A Study to Learn More About How Well BAY3018250 Works and How Safe it is for People With Proximal Deep Vein Thrombosis

NCT06149520 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: 221382023-503315-15-00
• Study Type: interventional
• Target: 258
• Locations: 13 countries
• Sites: 68

Brief Summary

Researchers are looking for a better way to treat people who have deep vein thrombosis (DVT). DVT is a condition that occurs when a blood clot forms in a deep vein in the leg. DVT is called 'proximal' when the clot is formed in the veins of the hip, thigh, and knee. DVT can cause serious health problems. The blood clots in the veins can break loose and can then travel through the bloodstream and get stuck in the lungs, blocking blood flow to the lungs. Symptoms of DVT include swelling, pain, and tenderness in the affected leg, as well as redness and warmth in the area. Currently, DVT is usually treated using blood thinners to prevent the clot from getting bigger or breaking off and traveling to the lungs. However, blood thinners may not be able to remove a blood clot quickly and may not be suitable for everyone who has DVT. BAY3018250 is a drug that works by dissolving blood clots. In this study, researchers will compare BAY3018250 with placebo to learn how well it works and how safe it is in participants with proximal DVT. A placebo looks like the study drug but does not have any medicine in it. Using a placebo helps researchers to confirm that the results observed during the study were caused by the study drug and not by other factors. The main purposes of this study are to learn:

• How well BAY3018250 works in dissolving blood clots in participants with proximal DVT and
• How safe is BAY3018250 as a treatment for participants with proximal DVT? For this, the researchers will use ultrasound tests to measure blood clots in participants before and at various times after study treatment. They call these measurements a clot burden score. They will compare the clot burden score before and after treatment and will calculate a complex measure called AUC. This tells researchers how the clots have changed over time. And researchers will collect the number of bleeding events that require medical attention. The study participants will be randomly (by chance) assigned to one of 3 treatment groups. Dependent on the group, they will receive a single dose of high dose or low dose of BAY3018250 or placebo. Researchers will closely monitor participants for 90 days after receiving the study treatment. During the study, the doctors and their study team will:
• take blood samples
• do physical examinations
• examine heart health using electrocardiogram (ECG)
• check vital signs such as blood pressure, heart rate
• undergo ultrasound tests to measure the blood clots
• ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.

Conditions

Thrombolysis; Symptomatic Proximal Deep Vein Thrombosis

Outcome Measures

Primary Outcomes (2)

• AUCn(6h-30d) of the ratio to baseline of clot burden, as assessed by repeated quantitative ultrasound

  Area under the curve (AUC) with respect to the measurement time points at 6 hours, 24 hours, 7 days and 30 days of the ratio to baseline of clot burden

  at 6 hours, 24 hours, Day 7, Day 30

• Number of participants with composite of major and clinically relevant non-major (CRNM) bleeding events (ISTH definition)

  The classify of bleeding events use the International Society on Thrombosis and Haemostasis (ISTH) definitions.

  up to Day 15

Secondary Outcomes (4)

• Ratio to baseline of clot burden, as assessed by quantitative ultrasound

  at 6 hours, 24 hours, Day 7, Day 30 and Day 90

• Change from baseline in leg pain severity

  at 6 hours, 24 hours, Day 7, Day 30 and Day 90

• Change from baseline in PVFS scale

  at Day 7, Day 30 and Day 90

• Number of participants with recurrent venous thromboembolism

  up to Day 90

Study Arms (3)

BAY3018250 Dose 1

EXPERIMENTAL

Participants will receive BAY3018250 Dose 1.

Drug: BAY3018250

BAY3018250 Dose 2

EXPERIMENTAL

Participants will receive BAY3018250 Dose 2.

Drug: BAY3018250

Placebo to BAY3018250

PLACEBO COMPARATOR

Participants will receive placebo to BAY3018250.

Drug: Placebo to BAY3018250

Interventions

BAY3018250 DRUG

Dose 1 or dose 2 of BAY3018250

BAY3018250 Dose 1; BAY3018250 Dose 2

Placebo to BAY3018250 DRUG

Matching placebo to BAY3018250

Placebo to BAY3018250

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female (if postmenopausal or hysterectomized) aged 18 years or older
• Acute symptomatic proximal deep vein thrombosis (DVT) documented by compression ultrasound (CUS) and all of the following:
• duration of symptoms 14 days or less
• Proximal DVT involving at least 1 of the following proximal veins: the popliteal vein, the femoral vein, the common femoral vein and the external iliac vein
• adequate visualization of the most proximal end of the thrombus
• receiving therapeutic dose anticoagulation with low molecular weight heparins (LMWHs) and/or direct oral anticoagulants (DOACs) according to the respective product labels
• Measured body weight within 50 to 130 kg
• Signed informed consent

You may not qualify if:

• Acute symptomatic pulmonary embolism (PE) requiring systemic or catheter-directed thrombolytic therapy, catheter-directed mechanical thrombectomy, or surgical embolectomy
• Active bleeding or high risk for bleeding (at the discretion of the investigator)
• Recent (\<3 months) ischemic stroke, myocardial infarction, intracranial hemorrhage, or major surgery or severe trauma (at the discretion of the investigator)
• Active cancer, i.e., locally active, regionally invasive or metastatic and/or anticancer therapy within the last 6 months, except basal cell or squamous cell carcinoma
• Therapeutic-dose anticoagulants for \> 72 hours before randomization, or current use of vitamin K antagonists
• Planned or current use of the following medications:
• Any antiplatelet therapy, except acetylsalicylic acid (ASA) ≤100 mg/day
• Antifibrinolytic drugs
• Therapeutic antibodies
• Male participants with women of childbearing potential (WOCBP) partners unwilling to use highly effective contraception from start of study intervention until end of study.

Sponsors & Collaborators

• Bayer: lead

Study Sites (68)

Universiteit Ziekenhuis Antwerpen | Thoraxheelkunde Afdeling

Antwerp, 2650, Belgium

Location

Imelda - Vascular Surgery Dept

Bonheiden, 2820, Belgium

Location

Ziekenhuis Oost-Limburg | Genk, Sint-Jan campus - Thoracic Vascular Surgery Department

Genk, 3600, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

AZ Groeninge - Campus Kennedylaan

Kortrijk, 8500, Belgium

Location

Katholieke Universiteit Leuven (KU Leuven) - Center for Molecular and Vascular Biology (CMVB)

Leuven, 3000, Belgium

Location

AZ Sint-Maarten

Mechelen, 2800, Belgium

Location

University Multiprofile Hospital For Active Treatment Kanev AD

Rousse, 7002, Bulgaria

Location

Specialized Hospital For Active Cardiology Treatment Medica Kor EAD

Rousse, 7013, Bulgaria

Location

University Multiprofile Hospital For Active Treatment 'Alexandrovska' EAD

Sofia, 1431, Bulgaria

Location

University Multiprofile Hospital for Active Treatment 'Sveta Ekaterina' EAD, Sofia

Sofia, 1431, Bulgaria

Location

Medical Institute Ministry of Interior

Sofia, 1606, Bulgaria

Location

Multiprofile Hospital for Active Treatment Dr. Stefan Cherkezov | Base 1 - Cardiology Department

Veliko Tarnovo, 5000, Bulgaria

Location

McGill University Health Centre - Glen Site

Montreal, Quebec, H4A 3J1, Canada

Location

Vojenská nemocnice Brno - Interní oddelení, pododbor kardiologie

Brno, 615 00, Czechia

Location

Interni oddeleni, Krnovska nemocnice, Sdruzene zdravotnicke zarizeni Krnov, prispevkova organizace

Krnov, 794 01, Czechia

Location

Kardiologicka klinika, Fakultni nemocnice Kralovske Vinohrady

Prague, 100 34, Czechia

Location

Všeobecná fakultní nemocnice v Praze - II. interní klinika - klinika kardiologie a angiologie, AJIP

Prague, 128 08, Czechia

Location

Nemocnice Roudnice nad Labem - interni oddeleni

Roudnice nad Labem, 41301, Czechia

Location

Interni a kardiologicka ambulance, Nemocnice Znojmo, prispevkova organizace

Znojmo, 669 02, Czechia

Location

Centre Hospitalier Universitaire Amiens Picardie Site Sud

Amiens Cedex1, 80054, France

Location

Centre Hospitalier Regional Universitaire (CHRU) Brest - Hopital de la Cavale Blanche

Brest, 29609, France

Location

Centre Hospitalier Universitaire de Clermont Ferrand - Gabriel Montpied

Clermont-Ferrand, 63003, France

Location

Hôpital Louis Mourier - Colombes Cedex

Colombes, 92701, France

Location

Centre Hospitalier Universitaire Grenoble Alpes (CHU Grenoble Alpes) - Hopital Albert Michallon

La Tronche, 38700, France

Location

AP-HP Hopital Europeen Georges-Pompidou (HEGP) - Service de medecine vasculaire

Paris, 75908, France

Location

Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord

Saint-Etienne, 42000, France

Location

Hopitaux Universitaires de Strasbourg - Le Nouvel Hopital Civil (NHC)

Strasbourg, 67091, France

Location

Hôpital Sainte Musse

Toulon, 83100, France

Location

Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital de Rangueil - Service de medecine vasculaire

Toulouse, 31059, France

Location

UNIVERSITAETSKLINIKUM FREIBURG - Universitaets-Herzzentrum Bad Krozingen | Klinik für Kardiologie und Angiologie

Bad Krozingen, 79189, Germany

Location

Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden | Medizinische Klinik I - FB Haemostaseologie

Dresden, 01307, Germany

Location

LMU Klinikum Campus Innenstadt | Medizinische Klinik und Poliklinik IV | FB Angiologie

