Clinical trial • Phase III • Other

ELINZANETANT for Vasomotor symptoms (hot flashes) due to adjuvant endocrine therapy

Phase III trial of ELINZANETANT for Vasomotor symptoms (hot flashes) due to adjuvant endocrine therapy.

Overview

Trial Therapeutic Area
Other
Trial Disease
Vasomotor symptoms (hot flashes) due to adjuvant endocrine therapy
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
12-01-2024
First CTIS Authorization Date
20-02-2024

Trial design

Randomised, placebo: bay 3427080 60 mg capsules placebo administered orally once daily for the first 12 weeks (placebo-controlled arm). test arm: elinzanetant (bay 3427080) 120 mg orally once daily for 52 weeks (and optionally up to an additional 3.5 years). Phase III trial in France, Hungary, Italy and others.

Randomised
Yes
Comparator
Placebo: BAY 3427080 60 mg capsules placebo administered orally once daily for the first 12 weeks (placebo-controlled arm). Test arm: elinzanetant (BAY 3427080) 120 mg orally once daily for 52 weeks (and optionally up to an additional 3.5 years).
Target Sample Size
57
Trial Duration For Participant
392

Eligibility

Recruits 57 isVulnerablePopulationSelected flag is true. Participants are adults (females aged 18 to 70). Informed consent is required from each participant. Subject information and informed consent forms (ICFs) and participant information sheets are provided in multiple country/language-specific versions (documents list includes ICFs in FR, HU, IT, DE, PL, RO, EN, ES, PT, FI among others). No assent or parental consent handling is specified (participants are adults)..

Vulnerable Population
isVulnerablePopulationSelected flag is true. Participants are adults (females aged 18 to 70). Informed consent is required from each participant. Subject information and informed consent forms (ICFs) and participant information sheets are provided in multiple country/language-specific versions (documents list includes ICFs in FR, HU, IT, DE, PL, RO, EN, ES, PT, FI among others). No assent or parental consent handling is specified (participants are adults).

Inclusion criteria

  • {"criterion_text":"- Females aged 18 to 70 years of age inclusive, at the time of signing the informed consent.\n- Women experiencing vasomotor symptoms (VMS) caused by adjuvant endocrine therapy that they are expected to use for the duration of the study a) Tamoxifen with or without the use of gonadotropin-releasing hormone (GnRH) analogues or b) Aromatase inhibitors with or without the use of GnRH analogues\n- Women must have a. a personal history of hormone-receptor positive breast cancer or b. a high risk for developing breast cancer.\n- Participant has completed Hot Flash Daily Diary (HFDD) for at least 11 days during the two weeks preceding baseline visit, and participant has recorded at least 35 moderate to severe hot flash (HF) (including night-time HF) over the last 7 days that the HFDD was completed (assessed at the Baseline Visit).\n- Contraceptive use by women (except for post-menopausal women or Women of Non childbearing potential [WONCBP]) should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies."}

