Clinical trial • Phase II • Respiratory

HUMANISED IGG1 LALAPS-YTE MONOCLONAL ANTIBODY AGAINST LYSOPHOSPHATIDIC ACID RECEPTOR 1 for Idiopathic pulmonary fibrosis

Phase II trial of HUMANISED IGG1 LALAPS-YTE MONOCLONAL ANTIBODY AGAINST LYSOPHOSPHATIDIC ACID RECEPTOR 1 for Idiopathic pulmonary fibrosis.

Overview

Trial Therapeutic Area
Respiratory
Trial Disease
Idiopathic pulmonary fibrosis
Trial Stage
Phase II
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
31-10-2025
First CTIS Authorization Date
10-03-2026

Trial design

Randomised, placebo for abbv-142 (placebo comparator; dose and schedule not specified in provided data)-controlled Phase II trial across 57 sites in Bulgaria, France, Germany and others.

Randomised
Yes
Comparator
Placebo for ABBV-142 (placebo comparator; dose and schedule not specified in provided data)
Target Sample Size
80

Eligibility

Recruits 80 No vulnerable population selected. Participants are adults (Patients aged ≥ 40 years). Consent/assent handling not described in the provided trial JSON..

Vulnerable Population
No vulnerable population selected. Participants are adults (Patients aged ≥ 40 years). Consent/assent handling not described in the provided trial JSON.

Inclusion criteria

  • {"criterion_text":"- Patients aged ≥ 40 years."}
  • {"criterion_text":"- History of IPF diagnosis within 7 years of screening visit."}
  • {"criterion_text":"- Confirmed diagnosis of IPF: a. Diagnosis of IPF based on 2022 ATS/ERS/JRS/ALAT Guideline as confirmed by the investigator based on chest high-resolution Computed Tomography (HRCT) scan taken within 12 months of screening visit and, if available, (historical) surgical lung biopsy or transbronchical lung cryobiopsy, AND b. Usual Interstitial Pneumonia (UIP) or \"probable UIP\" HRCT pattern consistent with the clinical diagnosis of IPF, as confirmed by central review prior to randomization visit. Patients with an \"Indeterminate\" HRCT finding are eligible if a clinical diagnosis of IPF can be confirmed locally based on (historical) surgical lung biopsy or cryobiopsy demonstrating a \"UIP\" or \"Probable UIP\" histopathology pattern. Subjects with an \"Alternative diagnosis\" HRCT finding are eligible if clinical diagnosis of IPF can be confirmed locally based on (historical) surgical lung biopsy or cryobiopsy demonstrating a \"UIP\" histopathology pattern."}
  • {"criterion_text":"- Either stable treatment with antifibrotics for at least 8 weeks prior to screening visit or not treated with antifibrotics for at least 4 weeks prior to screening visit."}
  • {"criterion_text":"- FVC ≥ 45% of predicted normal at screening visit."}
  • {"criterion_text":"- Percent predicted diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for hemoglobin (Hb) in a single breath ≥ 25% at screening visit."}

Exclusion criteria

  • {"criterion_text":"- Relevant airways obstruction defined as pre-bronchodilator forced expiratory volume 1 second (FEV1)/FVC < 0.7 at screening visit."}
  • {"criterion_text":"- Acute IPF exacerbation diagnosis within 4 months prior to screening and/or during the screening period (investigator determined)."}
  • {"criterion_text":"- Lower respiratory tract infection (e.g., infectious pneumonia, active tuberculosis) requiring antimicrobials within 4 weeks before screening visit and/or during the screening period."}
  • {"criterion_text":"- (No additional principal exclusion criteria text available in provided data beyond the three listed.)"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Absolute change from baseline in forced vital capacity (mL) at Week 24.","definition_or_measurement_approach":"Absolute change from baseline in forced vital capacity (FVC) measured in mL at Week 24 compared to baseline."}

