Clinical trial • Phase II • Immunology|Respiratory|Rare Disease

BI 1015550 for Systemic sclerosis-associated interstitial lung disease (SSc-ILD)

Phase II trial of BI 1015550 for Systemic sclerosis-associated interstitial lung disease (SSc-ILD).

Overview

Trial Therapeutic Area
Immunology|Respiratory|Rare Disease
Trial Disease
Systemic sclerosis-associated interstitial lung disease (SSc-ILD)
Trial Stage
Phase II
Drug Modality
Small molecule|Monoclonal antibody

Key dates

Initial CTIS Submission Date
08-04-2024
First CTIS Authorization Date
22-07-2024

Trial design

Randomised, placebo (matching for bi 1015550 and for amlitelimab). active comparator: bi 1015550 18 mg twice daily (bid) in subprotocol b. amlitelimab is compared with matching placebo (dose/schedule not specified in the ctis record).-controlled Phase II trial in Italy, Spain, Netherlands and others.

Randomised
Yes
Comparator
Placebo (matching for BI 1015550 and for Amlitelimab). Active comparator: BI 1015550 18 mg twice daily (BID) in Subprotocol B. Amlitelimab is compared with matching placebo (dose/schedule not specified in the CTIS record).
Target Sample Size
283
Trial Duration For Participant
364

Eligibility

Recruits 283 Vulnerable populations not selected (isVulnerablePopulationSelected: false). Participants must be adults (≥18 years) and provide informed consent. Subject information and informed consent forms are available (adult and pregnancy versions); no paediatric assent/consent processes are specified in the record..

Pregnancy Exclusion
Fertility: Women who are pregnant, nursing, or who plan to become pregnant while in the clinical study;
Vulnerable Population
Vulnerable populations not selected (isVulnerablePopulationSelected: false). Participants must be adults (≥18 years) and provide informed consent. Subject information and informed consent forms are available (adult and pregnancy versions); no paediatric assent/consent processes are specified in the record.

Inclusion criteria

  • {"criterion_text":"- Male or female ≥18 years of age at the time of signed informed consent.\n- SSc classification as defined by the 2013 American College of Rheumatology/European League Against Rheumatism criteria. Participants with diffuse, limited or sine cutaneous skin involvement are eligible.\n- Onset of SSc (defined by first non-Raynaud’s symptom) ≤7 years prior to the Screening Visit;\n- A modified Rodnan skin score (mRSS) of less than 40;\n- Presence of ILD with evidence of any fibrosis on HRCT (within ≤3 months of randomization)\n- Presence of an FVC ≥45% predicted normal\n- Presence of a diffusing capacity of the lung for carbon monoxide ≥30% predicted normal, corrected for hemoglobin\n- Other protocol and subprotocol defined criteria apply."}

Exclusion criteria

  • {"criterion_text":"- Scleroderma related: Presence of clinically significant pulmonary abnormalities inconsistent with ILD on HRCT (e.g., scarring due to previous active TB, sarcoidosis, lung mass, or other findings unrelated to SSc-ILD, as determined by a local radiologist/Investigator);\n- Other protocol and subprotocol-defined criteria apply.\n- Prior treatment: History of stem cell transplantation, bone marrow transplantation, chimeric antigen receptor T-cell therapy, or solid organ transplantation;\n- Fertility: Women who are pregnant, nursing, or who plan to become pregnant while in the clinical study;\n- Liver: History of Child-Pugh Class B or Class C liver disease or presence of acute or chronic congestive heart failure ;\n- Laboratory abnormalities: Presence of abnormal laboratory findings at the Screening Visit:\n- Bleeding risk: History of major trauma or hemorrhage within 30 days of the Screening Visit;\n- Bleeding risk: History of any clinically significant chronic intermittent bleeding, such as active gastric antral vascular ectasia or active peptic ulcer disease, within 60 days of the Screening Visit;\n- Cardiovascular: History of any cerebrovascular events, myocardial infarction or unstable angina, restrictive or congestive cardiomyopathy (other than mild), life-threatening cardiac arrhythmias, hemodynamically significant aortic or mitral valve disease, pulmonary veno-occlusive disease. Presence of acute or chronic congestive heart failure, severe uncontrolled hypertension at the Screening Visit.\n- Scleroderma related: History of scleroderma renal crisis within 6 months prior to the Screening Visit."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The change in Forced Vital Capacity (FVC, in mL), assessed from Baseline to the end of the treatment period at Week 52.","definition_or_measurement_approach":"Change in FVC (mL) from Baseline to Week 52, measured by spirometry (forced vital capacity in mL)."}

