Study on BI 685509 for Adults with Systemic Sclerosis to Assess Effects on Lung Function and Symptoms

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for systemic sclerosis, a condition that causes hardening and tightening of the skin and connective tissues. The treatment being tested is a medication called BI 685509, which is taken as a film-coated tablet. The purpose of the study is to determine if BI 685509 can improve lung function and other symptoms associated with systemic sclerosis.

Participants in the study will be randomly assigned to receive either the BI 685509 tablets or a placebo, which looks like the medication but does not contain the active ingredient. The study will last for at least 48 weeks, during which participants will take the tablets orally. Throughout the study, participants will have regular check-ups to monitor their health and assess any changes in their condition.

The main goal is to see if BI 685509 can slow down the decline in lung function over the course of the study. Additionally, researchers will look at other aspects of systemic sclerosis, such as skin symptoms and overall health, to understand the full impact of the treatment. This study aims to provide valuable information on the safety and effectiveness of BI 685509 for people living with systemic sclerosis.

1 joining the study

Upon joining the study, you will be randomly assigned to receive either the study medication, BI 685509, or a placebo. A placebo is a tablet that looks like the medication but does not contain the active ingredient. This process is called randomization and ensures that the study results are unbiased.

2 medication administration

You will take the assigned medication orally in the form of a film-coated tablet. The exact dosage and frequency will be provided by the study team. The treatment will last for at least 48 weeks.

3 regular check-ups

Throughout the study, you will have regular check-ups to monitor your health and the effects of the medication. These check-ups will include assessments of your lung function and other symptoms related to systemic sclerosis.

4 end of treatment evaluation

At the end of the 48-week treatment period, you will undergo a final evaluation. This will include measuring any changes in your symptoms and overall health status.

Who Can Join the Study?

Signed and dated written informed consent before joining the trial. This means you agree to participate after understanding the study details.
Must be a male or female aged 18 years or older.
Must meet the 2013 ACR/EULAR classification criteria for systemic sclerosis (SSc). These are guidelines used by doctors to diagnose this condition.
Must have either limited or diffuse cutaneous SSc. If you have limited cutaneous SSc, you need to test positive for anti Scl-70 antibodies, which are specific proteins in the blood.
If you have diffuse cutaneous SSc, the disease must have started within 7 years before the first visit. If you have limited cutaneous SSc, it must have started within 2 years before the first visit.
Must show signs of active disease, such as:
- New onset of SSc within the last 2 years before the first visit.
- New or worsening skin involvement in two new body areas within 6 months before the first visit.
- New or worsening skin involvement in one new body area if it is the chest or abdomen within 6 months before the first visit.
- Worsening of skin thickening by 2 or more points within 6 months before the first visit.
- At least one tendon friction rub, which is a grating sensation felt over a tendon.
Must have elevated biomarkers at the first visit, such as:
- CRP (C-reactive protein) level of 6 mg/L or higher, which indicates inflammation.
- Erythrocyte sedimentation rate (ESR) of 28 mm/h or higher, another marker of inflammation.
- KL-6 level of 1000 U/mL or higher, a marker related to lung involvement.
- If none of these are met, you can still join if the mDAI (modified Disease Activity Index) is 2.5 or higher.
Must have evidence of significant vasculopathy, which is a condition affecting blood vessels, such as:
- Active digital ulcers (DU) at the first visit, which are sores on the fingers or toes.
- A documented history of digital ulcers.
- Previous treatment for Raynaud’s phenomenon (RP) with certain medications.
- RP with elevated CRP of 6 mg/L or higher.
- If none of these are met, you can still join if you have a confirmed diagnosis of interstitial lung disease (ILD).

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 who have a history of drug or alcohol abuse within the past year.
Patients who are unable to comply with the study procedures.
Patients who have a known allergy to the study medication or its ingredients.
Patients with unstable or uncontrolled medical conditions.
Patients who have had a major surgery within the last 3 months.
Patients with a history of certain heart conditions.
Patients who are currently taking medications that might interfere with the study treatment.

Where you can join this trial?

Verified and Recommended Sites

Site Name	City	Country	Status
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy	Warsaw	Poland

Verified Sites

Site Name	City	Country
University Hospital Jena KöR	Jena	Germany
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Katholieke Universiteit te Leuven	Leuven	Belgium
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Oslo Universitetssykehus HF	Oslo	Norway
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium
Aqua-Med Consulting S.R.L.	Constanta	Romania
Spitalul Clinic Judetean De Urgenta Cluj	Cluj Napoca	Romania
Kuopio University Hospital	Kuopio	Finland