Exclusion criteria

  • {"criterion_text":"- Initial diagnosis of metastatic hormone-receptor positive breast cancer (stage IV) or recurrence under adjuvant endocrine therapy of hormonereceptor positive breast cancer.\n- Current or history (except complete remission for 5 years or more prior to signing informed consent) of any malignancy, except for hormone-receptor positive breast cancer (Stage 0-III), basal and squamous cell skin tumors.\n- Surgery or non-surgical (e.g., chemotherapy, radiotherapy, immunotherapy) treatment for breast cancer within the last 3 months prior to signing informed consent (except use of tamoxifen, aromatase inhibitors, GnRH analogues).\n- Any clinically significant prior or ongoing history of arrhythmias, heart block and QT prolongation either determined through clinical history or on electrocardiogram (ECG) evaluation.\n- Any active ongoing condition that could cause difficulty in interpreting VMS such as: infection that could cause pyrexia, pheochromocytoma, carcinoid syndrome.\n- Any unexplained vaginal bleeding.\n- Mammogram with clinically relevant malignant or suspicious findings that will require surgery, radiotherapy or chemotherapy as per local guidelines (mammogram should not be older than 12 months prior to signing informed consent). If a mammogram is not possible after partial mastectomy an ultrasound could be performed instead.\n- Disordered proliferative endometrium, endometrial hyperplasia, polyp, or endometrial cancer diagnosed based on endometrial biopsy during screening.\n- Current arterial or venous vascular event (e.g., Myocardial infarction (MI), Transient ischemic attack (TIA), stroke, deep vein thrombosis (DVT), i.e., within the last 6 months prior to signing informed consent."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Mean change in frequency of moderate to severe hot flash (HF) from baseline to Week 4 (assessed by hot flash daily diary [HFDD]).","definition_or_measurement_approach":"Assessed by hot flash daily diary (HFDD); endpoint is mean change in frequency of moderate to severe hot flashes from baseline to Week 4."}
  • {"endpoint_text":"- Mean change in frequency of moderate to severe HF from baseline to Week 12 (assessed by HFDD).","definition_or_measurement_approach":"Assessed by hot flash daily diary (HFDD); endpoint is mean change in frequency of moderate to severe hot flashes from baseline to Week 12."}

Secondary endpoints

  • {"endpoint_text":"- Mean change in severity of moderate to severe HF from baseline to Week 4 (assessed by HFDD).","definition_or_measurement_approach":"Assessed by HFDD; mean change in severity of moderate to severe hot flashes from baseline to Week 4."}
  • {"endpoint_text":"- Mean change in severity of moderate to severe HF from baseline to Week 12 (assessed by HFDD).","definition_or_measurement_approach":"Assessed by HFDD; mean change in severity of moderate to severe hot flashes from baseline to Week 12."}
  • {"endpoint_text":"- Mean change in frequency of moderate to severe HF from baseline to Week 1 (assessed by HFDD).","definition_or_measurement_approach":"Assessed by HFDD; mean change in frequency from baseline to Week 1."}
  • {"endpoint_text":"- Mean change in frequency of moderate to severe HF from baseline over time.","definition_or_measurement_approach":"Assessed by HFDD; mean change in frequency over time relative to baseline."}
  • {"endpoint_text":"- Mean change in patient-reported outcomes measurement information system sleep disturbance short form 8b (PROMIS SD SF 8b) total score from baseline to Week 12.","definition_or_measurement_approach":"Assessed using PROMIS SD SF 8b; mean change in total score from baseline to Week 12."}
  • {"endpoint_text":"- Mean change in menopause specific quality of life scale (MENQOL) total score from baseline to Week 12.","definition_or_measurement_approach":"Assessed using MENQOL questionnaire; mean change in total score from baseline to Week 12."}

Recruitment

Digital Remote Recruitment
True, recruitment includes digital/remote methods: social media ads, website landing pages, digital ad creatives, patient web videos, online user flows and digital recruitment workflows (documents reference Social Media, Digital Ads, Website Creative Pack, Web Video storyboard, and Probando platform materials).
Planned Sample Size
57
Recruitment Window Months
68
Consent Approach
Informed consent is obtained from each participant (adult females 18–70). Subject information and informed consent forms (ICFs) and participant information sheets are provided in multiple country/language versions (documents list includes ICFs in FR, HU, IT, DE, PL, RO, EN, ES, PT, FI etc.). No mention of parental consent or assent (participants are adults).

Methods

  • Posters (country/language specific) — patient-facing posters listed in recruitment materials for multiple countries.
  • Trifold brochures / patient brochures for distribution at sites.
  • Flipcharts and IC flipcharts for site staff.
  • Local advertisements and local newspaper advertisements (country specific).
  • Social media advertising / Social Media Ad Text (digital ads, teaser text) including XFactor Digital Ads creative and Social Media scripts.
  • Website landing pages / study webpages and website creative packs.
  • Patient Web Video / Video Pack study overview and web video storyboards.
  • Patient letters and patient booklets sent by sites.
  • Patient feedback surveys and access cards.
  • Digital recruitment workflows and online user flows (Probando platform materials referenced).
  • Posting materials across multiple channels (print, digital, video) adapted by country.