Secondary endpoints

  • {"endpoint_text":"- The change in HRCT QILD-WL from Baseline to the end of the treatment period at Week 52;","definition_or_measurement_approach":"Change from Baseline to Week 52 in quantitative ILD (QILD) whole lung (WL) score assessed on high-resolution CT (HRCT)."}
  • {"endpoint_text":"- The change in FACIT-Dyspnea score from Baseline to the end of the treatment period at Week 52;","definition_or_measurement_approach":"Change from Baseline to Week 52 in FACIT-Dyspnea patient-reported score."}
  • {"endpoint_text":"- The proportion of study participants with an improvement in the revised CRISS score at Week 52, in study participants with diffuse cutaneous SSc and Baseline mRSS ≥10.","definition_or_measurement_approach":"Proportion of participants meeting improvement criteria on the Revised Composite Response Index in diffuse SSc (CRISS) at Week 52 among those with diffuse cutaneous SSc and baseline mRSS ≥10."}
  • {"endpoint_text":"- SUBPROTOCOL A: - The absolute change in mRSS from baseline to Week 52 in participants with diffuse cutaneous SSc and baseline mRSS ≥10; and - The absolute change in HAQ-DI, assessed with SHAQ, from baseline to Week 52","definition_or_measurement_approach":"SUBPROTOCOL A: Absolute change from Baseline to Week 52 in modified Rodnan skin score (mRSS) and absolute change in HAQ-DI (assessed with SHAQ) in specified participants."}
  • {"endpoint_text":"- SUBPROTOCOL B: - Change from Baseline in mRSS at Week 52 in study participants with diffuse cutaneous SSc and baseline mRSS ≥10; - Achievement of disease improvement at Week 52, defined by Revised CRISS criteria in study participants with diffuse cutaneous SSc and baseline mRSS ≥10 (≥25% relative improvement [≥5% improvement for FVC percent predicted] from Baseline at Week 52 on at least 2 of the 5 core set measures, without worsening on more than 1 measure).","definition_or_measurement_approach":"SUBPROTOCOL B: Change in mRSS from Baseline to Week 52 and achievement of disease improvement by revised CRISS criteria (≥25% relative improvement on ≥2/5 core measures, with no worsening on >1 measure; FVC percent predicted improvement threshold ≥5%)."}

Recruitment

Registry Or Advocacy Recruitment
True, Scleroderma Research Foundation
Digital Remote Recruitment
True, digital/remote methods include social media kits, website content, patient video and electronic recruitment materials (K2 Social Media kits, Website, Patient video and Infographics).
Planned Sample Size
283
Recruitment Window Months
26
Consent Approach
Informed consent is provided by the participant (participants must be ≥18 years). Subject information sheets and informed consent forms (L1_SIS and ICF) are provided, including adult and pregnancy versions. Translated ICFs and patient information materials are available in multiple languages (English, French, Spanish, Dutch, Polish, German, Portuguese, Norwegian as per uploaded documents). No paediatric assent processes are specified in the CTIS record.

