A Study to Learn How Well People With Bronchiectasis Tolerate Continued Treatment With Verducatib After Earlier Studies (AIRTIVITY®-ON)

October 30, 2026 updated by: Boehringer Ingelheim

An Open-label, Roll-over Study Evaluating the Long-term Safety and Efficacy of an Oral Dose of Verducatib q.d. in Patients With Bronchiectasis (AIRTIVITY®-ON)

This study is for adults and adolescents who are at least 12 years old and have bronchiectasis. People can participate if they completed a previous study with the study medicine called verducatib. The purpose of this study is to find out how well verducatib is tolerated when people with bronchiectasis take it for a long time. The study also looks at breathing problems, how often lung flare-ups happen, and how quickly lung function changes.

This is a roll-over study for participants who completed a previous study with verducatib: AIRTIVITY® (1397-0014) or CLAIRLEAF® (1397-0017). All participants receive verducatib. Participants take verducatib as tablets once a day at home. They may continue their usual treatment for bronchiectasis during the study.

Participants can stay in the study for up to 1 year and 9 months. Treatment with verducatib can continue for up to 1 year and 6 months. About 6 study visits are done at the study site and about 4 are done by phone. At all visits, the doctors check participants' health and collect information on any health problems that occur during the study. The doctors also look at lung flare-ups and measure lung function over time.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Alberdi Sur, Argentina, X5003DCE
      • Buenos Aires, Argentina, C1128AAF
      • CABA, Argentina, C1428BNF
      • CABA, Argentina, 1425
      • CABA, Argentina, 1182
        • Fundacion NIBA Neurologia Infantil Buenos Aires
        • Contact:
      • Capital Federal, Argentina, C1118AAT
      • Ciudad Autonoma Buenos Aires, Argentina, C1046AAQ
      • Mar del Plata, Argentina, 7600
      • Quilmes, Argentina, B1878FNR
      • Rosario, Argentina, 2000
        • Instituto de Especialidades de la Salud Rosario
        • Contact:
      • Santa Fe, Argentina, 3000
  • Austria
  • Belgium
      • Brussels, Belgium, 1200
      • Ghent, Belgium, 9000
      • Leuven, Belgium, 3000
      • Sint-Niklaas, Belgium, 9100
  • Brazil
      • Barra Mansa, Brazil, 27323240
        • Serviços Medicos Respirar Sul Fluminense
        • Contact:
      • Botucatu, Brazil, 18618-687
        • Faculdade de Medicina de Botucatu - UNESP
        • Contact:
      • Brasília, Brazil, 72145-450
      • Goiânia, Brazil, 74605-020
        • HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
        • Contact:
      • Porto Alegre, Brazil, 90035-074
        • Irmandade da Santa Casa de Misericórdia de Porto Alegre
        • Contact:
      • São Bernardo do Campo, Brazil, 09750-420
        • Netspiro Clinica Medica Ltda - Respsono
        • Contact:
      • São Paulo, Brazil, 05403-000
        • INCOR e Hospital das Clínicas da Universidade de São Paulo
        • Contact:
  • Bulgaria
      • Kozloduy, Bulgaria, 3320
      • Montana, Bulgaria, 3400
      • Pernik, Bulgaria, 2300
      • Plovdiv, Bulgaria, 4023
      • Razgrad, Bulgaria, 7200
      • Rousse, Bulgaria, 7002
        • Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov-Ruse
        • Contact:
      • Sofia, Bulgaria, 1510
      • Sofia, Bulgaria, 1606
      • Sofia, Bulgaria, 1680
      • Sofia, Bulgaria, 1756
      • Veliko Tarnovo, Bulgaria, 5000
      • Vidin, Bulgaria, 3700
      • Vratsa, Bulgaria, 3001
        • Specialized Hospital For Active Treatment Of Pneumo-Physiatiric Diseases Vraca /Sbalpfz Vratsa EOOD
        • Contact:
  • Canada
      • Québec, Canada, G1V 4G5
        • Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
        • Contact:
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
    • Ontario
      • Burlington, Ontario, Canada, L7N 3V2
    • Quebec
      • Montreal, Quebec, Canada, H2X 0A9
        • Centre Hospitalier de l'Universite de Montreal (CHUM)
        • Contact:
  • Chile
      • Santiago, Chile, 7750000
      • Talca, Chile, 3465586
        • Centro de Investigacion del Maule
        • Contact:
  • China
      • Beijing, China, 100730
        • Peking Union Medical College Hospital
        • Contact:
      • Beijing, China, 100191
        • Peking University Third Hospital
        • Contact:
      • Beijing, China, 100029
        • China-Japan Friendship Hospital
        • Contact:
      • Beijing, China, 100045
        • Beijing Children's Hospital, Capital Medical University
        • Contact:
      • Changchun, China, 130000
        • The Second Hospital of Jilin University
        • Contact:
      • Changchun, China, 130000