Geography

Total Number Of Sites
91
Total Number Of Participants
421

France

Earliest CTIS Part Ii Submission Date
06-02-2024
Latest Decision Or Authorization Date
05-12-2025
Processing Time Days
668
Number Of Sites
7
Number Of Participants
36

Sites

Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Oncogynecologie et senologie
Contact Person Name
Sophie Gau
Contact Person Email
contact.crc@icm.unicancer.fr
Site Name
Centre Francois Baclesse
Department Name
Pathologie mammaire
Contact Person Name
George Emile
Contact Person Email
g.emile@baclesse.unicancer.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Gynecologie medicale
Contact Person Name
Aliette Dezellus
Site Name
Centre Leon Berard
Department Name
Gynecologie médicale
Contact Person Name
Christine Rousset-Jablonski
Site Name
Hopital Tenon
Department Name
Gynecologie Obstetrique Medecine de la Reproduction
Contact Person Name
Nathalie Chabbert-Buffet
Site Name
Centre Regional Lutte Contre Le Cancer
Department Name
Oncologie
Contact Person Name
Thierry Petit
Contact Person Email
t.petit@icans.eu
Site Name
Institut De Cancerologie De L Ouest (Angers)
Department Name
Oncologie
Contact Person Name
Baptiste Sauterey

Hungary

Earliest CTIS Part Ii Submission Date
06-02-2024
Latest Decision Or Authorization Date
15-12-2025
Processing Time Days
678
Number Of Sites
3
Number Of Participants
20

Sites

Site Name
Thoeris Psy Kft.
Department Name
Rub-Int Noi Egeszsegcentrum
Contact Person Name
Levente Rubliczky
Contact Person Email
dr.rubliczky@gmail.com
Site Name
Axon Kft.
Contact Person Name
Tamas Nyirady
Contact Person Email
nyiradyt@hotmail.com
Site Name
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Department Name
Onkoradiologia
Contact Person Name
Agnes Weber
Contact Person Email
agneswebermd@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
06-02-2024
Latest Decision Or Authorization Date
10-12-2025
Processing Time Days
673
Number Of Sites
9
Number Of Participants
47

Sites

Site Name
Centro Ricerche Cliniche Di Verona S.r.l.
Department Name
Centro di Ricerche Cliniche
Contact Person Name
Valentino Bergamini
Site Name
Azienda Ospedaliera Ordine Mauriziano Di Torino
Department Name
SCDU Ginecologia e Ostetricia – settore MED 40
Contact Person Name
Valentina Elisabetta Bounous
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
UOC Clinica Ostetrica e Ginecologica
Contact Person Name
Angelo Cagnacci
Contact Person Email
angelo.cagnacci@unige.it
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
Centro Hub e Spoke del CTF-MO
Contact Person Name
Federico Piacentini
Contact Person Email
federico.piacentini@unimore.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Unità Operativa di Ginecologia Oncologica Area Salute della Donna
Contact Person Name
Paola Villa
Site Name
European Institute Of Oncology S.r.l.
Department Name
Unità di Ginecologia Preventiva
Contact Person Name
Dorella Franchi
Contact Person Email
dorella.franchi@ieo.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
U.O. Clinica Ostetrica e Ginecologica e Riproduzione Umana
Contact Person Name
Rossella Nappi
Contact Person Email
r.nappi@smatteo.pv.it
Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
Unità di Ostetricia e Ginecologia
Contact Person Name
Giuseppe Bifulco
Contact Person Email
giuseppe.bifulco@unina.it
Site Name
Centro Ricerche Cliniche Di Verona S.r.l. (additional listing)
Department Name
Centro di Ricerche Cliniche

Austria

Earliest CTIS Part Ii Submission Date
06-02-2024
Latest Decision Or Authorization Date
05-12-2025
Processing Time Days
668
Number Of Sites
3
Number Of Participants
16