Methods

  • Social media kits and campaigns (K2_Recruitment material_Social Media kits) targeting patients and the public (materials available in multiple country packs).
  • Study website content / website package (K2_Recruitment material_Website_SRF / Website Package) providing information to potential participants.
  • Participant brochures and flyers (K2_Recruitment material_Participant Brochure / Participant Flyer) distributed to patients and clinics.
  • Infographics (CONQUEST Infographic, country-specific infographics) for patient-facing education.
  • Patient video materials (K2_Recruitment material_Patient video_SRF) for outreach and information.
  • Dear colleague letters / site-facing press materials (country-specific K2/K1 packaging) to engage clinicians and referral networks.
  • Site-facing pre-screening checklists and talking points to support site recruitment and prescreening.

Geography

Total Number Of Sites
57
Total Number Of Participants
172

Italy

Earliest CTIS Part Ii Submission Date
03-06-2024
Latest Decision Or Authorization Date
29-07-2024
Processing Time Days
56
Number Of Sites
6
Number Of Participants
21

Sites

Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
Reumatologia
Contact Person Name
Dilia Giuggioli
Contact Person Email
dilia.giuggioli@unimore.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Unità Operative Complesse (U.O.C) Reumatologia e Immunologia Clinica
Contact Person Name
Paolo Airò
Contact Person Email
airopaolo@gmail.com
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Presidio Columbus di Roma
Contact Person Name
Maria Antonietta D'Agostino
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
SOD Clinica Medica - Dipartimento di Medicina Interna
Contact Person Name
Gianluca Moroncini
Contact Person Email
g.moroncini@staff.univpm.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Unità di Immunologia, Reumatologia, Allergologia e Malattie Rare
Contact Person Name
Marco Matucci-Cerinic
Contact Person Email
MatucciCerinic.Marco@hsr.it
Site Name
Careggi University Hospital
Department Name
Strutture Organizzative Dipartimentali (SOD) Reumatologia e Scleroderma Unit
Contact Person Name
Serena Guiducci
Contact Person Email
serena.guiducci@unifi.it

Spain

Earliest CTIS Part Ii Submission Date
04-07-2024
Latest Decision Or Authorization Date
05-03-2026
Processing Time Days
609
Number Of Sites
8
Number Of Participants
29

Sites

Site Name
Parc Tauli Hospital Universitari
Department Name
Rheumatology
Contact Person Name
Joan Calvet Fontova
Contact Person Email
calvet.parctauli@gmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Rheumatology
Contact Person Name
Patricia Esmeralda Carreira Delgado
Contact Person Email
carreira@h12o.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Internal medicine
Contact Person Name
Alfredo Guillen del Castillo
Contact Person Email
alfredo.guillen@vallhebron.cat
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Pulmonologist
Contact Person Name
Jose Manuel Cifrian Martinez
Contact Person Email
josemanuel.cifrian@scsalud.es
Site Name
Hospital Universitario Dr Peset Aleixandre
Department Name
Rheumatology
Contact Person Name
Juan Jose Alegre Sancho
Contact Person Email
alegre_juasan@gva.es
Site Name
Hospital General Universitario Reina Sofia
Department Name
Rheumatology
Contact Person Name
Alejandro Escudero Contreras
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Rheumatology
Contact Person Name
Fredeswinda Isabel Romero Bueno
Contact Person Email
FRomero@dd.es
Site Name
Hospital Universitario Vall D Hebron (additional site entry)
Department Name
Internal medicine
Contact Person Name
Alfredo Guillen del Castillo
Contact Person Email
alfredo.guillen@vallhebron.cat

Netherlands

Earliest CTIS Part Ii Submission Date
25-06-2024
Latest Decision Or Authorization Date
04-03-2026
Processing Time Days
617
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Universitair Medisch Centrum Groningen
Department Name
Internal Medicine
Contact Person Name
Udo Mulder
Contact Person Email
d.j.mulder@umcg.nl
Site Name
Universitair Medisch Centrum Utrecht
Department Name
Rheumatology & Clinical Immunology
Contact Person Name
Julia Sperings
Contact Person Email
j.spierings@umcutrecht.nl
Site Name
Leids Universitair Medisch Centrum (LUMC)
Department Name
Rheumatology
Contact Person Name
Jeska de Vries-Bouwstra
Contact Person Email
J.K.de_Vries-Bouwstra@lumc.nl