        • The First Hospital of Jilin University
        • Contact:
      • Changsha, China, 410011
        • The Second Xiangya Hospital Of Central South University
        • Contact:
      • Chengdu, China, 610041
        • West China Hospital, Sichuan University
        • Contact:
      • Guangzhou, China, 510080
        • Guangdong Provincial People's Hospital
        • Contact:
      • Guangzhou, China, 510000
        • First Affiliated Hospital of Guangzhou Medical University
        • Contact:
      • Guiyang, China, 550002
        • Guizhou Provincial People's Hospital
        • Contact:
      • Hangzhou, China, 310009
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
      • Hangzhou, China, 310006
        • Hangzhou First People's Hospital
        • Contact:
      • Hangzhou, China, 310016
        • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
        • Contact:
      • Hangzhou, China, 310030
      • Hefei, China, 230022
        • The First Affiliated Hospital of Anhui Medical University
        • Contact:
      • Huzhou, China, 313000
      • Jiangmen, China, 529030
      • Nanchang, China, 330006
        • The Second Affiliated Hospital to Nanchang University
        • Contact:
      • Nanchang, China, 330000
        • The First Affiliated Hospital of Nanchang University
        • Contact:
      • Nanjing, China, 210008
      • Nanjing, China, 210006
      • Nantong, China, 226001
        • Affiliated Hospital of Nantong University
        • Contact:
      • Ningbo, China, 315000
        • Ningbo Medical Center Lihuili Hospital
        • Contact:
      • Ningbo, China, 315010
        • The First Affiliated Hospital of Ningbo University
        • Contact:
      • Pingxiang, China, 337000
      • Qingdao, China, 266011
      • Quanzhou, China, 362000
        • The Second Affiliated Hospital of Fujian Medical University
        • Contact:
      • Shanghai, China, 200240
        • Shanghai Fifth People's Hospital affiliated to Fudan University
        • Contact:
      • Shanghai, China, 200433
      • Shanghai, China, 200032
        • Zhongshan Hospital Affiliated to Fudan University
        • Contact:
      • Shanghai, China, 200080
      • Shanghai, China, 200040
        • Huadong Hospital affiliated to Fudan University
        • Contact:
      • Shanghai, China, 200025
        • Ruijin Hospital Shanghai Jiao Tong University School of Medicine
        • Contact:
      • Shanghai, China, 201700
        • Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University
        • Contact:
      • Shanghai, China, 201102
        • The Children's Hospital of Fudan University
        • Contact:
      • Shenzhen, China, 518020
      • Suzhou, China, 215006
        • The First Affiliated Hospital of Soochow University
        • Contact:
      • Tianjin, China, 300052
        • Tianjin Medical University General Hospital
        • Contact:
      • Wenzhou, China, 325000
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
      • Wenzhou, China, 325006
      • Wuhan, China, 430030
        • Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
        • Contact:
      • Wuhan, China, 430022
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
        • Contact:
      • Wuxi, China, 214043
      • Xi'an, China, 710061
        • First Affiliated Hospital of Xi'an JiaoTong University
        • Contact:
      • Xuzhou, China, 221006
        • The Affiliated Hospital of Xuzhou Medical College
        • Contact:
      • Yangzhou, China, 225001
        • Northern Jiangsu People's Hospital
        • Contact:
      • Yixing, China, 214258
  • Czechia
      • Jindřichův Hradec, Czechia, 377 01
      • Prague, Czechia, 19000
        • The First Pulmonary Private Practice
        • Contact:
  • Denmark
      • Aalborg, Denmark, 9000
      • Aarhus N, Denmark, 8200
      • Hvidovre, Denmark, 2650
      • Københagen Ø, Denmark, 2100
        • Copenhagen University Hospital, Rigshospitalet
        • Contact:
      • Odense C, Denmark, 5000
      • Vejle, Denmark, 7100
  • Finland
      • Helsinki, Finland, 00290 HUS
      • Oulu, Finland, 90150
        • Northern Clinical Trial Coordinators
        • Contact:
      • Tampere, Finland, 33520
      • Turku, Finland, 20521
        • Turku University Hospital / TYKS
        • Contact:
  • France
      • Amiens, France, 80054
      • Créteil, France, 94000
      • Lille, France, 59037
      • Lyon, France, 69004
      • Montpellier, France, 34295
      • Nice, France, 06001
      • Paris, France, 75014
      • Pessac, France, 33604
      • Rennes, France, 35000
      • Saint-Herblain, France, 44093
      • Tououse, France, 31059
  • Germany
      • Aachen, Germany, 52074
      • Ahrensburg, Germany, 22926
      • Bamberg, Germany, 96049
      • Berlin, Germany, 12351
