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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05483907




Registration number
NCT05483907
Ethics application status
Date submitted
27/07/2022
Date registered
2/08/2022
Date last updated
13/08/2024

Titles & IDs
Public title
To Evaluate the Efficacy, Safety, and Tolerability of BBT-877 in Patients With IPF
Scientific title
A Phase 2, Randomized, Double-blind, Placebo-controlled, 24-Week Study to Evaluate the Efficacy, Safety, and Tolerability of BBT-877, as Mono- or add-on Therapy, in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Secondary ID [1] 0 0
BBT877-IPF-004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis 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 - BBT-877
Treatment: Drugs - Placebo

Experimental: BBT-877 - 200 mg twice daily (BID)of BBT-877 in patients with IPF, with or without AF approved background therapies (pirfenidone or nintedanib).

Placebo comparator: Placebo - 200 mg twice daily (BID)of Placebo in patients with IPF, with or without AF approved background therapies (pirfenidone or nintedanib).


Treatment: Drugs: BBT-877
BBT-877 24 weeks + Follow-up 4 weeks

Treatment: Drugs: Placebo
Placebo 24 weeks + Follow-up 4 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
In patients with IPF by measuring the reduction in forced vital capacity (FVC) in mL decline compared to placebo
Timepoint [1] 0 0
After 24 weeks of treatment
Secondary outcome [1] 0 0
In patients with IPF by measuring the reduction in forced vital capacity (FVC) % predicted decline compared to placebo
Timepoint [1] 0 0
After 24 weeks of treatment
Secondary outcome [2] 0 0
To evaluate the effect of on diffusing capacity of lung for carbon monoxide (DLCO) of BBT-877 compared to placebo
Timepoint [2] 0 0
After 24 weeks of treatment
Secondary outcome [3] 0 0
To evaluate the effect on functional exercise capacity (measured by the 6-Minute Walk Test [6MWT]) of BBT-877 compared to placebo
Timepoint [3] 0 0
After 24 weeks of treatment
Secondary outcome [4] 0 0
To assess the change in IPF impacts from the patient perspective after 24 weeks of treatment of BBT-877 compared to placebo
Timepoint [4] 0 0
after 24 weeks of treatment
Secondary outcome [5] 0 0
To assess the change in IPF symptoms from the patient perspective after 24 weeks of treatment of BBT-877 compared to placebo
Timepoint [5] 0 0
after 24 weeks of treatment
Secondary outcome [6] 0 0
To evaluate potential effect of BBT-877 on pharmacokinetics (PK)of each antifibrotic(AF)in patients with IPF
Timepoint [6] 0 0
0, 4, 12, 24 weeks of treatment
Secondary outcome [7] 0 0
To evaluate the potential effect of each AF on PK of BBT-877 in patients with IPF
Timepoint [7] 0 0
0, 4, 12, 24 weeks of treatment
Secondary outcome [8] 0 0
To assess the safety of BBT-877 compared to placebo
Timepoint [8] 0 0
over 24 weeks

Eligibility
Key inclusion criteria
* Male patients who have completed family planning or female patient, aged 40 years or older
* Diagnosis of IPF in accordance with American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines for diagnosis in effect at the time of screening
* Chest high-resolution computed tomography (HRCT) performed according to ATS guidelines within 12 months prior to screening and according to minimum requirements for IPF diagnosis by central review based on HRCT and lung biopsy. If no historical acceptable HRCT is available prior to screening, an HRCT can be performed during screening. In both cases, a central reading of the HRCT has to be done as well as a review of lung biopsy slides, if available and potentially supportive for diagnosis.
* Able to walk at least 150 meters during the 6MWT at screening
* Resting oxygen saturation of =89% using a maximum of 6 L/min of supplemental oxygen at sea level, and up to 8 L/min at altitude during screening
* FVC =45% predicted of normal
* Ratio of forced expiratory volume in the first second (FEV1) to FVC =0.7
* Diffusing capacity for the DLCO corrected for hemoglobin =30% predicted of normal
* Absence of IPF improvement in the past year, as determined by the investigator
* Patients receiving either pirfenidone or nintedanib, should be on it for at least 3 months and with a stable dose in the 4 weeks prior to screening, OR taking neither pirfenidone
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Unable to perform spirometry as per ATS
* Evidence of IPF exacerbation within 3 months prior to and/or during screening
* Evidence of emphysema extent greater than the extent of fibrosis
* Current smoker (tobacco, e-cigarette)
* History of lung transplant or lung volume reduction surgery
* Current immunosuppressive condition
* Estimated life expectancy of less than 12 months or 30 months in the opinion of the investigator
* Congestive heart failure class III or IV according to New-York Heart Association classification
* Pulmonary hypertension (PH) requiring PH specific therapy
* Unstable cardiovascular, pulmonary or other disease within 6 months prior to screening or during the screening period
* Use of other medications likely to interfere with study assessments
* Any other current or prior medical condition, medical or surgical therapies, or clinical trial participation expected to interfere with the conduct of the study or the evaluation of its results

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 administering 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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
Accrual to date
Final
129
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Royal Brisbane & Women's Hospital - Herston
Recruitment hospital [3] 0 0
Institute for Respiratory Health - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4006 - Herston
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
South Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
Israel
State/province [11] 0 0
HaDarom
Country [12] 0 0
Israel
State/province [12] 0 0
HaMerkaz
Country [13] 0 0
Israel
State/province [13] 0 0
Tel-Aviv
Country [14] 0 0
Israel
State/province [14] 0 0
Yerushalayim
Country [15] 0 0
Israel
State/province [15] 0 0
Haifa
Country [16] 0 0
Israel
State/province [16] 0 0
Petah Tikva
Country [17] 0 0
Israel
State/province [17] 0 0
Petah tikva
Country [18] 0 0
Israel
State/province [18] 0 0
Re?ovot
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Chungcheongnam-do
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Gangnam-gu
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Gyeonggi-do
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Gyeonggido
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Gyeongsangnamdo
Country [24] 0 0
Korea, Republic of
State/province [24] 0 0
Incheon
Country [25] 0 0
Korea, Republic of
State/province [25] 0 0
Seongbuk-gu
Country [26] 0 0
Korea, Republic of
State/province [26] 0 0
Seoul
Country [27] 0 0
Korea, Republic of
State/province [27] 0 0
Songpa-gu
Country [28] 0 0
Korea, Republic of
State/province [28] 0 0
Busan
Country [29] 0 0
Poland
State/province [29] 0 0
Slaskie
Country [30] 0 0
Poland
State/province [30] 0 0
Bydgoszcz

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bridge Biotherapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Bridge Biotherapeutics, Inc.
Address 0 0
Country 0 0
Phone 0 0
+82-31-8092-3280
Fax 0 0
Email 0 0
[email protected]
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/NCT05483907