Denmark

Earliest CTIS Part Ii Submission Date
24-06-2024
Latest Decision Or Authorization Date
02-03-2026
Processing Time Days
616
Number Of Sites
1
Number Of Participants
6

Sites

Site Name
Odense University Hospital
Department Name
Department of Rheumatology
Contact Person Name
Kasper Søltoft Larsen
Contact Person Email
Kasper.Soeltoft@rsyd.dk

Belgium

Earliest CTIS Part Ii Submission Date
13-09-2024
Latest Decision Or Authorization Date
03-03-2026
Processing Time Days
536
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Universitair Ziekenhuis Gent
Department Name
Rheumatology
Contact Person Name
Vanessa Smith
Contact Person Email
vanessa.smith@ugent.be
Site Name
Centre Hospitalier Universitaire De Liege
Department Name
Rheumatology
Contact Person Name
Béatrice André
Contact Person Email
bandre@chu.ulg.ac.be

Portugal

Earliest CTIS Part Ii Submission Date
31-07-2024
Latest Decision Or Authorization Date
06-03-2026
Processing Time Days
583
Number Of Sites
7
Number Of Participants
10

Sites

Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Rheumatology Department
Contact Person Name
Catarina Resende
Contact Person Email
catarinalopesresende@gmail.com
Site Name
Unidade Local De Saude De Amadora Sintra E.P.E.
Department Name
Systemic Immunomediated Diseases Unit
Contact Person Name
José Alves
Contact Person Email
uic@hff.min-saude.pt
Site Name
Unidade Local De Saude De Almada-Seixal E.P.E.
Department Name
Rheumatology Department
Contact Person Name
Ana Cordeiro
Contact Person Email
ccordeiro.ana@gmail.com
Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
Rheumatology Department
Contact Person Name
Maria João Henriques
Contact Person Email
mjsalvadorhenriques@gmail.com
Site Name
Unidade Local De Saude Do Alto Minho E.P.E.
Department Name
Rheumatology Department
Contact Person Name
Francisca Guimarães
Contact Person Email
helena.pires@blueclinical.pt
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Rheumatology Department
Contact Person Name
Joana Neves
Contact Person Email
joana.neves@hb.min-saude.pt
Site Name
Unidade Local De Saude De Santa Maria E.P.E. (additional contact)
Department Name
Rheumatology Department
Contact Person Name
Catarina Resende
Contact Person Email
catarinalopesresende@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
12-07-2024
Latest Decision Or Authorization Date
07-03-2026
Processing Time Days
603
Number Of Sites
10
Number Of Participants
36