      • Berlin, Germany, 13353
      • Berlin, Germany, 10117
      • Bochum, Germany, 44791
      • Bonn, Germany, 53127
      • Cologne, Germany, 50937
      • Cologne, Germany, 50678
      • Donaustauf, Germany, 93093
      • Dortmund, Germany, 44145
      • Dresden, Germany, 01307
      • Essen, Germany, 45239
        • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
        • Contact:
      • Frankfurt, Germany, 60590
      • Frankfurt, Germany, 60596
      • Freiburg im Breisgau, Germany, 79106
      • Gauting, Germany, 82131
      • Halle, Germany, 06120
      • Hanover, Germany, 30625
      • Heidelberg, Germany, 69126
        • Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
        • Contact:
      • Jena, Germany, 07747
      • Kiel, Germany, 24105
      • Lübeck, Germany, 23552
      • Mainz, Germany, 55131
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
        • Contact:
      • München, Germany, 80336
      • München, Germany, 81241
      • Münster, Germany, 48149
      • Potsdam, Germany, 14467
      • Stralstund, Germany, 18435
      • Wiesbaden, Germany, 65183
  • Hong Kong
      • Hong Kong, Hong Kong, 999077
      • Hong Kong, Hong Kong, 999077
  • Hungary
  • Ireland
  • Israel
      • Beersheba, Israel, 8410101
      • Haifa, Israel, 3436212
      • Jerusalem, Israel, 9112001
      • Jerusalem, Israel, 9765422
      • Petah Tikva, Israel, 4941492
      • Tel Aviv, Israel, 6093246
  • Italy
      • Bologna, Italy, 40138
      • Catania, Italy, 95121
        • Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
        • Contact:
      • Florence, Italy, 50139
      • Genova, Italy, 16147
      • Genova, Italy, 16132
      • Messina, Italy, 98124
      • Milan, Italy, 20122
        • Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
        • Contact:
      • Monza (MB), Italy, 20900
        • Azienda Socio Sanitaria Territoriale Di Monza
        • Contact:
      • Naples, Italy, 80131
        • Azienda Ospedaliera Universitaria "Federico II"
        • Contact:
      • Padova, Italy, 35128
        • Azienda Ospedaliera Universitaria di Padova
        • Contact:
      • Palermo, Italy, 90127
      • Pavia, Italy, 27100
        • Fondazione IRCCS Policlinico S. Matteo
        • Contact:
      • Roma, Italy, 00165
      • Rozzano (MI), Italy, 20089
      • Verona, Italy, 37126
        • Azienda Ospedaliera Universitaria Integrata Verona
        • Contact:
  • Japan
      • Aichi, Nagoya, Japan, 466-8560
      • Aomori, Hirosaki, Japan, 036-8563
      • Chiba, Chiba, Japan, 260-8677
      • Chiba, Kamogawa, Japan, 296-0041
      • Fukuoka, Fukuoka, Japan, 812-8582
      • Fukuoka, Fukuoka, Japan, 814-0180
      • Hyogo, Himeji, Japan, 670-0849
        • Terada Clinic, Respiratory Medicine & General practice
        • Contact:
      • Ibaraki, Naka-gun, Japan, 319-1113
      • Ibaraki, Tsukuba, Japan, 305-8576
      • Kagoshima, Kagoshima, Japan, 890-8520
      • Kanagawa, Yokohama, Japan, 236-0051
        • Kanagawa Cardiovascular and Respiratory Center
        • Contact:
      • Kyoto, Joyo, Japan, 610-0113
      • Kyoto, Kyoto, Japan, 606-8507
      • Mie, Matsusaka, Japan, 515-8544
      • Miyagi, Sendai, Japan, 980-8574
      • Nagasaki, Nagasaki, Japan, 852-8501
      • Niigata, Niigata, Japan, 951-8520
        • Niigata University Medical and Dental Hospital
        • Contact:
      • Oita, Yufu, Japan, 879-5593
      • Okayama, Kurashiki, Japan, 710-8602
      • Osaka, Sakai, Japan, 591-8555
        • National Hospital Organization Kinki-Chuo Chest Medical Center
        • Contact:
      • Osaka, Toyonaka, Japan, 560-8552
      • Saga, Saga, Japan, 849-8501
      • Saitama, Kumagaya, Japan, 360-0197
        • Saitama Cardiovascular and Respiratory Center
        • Contact:
      • Shiga, Otsu, Japan, 520-2192
        • Shiga University of Medical Science Hospital
        • Contact:
      • Shimane, Matsue, Japan, 690-8556
      • Shizuoka, Hamamatsu, Japan, 431-3192
      • Shizuoka, Hamamatsu, Japan, 434-8511
      • Tokushima, Tokushima, Japan, 770-8503
      • Tokyo, Bunkyo-ku, Japan, 113-8519
        • Institute of Science Tokyo Hospital
        • Contact:
      • Tokyo, Itabashi-ku, Japan, 173-8610
        • Nihon University Itabashi Hospital
        • Contact:
      • Tokyo, Kiyose, Japan, 204-8522
      • Tokyo, Minato-ku, Japan, 105-8470
      • Tokyo, Shinjuku-ku, Japan, 162-8666
        • Tokyo Women's Medical University Hospital
        • Contact:
      • Tokyo, Shinjuku-ku, Japan, 160-8582
      • Yamaguchi, Ube, Japan, 755-8505
  • Kazakhstan
      • Astana, Kazakhstan, 010000
        • Multidisciplinary City Hospital №1 of the Akimat of Astana
        • Contact:
      • Karaganda, Kazakhstan, 100019