München, 80336, Germany

Location

Universitaetsklinikum Muenster | Klinik fuer Kardiologie I Sektion Angiologie

Münster, 48149 Münster, Germany

Location

General Hospital Of Athens G Gennimatas- Department of Vascular Surgery

Athens, 115 27, Greece

Location

University General Hospital Attikon - 1st Department of Vascular surgery University of Athens

Athens, 124 62, Greece

Location

General Hospital Of Thessaloniki Papageorgiou- 1st Department of Surgery

Efkarpia, 564 29, Greece

Location

University General Hospital Of Ioannina- Department of Surgery, Vascular Unit Faculty

Ioannina, 455 00, Greece

Location

General University Hospital Of Patras- Department of Vascular Surgery

Pátrai, 265 04, Greece

Location

Bekes Varmegyei Kozponti Korhaz - Dr. Rethy Pal Tagkorhaz

Békéscsaba, 5600, Hungary

Location

Semmelweis Egyetem - Belgyógyászati és Hematológiai Klinika, Kardiológia

Budapest, 1088, Hungary

Location

Somogy Varmegyei Kaposi Mor Oktato Korhaz - Általános Belgyógyászati Osztály

Kaposvár, 7400, Hungary

Location

Kistarcsai Flor Ferenc Korház - II. Belgyógyászat - Angiológia

Kistarcsa, 2143, Hungary

Location

Szegedi Tudományegyetem, Szent-Györgyi Albert Klinikai Központ - Belgyógyászati Klinika

Szeged, 6725, Hungary

Location

Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz - II. Belgyogyaszat

Székesfehérvár, 8000, Hungary

Location

Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Angiologia e Malattie della Coagulazione

Bologna, 40138, Italy

Location

Azienda Unita Locale Socio Sanitaria 2 Marca Trevigiana | Castelfranco Veneto Hospital - Angiologia Department

Castelfranco Veneto, <unknown>, Italy

Location

Azienda Ospedale-Università di Padova - Medicina Generale ad indirizzo trombotico-emorragico

Padua, 35128, Italy

Location

Azienda Unita Sanitaria Locale di Reggio Emilia | Arcispedale Santa Maria Nuova - Cardiovascular Medicine

Reggio Emilia, 42122, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOSD Malattie Emorragiche e Trombotiche

Roma, 00168, Italy

Location

Humanitas Mirasole S.p.A. - Centro Trombosi e Malattie Emorragiche

Rozzano, 20089, Italy

Location

AULSS N. 2 Marca Trevigiana_Ospedale di Treviso - UOC Pronto Soccorso

Treviso, 31100, Italy

Location

ASST dei Sette Laghi | Ospedale Di Circolo e Fondazione Macchi Di Varese - Centro Trombosi ed Emostasi

Varese, 21100, Italy

Location

Albert Schweitzer Hospital | Internal Medicine - Hematology Department

Dordrecht, 3318 AT, Netherlands

Location

Zuyderland Medical Centre | Internal Medicine Department

Geleen, 6162 BG, Netherlands

Location

Leids Universitair Medisch Centrum (LUMC) (Leiden University Medical Center)

Leiden, 2300 RC, Netherlands

Location

Penta Hospitals | Zeleznicna Nemocnica Kosice - Angiologicka ambulancia

Košice, 040 01, Slovakia

Location

Kardiocentrum AGEL a.s. - Angiologické oddelenie

Košice, 040 15, Slovakia

Location

Nemocnicná a.s. - Interné oddelenie

Malacky, 901 22, Slovakia

Location

Penta Hospitals | Hospital and Polyclinic Spisska Nova Ves - Internal Medicine Department

Spišská Nová Ves, 052 01, Slovakia

Location

Hospitale, s.r.o. - Interné oddelenie

Šahy, 936 01, Slovakia

Location

Hospital Universitario Infanta Sofia | Medicina Interna

San Sebastián de los Reyes, Madrid, 28702, Spain

Location

Hospital Universitari De Girona Doctor Josep Trueta | Medicina Interna

Girona, 17007, Spain

Location

Ankara Bilkent Sehir Hastanesi

Bilkent Ankara, 6800, Turkey (Türkiye)

Location

Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi

Istanbul, 34098, Turkey (Türkiye)

Location

Saglik Bilimleri Üniversitesi Dr. Siyami Ersek Gögüs Kalp ve Damar Cerrahisi Egitim Ve Arastirma Hastanesi

Istanbul, 34744, Turkey (Türkiye)

Location

Izmir Sehir Hastanesi

Izmir, 35540, Turkey (Türkiye)

Location

Erciyes Universitesi Tip Fakultesi

Kayseri, 38039, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 29, 2023
• Study Start: January 15, 2024
• Primary Completion: October 7, 2025
• Study Completion: December 2, 2025
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (8); DE (4); BE (7); CA (1); GR (5); NL (3); FR (10); SL (5); ES (2); CZ (6); HU (6); BU (6); TU (5)