Clinical trial NCT04419506: A Study to Test How Taking BI 1015550 for 12 Weeks Affects Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)
Official title: A Randomised, Double-blind, Placebo-controlled Parallel Group Study in IPF Patients Over 12 Weeks Evaluating Efficacy, Safety and Tolerability of BI 1015550 Taken Orally
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2020-06-05
Enrollment: 147
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is open to adults with idiopathic pulmonary fibrosis (IPF) who are at least 40 years old. People taking standard medicines for IPF, including antifibrotic medicines, can continue taking them throughout the study.

The purpose of the study is to find out whether a medicine called BI 1015550 can slow down the worsening of lung function. Participants are in the study for about 4 months. During this time, they visit the study site about 7 times. At the beginning, they visit the study site every 2 weeks.

After 1 month of treatment, they visit the study site every 4 weeks.

The participants are put into 2 groups by chance. 1 group gets BI 1015550. The other group gets placebo. Placebo tablets look like BI 1015550 tablets but contain no medicine. The participants take BI 1015550 or placebo tablets twice a day.

The participants have lung function tests at study visits. The results of the lung function tests are compared between the BI 1015550 group and the placebo group. The doctors also regularly check the general health of the participants.


Eligibility criteria: Inclusion Criteria:

1. Patients aged ≥40 years when signing the informed consent.
2. Diagnosis:

   1. IPF based on 2018 ATS/ERS/JRS/ALAT Guideline as confirmed by the investigator based on chest High Resolution Computed Tomography Scan (HRCT) scan taken within 12 months of Visit 1 and if available surgical lung biopsy.

      and
   2. Usual interstitial pneumonia (UIP) or probable UIP HRCT pattern consistent with the clinical diagnosis of IPF, as confirmed by central review prior to Visit 2\*

      * if indeterminate HRCT finding IPF may be confirmed locally by (historical) biopsy
3. Stable for at least 8 weeks prior to Visit 1. Patients have to be either :

   * not on therapy with nintedanib or pirfenidone for at least 8 weeks prior to Visit 1 (combination of nintedanib plus pirfenidone not allowed), or
   * on stable\* therapy with nintedanib or pirfenidone for at least 8 weeks prior to Visit 1 and planning to stay stable on this background therapy after randomisation.

   \[\*stable therapy is defined as the individually and general tolerated regimen of either pirfenidone or nintedanib\]
4. Forced Vital Capacity (FVC) ≥45% of predicted normal at Visit 1
5. Diffusion capacity of the lung for carbon monoxide (DLCO) (corrected for haemoglobin \[Hb\] \[Visit 1\]) ≥ 25% to \< 80% of predicted normal at Visit 1.
6. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.

Exclusion Criteria:

1. Relevant airways obstruction (pre-bronchodilator Forced Expiratory Volume in one second (FEV1)/Forced Vital Capacity (FVC) \< 0.7) at Visit 1.
2. In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
3. Acute IPF exacerbation within 4 months prior to screening and/or during the screening period (investigator-determined).
4. Lower respiratory tract infection requiring antibiotics within 4 weeks prior to Visit 1 and/or during the screening period.
5. Major surgery (major according to the investigator's assessment) performed within 3 months prior to Visit 1 or planned during the course of the trial. (Being on a transplant list is allowed).
6. Any documented active or suspected malignancy or history of malignancy within 5 years prior to Visit 1, except appropriately treated basal cell carcinoma of the skin, "under surveillance" prostate cancer or in situ carcinoma of uterine cervix.
7. Evidence of active infection (chronic or acute) based on clinical exam or laboratory findings at Visit 1 or at Visit 2.
8. Any suicidal behaviour in the past 2 years (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior).
9. The patient has a confirmed infection with SARS-CoV-2 within the 4 weeks prior to Visit 1 and/or during the screening period.

Further exclusion criteria apply.