        • Regional Clinical Hospital of the Health Department of the Karaganda Region
        • Contact:
  • Latvia
      • Daugavpils, Latvia, 5401
      • Daugavpils, Latvia, LV-5410
      • Jūrmala, Latvia, 2015
      • Riga, Latvia, LV-1002
        • Pauls Stradins Clinical University Hospital
        • Contact:
      • Riga, Latvia, 1001
      • Riga, Latvia, 2118
        • Rigas Austrumu kliniska universitates slimnica SIA
        • Contact:
      • Riga, Latvia, LV-1011
        • Mediciniskas pecdiploma izglitibas instituts SIA
        • Contact:
  • Lithuania
      • Kaunas, Lithuania, 50161
        • Hospital of Lithuanian University of Health Sciences Kauno Klinikos
        • Contact:
      • Klaipėda, Lithuania, 92231
      • Vilnius, Lithuania, 08406
  • Malaysia
      • Kajang, Malaysia, 43000
      • Kelantan, Malaysia, 15586
      • Kuala Lumpur, Malaysia, 59100
      • Kuching, Malaysia, 93586
  • Mexico
      • Chihuahua City, Mexico, 31203
        • Centro de Investigacion Integral MEDIVEST S.C
        • Contact:
      • Chihuahua City, Mexico, 31203
        • Mediadvance Clinical S.A.P.I de C.V.
        • Contact:
      • León, Mexico, 37160
        • Centro de Investigacion Farmacologica del Bajío, S.C.
        • Contact:
      • Mexico City, Mexico, 03650
        • Soluciones terapeuticas medico quirurgicas S de RL de CV
        • Contact:
      • Monterrey, Nuevo León, Mexico, C.P. 64460
        • Hospital Universitario Nuevo de Nuevo León - CEPREP
        • Contact:
      • Oaxaca City, Mexico, 68000
        • Oaxaca Site Management Organization, S.C.
        • Contact:
      • Tlalnepantla, Mexico, 54055
  • Netherlands
      • Alkmaar, Netherlands, 1815 JD
      • Amsterdam, Netherlands, 1081HV
      • Rotterdam, Netherlands, 3015 GD
      • The Hague, Netherlands, 2545 AA
      • Utrecht, Netherlands, 3584 CX
      • Zutphen, Netherlands, 7207 AE
  • Philippines
      • Iloilo City, Philippines, 5000
      • Iloilo City, Philippines, 5000
      • Mandaluyong, Philippines, 1552
      • Quezon City, Philippines, 1109
      • Taft, Manila, Philippines, 1000
  • Poland
      • Bialystok, Poland, 15-044
        • Respiratory Medicine Centre, private prac., Bialystok
        • Contact:
      • Chorzów, Poland, 41-500
      • Piaseczno, Poland, 05500
      • Rzeszów, Poland, 35205
        • EMED, Center of Medical Services,Private Prac,Rzeszow
        • Contact:
      • Warsaw, Poland, 01-456
        • Altamed Specjalistyczna Praktyka Lekarska Pawel Sliwinski
        • Contact:
      • Wroclaw, Poland, 51-162
        • Centrum Badan Klinicznych Piotr Napora Lekarze sp.p.
        • Contact:
      • Świdnik, Poland, 21040
        • Przychodnia Alergologiczno-Pulmonologiczna Alergopneuma Sp. z o.o.
        • Contact:
  • Portugal
      • Aveiro, Portugal, 3814-501
      • Braga, Portugal, 4710-243
      • Coimbra, Portugal, 3004-561
        • CHUC - Centro Hospitalar e Universitario de Coimbra, EPE
        • Contact:
      • Guimarães, Portugal, 4835-045
      • Leiria, Portugal, 2410-197
      • Lisbon, Portugal, 1649-035
      • Porto, Portugal, 4202-451
        • Centro Hospitalar Universitário São João,EPE
        • Contact:
  • Romania
      • Bucharest, Romania, 050159
        • Institutul De Pneumoftiziologie Marius Nasta
        • Contact:
      • Cluj-Napoca, Romania, 400003
      • Cluj-Napoca, Romania, 400371
        • Spitalul Clinic De Pneumoftiziologie Leon Daniello
        • Contact:
      • Timișoara, Romania, 300310
        • Clinical Hospital Of Infectious Diseases And Pneumophysiology Dr.Victor Babes Timisoara
        • Contact:
  • Singapore
      • Singapore, Singapore, 169608
      • Singapore, Singapore, 308433
      • Singapore, Singapore, 529905
  • Slovakia
      • Martin, Slovakia, 036 01
      • Spišská Nová Ves, Slovakia, 05201
  • South Korea
      • Anyang, South Korea, 14068
        • Hallym University Sacred Heart Hospital
        • Contact:
      • Cheongju-si, South Korea, 28644
        • Chungbuk National University Hospital
        • Contact:
      • Daegu, South Korea, 42415
      • Dong-gu Ulsan, South Korea, 44033
      • Incheon, South Korea, 21431
        • The Catholic University of Korea, Incheon St. Mary's Hospital
        • Contact:
      • Seoul, South Korea, 05505
      • Seoul, South Korea, 06351
      • Seoul, South Korea, 03722
      • Seoul, South Korea, 08308
      • Seoul, South Korea, 05030
      • Seoul, South Korea, 137-701
        • The Catholic University of Korea, Seoul St.Mary's Hospital
        • Contact:
      • Seoul, South Korea, 03312
        • The Catholic University of Korea, Eunpyeong St. Mary's Hospital
        • Contact:
      • Seoul, South Korea, 07071
      • Seoul, South Korea, 150-950
        • Hallym University Kangnam Sacred Heart Hospital
