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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06588686


Additional trial details provided through ANZCTR are available at the end of this record.


Registration number
NCT06588686
Ethics application status
Date submitted
6/09/2024
Date registered
19/09/2024
Date last updated
19/12/2024

Titles & IDs
Public title
A Trial to Evaluate Efficacy and Safety of Buloxibutid in People with Idiopathic Pulmonary Fibrosis.
Scientific title
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Trial Evaluating the Efficacy and Safety of 2 Doses of Buloxibutid Over 52 Weeks in People with Idiopathic Pulmonary Fibrosis.
Secondary ID [1] 0 0
VP-C21-011
Universal Trial Number (UTN)
Trial acronym
ASPIRE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis (IPF) 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Buloxibutid
Treatment: Drugs - Placebo

Experimental: Buloxibutid 100 mg BID - For 52 weeks.

Experimental: Buloxibutid 50 mg BID - For 52 weeks.

Placebo comparator: Placebo BID - For 52 weeks.


Treatment: Drugs: Buloxibutid
Buloxibutid

Treatment: Drugs: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the efficacy of buloxibutid compared to placebo in participants with IPF as assessed by FVC
Timepoint [1] 0 0
week 52
Secondary outcome [1] 0 0
To further evaluate the effects of buloxibutid on disease progression, respiratory-related hospitalization or death compared to placebo in participants with IPF
Timepoint [1] 0 0
week 52

Eligibility
Key inclusion criteria
Inclusion Criteria

1. Age = 40 years at the time of signing the informed consent.
2. Diagnosed with IPF within 5 years prior to visit 1, as per ATS/ERS/JRS/ALAT 2022 guidelines (Raghu et al., 2022).
3. HRCT scan within 36 months prior to visit 1 with central reading confirming either a or b, and c

1. A pattern consistent with usual interstitial pneumonia (UIP) according to ATS/ERS/JRS/ALAT 2022 guideline (Raghu et al., 2022) UIP or probable UIP.
2. A pattern indeterminate for UIP according to ATS/ERS/JRS/ALAT 2022 guidelines (Raghu et al., 2022) and a historical biopsy (surgical lung biopsy or transbronchial lung cryobiopsy) consistent with IPF.
3. Extent of fibrosis > extent of emphysema.
4. FVC =50% predicted at visit 1 and visit 2.
5. DLCO (corrected for hemoglobin) =35% predicted at visit 1.
6. Either:

1. On a stable dose of licensed IPF therapy for at least 8 weeks prior to visit 1 and expected to remain on this background treatment after randomization. Due to the risk of DDIs, concomitant treatment with pirfenidone is not allowed in this trial.
2. Not currently receiving treatment for IPF with a licensed therapy for any reason, including prior intolerance, non-responsiveness, ineligibility, lack of access or voluntarily decline. Any such previous treatment must have been discontinued >8 weeks prior to visit 1.
7. Anticipated life expectancy of at least 12 months at visit 1 and not anticipated to require a lung transplant during the trial period (being on a transplant list does not exclude a participant from the trial).
8. Contraceptive use by women of childbearing potential (WOCBP) which is highly effective and consistent with local regulations regarding the methods of contraception for those participating in clinical trials.
9. Written informed consent, consistent with ICH-GCP and local laws, obtained before the initiation of any trial-related procedure.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

Participants are excluded from the trial if any of the following criteria apply:

