Idiopathic Pulmonary FibrosisPhase 2NCT04419506
A Study to Test How Taking BI 1015550 for 12 Weeks Affects Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)
A Phase 2 study testing BI 1015550 in people with Idiopathic Pulmonary Fibrosis, run by Boehringer Ingelheim at 75 sites in 22 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- BI 1015550
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- 75 sitesin 22 countries
- Study dates
- 28 Jul 2020to 15 Oct 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥40 years when signing the informed consent.
- Diagnosis:
- 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
- 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
Show all 13Show fewer
- 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]
- Forced Vital Capacity (FVC) ≥45% of predicted normal at Visit 1
- Diffusion capacity of the lung for carbon monoxide (DLCO) (corrected for haemoglobin [Hb] [Visit 1]) ≥ 25% to < 80% of predicted normal at Visit 1.
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
Who cannot join
- Relevant airways obstruction (pre-bronchodilator Forced Expiratory Volume in one second (FEV1)/Forced Vital Capacity (FVC) < 0.7) at Visit 1.
- In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
- Acute IPF exacerbation within 4 months prior to screening and/or during the screening period (investigator-determined).
- Lower respiratory tract infection requiring antibiotics within 4 weeks prior to Visit 1 and/or during the screening period.
- 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).
- 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.
Show all 10Show fewer
- Evidence of active infection (chronic or acute) based on clinical exam or laboratory findings at Visit 1 or at Visit 2.
- Any suicidal behaviour in the past 2 years (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior).
- 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.
Trial locations and contacts
75 sites in 22 countries.
75 sites in 22 countries
United States11 sites
The Lung Research Center, LLC
Chesterfield, Missouri, 63017
St. Francis Medical Institute
Clearwater, Florida, 33765
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
University of Florida
Gainesville, Florida, 32610
University of Kansas Medical Center
Kansas City, Kansas, 66160
Creighton University
Omaha, Nebraska, 68124
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Mayo Clinic, Rochester
Rochester, Minnesota, 55905
University of Utah Health Sciences Center
Salt Lake City, Utah, 84108
Diagnostics Research Group
San Antonio, Texas, 78229
Southeastern Research Center
Winston-Salem, North Carolina, 27103
Japan6 sites
Tosei General Hospital
Aichi, Seto, 489-8642
National Hospital Organization Kyushu Medical Center
Fukuoka, Fukuoka, 810-8563
Kanagawa Cardiovascular and Respiratory Center
Kanagawa, Yokohama, 236-0051
National Hospital Organization Kinki-Chuo Chest Medical Center
Osaka, Sakai, 591-8555
Hamamatsu University Hospital
Shizuoka, Hamamatsu, 431-3192
Center Hospital of the National Center for Global Health and Medicine
Tokyo, Shinjuku-ku, 162-8655
Spain6 sites
Policlínica Barcelona
Barcelona, 08006
Hospital Clínic de Barcelona
Barcelona, 08036
Hospital de Bellvitge
L'Hospitalet de Llobregat, 08907
Hospital La Princesa
Madrid, 28006
Hospital Central de Asturias
Oviedo, 33011
Hospital Son Espases
Palma de Mallorca, 07120
Canada5 sites
Queen's University
Kingston, Ontario, K7L 2V6
Dr. Georges-L.-Dumont University Hospital Centre
Moncton, New Brunswick, E1C 2Z3
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, H2X 0A9
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Dr. Syed Anees Medicine Professional Corporation
Windsor, Ontario, N8X 1T3
China5 sites
Peking Union Medical College Hospital
Beijing, 100032
The Second Hospital of Jilin University
Changchun, 130041
West China Hospital
Chengdu, 610041
Zhongshan Hospital Fudan University
Shanghai, 200032
Shanghai Pulmonary Hospital
Shanghai, 200433
Finland5 sites
HYKS Keuhkosairauksien tutkimusyksikkö
Helsinki, 00290
KYS, Keuhkosairauksien
Kuopio, 70210
Oulun yliopistollinen keskussairaala
Oulu, FIN-90220
Tampere University Hospital
Tampere, 33521
TYKS
Turku, 20520
Germany5 sites
Fachkrankenhaus Coswig GmbH
Coswig, 01640
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, 45239
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
Heidelberg, 69126
Lungenfachklinik Immenhausen
Immenhausen, 34376
Universitätsklinikum Münster
Münster, 48149
Italy4 sites
Ospedale Colonnello D Avanzo
Foggia, 71100
Azienda Ospedaliera Universitaria di Padova
Padova, 35128
Poli Univ A. Gemelli
Roma, 00168
A.O.U. Senese Policlinico Santa Maria alle Scotte
Siena, 53100
Denmark3 sites
Aarhus University Hospital
Aarhus N, 8200
Herlev and Gentofte Hospital