        • Contact:
      • Seoul, South Korea, 54907
        • Jeonbuk National University Hospital
        • Contact:
      • Wŏnju, South Korea, 26426
        • Yonsei University Wonju Severance Christian Hospital
        • Contact:
  • Spain
      • A Coruña, Spain, 15006
        • Complejo Hospitalario Universitario A Coruña
        • Contact:
      • Badalona, Spain, 08916
      • Barcelona, Spain, 08035
      • Barcelona, Spain, 08036
      • El Palmar, Spain, 30120
        • Hospital Universitario Virgen de la Arrixaca
        • Contact:
      • Girona, Spain, 17007
        • Hospital Universitari de Girona Doctor Josep Trueta
        • Contact:
      • Huelva, Spain, 21080
      • Huelva, Spain, 21005
      • Jerez de la Frontera, Spain, 11407
      • L'Hospitalet Del Llobregat, Spain, 08907
      • Madrid, Spain, 28046
      • Mérida, Spain, 06800
      • Oviedo, Spain, 33011
      • Palma de Mallorca, Spain, 07120
      • Pamplona, Spain, 31008
      • Pozuelo de Alarcón, Spain, 28223
      • Santander, Spain, 39008
        • Hospital Universitario Marqués de Valdecilla
        • Contact:
      • Santiago, Spain, 15706
        • Complexo Hospitalario Universitario De Santiago
        • Contact:
      • Seville, Spain, 41009
        • Hospital Universitario Virgen De La Macarena
        • Contact:
      • Seville, Spain, 41013
      • Valencia, Spain, 46026
        • Hospital Universitari i Politècnic La Fe
        • Contact:
  • Sweden
      • Stockholm, Sweden, SE-171 64
      • Uppsala, Sweden, 752 37
      • Örebro, Sweden, 703 82
  • Switzerland
      • Basel, Switzerland, 4031
      • Lausanne, Switzerland
  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • Kaohsiung Chang Gung Memorial Hospital
        • Contact:
      • Kaohsiung City, Taiwan, 807
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
        • Contact:
      • Taichung, Taiwan, 40705
      • Taoyuan City, Taiwan, 333
        • Chang Gung Memorial Hospital, Linkou
        • Contact:
  • Thailand
      • Bangkok, Thailand, 10700
      • Ratchathewi, Thailand, 10400
  • United Kingdom
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
    • California
      • Newport Beach, California, United States, 92663
      • Redding, California, United States, 96001
      • Sacramento, California, United States, 95817
    • Colorado
      • Denver, Colorado, United States, 80206
    • Florida
      • Brandon, Florida, United States, 33511
      • Jacksonville, Florida, United States, 32224
      • Jacksonville, Florida, United States, 32209
      • Naples, Florida, United States, 34102
      • Tampa, Florida, United States, 33614
      • Weston, Florida, United States, 33331
    • Georgia
      • Augusta, Georgia, United States, 30912
    • Kansas
      • Kansas City, Kansas, United States, 66160
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
    • Minnesota
      • Rochester, Minnesota, United States, 55905
      • Saint Paul, Minnesota, United States, 55130
    • Missouri
      • St Louis, Missouri, United States, 63110
    • Nebraska
      • Omaha, Nebraska, United States, 68198-5910
    • New York
      • Hawthorne, New York, United States, 10532
      • New Hyde Park, New York, United States, 11040
      • New York, New York, United States, 10029
      • New York, New York, United States, 10017
      • New York, New York, United States, 10032
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
      • Pinehurst, North Carolina, United States, 28374
    • Ohio
      • Cincinnati, Ohio, United States, 45267
      • Cleveland, Ohio, United States, 44106
    • Pennsylvania
      • DuBois, Pennsylvania, United States, 15801
      • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia, Pennsylvania, United States, 19107
    • South Carolina
      • Charleston, South Carolina, United States, 29425
      • Rock Hill, South Carolina, United States, 29732
    • Texas
      • Cypress, Texas, United States, 77429
      • Dallas, Texas, United States, 75390
      • Dallas, Texas, United States, 75246
      • El Paso, Texas, United States, 79902
      • Galveston, Texas, United States, 77555
      • Houston, Texas, United States, 77030
      • McKinney, Texas, United States, 75069
      • San Antonio, Texas, United States, 78229
      • Tyler, Texas, United States, 75708
    • Utah
      • Murray, Utah, United States, 84107-4107
    • Vermont
      • Colchester, Vermont, United States, 05446
    • Virginia
      • Falls Church, Virginia, United States, 22042
      • Richmond, Virginia, United States, 23219
    • Washington
      • Seattle, Washington, United States, 98195
      • Spokane, Washington, United States, 99204
    • Wisconsin
      • Madison, Wisconsin, United States, 53792