1. Concurrent serious medical condition that in the opinion of the investigator constitutes a risk or a contraindication for participation in the trial or that could interfere with the trial objectives, conduct or evaluation, including active or suspected malignancy or history of malignancy within 5 years prior to visit 1, except appropriately treated basal cell carcinoma of the skin, fully resected and cured squamous cell carcinoma of the skin, "under surveillance" prostate cancer or in situ carcinoma of uterine cervix.
2. Airways obstruction with a pre-bronchodilator forced expiratory volume in one second (FEV1)/FVC ratio <0.7 at visit 1 or visit 2.
3. Lower respiratory tract infection requiring antibiotics and not fully recovered according to investigator judgement within 4 weeks prior to visit 2.
4. Confirmed infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) requiring hospitalization and not fully recovered according to investigator judgement within 4 weeks prior to visit 2.
5. Known impaired hepatic function or clinically significant liver disease (Child-Pugh B or C hepatic impairment), or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 times upper limit of normal (ULN) or total bilirubin >1.5 times ULN at visit 1.
6. Severe renal impairment (i.e., estimated glomerular filtration rate (eGFR) =35 ml/min/1.73 m2 at visit 1 according to Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula).
7. Prolonged QTcF (QT interval with Fridericia's correction) (>450 ms), AV-block II or III, uncontrolled arrhythmia, or other clinically significant abnormality in the resting ECG at visit 1, as judged by the investigator.
8. Heart failure NYHA Class IV, acutely decompensated right heart failure, PH with syncopal episode, confirmed myocardial infarction, unstable angina or uncontrolled hypertension, within 6 months prior to visit 1.
9. Known hypersensitivity or intolerance to buloxibutid or to any other components of the test product, including excipients.
10. Pregnant or breast-feeding female participants.
11. Acute IPF exacerbation within 3 months prior to visit 1 and/or during the screening period, as defined by Collard et al., 2016:

1. Acute worsening or development of dyspnea typically <1 month duration.
2. Computed tomography with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with usual interstitial pneumonia pattern (if no previous computed tomography is available, the qualifier "new" can be dropped).
3. Deterioration not fully explained by cardiac failure or fluid overload.
12. Inability to generate spirometry data at least twice at visit 1 or visit 2 meeting the minimum standards of the ATS/ERS 2019 guideline (Graham et al., 2019).
13. Treatment with pirfenidone within 8 weeks prior to visit 1 or anticipated need for pirfenidone during participation in the trial.

More exclusion criteria may apply.