Sites

Site Name
Medizinische Universitaet Innsbruck
Department Name
Universitaetsklinik fuer Gynaekologie und Geburtshilfe
Contact Person Name
Christine Brunner
Contact Person Email
c.brunner@tirol-kliniken.at
Site Name
Medical University Of Vienna
Department Name
Universitaetsklinik fuer Frauenheilkunde
Contact Person Name
Georg Pfeiler
Contact Person Email
georg.pfeiler@meduniwien.ac.at
Site Name
Medical University Of Graz
Department Name
Universitaetsklinik fuer Frauenheilkunde und Geburtshilfe
Contact Person Name
Karl Tamussino
Contact Person Email
karl.tamussino@medunigraz.at

Poland

Earliest CTIS Part Ii Submission Date
06-02-2024
Latest Decision Or Authorization Date
09-12-2025
Processing Time Days
672
Number Of Sites
7
Number Of Participants
75

Sites

Site Name
Pratia S.A. (Cracow)
Department Name
Not Applicable
Contact Person Name
Bozena Cybulska-Stopa
Contact Person Email
bcybulska-stopa@pratia.pl
Site Name
Niepubliczny Zaklad Opieki Zdrowotnej Medem Wilk Sp. j.
Department Name
Not Applicable
Contact Person Name
Krzysztof Wilk
Contact Person Email
krzysztof.wilk@onet.pl
Site Name
Clinical Medical Research Sp. z o.o.
Department Name
Not Applicable
Contact Person Name
Dagmara Makowska-Mainka
Site Name
Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultrasonografia prof. dr med. Jacek Suzin
Department Name
Not Applicable
Contact Person Name
Jacek Suzin
Contact Person Email
grabskakobylecka@gmail.com
Site Name
Specjalistyczna Poradnia Ginekologiczna Janusz Tomaszewski sp.k.
Department Name
Not Applicable
Contact Person Name
Janusz Tomaszewski
Contact Person Email
klinika.jtomaszewski@wp.pl
Site Name
Pratia S.A. (Poznan)
Department Name
Not Applicable
Contact Person Name
Krzysztof Szymanowski
Contact Person Email
kszymanowski@pratia.pl
Site Name
Clinical Medical Research / additional listed site
Department Name
Not Applicable

Romania

Earliest CTIS Part Ii Submission Date
06-02-2024
Latest Decision Or Authorization Date
15-12-2025
Processing Time Days
678
Number Of Sites
2
Number Of Participants
17

Sites

Site Name
Oncolab S.R.L.
Department Name
Oncology
Contact Person Name
Dan Stelian Stefan Lungulescu
Contact Person Email
dan.lungulescu@yahoo.com
Site Name
Ovidius Clinical Hospital S.R.L.
Department Name
Oncology
Contact Person Name
Laura Mazilu
Contact Person Email
office@ovidius-ch.ro

Spain

Earliest CTIS Part Ii Submission Date
06-02-2024
Latest Decision Or Authorization Date
20-01-2026
Processing Time Days
714
Number Of Sites
7
Number Of Participants
37

Sites

Site Name
Sanitas Sociedad Anonima De Hospitales
Department Name
Oncology
Contact Person Name
Oscar Torres Lantada
Contact Person Email
otorres@sanitas.es
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncology
Contact Person Name
Yolanda Jerez Gilarranz
Contact Person Email
yolanda.jerez@salud.madrid.org
Site Name
Hospital Universitario Virgen De Las Nieves
Department Name
Oncology
Contact Person Name
Encarna Gonzalez Flores
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Oncology
Contact Person Name
Patricia Palacios Ozores
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncology
Contact Person Name
Javier Salvador Bofill
Site Name
Hospital Del Mar
Department Name
Ginecology and Obstetrics
Contact Person Name
Mireia Gonzalez Comadran
Contact Person Email
mgonzalezcomadran@psmar.cat
Site Name
University Hospital Virgen Del Rocio S.L. (additional listing)

Portugal

Earliest CTIS Part Ii Submission Date
06-02-2024
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
763
Number Of Sites
8
Number Of Participants
31