Other Sites

Site Name	City	Country
Revmatologicky Ustav	Prague	Czechia
Fraunhofer Institute for Translational Medicine and Pharmacology ITMP	Frankfurt	Germany
Hôpital Pontchaillou-CHU Rennes	Rennes	France
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Ospedale San Raffaele S.r.l.	Milan	Italy
Centre Hospitalier Universitaire De Toulouse	Toulouse	France
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Turku University Hospital	Turku	Finland
Universita’ Politecnica Delle Marche	Ancona	Italy
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Centre Hospitalier Universitaire De Nantes	Nantes	France
Region Midtjylland	Aarhus	Denmark
Rigshospitalet	Copenhagen	Denmark
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Centre hospitalier universitaire de Liege	Liege	Belgium
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital Universitario 12 De Octubre	Madrid	Spain
Universita Degli Studi Di Brescia	Brescia	Italy
Medaudio-Optica S.R.L.	Ramnicu Valcea	Romania
Fondazione Italiana Sindromi Mielodisplastiche Onlus	Florence	Italy
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Connolly Hospital	Dublin	Ireland
Les Hopitaux Universitaires De Strasbourg	STRASBOURG, Alsace	France
Medyczne Centrum Hetmanska	Poznan	Poland
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Academisch Ziekenhuis Leiden	Leiden	The Netherlands
Spitalul Judetean De Urgenta Bacau	Bacau	Romania
Saint Maria Hospital	Bucharest	Romania
Charite Research Organisation GmbH	Berlin	Germany
Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto	Milan	Italy
Hospital Universitario Dr Peset Aleixandre	Valencia	Spain
Malopolskie Badania Kliniczne Sp. z o.o.	Cracow	Poland
Policlinica CCBR S.R.L.	Bucharest	Romania
Westfaelische Wilhelms Universitaet Muenster	Munster	Germany
Lixqo Gptayea Htqrgexj Oq Aomsgo	Athens	Greece
Hluilade Vyvy dptfnmpu	Barcelona	Spain
Uoegkbpgfg Hhfnseba Cqhpxdw	Cologne	Germany
Umonbeernfeiomiwhxvrf Dzwvzjqjlef Aly	Duesseldorf	Germany
Mzwynae Upkzkaghck Oh Goms	Graz	Austria
Cqzi Dw Nicve	Vandoeuvre Les Nancy	France
Sjcdjxuupvx Uwgctbxlsl Hgamsindctckhtb Gvimdycjggtyoiyed	Gothenburg	Sweden
Hhczixzo Dp Lo Slfdx Cmvh I Spnj Ppr	Barcelona	Spain
Sv Vyynxsluankoups Ulxeecwrqq Hfugzjyp	Dublin	Ireland
Unamguvtrh Dchma Snnof Dk Rvng Ln Sarmftzr	Rome	Italy
Occzqgebnqvjqw Lech Gfio	Linz	Austria
Chwzlhh Mtibfgn Di Dadvgqgrcd Sk Txxivgovc Amdxjiddb Neomnl Shetsu	Brasov	Romania
Nyesocqs Ikcewaih Gypreydno Rkkmwxtwarjd I Riukaswxlovly Iz Pqyfz Dd Hvmt Mtia Eessqngo Rgyjjgf	Warsaw	Poland
Riexxgrgtrpp Pjpqkgn Pvddfkua “dzi Erfwx Soizjc	Timisoara	Romania
Sufjxpyj Cebynv &phlkuwbpl Iz Clsbygtvcvfjzdolqc	Bucharest	Romania
Cxl djlpozuaeweuge	Epagny Metz Tessy	France
Apwvzvltsf Pujlctoe Hyxuajhe Du Pyeog	Paris	France
Siexkpacz Rzbkbmz Uxgtsdugfg Mmygmnr Cjqnud	Nijmegen	The Netherlands
Lewrnl Mpuzruvgqy Uapvndrpfe Oz Mzscjo	Munich	Germany
Pkqstebrg Ilahbvfm Mpzsarua Mxxwkfdzakpn Shprr Wcqihwqckpmx I Agggjucjyyann	Warsaw	Poland

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	13.12.2023
Belgium	Not recruiting	13.12.2023
Czechia	Not recruiting	13.12.2023
Denmark	Not recruiting	13.12.2023
Finland	Not recruiting	13.12.2023
France	Not recruiting	13.12.2023
Germany	Not recruiting	13.12.2023
Greece	Not recruiting	13.12.2023
Ireland	Not recruiting	13.12.2023
Italy	Not recruiting	13.12.2023
Norway	Not recruiting	13.12.2023
Poland	Not recruiting	13.12.2023
Portugal	Not recruiting	13.12.2023
Romania	Not recruiting	13.12.2023
Spain	Not recruiting	13.12.2023
Sweden	Not recruiting	13.12.2023
The Netherlands	Not recruiting	13.12.2023

Trial locations

Investigated Drugs:

Bi 685509

BI 685509 is an experimental medication being tested for its potential to help people with progressive systemic sclerosis, a condition that affects the skin and internal organs. This medication is taken orally, which means it is swallowed in the form of a pill or liquid. The main goal of using BI 685509 in this trial is to see if it can slow down the worsening of lung function over a period of 48 weeks. Researchers are interested in finding out if this medication can help maintain lung health better than not taking it at all. Participants in the trial will be monitored to see how their lung function changes while taking this medication.

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, leading to fibrosis. As the disease advances, it can affect internal organs such as the lungs, heart, and kidneys, causing them to function less effectively. The skin may become thickened and lose its elasticity, and blood vessels may also be affected, leading to issues such as Raynaud’s phenomenon. Over time, systemic sclerosis can lead to significant physical changes and impairments. The progression and severity of symptoms can vary widely among individuals.

Trial ID:

2022-500332-11-00

Protocol code:

1366-0031

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on BI 685509 for Adults with Systemic Sclerosis to Assess Effects on Lung Function and Symptoms

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?