Primary outcomes:
measure: The Change From Baseline in Forced Vital Capacity (FVC) at 12 Weeks
timeFrame: Baseline (day 1) and week 12.
Secondary outcomes:
measure: The Number of Patients With Treatment Emergent Adverse Event
timeFrame: From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Other outcomes:
Locations:
city: Clearwater
country: United States
facility: St. Francis Medical Institute
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Rochester
country: United States
facility: Mayo Clinic, Rochester
state: Minnesota
city: Chesterfield
country: United States
facility: The Lung Research Center, LLC
state: Missouri
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
city: Winston-Salem
country: United States
facility: Southeastern Research Center
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: San Antonio
country: United States
facility: Diagnostics Research Group
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Health Sciences Center
state: Utah
city: C.a.b.a
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Graz
country: Austria
facility: LKH-Univ. Hospital Graz
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Moncton
country: Canada
facility: Dr. Georges-L.-Dumont University Hospital Centre
state: New Brunswick
city: Kingston
country: Canada
facility: Queen's University
state: Ontario
city: Windsor
country: Canada
facility: Dr. Syed Anees Medicine Professional Corporation
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal (CHUM)
state: Quebec
city: Providencia, Santiago De Chile
country: Chile
facility: Instituto Nacional del Tórax
city: Talca
country: Chile
facility: Centro de Investigación del Maule
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Changchun
country: China
facility: The Second Hospital of Jilin University
city: Chengdu
country: China
facility: West China Hospital
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
city: Praha 4 - Krc
country: Czechia
facility: University Thomayer's Hospital
city: Praha
country: Czechia
facility: University Hospital Na Bulovce, Prague
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
city: Hellerup
country: Denmark
facility: Herlev and Gentofte Hospital
city: Odense C
country: Denmark
facility: Odense University Hospital
city: Helsinki
country: Finland
facility: HYKS Keuhkosairauksien tutkimusyksikkö
city: Kuopio
country: Finland
facility: KYS, Keuhkosairauksien
city: Oulu
country: Finland
facility: Oulun yliopistollinen keskussairaala
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: TYKS
city: Coswig
country: Germany
facility: Fachkrankenhaus Coswig GmbH
city: Essen
country: Germany
facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
city: Heidelberg
country: Germany
facility: Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
city: Immenhausen
country: Germany
facility: Lungenfachklinik Immenhausen
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Athens
country: Greece
facility: Athens Medical Center
city: Crete
country: Greece
facility: University General Hospital of Heraklion
city: Patras
country: Greece
facility: Univ. Gen. Hosp. of Patras
city: Budapest
country: Hungary
facility: Semmelweis University
city: Foggia
country: Italy
facility: Ospedale Colonnello D Avanzo
city: Padova
country: Italy
facility: Azienda Ospedaliera Universitaria di Padova
city: Roma
country: Italy
facility: Poli Univ A. Gemelli
city: Siena
country: Italy
facility: A.O.U. Senese Policlinico Santa Maria alle Scotte
city: Aichi, Seto
country: Japan
facility: Tosei General Hospital
city: Fukuoka, Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center
city: Kanagawa, Yokohama
country: Japan
facility: Kanagawa Cardiovascular and Respiratory Center
city: Osaka, Sakai
country: Japan
facility: National Hospital Organization Kinki-Chuo Chest Medical Center
city: Shizuoka, Hamamatsu
country: Japan
facility: Hamamatsu University Hospital
city: Tokyo, Shinjuku-ku
country: Japan
facility: Center Hospital of the National Center for Global Health and Medicine
city: Bucheon
country: Korea, Republic of
facility: The Catholic University of Korea, Bucheon St.Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Heerlen
country: Netherlands
facility: Zuyderland Medisch Centrum
city: Nieuwegein
country: Netherlands
facility: St. Antonius ziekenhuis, locatie Nieuwegein
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Gdansk
country: Poland
facility: University Clinical Center, Gdansk
city: Moscow
country: Russian Federation
facility: Federal state budgetary scientific institution "Research Institute of occupational medicine named after academician N. F. Izmerov
city: Moscow
country: Russian Federation
facility: Moscow 1st State Med.Univ.n.a.I.M.Sechenov
city: Yaroslavl
country: Russian Federation
facility: Emergency Clinical Hospital n. a. N. V. Solovyev, Yaroslavl
city: Barcelona
country: Spain
facility: Policlínica Barcelona
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital de Bellvitge
city: Madrid
country: Spain
facility: Hospital La Princesa
city: Oviedo
country: Spain
facility: Hospital Central de Asturias
city: Palma de Mallorca
country: Spain
facility: Hospital Son Espases
city: Dnyepropyetrovsk
country: Ukraine
facility: Dnyepropyetrovsk Medical Academy, Clinical Hospital No. 6
city: Kyiv
country: Ukraine
facility: Instit.Phthisiology&Pulmon.na Yanovskiy,Non-Specif.Lung,Kyiv
city: Bristol
country: United Kingdom
facility: Southmead Hospital
city: London
country: United Kingdom
facility: Royal Brompton Hospital
Study officials:
References:
citation: Richeldi L, Azuma A, Cottin V, Hesslinger C, Stowasser S, Valenzuela C, Wijsenbeek MS, Zoz DF, Voss F, Maher TM; 1305-0013 Trial Investigators. Trial of a Preferential Phosphodiesterase 4B Inhibitor for Idiopathic Pulmonary Fibrosis. N Engl J Med. 2022 Jun 9;386(23):2178-2187. doi: 10.1056/NEJMoa2201737. Epub 2022 May 15.