Sites

Site Name
Centro Hospitalar E Universitario De Coimbra E.P.E.
Department Name
Ginecology
Contact Person Name
Fernanda Águas
Contact Person Email
faguas@netcabo.pt
Site Name
Champalimaud Clinical Centre
Department Name
Oncology
Contact Person Name
Leonor Matos
Site Name
Hospital Da Luz S.A.
Department Name
Oncology
Contact Person Name
João Godinho
Contact Person Email
joao.godinho@hbeatrizangelo.pt
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Senology
Contact Person Name
Rafaela Pires
Contact Person Email
rafaela.pires@hb.min-saude.pt
Site Name
Centro Hospitalar De Lisboa Ocidental E.P.E.
Department Name
Oncology
Contact Person Name
Ana Martins
Contact Person Email
ammourao@chlo.min-saude.pt
Site Name
Hospital CUF Porto S.A.
Department Name
Oncology
Contact Person Name
Yuliya Shvets
Contact Person Email
yuliya.shvets@cuf.pt
Site Name
Hospital Beatriz Angelo
Department Name
Ginecology
Contact Person Name
Sara Valadares
Site Name
Centro Hospitalar E Universitario De Coimbra E.P.E. (additional listing)

Belgium

Earliest CTIS Part Ii Submission Date
06-02-2024
Latest Decision Or Authorization Date
16-03-2026
Processing Time Days
769
Number Of Sites
7
Number Of Participants
41

Sites

Site Name
Ziekenhuis Oost Limburg
Department Name
gynecology and obstetrics
Contact Person Name
Eric De Jonge
Contact Person Email
eric.dejonge@zol.be
Site Name
CHU Saint Pierre
Department Name
Gynécologie-Obstétrique
Contact Person Name
Serge Rozenberg
Site Name
Universitair Ziekenhuis Gent
Department Name
Vrouwenkliniek
Contact Person Name
Herman Depypere
Contact Person Email
Herman.Depypere@UGent.be
Site Name
UZ Leuven
Department Name
Gynaecologie - Verloskunde
Contact Person Name
Patrick Neven
Contact Person Email
Patrick.neven@uzleuven.be
Site Name
Femicare
Department Name
Not Applicable
Contact Person Name
Veerle Van Gerven
Contact Person Email
veerle.van.gerven@femicare.net
Site Name
GasthuisZusters Antwerpen
Department Name
Medische oncologie
Contact Person Name
An Vandebroek
Contact Person Email
An.vandebroek@zas.be
Site Name
Hopital Erasme
Department Name
Gynécologie-Obstétrique
Contact Person Name
Philippe Simon

Ireland

Earliest CTIS Part Ii Submission Date
06-02-2024
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
763
Number Of Sites
5
Number Of Participants
18

Sites

Site Name
University Hospital Galway
Department Name
Advanced Therapies and Cancer
Contact Person Name
Maccon Keane
Contact Person Email
maccon.keane@hse.ie
Site Name
St James's Hospital
Department Name
Cancer Clinical Trials Unit
Contact Person Name
Ciara O'Hanlon Brown
Site Name
St Vincent's University Hospital
Department Name
Medical Oncology Research Department
Contact Person Name
Michaela Higgins
Contact Person Email
patientsupport@svhg.ie
Site Name
Mater Misericordiae University Hospital
Department Name
Catherine McAuley Research Centre
Contact Person Name
Donal Brennan
Contact Person Email
mater.medicine@ucd.ie
Site Name
University Hospital Waterford
Department Name
Old School of Nursing
Contact Person Name
Rizwan Sheikh
Contact Person Email
Rizwan.Sheikh@hse.ie

Finland

Earliest CTIS Part Ii Submission Date
06-02-2024
Latest Decision Or Authorization Date
23-03-2026
Processing Time Days
776
Number Of Sites
5
Number Of Participants
23