Sites

Site Name
Pratia S.A.
Department Name
Centrum Medyczne Pratia Katowice
Contact Person Name
Tomasz Dziewit
Contact Person Email
tdziewit@pratia.pl
Site Name
Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.
Contact Person Name
Agata Wytyk-Nowak
Contact Person Email
wytyk@twojaprzychodnia.com
Site Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
Uniwersyteckie Centrum Wsparcia Badań Klinicznych – Ośrodek Faz Wczesnych
Contact Person Name
Piotr Wiland
Contact Person Email
piotr.wiland@usk.wroc.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Ośrodek Badań Klinicznych Wczesnych Faz
Contact Person Name
Anna Wojteczek
Contact Person Email
a.wojteczek@gumed.edu.pl
Site Name
Uniwersytecki Szpital Kliniczny Nr 1 Im. Prof. Tadeusza Sokolowskiego Pum W Szczecinie
Department Name
Centrum Wsparcia Badań Klinicznych
Contact Person Name
Marek Brzosko
Contact Person Email
brzoskom@pum.edu.pl
Site Name
Uniwersytecki Szpital Kliniczny W Bialymstoku
Department Name
Klinika Reumatologii i Chorób Wewnętrznych
Contact Person Name
Otylia Kowal–Bielecka
Contact Person Email
otylia.bielecka@gmail.com
Site Name
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Department Name
Centrum Wsparcia Badań Klinicznych
Contact Person Name
Witold Tłustochowicz
Contact Person Email
wtlustochowicz@wim.mil.pl
Site Name
Klinika Reuma Park Sp. z o.o. S.K.
Department Name
CENTRUM MEDYCZNE REUMA PARK
Contact Person Name
Anna Zubrzycka-Sienkiewicz
Contact Person Email
annazub1@wp.pl
Site Name
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Department Name
Klinika Reumatologii i Układowych Chorób Tkanki Łącznej Chorób Tkanki Łącznej
Contact Person Name
Iwona Dankiewicz-Fares
Contact Person Email
iwonafares@wp.pl
Site Name
Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W Katowicach
Department Name
Oddział Chorób Wewnętrznych i Reumatologii
Contact Person Name
Robert Pieczyrak
Contact Person Email
robertpieczyrak@gmail.com

France

Earliest CTIS Part Ii Submission Date
02-07-2024
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
615
Number Of Sites
9
Number Of Participants
21

Sites

Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
vascular medicine
Contact Person Name
Sofie Blaise
Contact Person Email
SBlaise@chu-grenoble.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
pneumology
Contact Person Name
Elodie Blanchard
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
internal medicine and clinical immunology
Contact Person Name
Alain Lescoat
Contact Person Email
alain.lescoat@chu-rennes.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Internal Medicine
Contact Person Name
David Launay
Contact Person Email
david.launay@univ-lille.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
pneumology
Contact Person Name
Gregoire Prevot
Contact Person Email
prevot.g@chu-toulouse.fr
Site Name
Assistance Publique Hopitaux De Paris (Paris)
Department Name
rheumatology
Contact Person Name
Yannick Allanore
Contact Person Email
yannick.allanore@aphp.fr
Site Name
Hospices Civils De Lyon
Department Name
pneumology
Contact Person Name
Vincent Cottin
Contact Person Email
Vincent.cottin@chu-lyon.fr
Site Name
Assistance Publique Hopitaux De Paris (Bobigny)
Department Name
pneumology
Contact Person Name
Yurdagul Uzunhan
Contact Person Email
yurdagul.uzunhan@aphp.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
internal medicine and clinical immunology
Contact Person Name
Thierry Martin

Norway

Earliest CTIS Part Ii Submission Date
03-07-2024
Latest Decision Or Authorization Date
03-03-2026
Processing Time Days
608
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Oslo University Hospital HF
Department Name
OUH
Contact Person Name
Anna-Maria Hoffmann-Vold
Site Name
Universitetssykehuset Nord-Norge HF
Department Name
UNN Tromso
Contact Person Name
Gunnstein Bakland
Contact Person Email
gunnstein.bakland@unn.no

Germany

Earliest CTIS Part Ii Submission Date
01-07-2024
Latest Decision Or Authorization Date
05-03-2026
Processing Time Days
612
Number Of Sites
6
Number Of Participants
15

Sites

Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Medical Clinic III
Contact Person Name
Christina Bergmann
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Rheumatology
Contact Person Name
Hendrik Schulze-Koops
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Rheumatology and Clinical Immunology
Contact Person Name
Gabriela Riemekasten
Contact Person Email
gabriela.riemekasten@uksh.de
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Klinik fuer Pneumologie, Zentrum fuer Thoraxerkrankungen
Contact Person Name
Michael Kreuter
Contact Person Email
kreuterm@uni-mainz.de
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Rheumatology
Contact Person Name
Joerg Distler
Site Name
Marienhaus Klinikum Mainz GmbH
Department Name
Klinik für Rheumatologie, Klinische Immunologie und Physikalische Therapie
Contact Person Name
Peter Härle
Contact Person Email
Peter.Haerle@marienhaus.de