Secondary endpoints

  • {"endpoint_text":"- Absolute change from baseline in FVC (mL) at Week 52.","definition_or_measurement_approach":"Absolute change from baseline in FVC measured in mL at Week 52 compared to baseline."}
  • {"endpoint_text":"- Relative change from baseline in FVC (mL) at Week 24.","definition_or_measurement_approach":"Relative (percentage) change from baseline in FVC measured at Week 24."}
  • {"endpoint_text":"- Relative change from baseline in FVC (mL) at Week 52.","definition_or_measurement_approach":"Relative (percentage) change from baseline in FVC measured at Week 52."}
  • {"endpoint_text":"- Absolute and relative change from Baseline in FVC % predicted at Week 24.","definition_or_measurement_approach":"Absolute and relative change from baseline in percent predicted FVC at Week 24."}
  • {"endpoint_text":"- Absolute and relative change from Baseline in FVC % predicted at Week 52.","definition_or_measurement_approach":"Absolute and relative change from baseline in percent predicted FVC at Week 52."}
  • {"endpoint_text":"- Time to first ≥ 10% absolute decline in FVC% predicted.","definition_or_measurement_approach":"Time-to-event endpoint measuring time until first occurrence of an absolute ≥10% decline in percent predicted FVC."}
  • {"endpoint_text":"- Time to first ≥ 5% absolute decline in FVC% predicted.","definition_or_measurement_approach":"Time-to-event endpoint measuring time until first occurrence of an absolute ≥5% decline in percent predicted FVC."}

Recruitment

Planned Sample Size
80
Recruitment Window Months
41
Consent Approach
Informed consent is obtained using country-specific subject information and informed consent forms (ICFs). ICF documents for multiple countries and languages are provided (examples in the public document list include country-specific Main ICFs and Pregnant Partner ICFs for Bulgaria, Germany, France, Italy, Portugal, Spain, Hungary, Romania, Sweden, Poland, etc., and some English versions). Consent is to be provided by the adult participant; no assent process for minors is described in the provided data.

Geography

Total Number Of Sites
57
Total Number Of Participants
85

Bulgaria

Earliest CTIS Part Ii Submission Date
28-02-2026
Latest Decision Or Authorization Date
12-03-2026
Processing Time Days
12
Number Of Sites
5
Number Of Participants
20

Sites

Site Name
Diagnostics And Consultation Center Convex Ltd.
Contact Person Name
Kosta Kostov
Contact Person Email
korokostov@gmail.com
Site Name
Acibadem City Clinic Tokuda University Hospital EAD
Department Name
Clinic of Pneumology
Contact Person Name
Ventsyslav Dimitrov
Contact Person Email
ventsyslav.d2@gmail.com
Site Name
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
Department Name
Clinic of Pneumology and Phthisiology
Contact Person Name
Yavor Ivanov
Contact Person Email
pulmovan@gmail.com
Site Name
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Department Name
Clinic of Pneumology and Phthisiology
Contact Person Name
Vladimir Hodzhev
Site Name
Diagnostics And Consultation Center Convex Ltd.
Contact Person Name
Georgi Hinkov
Contact Person Email
drhinkov@abv.bg

France

Earliest CTIS Part Ii Submission Date
28-01-2026
Latest Decision Or Authorization Date
13-03-2026
Processing Time Days
44
Number Of Sites
8
Number Of Participants
8

Sites

Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Service de Pneumologie
Contact Person Name
Arnaud Bourdin
Contact Person Email
a-bourdin@chu-montpellier.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Service de Pneumologie
Contact Person Name
Sylvain Marchand Adam
Contact Person Email
s.marchandadam@univ-tours.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Pneumology Department
Contact Person Name
Hilario Nunes
Contact Person Email
hilario.nunes@aphp.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service de Pneumologie A
Contact Person Name
Bruno Crestani
Contact Person Email
bruno.crestani@aphp.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Service des maladies pulmonaires (Hopital Nord)
Contact Person Name
Martine Reynaud Gaubert
Contact Person Email
martine.reynaud@ap-hm.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Service Maladies Respiratoires
Contact Person Name
Elodie Blanchard
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Service de Pneumologie
Contact Person Name
Stephane Jouneau
Contact Person Email
stephane.jouneau@chu-rennes.fr
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Department of Respiratory Diseases
Contact Person Name
Clarie Andrejak
Contact Person Email
andrejak.claire@chu-amiens.fr