Sites

Site Name
Tampere University Hospital
Department Name
Syopatautien poliklinikka
Contact Person Name
Krista Kankaanranta
Contact Person Email
krista.kankaanranta@pirha.fi
Site Name
Vaasa Central Hospital
Department Name
Onkologian poliklinikka
Contact Person Name
Antti Jekunen
Contact Person Email
antti.jekunen@ovph.fi
Site Name
Laeaekaerikeskus Gyneko Oy
Contact Person Name
Anne Talvensaari-Mattila
Site Name
Mehilaeinen Oy (Kuopio)
Contact Person Name
Marjo Tuppurainen
Site Name
Mehilaeinen Oy (Helsinki)
Contact Person Name
Johanna Maenpaa
Contact Person Email
johanna.maenpaa@docrates.com

Germany

Earliest CTIS Part Ii Submission Date
06-02-2024
Latest Decision Or Authorization Date
07-05-2026
Processing Time Days
821
Number Of Sites
9
Number Of Participants
56

Sites

Site Name
Frauenärzte Am Schloss Borbeck
Contact Person Name
Steffen Tauber
Contact Person Email
praxis@fas-borbeck.de
Site Name
Dr. med. Stefan Fiedler
Contact Person Name
Stefan Fiedler
Contact Person Email
praxis.fiedler.gyn@web.de
Site Name
Praxis für Frauenheilkunde und Geburtshilfe
Contact Person Name
Inka Kiesche
Contact Person Email
kontakt@dr-kiesche.de
Site Name
Gynaekologisches Zentrum Bonn
Contact Person Name
Christian Kurbacher
Site Name
Praxis für Gynäkologie und Geburtshilfe
Contact Person Name
Andrea Heweker
Contact Person Email
frauenarzt@praxis-heweker.de
Site Name
Evangelisches Krankenhaus Bergisch Gladbach gGmbH
Department Name
Klinik für Gynäkologie
Contact Person Name
Christian Rudlowski
Contact Person Email
frauenklinik@evk.de
Site Name
Klinische Forschung Hannover-Mitte GmbH
Contact Person Name
Jürgen Anders
Contact Person Email
matilde.planer@pratia.com
Site Name
MedPlus
Contact Person Name
Adrian Flohr
Contact Person Email
study@medplus-krefeld.de
Site Name
Frauenarztpraxis Aurora
Contact Person Name
Martin Sillem
Contact Person Email
prof.sillem@aurora.med

Sponsor

Primary sponsor

Full Name
Bayer Consumer Care AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
Suvoda LLC
Responsibilities
[{"code":"3"}]
Name
Syneos Health Clinique Inc.
Responsibilities
[{"code":"4"}]
Name
Eresearchtechnology Inc.
Responsibilities
[{"code":"7"}]
Name
DATAN Analytics GmbH
Responsibilities
[{"code":"10"}]

Third parties

  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"[{\"code\":\"3\"}]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Germany","full_name":"DATAN Analytics GmbH","duties_or_roles":"[{\"code\":\"10\"}]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Germany","full_name":"LKF Laboratorium fuer Klinische Forschung GmbH","duties_or_roles":"[{\"code\":\"4\"}]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Switzerland","full_name":"Swiss BioQuant AG","duties_or_roles":"[{\"code\":\"4\"}]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"[{\"code\":\"7\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"[{\"code\":\"15\",\"value\":\"Long term storage\"},{\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Syneos Health Clinique Inc.","duties_or_roles":"[{\"code\":\"4\"}]","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Germany","full_name":"IMGM Laboratories GmbH","duties_or_roles":"[{\"code\":\"4\"}]","organisation_type":"Laboratory/Research/Testing facility"}

Co-sponsors

  • Bayer AG

Investigational products

Investigational Product Name
BAY 3427080
Active Substance
ELINZANETANT
Modality
Small molecule
Routes Of Administration
ORAL
Route
oral
Authorisation Status
1
Starting Dose
120 mg
Dose Levels
120 mg
Frequency
once daily
Maximum Dose
120 mg
Investigational Product Name
BAY 3427080 60 mg capsules placebo
Modality
Other
Dose Levels
placebo
Frequency
once daily (placebo for first 12 weeks then active per protocol)

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