Trial website: www.aspire-ipf.com

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/12/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2027
Actual
Sample size
Target
270
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders Medical Centre - Adelaide
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital, Department of Respiratory Medicine - Concord
Recruitment hospital [3] 0 0
St Vincent's Hospital, Sydney Ltd. - Darlinghurst
Recruitment hospital [4] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [5] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [6] 0 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 0 0
5042 - Adelaide
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
NSW 2010 - Darlinghurst
Recruitment postcode(s) [4] 0 0
VIC 3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
NSW 2050 - Sydney
Recruitment postcode(s) [6] 0 0
SA 5011 - Woodville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
South Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Utah
Country [17] 0 0
United States of America
State/province [17] 0 0
Wisconsin
Country [18] 0 0
Argentina
State/province [18] 0 0
Cordoba
Country [19] 0 0
Argentina
State/province [19] 0 0
Tucuman
Country [20] 0 0
Argentina
State/province [20] 0 0
Buenos Aires
Country [21] 0 0
Argentina
State/province [21] 0 0
Godoy Cruz
Country [22] 0 0
Argentina
State/province [22] 0 0
Mar Del Plata
Country [23] 0 0
Argentina
State/province [23] 0 0
Mendoza
Country [24] 0 0
Austria
State/province [24] 0 0
Linz
Country [25] 0 0
Austria
State/province [25] 0 0
Salzburg
Country [26] 0 0
Austria
State/province [26] 0 0
Vienna
Country [27] 0 0
Belgium
State/province [27] 0 0
Brussels
Country [28] 0 0
Belgium
State/province [28] 0 0
Liège
Country [29] 0 0
Belgium
State/province [29] 0 0
Yvoir
Country [30] 0 0
Canada
State/province [30] 0 0
Trois-Rivieres
Country [31] 0 0
Germany
State/province [31] 0 0
Berlin
Country [32] 0 0
Germany
State/province [32] 0 0
Essen
Country [33] 0 0
Germany
State/province [33] 0 0
Freiburg
Country [34] 0 0
Germany
State/province [34] 0 0
Hannover
Country [35] 0 0
Germany
State/province [35] 0 0
Heidelberg
Country [36] 0 0
Germany
State/province [36] 0 0
Immenhausen
Country [37] 0 0
Germany
State/province [37] 0 0
Tuebingen
Country [38] 0 0
Greece
State/province [38] 0 0
Athens
Country [39] 0 0
Greece
State/province [39] 0 0
Heraklion
Country [40] 0 0
Greece
State/province [40] 0 0
Ioánnina
Country [41] 0 0
Greece
State/province [41] 0 0
Patras
Country [42] 0 0
Italy
State/province [42] 0 0
Ancona
Country [43] 0 0
Italy
State/province [43] 0 0
Bergamo
Country [44] 0 0
Italy
State/province [44] 0 0
Modena
Country [45] 0 0
Italy
State/province [45] 0 0
Monza
Country [46] 0 0
Italy
State/province [46] 0 0
Roma
Country [47] 0 0
Italy
State/province [47] 0 0
Turin
Country [48] 0 0
Korea, Republic of
State/province [48] 0 0
Bucheon
Country [49] 0 0
Korea, Republic of
State/province [49] 0 0
Busan
Country [50] 0 0
Korea, Republic of
State/province [50] 0 0
Goyang-si
Country [51] 0 0
Korea, Republic of
State/province [51] 0 0
Seoul
Country [52] 0 0
Mexico
State/province [52] 0 0
Mexico City
Country [53] 0 0
Mexico
State/province [53] 0 0
Monterrey
Country [54] 0 0
Mexico
State/province [54] 0 0
Oaxaca
Country [55] 0 0
Mexico
State/province [55] 0 0
San Nicolás De Los Garza
Country [56] 0 0
Poland
State/province [56] 0 0
Bydgoszcz
Country [57] 0 0
Poland
State/province [57] 0 0
Nowa Sól
Country [58] 0 0
Poland
State/province [58] 0 0
Swidnik
Country [59] 0 0
Taiwan
State/province [59] 0 0
Kaohsiung
Country [60] 0 0
Taiwan
State/province [60] 0 0
New Taipei City
Country [61] 0 0
Taiwan
State/province [61] 0 0
Taichung
Country [62] 0 0
Taiwan
State/province [62] 0 0
Tainan
Country [63] 0 0
Taiwan
State/province [63] 0 0
Taipei
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Birmingham
Country [65] 0 0
United Kingdom
State/province [65] 0 0
London
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Manchester
Country [67] 0 0
United Kingdom
State/province [67] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Vicore Pharma AB
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Population Services International
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Cecilia Ganslandt, MD
Address 0 0
Vicore Pharma AB
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Thomas Eskildsen, MSc. Pharm.
Address 0 0
Country 0 0
Phone 0 0
+ 46 317880560
Fax 0 0
Email 0 0
info@aspire-ipf.com
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06588686

Additional trial details provided through ANZCTR
Accrual to date
Recruiting in Australia
Recruitment state(s)
NSW
Funding & Sponsors
Primary sponsor
Primary sponsor name
Primary sponsor address
Primary sponsor country
Ethics approval
Ethics application status
Approved
Ethics committee name [1] 84
St Vincent's Hospital (Melbourne)
Address [1] 84
41 Victoria Parade, Fitzroy, VIC 3065
Country [1] 84
Australia
Date submitted for ethics approval [1] 84
06/08/2024
Approval date [1] 84
10/09/2024
Ethics approval number [1] 84
HREC Ref: 184/24
 
Public notes

Contacts
Principal investigator
Title 477 0
Dr
Name 477 0
Claire Thomson
Address 477 0
390 Victoria Street, Darlinghurst, NSW 2010
Country 477 0
Australia
Phone 477 0
+61 (0)430 025909
Fax 477 0
Email 477 0
claire.thomson@svha.org.au
Contact person for public queries
Title 478 0
Dr
Name 478 0
Claire Thomson
Address 478 0
390 Victoria Street, Darlinghurst, NSW 2010
Country 478 0
Australia
Phone 478 0
+61 (0)430 025909
Fax 478 0
Email 478 0
claire.thomson@svha.org.au
Contact person for scientific queries
Title 479 0
Dr
Name 479 0
Claire Thomson
Address 479 0
390 Victoria Street, Darlinghurst, NSW 2010
Country 479 0
Australia
Phone 479 0
+61 (0)430 025909
Fax 479 0
Email 479 0
claire.thomson@svha.org.au