Germany

Earliest CTIS Part Ii Submission Date
27-02-2026
Latest Decision Or Authorization Date
12-03-2026
Processing Time Days
13
Number Of Sites
5
Number Of Participants
8

Sites

Site Name
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH
Contact Person Name
Christian Grohé
Contact Person Email
studien.lungenklinik@jsd.de
Site Name
Caritas Krankenhaus St. Maria gGmbH
Contact Person Name
Christoph Fisser
Site Name
Martin-Luther-Universitaet Halle-Wittenberg
Contact Person Name
Stephan Eisenmann
Contact Person Email
stephan.eisenmann@uk-halle.de
Site Name
Klinikum Konstanz GmbH
Contact Person Name
Stephan Walterspacher
Contact Person Email
stephan.walterspacher@glkn.de
Site Name
Zentralklinik Bad Berka GmbH
Contact Person Name
Michael Weber
Contact Person Email
pne@zentralklinik.de

Greece

Earliest CTIS Part Ii Submission Date
14-11-2025
Latest Decision Or Authorization Date
11-03-2026
Processing Time Days
117
Number Of Sites
6
Number Of Participants
7

Sites

Site Name
Thoracic General Hospital Of Athens I Sotiria
Department Name
5th Pulmonary Department
Contact Person Name
Ioannis Tomos
Contact Person Email
etomos@hotmail.com
Site Name
University General Hospital Of Heraklion
Department Name
Pulmonary Department
Contact Person Name
Katerina Antoniou
Contact Person Email
kantoniou@med.uoc.gr
Site Name
General Hospital Of Corfu Agia Eirini
Department Name
Pulmonary Department
Contact Person Name
Ilias Papanikolaou
Contact Person Email
icpapanikolaou@hotmail.com
Site Name
General University Hospital Of Patras
Department Name
Respiratory Medicine Department
Contact Person Name
Argyrios Tzouvelekis
Contact Person Email
ctpneumo@gmail.com
Site Name
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department Name
Pulmonary Department
Contact Person Name
Katerina Manika
Contact Person Email
ktmn05@yahoo.gr
Site Name
University General Hospital Of Ioannina
Department Name
Respiratory Medicine Department
Contact Person Name
Konstantinos Kostikas

Hungary

Earliest CTIS Part Ii Submission Date
09-01-2026
Latest Decision Or Authorization Date
12-03-2026
Processing Time Days
62
Number Of Sites
3
Number Of Participants
3

Sites

Site Name
University Of Debrecen
Department Name
Klinikai Kozpont Tudogyogyaszati Klinika
Contact Person Name
Ildiko Horvath
Contact Person Email
horvath.ildiko@med.unideb.hu
Site Name
Clinic Of Pulmonology Semmelweis University
Department Name
Pulmonologiai Klinika
Contact Person Name
Veronika Muller
Contact Person Email
muller.veronika@semmelweis.hu
Site Name
Orszagos Koranyi Pulmonologiai Intezet
Department Name
Rehabilitacios osztaly
Contact Person Name
Reka Gajdocsi
Contact Person Email
gajdocsi@koranyi.hu

Italy

Earliest CTIS Part Ii Submission Date
14-11-2025
Latest Decision Or Authorization Date
10-03-2026
Processing Time Days
116
Number Of Sites
5
Number Of Participants
6

