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A Phase 2a Multicenter Platform Study of Investigational Products for the Treatment of Adult Subjects With Idiopathic Pulmonary Fibrosis

Status: Recruiting
Location: See all (57) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Idiopathic Pulmonary Fibrosis (IPF) is a rare, long-lasting lung disease that causes scarring of lung tissue, shortness of breath, and loss of lung function. IPF leads to significant loss of quality of life and shortened lifespan. This study is a platform study evaluating different types of treatments in patients with IPF. A platform study is a type of study that uses a single master protocol to evaluate different study treatments allowing for new study treatments or substudies to be added or closed over time. The main goals of the study are to evaluate the safety, tolerability (the degree to which the adverse symptoms can be handled by the patients during the study) and efficacy (how well study treatment works) of the study treatments, including ABBV-142 in Substudy 1 (SS1). ABBV-142 is an investigational drug being developed for the treatment of IPF. In SS1, participants will be randomly assigned to one of the 2 groups to receive either ABBV-142 or a matching placebo. This study is double-blind, meaning that neither the participants nor the study doctors know who is given which study treatment. Approximately 165 adult participants with IPF will be enrolled in approximately 125 sites across the world. Participants will receive ABBV-142 or matching placebo for 52 weeks during the double-blind treatment period. Eligible participants may receive ABBV-142 for 52 weeks in open-label treatment period. All participants will be followed for 120 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• \- Diagnosis of Idiopathic Pulmonary Fibrosis (IPF) within 7 years prior to screening, confirmed by the investigator at screening that is supported by centrally read chest high-resolution computed tomography (HRCT) obtained within 12 months of the screening visit and verification of usual interstitial pneumonia(UIP) or probable UIP.

Locations
United States
Alabama
The University of Alabama at Birmingham /ID# 277613
RECRUITING
Birmingham
Sec Clinical Research - East - Dothan - Graceland /ID# 278328
RECRUITING
Dothan
Florida
Clinical Research Specialists - Kissimmee /ID# 279184
RECRUITING
Kissimmee
Illinois
Christie Clinic on University /ID# 277871
RECRUITING
Champaign
Michigan
University of Michigan Health System - Ann Arbor /ID# 279994
RECRUITING
Ann Arbor
Henry Ford Hospital /ID# 277843
RECRUITING
Detroit
Missouri
Hannibal Regional Hospital /ID# 277984
RECRUITING
Hannibal
Pennsylvania
Jefferson Health Honickman Center /ID# 279127
RECRUITING
Philadelphia
Virginia
Inova Fairfax Hospital /ID# 278469
RECRUITING
Falls Church
Virginia Commonwealth University Medical Center /ID# 277992
RECRUITING
Richmond
Other Locations
Australia
Eastern Health /ID# 278245
RECRUITING
Box Hill
Lung Research Queensland /ID# 278838
RECRUITING
Nundah
Bulgaria
University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski /ID# 277845
RECRUITING
Pleven
University Multiprofile Hospital For Active Treatment Sveti Georgi - Plovdiv /ID# 279367
RECRUITING
Plovdiv
Acibadem City Clinic Tokuda University Hospital EAD /ID# 277846
RECRUITING
Sofia
Diagnostic Consultative Center Convex /ID# 277848
RECRUITING
Sofia
Diagnostic Consultative Center Convex /ID# 277849
RECRUITING
Sofia
Canada
Centre d'Investigation Clinique Mauricie /ID# 277949
RECRUITING
Trois-rivières
France
Hopital Avicenne /ID# 279212
RECRUITING
Bobigny
Hopital Arnaud de Villeneuve /ID# 278322
RECRUITING
Montpellier
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou /ID# 278333
RECRUITING
Rennes
Germany
Caritas-Krankenhaus St. Maria gGmbH /ID# 278138
RECRUITING
Donaustauf
Klinikum Konstanz /ID# 278139
RECRUITING
Konstanz
Greece
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 277724
RECRUITING
Athens
University General Hospital of Heraklion /ID# 277717
RECRUITING
Heraklion
University Hospital of Ioannina /ID# 277719
RECRUITING
Ioannina
University General Hospital of Patras /ID# 277726
RECRUITING
Pátrai
General Hospital of Thessaloniki George Papanikolaou /ID# 277819
RECRUITING
Thessaloniki
Japan
NHO Kinki Chuo Chest Medical Center /ID# 280225
RECRUITING
Sakai-shi
Poland
Vitamed Galaj i Cichomski Sp.j. /ID# 278145
RECRUITING
Bydgoszcz
Portugal
Unidade Local de Saude do Algarve, EPE /ID# 278388
RECRUITING
Faro
Unidade Local de Saude de Loures-Odivelas-Hospital Beatriz Angelo /ID# 278357
RECRUITING
Loures
Unidade Local de Saude de Matosinhos EPE /ID# 277980
RECRUITING
Senhora Da Hora
Republic of Korea
The Catholic University Of Korea, Bucheon St. Mary'S Hospital /ID# 278068
RECRUITING
Bucheon-si
Inje University Haeundae Paik Hospital /ID# 278000
RECRUITING
Busan
Seoul National University Bundang Hospital /ID# 278059
RECRUITING
Seongnam-si
Yonsei University Health System Severance Hospital /ID# 278166
RECRUITING
Seoul
Serbia
University Clinical Center Serbia /ID# 278496
RECRUITING
Belgrade
Institute For Pulmonary Diseases Of Vojvodina /ID# 278499
RECRUITING
Kamenitz
South Africa
Dr Hannes J van Rensburg inc /ID# 278278
RECRUITING
Cape Town
Dr JM Engelbrecht Trial Site /ID# 278287
RECRUITING
Somerset West
Spain
Hospital Clinico Universitario de Valencia /ID# 277921
RECRUITING
Valencia
Hospital Universitari i Politecnic La Fe /ID# 278478
RECRUITING
Valencia
Taiwan
Kaohsiung Chang Gung Memorial Hospital /ID# 278043
RECRUITING
Kaohsiung City
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 278029
RECRUITING
Kaohsiung City
China Medical University Hospital /ID# 278039
RECRUITING
Taichung
National Taiwan University Hospital /ID# 278041
RECRUITING
Taipei
Taipei Veterans General Hospital /ID# 278038
RECRUITING
Taipei
Linkou Chang Gung Memorial Hospital /ID# 278042
RECRUITING
Taoyuan City
Turkey
Gulhane Egitim ve Arastirma Hastanesi /ID# 278944
RECRUITING
Ankara
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 278943
RECRUITING
Istanbul
United Kingdom
Royal Papworth Hospital NHS Foundation Trust /ID# 278055
RECRUITING
Cambridge
Edinburgh Royal Infirmary - NHS Lothian /ID# 278631
RECRUITING
Edinburgh
Royal Brompton Hospital /ID# 278007
RECRUITING
London
UCLH NHS FT - University College Hospital /ID# 279198
RECRUITING
London
Norfolk and Norwich University Hospital /ID# 278224
RECRUITING
Norwich
University Hospital Southampton /ID# 278223
RECRUITING
Southampton
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2026-01-23
Estimated Completion Date: 2029-09
Participants
Target number of participants: 165
Treatments
Experimental: Substudy 1: ABBV-142
Participants will receive ABBV-142 for 52 week during double-blind treatment period. Eligible participants may receive ABBV-142 for 52 weeks during open-label treatment period.
Placebo_comparator: Substudy 1: Placebo for ABBV-142
Participants will receive placebo for ABBV-142 for 52 week during double-blind treatment period. Eligible participants may receive ABBV-142 for 52 weeks during open-label treatment period.
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov

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