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. Participants (adults and adolescents ≥12 years of age) who completed the treatment period in trials 1397-0014 or 1397-0017 as planned per protocol and did not discontinue trial treatment prematurely.
  2. Male or female participants. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Council of Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the participant information.
  3. Signed and dated written informed consent and assent, if applicable, prior to admission to the trial, in accordance with Good Clinical Practice (GCP) and local legislation.

Exclusion criteria:

  1. Moderate or severe liver disease (defined by Child-Pugh score B or C hepatic impairment), unless the investigator determines it is in the best interest of the participant to enrol in the trial.
  2. Estimated glomerular filtration rate (eGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula (adults) and Chronic Kidney Disease Under 25 (CKiD-U25) (adolescents) <30 mL/min at Visit 1 (or at the last safety assessment in the parent trial, if no more than 6 weeks passed since then), unless the investigator determines it is in the best interest of the participant to enrol in the trial.
  3. An absolute blood neutrophil count <1000/mm^3 (equivalent to <1000 cells/µL or <10^9 cells/L) at Visit 1 (or at the last safety assessment in the parent trial, if no more than 6 weeks passed since then).
  4. Any findings in the medical examination and/or laboratory value assessed at Visit 1 (or at the last safety assessment in the parent trial, concerning the laboratory tests, if no more than 6 weeks passed since then), that in the opinion of the investigator may put the participant at risk by participating in the trial.
  5. Diagnosis of primary or secondary immunodeficiency made after end of treatment in preceding trial.
  6. Any relevant pulmonary, gastrointestinal, hepatic, renal, cardiovascular, metabolic, immunological, hormonal, or other disorder that, in the opinion of the investigator, may put the participant at risk by participating in the study.
  7. Participants who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
  8. Participants not expected to comply with the protocol requirements or not expected to complete the trial as scheduled, i.e. chronic alcohol or drug abuse or any other condition that, in the investigator's opinion, makes the participant an unreliable trial participant.