Sites

Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
Interventional Pulmonology Unit
Contact Person Name
Sara Tomassetti
Contact Person Email
sara.tomassetti@unifi.it
Site Name
Centro Ricerche Cliniche Di Verona S.r.l.
Department Name
UOC Pneumology
Contact Person Name
Claudio Micheletto
Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
U.O.C. Malattie dell'Apparato Respiratorio
Contact Person Name
Paola Rogliani
Contact Person Email
paola.rogliani@uniroma2.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Department Name
U.O.C. di Pneumologia
Contact Person Name
Carlo Vancheri
Contact Person Email
vancheri@unict.it
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
Struttura Complessa di Malattie dell’Apparato Respiratorio
Contact Person Name
Stefania Cerri
Contact Person Email
stefania.cerri@unimore.it

Portugal

Earliest CTIS Part Ii Submission Date
19-01-2026
Latest Decision Or Authorization Date
12-03-2026
Processing Time Days
52
Number Of Sites
5
Number Of Participants
6

Sites

Site Name
Unidade Local De Saude De Matosinhos E.P.E.
Department Name
Pulmonology
Contact Person Name
Ines Neves
Site Name
Unidade Local de Saude do Algarve E.P.E.
Department Name
Pulmonology
Contact Person Name
Claudia Guerreiro
Site Name
Unidade Local De Saude De Loures-Odivelas EPE
Department Name
Pulmonology
Contact Person Name
Susana Clemente
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Pulmonology
Contact Person Name
Rui Rolo
Contact Person Email
rui.rolo@ulsb.min-saude.pt
Site Name
Unidade Local de Saude de Sao Joao E.P.E.
Department Name
Pulmonology
Contact Person Name
Patricia Mota

Romania

Earliest CTIS Part Ii Submission Date
13-02-2026
Latest Decision Or Authorization Date
16-03-2026
Processing Time Days
31
Number Of Sites
4
Number Of Participants
5

Sites

Site Name
Institutul De Pneumoftiziologie Marius Nasta
Department Name
Pneumology
Contact Person Name
Claudia Toma
Contact Person Email
claudiatoma@yahoo.co.uk
Site Name
Spitalul de Pneumologie Dr. Lavinia Davidescu S.R.L
Department Name
Pneumology
Contact Person Name
Lavinia Davidescu-Butar
Contact Person Email
lavinia.davidescu@yahoo.com
Site Name
Institutul De Pneumoftiziologie Marius Nasta
Department Name
Pneumology
Contact Person Name
Irina Strambu
Contact Person Email
istrambu@yahoo.com
Site Name
Spitalul Clinic Judetean Mures - Sectia Clinica Pneumologie
Department Name
Pneumology
Contact Person Name
Corina Budin
Contact Person Email
cora_bud@yahoo.com

Spain

Earliest CTIS Part Ii Submission Date
24-02-2026
Latest Decision Or Authorization Date
13-03-2026
Processing Time Days
17
Number Of Sites
8
Number Of Participants
10

Sites

Site Name
Hospital Clinic De Barcelona
Department Name
Pneumology
Contact Person Name
Jacobo Sellares Torres
Contact Person Email
sellares@clinic.cat
Site Name
Hospital Universitari Vall D Hebron
Department Name
Pneumology
Contact Person Name
Iñigo Ojanguren Arranz
Contact Person Email
inigo.ojanguren@vallhebron.cat
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Pneumology
Contact Person Name
José María Echave-Susaeta María-Tomé
Contact Person Email
jose.echave@quironsalud.es
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Pneumology
Contact Person Name
Jaime Signes-Costa Miñana
Contact Person Email
jaimesignescosta@gmail.com
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Pneumology
Contact Person Name
Manuela Martinez Frances
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Pneumology
Contact Person Name
Juan Luis Suarez-Antelo
Contact Person Email
jsuaantelo@gmail.com
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Pneumology
Contact Person Name
José Manuel Cifrián Martínez
Contact Person Email
josemanuel.cifrian@scsalud.es
Site Name
Hospital Universitario De La Princesa
Department Name
Pneumology
Contact Person Name
Claudia Valenzuela
Contact Person Email
claudiavale@hotmail.com

