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 Państwowy Instytut Badawczy	Warsaw	Poland

Verified Sites

Site Name	City	Country
University Hospital Jena KöR	Jena	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
Ospedale San Raffaele S.r.l.	Milan	Italy
Turku University Hospital	Turku	Finland
Centre Hospitalier Universitaire De Nantes	Nantes	France
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Connolly Hospital	Dublin	Ireland
Medyczne Centrum Hetmanska	Poznan	Poland
Rkyfbwpxaweylu Usvbv	Prague	Czechia
Lgkun Gxmjyto Hvbqhmtm Ou Aarymc	Athens	Greece
Hjyhwxbr Vdvz doxvlrug	Barcelona	Spain
Fqkavwvjvl Ifllbvabp flw Trjhrqxjkprvz Mhpybwxf akz Pkyjzabvudzq Imkf	Frankfurt	Germany
Hmrpudi Pwwizluefpqqqszn Rjnbjz	Rennes	France
Uewkmldepn Hcawhemx Clguhii	Cologne	Germany
Ustnumfrmjicytfnkihfo Erejmrqv Ahz	Erlangen	Germany
Cgbucu Hximtxinydt Uifejpyehvmqt Df Tykbggft	Toulouse	France
Uegdhxoqygnspcnfawulo Dwhkykjaism Akg	Duesseldorf	Germany
Mwtyvkl Ujvianhmlm Ow Gaih	Graz	Austria
Ixyad Oqmrinqs Preclwxlqmq Spz Mjszhnv	Genoa	Italy
Ulusdbgbmlcmhqxyy Pbotqpxzxda Dcmlj Mhjkoc	Ancona	Italy
Uyiztogdpwde Dy Szddrsqn Dx Cmeeubxjha	Santiago De Compostela	Spain
Czya Dn Noomr	Vandoeuvre Les Nancy	France
Ubecssafzhhvwdbwqokfz Hvvirgnzwy Add	Heidelberg	Germany
Slplkctospa Uvxynryhgp Hhpbmmgofsmbzrb Gxjwbrlkmzbuzizqd	Gothenburg	Sweden
Rctlyi Mewfujeyjww	Aarhus	Denmark
Rjntqldexcyvlj	Copenhagen	Denmark
Hebkokqe Dr Ln Syqqv Cvrd I Sfjb Pze	Barcelona	Spain
Sp Vorsuhtcwnrjltt Uwfgphpeun Hjxnjqnw	Dublin	Ireland
Uluxmlbnns Dzjks Sgtos Dv Rqic Ln Smmwighi	Rome	Italy
Owtajsshlaicsg Lyuw Gcje	Linz	Austria
Cbpwue hnmzsydojgv uvkvphfhiwioj de Lsiip	Liege	Belgium
Uuxsuqlgvipr Zjsjnjqrai Gmgd	Gent	Belgium
Hengnjod Uvnbbxckzhtdz 1m Ds Ozyqrlp	Madrid	Spain
Ukhtldppwx Dufdc Sstwm Dl Btltkdu	Brescia	Italy
Cqccqwo Mmahktf Dl Dremlczrtq Sr Tzwahjvri Acakktgun Nezgeu Sktmnj	Brasov	Romania
Nsxuctcn Imveewgh Goebblecs Rkuezbepsfbe I Rkmetllmtcvtu Iq Plcuv Dp Hfqf Mlhc Ejssadpz Rbqgxwv	Warsaw	Poland
Mfgyuvrreivphnw Svzqkq	Ramnicu Valcea	Romania
Rieepdwbypvv Pkjsrfg Pqpdduml “ire Egeid Sgpybq	Timisoara	Romania
Sjtguhdk Cazchv &resvkyhxa It Cvnsthbnguccfjkuia	Bucharest	Romania
Cwj dznudsrjagihhk	Epagny Metz Tessy	France
Fxmobyvxxo Ikpkxyyi Sqjqezxi Mrwjucolqeyguctty Ogvla	Florence	Italy
Cyilxt Haqcijmkyss Ubvzgepubwfhb Dd Bdbzbner	Bordeaux	France
Lsl Heckvtpv Uafmjxbqijobrl Dz Ssovglhooh	STRASBOURG, Alsace	France
Aitixfsskn Pydblpcq Hwicqttf Di Ppjzb	Paris	France
Urjrwmfuagwwcwgxq Ccqemp Bwsnxawert Dk Rgin	Rome	Italy
Auetkngkmy Zdizhciwob Lkxuqg	Leiden	The Netherlands
Srmyevdxp Rcrdzrq Usuttgspnf Mocmgzs Cjgfrj	Nijmegen	The Netherlands
Lhcwhf Mrrbmuoguc Uuliqagaxb Oq Mmfmgr	Munich	Germany
Pdonnwmae Ikufakzg Mzvebetb Muqqlciugxao Siinv Wwaedzujheeg I Aalmwdbwzyueh	Warsaw	Poland
Syqnpvui Jymspbhm Da Ujjabce Bdkgu	Bacau	Romania
Sguhq Mtzwm Hgdeceab	Bucharest	Romania
Cwagjam Rmkppkvv Obejfjgfkohu Gbks	Berlin	Germany
Amly Ctgkzl Sfergyodjgulo Oaibelibij Teeafpdarcbpne Gqbprax Pfke Cwq	Milan	Italy
Hsofomfe Uelqknahilerj Da Pyxbt Ayqfcfaglg	Valencia	Spain
Mwnupgiuvkg Btxhsuu Kbpzvnfbv Smu z oicv	Cracow	Poland
Pvjvqolkiht Cwdu Scskob	Bucharest	Romania
Wqauqhzlzrvzf Wgtjbbim Uedaummrmnpb Mljfquua	Munster	Germany

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?