Further exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Participants with bronchiectasis rolling over from parent trials

Participants with bronchiectasis who completed parent trials AIRTIVITY® (1397-0014) or CLAIRLEAF® (1397-0017) and did not prematurely discontinue the trial drug.
Drug: verducatib

verducatib

Other Names:
  • BI 1291583

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Occurrence of treatment-emergent adverse events (TEAEs) over the course of this trial
Time Frame: up to 78 weeks
up to 78 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Annualised rate of pulmonary exacerbations (number of events per person-time) up to Week 78
Time Frame: up to 78 weeks
up to 78 weeks
Time to first pulmonary exacerbation from first drug administration up to Week 78
Time Frame: up to 78 weeks
up to 78 weeks
Absolute change from baseline in post-bronchodilator forced expiratory volume in the first second (FEV1) %pred up to Week 78
Time Frame: at baseline, at week 78
at baseline, at week 78
Absolute change from baseline in post-bronchodilator forced vital capacity (FVC) %pred up to Week 78
Time Frame: at baseline, at week 78
at baseline, at week 78
High-resolution computed tomography (HRCT) substudy: Change from baseline (52-week HRCT from the parent trial) in total number of mucus plugs at Week 78
Time Frame: at baseline, at week 78
at baseline, at week 78
HRCT substudy: Change from baseline (52-week HRCT from the parent trial) in volume of mucus plugs at Week 78
Time Frame: at baseline, at week 78
at baseline, at week 78
HRCT substudy: Change from baseline (52-week HRCT from the parent trial) in bronchial wall area over bronchial outer area (Bwa/Boa) at Week 78
Time Frame: at baseline, at week 78
at baseline, at week 78

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 11, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 10, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1397-0018
  • U1111-1341-3104 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))
  • 2026-527086-30-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined on the website.

IPD Sharing Time Frame

One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

IPD Sharing Access Criteria

For study documents - upon signing of a "Document Sharing Agreement". For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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