Sweden

Earliest CTIS Part Ii Submission Date
14-11-2025
Latest Decision Or Authorization Date
11-03-2026
Processing Time Days
117
Number Of Sites
4
Number Of Participants
4

Sites

Site Name
Soedersjukhuset AB
Department Name
Lung- och allergi­mottagningen
Contact Person Name
Jelena Krjukova
Site Name
Uppsala University Hospital
Department Name
Lung- och allergisektionen
Contact Person Name
Emil Ekbom
Contact Person Email
emil.ekbom@akademiska.se
Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Lungkliniken
Contact Person Name
Emily Krantz
Contact Person Email
emily.amundson@vgregion.se
Site Name
Karolinska University Hospital
Department Name
Lungmedicin och Allergologi
Contact Person Name
Ulrica Forslöw

Poland

Earliest CTIS Part Ii Submission Date
06-02-2026
Latest Decision Or Authorization Date
13-03-2026
Processing Time Days
35
Number Of Sites
4
Number Of Participants
8

Sites

Site Name
National Institute Of Tuberculosis And Lung Diseases
Department Name
I Klinika Chorob Pluc
Contact Person Name
Malgorzata Sobiecka
Contact Person Email
m.sobiecka@igichp.edu.pl
Site Name
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Department Name
Klinika Pulmonologii, Chorób wewnętrznych, Pulmonologii Onkologicznej i Transplantologicznej
Contact Person Name
Katarzyna Gorska
Site Name
Vitamed Galaj I Cichomski Sp. j.
Contact Person Name
Iwona Patyk
Contact Person Email
i.patyk@vitamed.info
Site Name
PULMAG s. c.
Contact Person Name
Grzegorz Gasior
Contact Person Email
grzegorz.g15@wp.pl

Sponsor

Primary sponsor

Full Name
AbbVie Deutschland GmbH & Co. KG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Contract research organisations

Name
IQVIA Limited
Responsibilities
Clinical trial services (sponsor duties code: 3) / CRO activities (listed as third party)
Name
Parexel International (IRL) Limited
Responsibilities
IV Bag Covers (for blinding)
Name
Ametris
Responsibilities
Digital Health Tool (Actigraphy)
Name
Axio Research LLC
Responsibilities
Data Monitoring Committee
Name
Perceptive Informatics Inc.
Responsibilities
Central Imaging
Name
Medidata Solutions Inc.
Responsibilities
ePROs
Name
MESM Ltd
Responsibilities
Home Urine Pregnancy Tests

Third parties

  • {"country":"United States","full_name":"Ametris","duties_or_roles":"Digital Health Tool (Actigraphy)","organisation_type":"Industry"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Sponsor duties code: 3","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services","duties_or_roles":"Sponsor duties code: 4 (central laboratory services)","organisation_type":"Health care"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Sponsor duties code: 4 (central laboratory services)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Axio Research LLC","duties_or_roles":"Data Monitoring Committee","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Central Imaging","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"ePROs and other duties (code: 7)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"MESM Ltd","duties_or_roles":"Home Urine Pregnancy Tests","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Sponsor duties code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient stipends and reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Clario","duties_or_roles":"Spirometry","organisation_type":"Industry"}
  • {"country":"Singapore","full_name":"Labcorp Development (Asia) Pte Ltd","duties_or_roles":"Sponsor duties code: 4 (laboratory services)","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"IV Bag Covers (for blinding)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Clinical Trial Media Inc.","duties_or_roles":"Sponsor duties code: 2","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Sponsor duties code: 4 (laboratory services)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
ABBV-142
Active Substance
HUMANISED IGG1 LALAPS-YTE MONOCLONAL ANTIBODY AGAINST LYSOPHOSPHATIDIC ACID RECEPTOR 1
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS ADMINISTRATION
Route
INTRAVENOUS
Investigational Product Name
Placebo for ABBV-142
Modality
Other
Combination Treatment
Yes

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