Hellerup, 2900
Odense University Hospital
Odense C, 5000
Greece3 sites
Athens Medical Center
Athens, 15125
University General Hospital of Heraklion
Crete, 71110
Univ. Gen. Hosp. of Patras
Pátrai, 26504
Netherlands3 sites
Zuyderland Medisch Centrum
Heerlen, 6419 PC
St. Antonius ziekenhuis, locatie Nieuwegein
Nieuwegein, 3435 CM
Erasmus Medisch Centrum
Rotterdam, 3015 CE
Russia3 sites
Federal state budgetary scientific institution "Research Institute of occupational medicine named after academician N. F. Izmerov
Moscow, 105275
Moscow 1st State Med.Univ.n.a.I.M.Sechenov
Moscow, 119992
Emergency Clinical Hospital n. a. N. V. Solovyev, Yaroslavl
Yaroslavl, 150003
South Korea3 sites
The Catholic University of Korea, Bucheon St.Mary's Hospital
Bucheon-si, 14647
Seoul National University Hospital
Seoul, 03080
Asan Medical Center
Seoul, 05505
Chile2 sites
Instituto Nacional del Tórax
Providencia, Santiago de Chile, 7500691
Centro de Investigación del Maule
Talca, 3465586
Czechia2 sites
University Hospital Na Bulovce, Prague
Prague, 180 81
University Thomayer's Hospital
Praha 4 - Krc, 140 59
Ukraine2 sites
Dnyepropyetrovsk Medical Academy, Clinical Hospital No. 6
Dnyepropyetrovsk, 49074
Instit.Phthisiology&Pulmon.na Yanovskiy,Non-Specif.Lung,Kyiv
Kyiv, 03680
United Kingdom2 sites
Southmead Hospital
Bristol, BS10 5NB
Royal Brompton Hospital
London, SW3 6NP
Argentina1 site
Centro de Investigaciones Metabólicas (CINME)
C.a.b.a, C1027AAP
About this study
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
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.
Read more
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.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- BI 1015550, Placebo
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 1015550Drug
18 milligram (mg) BI 1015550 taken orally as film-coated tablets (1x 6mg tablet, 1x 12 mg tablet) twice daily (36 mg daily), in the morning and in the evening for 12 weeks.
PlaceboDrug
placebo matching BI 1015550 taken orally as film-coated tablets (matching the respective BI 1015550 tablets) twice daily, in the morning and in the evening for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo, Antifibrotics at baseline | Placebo comparator | Idiopathic pulmonary fibrosis (IPF) patients on stable antifibrotic treatment with nintedanib or pirfenidone at baseline were administered placebo matching BI 1015550 taken orally as film-coated tablets (matching the respective BI 1015550 tablets) twice daily, in the morning and in the evening for 12 weeks. During the 12-weeks of administration of BI 1015550 patients stayed on their stable background therapy of nintedanib or prifenidone. Receives: Drug: Placebo |
| BI 1015550, Antifibrotics at baseline | Experimental | Idiopathic pulmonary fibrosis (IPF) patients on stable antifibrotic treatment with nintedanib or pirfenidone at baseline were administered 18 milligram (mg) BI 1015550 taken orally as film-coated tablets (1x 6mg tablet, 1x 12 mg tablet) twice daily (36 mg daily), in the morning and in the evening for 12 weeks. During the 12-weeks of administration of BI 1015550 patients stayed on their stable background therapy of nintedanib or prifenidone. Receives: Drug: BI 1015550 |
| Placebo, Non-antifibrotics at baseline | Placebo comparator | Idiopathic pulmonary fibrosis (IPF) patients not on stable antifibrotic treatment at baseline were administered placebo matching BI 1015550 taken orally as film-coated tablets (matching the respective BI 1015550 tablets) twice daily, in the morning and in the evening for 12 weeks. Receives: Drug: Placebo |
| BI 1015550, Non-antifibrotics at baseline | Experimental | Idiopathic pulmonary fibrosis (IPF) patients not on stable antifibrotic treatment at baseline were administered 18 milligram (mg) BI 1015550 taken orally as film-coated tablets (1x 6mg tablet, 1x 12 mg tablet) twice daily (36 mg daily), in the morning and in the evening for 12 weeks. Receives: Drug: BI 1015550 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change From Baseline in Forced Vital Capacity (FVC) at 12 Weeks
The change from baseline in Forced vital capacity (FVC) at 12 weeks. Data were analysed with a restricted maximum likelihood (REML)-based approach using a mixed model with repeated measures (MMRM). The analysis included the fixed, categorical effect of treatment at each visit, and the fixed, continuous effects of baseline FVC at each visit. Visit was treated as the repeated measure, with an unstructured covariance structure used to model the within-patient measurements.
Measured: Baseline (day 1) and week 12.
Secondary outcomes (1)
The Number of Patients With Treatment Emergent Adverse Event
The number of patients with any adverse event during the on-treatment period.
