation includes changes in lung function, specifically the forced vital capacity (FVC) percentage predicted at Week 52.

4 secondary assessments

Additional assessments include changes in health assessment questionnaire-disability index (HAQ-DI), medical doctor global assessment (MDGA), patient global assessment (PTGA), and physical effects subscale of the SSPRO-18 at Week 52.

5 completion of the trial

The trial concludes after 52 weeks of treatment and evaluation.

The estimated end date for the trial is July 31, 2026.

Who Can Join the Study?

  • You must provide written informed consent, which means you agree to participate in the study after being fully informed about it.
  • You must have completed the previous part of the study, called the double-blind Treatment Period, which lasted 52 weeks. If you stopped the study early for reasons other than safety or side effects, you might still be able to join if the study doctor agrees.
  • You need to be willing and able to follow the treatment plan and attend all required check-ups and evaluations for the entire duration of the study.
  • Both men and women can participate in the study.
  • The study includes people from a range of age groups, including adults and older adults.
  • The study may include people who are considered part of a vulnerable population, which means they might need extra protection or care.

Who Cannot Join the Study?

  • Patients who have not completed the initial 52-week clinical trial (HZNP-HZN-825-301) cannot participate.
  • Patients with any other serious health conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are currently using other medications that might interfere with the study drug cannot participate.
  • Patients with a history of allergic reactions to similar medications cannot participate.
  • Patients who have participated in another clinical trial within the last 30 days cannot participate.
  • Patients with a history of drug or alcohol abuse within the past year cannot participate.
  • Patients who are unable to comply with the study requirements cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Hippokration Hospital Athens Greece
Universitaetsklinikum Erlangen AöR Erlangen Germany
Ospedale San Raffaele S.r.l. Milan Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
IRCCS Ospedale Policlinico San Martino Genoa Italy
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Hopital Beaujon Clichy France
Hopital Huriez Lille France
Pratia S.A. Skorzewo Poland
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Saint Maria Hospital Bucharest Romania
Hospital Universitario Dr Peset Aleixandre Valencia Spain
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o. Nowa Sol Poland
Malopolskie Centrum Kliniczne Cracow Poland
Unidade Local De Saude Do Alto Minho E.P.E. Ponte De Lima Portugal
Hospital De Merida Merida Spain
MICS Centrum Medyczne Warszawa Warsaw Poland
Lcrgo Gygdnae Hojugcah Og Agooma Athens Greece
Hfwlrtzz Vwwi dbcbwplv Barcelona Spain
Hiahoyxl Uonscrkqilnhm dd A Ceyjdi A Coruna Galicia Spain
Ukgktchhxnjuigidptnze Dcuxjdgvzkf Abo Duesseldorf Germany
Knqvhbdz dpt Ufjbviyyuszq Mqpdlgtt Ama Munich Germany
Ughdqciypjyjrvicnhntp Wfibjhina Ank Wuerzburg Germany
Hagyfmmi Dp Lb Ssmtj Cujt I Svsw Pub Barcelona Spain
Hjnxanhy Utmjwqyhqaqoh Mrtuvdi Dy Vjyaqqzekb Santander Spain
Chuijbt Myfabzu Dq Dxevibpprx Si Tsnjorvwy Ahboqyaan Naexnb Suokda Brasov Romania
Hbmwrvpf Ucyqsgikyjrrts Scllstzatz &twupzj Hrscfub dn Hcefhoaurfn STRASBOURG, Alsace France
Ppow Tgska Hblcuqbt Ufijtwjmawbt Sabadell Spain
Exojvngcth Ktkuuqb Srucgeg Thessaloniki Greece
Sgvumqen Cwfrff &tsgzdkxxe It Czcxupscfhzmxoxedh Bucharest Romania

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
02.02.2023
France France
Not recruiting
02.02.2023
Germany Germany
Not recruiting
02.02.2023
Greece Greece
Not recruiting
02.02.2023
Italy Italy
Not recruiting
02.02.2023
Poland Poland
Not recruiting
02.02.2023
Portugal Portugal
Not recruiting
02.02.2023
Romania Romania
Not recruiting
02.02.2023
Spain Spain
Not recruiting
02.02.2023

Trial locations

Investigated Drugs:

HZN-825 is a medication being studied for its effectiveness, safety, and how well patients can tolerate it. It is used in patients with diffuse cutaneous systemic sclerosis, a condition that affects the skin and other organs. HZN-825 works by blocking a specific receptor in the body, known as LPAR1, which may help reduce symptoms of the disease. This trial is an extension of a previous study, allowing researchers to gather more information over a longer period.

Investigated Diseases:

Diffuse Cutaneous Systemic Sclerosis – This is a rare autoimmune disease characterized by the hardening and tightening of the skin and connective tissues. It primarily affects the skin but can also involve internal organs such as the lungs, heart, and kidneys. The disease progresses with the overproduction of collagen, leading to thickened skin and sometimes causing joint pain and stiffness. As it advances, it may result in reduced mobility and function of affected areas. The condition can vary greatly in severity and progression among individuals. It is part of a group of diseases known as scleroderma.

Trial ID:
2023-509783-23-00
Protocol code:
HZNP-HZN-825-302
NCT ID:
NCT04781543
Trial Phase:
Therapeutic exploratory (Phase II)

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