Austria

Earliest CTIS Part Ii Submission Date
16-09-2024
Latest Decision Or Authorization Date
05-03-2026
Processing Time Days
535
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Medical University Of Vienna
Department Name
Universitätsklinik für Innere Medizin III - Klinische Abteilung für Rheumatologie
Contact Person Name
Clemens Scheinecker
Site Name
Johannes Kepler University Linz
Department Name
Universitätsklinik für Innere Medizin 4 - Pulmologie
Contact Person Name
David Lang
Site Name
Ordensklinikum Linz GmbH
Department Name
Abteilung für Pneumologie
Contact Person Name
Dominik Maurer

Sponsor

Primary sponsor

Full Name
Scleroderma Research Foundation
Organisation Type
Laboratory/Research/Testing facility
Country Of Registered Address
United States

Contract research organisations

Name
Medpace Finland Oy
Responsibilities
Multiple sponsor duties listed in record (codes:1,10,11,12,13,2,4,5,6,7,8) - regulatory and study management roles indicated by functional contact usage
Name
PPD Development L.P.
Responsibilities
Sponsor duty code:4 (as listed in record)
Name
Suvoda LLC
Responsibilities
Sponsor duty code:3 (as listed in record) - eClinical / site systems vendor indicated by role code
Name
Voiant LLC
Responsibilities
Central Reading (HRCT imaging)

Third parties

  • {"country":"Denmark","full_name":"Nordic Bioscience A/S","duties_or_roles":"sponsorDuties codes present (code:4)","organisation_type":"Pharmaceutical company"}
  • {"country":"Finland","full_name":"Medpace Finland Oy","duties_or_roles":"sponsorDuties codes present (codes:1,10,11,12,13,2,4,5,6,7,8) - listed in record","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Myriad RBM Inc.","duties_or_roles":"sponsorDuties codes present (code:4)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Germany","full_name":"Boehringer Ingelheim Pharma GmbH & Co. KG","duties_or_roles":"sponsorDuties codes present (code:4)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Quest Diagnostics Nichols Institute Inc.","duties_or_roles":"sponsorDuties codes present (code:4)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Voiant LLC","duties_or_roles":"Central Reading (HRCT imaging)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"sponsorDuties codes present (code:4)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsorDuties codes present (code:3)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"PPD Development L.P.","duties_or_roles":"sponsorDuties codes present (code:4)","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Firalis","duties_or_roles":"sponsorDuties codes present (code:4)","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Nuvisan GmbH","duties_or_roles":"sponsorDuties codes present (code:4)","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Vitalograph Limited","duties_or_roles":"Central reading (Spirometry)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Arup Laboratories Inc.","duties_or_roles":"sponsorDuties codes present (code:4)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"Catalent Cts (Edinburgh) Limited","duties_or_roles":"sponsorDuties codes present (code:14)","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"SGS France","duties_or_roles":"sponsorDuties codes present (code:4)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
BI 1015550
Active Substance
BI 1015550
Modality
Small molecule
Routes Of Administration
ORAL
Route
Oral
Authorisation Status
prodAuthStatus:1
Starting Dose
18 mg twice daily (BID) (Subprotocol B)
Dose Levels
18 mg BID
Frequency
Twice daily (BID)
Maximum Dose
36 mg daily (maxDailyDoseAmount: 36 mg)
Investigational Product Name
Amlitelimab
Active Substance
AMLITELIMAB
Modality
Monoclonal antibody (protein origin)
Routes Of Administration
SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE (injection)
Route
Injection (prefilled syringe)
Authorisation Status
prodAuthStatus:1
Maximum Dose
500 mg (maxDailyDoseAmount: 500 mg)