Measured: From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start28 Jul 2020
- Primary completion6 Oct 2021
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419506
- Sponsor's protocol ID
- 1305-0013
- Other IDs
- 2019-004167-45, 2019
- Status last verified
- Oct 2022
- First submitted
- 4 Jun 2020
- Last updated
- 1 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to 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 in the website. The data shared are the raw clinical study data sets.
Publications
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.
PubMed 35569036
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04419506
- Acronym / sponsor ID
- 1305-0013
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- 6 Oct 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 5 Jun 2020 (actual)
- Results
- Posted 1 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo, Antifibrotics at baseline | Placebo comparator | Drug: PlaceboIdiopathic pulmonary fibrosis (IPF) patients on stable antifibrotic treatment with nintedanib or pirfenidone at baseline were administered placebo matching BI 1015550 taken orally as film-coated tablets (matching the respective BI 1015550 tablets) twice daily, in the morning and in the evening for 12 weeks. During the 12-weeks of administration of BI 1015550 patients stayed on their stable background therapy of nintedanib or prifenidone. |
| BI 1015550, Antifibrotics at baseline | Experimental | Drug: BI 1015550Idiopathic pulmonary fibrosis (IPF) patients on stable antifibrotic treatment with nintedanib or pirfenidone at baseline were administered 18 milligram (mg) BI 1015550 taken orally as film-coated tablets (1x 6mg tablet, 1x 12 mg tablet) twice daily (36 mg daily), in the morning and in the evening for 12 weeks. During the 12-weeks of administration of BI 1015550 patients stayed on their stable background therapy of nintedanib or prifenidone. |
| Placebo, Non-antifibrotics at baseline | Placebo comparator | Drug: PlaceboIdiopathic pulmonary fibrosis (IPF) patients not on stable antifibrotic treatment at baseline were administered placebo matching BI 1015550 taken orally as film-coated tablets (matching the respective BI 1015550 tablets) twice daily, in the morning and in the evening for 12 weeks. |
| BI 1015550, Non-antifibrotics at baseline | Experimental | Drug: BI 1015550Idiopathic pulmonary fibrosis (IPF) patients not on stable antifibrotic treatment at baseline were administered 18 milligram (mg) BI 1015550 taken orally as film-coated tablets (1x 6mg tablet, 1x 12 mg tablet) twice daily (36 mg daily), in the morning and in the evening for 12 weeks. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients aged ≥40 years when signing the informed consent.
- Diagnosis:
- and
- Stable for at least 8 weeks prior to Visit 1. Patients have to be either :
- [stable therapy is defined as the individually and general tolerated regimen of either pirfenidone or nintedanib]
Key exclusion criteria (10 listed)
- Relevant airways obstruction (pre-bronchodilator Forced Expiratory Volume in one second (FEV1)/Forced Vital Capacity (FVC) < 0.7) at Visit 1.
- In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
- Acute IPF exacerbation within 4 months prior to screening and/or during the screening period (investigator-determined).
- Lower respiratory tract infection requiring antibiotics within 4 weeks prior to Visit 1 and/or during the screening period.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 101555018 milligram (mg) BI 1015550 taken orally as film-coated tablets (1x 6mg tablet, 1x 12 mg tablet) twice daily (36 mg daily), in the morning and in the evening for 12 weeks. | Drug | BI 1015550, Antifibrotics at baseline, BI 1015550, Non-antifibrotics at baseline |
| Placeboplacebo matching BI 1015550 taken orally as film-coated tablets (matching the respective BI 1015550 tablets) twice daily, in the morning and in the evening for 12 weeks. | Drug | Placebo, Antifibrotics at baseline, Placebo, Non-antifibrotics at baseline |
Primary outcome
The Change From Baseline in Forced Vital Capacity (FVC) at 12 Weeks
Time frame: Baseline (day 1) and week 12.
The change from baseline in Forced vital capacity (FVC) at 12 weeks. Data were analysed with a restricted maximum likelihood (REML)-based approach using a mixed model with repeated measures (MMRM). The analysis included the fixed, categorical effect of treatment at each visit, and the fixed, continuous effects of baseline FVC at each visit. Visit was treated as the repeated measure, with an unstructured covariance structure used to model the within-patient measurements.
1 secondary outcome
The Number of Patients With Treatment Emergent Adverse Event
Time frame: From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35569036Richeldi 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to 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 in the website. The data shared are the raw clinical study data sets.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
75 sites in 22 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BI 1015550 in people with Idiopathic Pulmonary Fibrosis, run by Boehringer Ingelheim at 75 sites in 22 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 75 sites in United States, Japan, Spain, Canada, China and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Change From Baseline in Forced Vital Capacity (FVC) at 12 Weeks (time frame: Baseline (day 1) and week 12.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04419506, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.