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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04968574




Registration number
NCT04968574
Ethics application status
Date submitted
29/06/2021
Date registered
20/07/2021
Date last updated
2/12/2024

Titles & IDs
Public title
A Study Evaluating the Safety and Efficacy of ENV-101 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Scientific title
A Phase 2, Multi-Center Study Evaluating the Safety and Efficacy of ENV-101 (Taladegib) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Secondary ID [1] 0 0
ENV-IPF-101
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 - taladegib
Treatment: Drugs - placebo

Experimental: ENV-101 - taladegib, 200 mg tablet, once daily for 12 weeks

Placebo comparator: placebo - placebo, tablet, once daily for 12 weeks


Treatment: Drugs: taladegib
hedgehog pathway inhibitor dosed once daily

Treatment: Drugs: placebo
identical tablets to the experimental arm with no active ingredient
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in frequency of adverse events (AEs)
Assessment method [1] 0 0
An AE is any untoward medical occurrence in a study subject administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment under investigation. Frequency of a given AE is determined by dividing the total number of that AE observed during the study by the total number of subjects in the study.
Timepoint [1] 0 0
Baseline to Week 18
Primary outcome [2] 0 0
Change from baseline in severity of AEs
Assessment method [2] 0 0
Severity of AEs are categorized as mild, moderate or severe as described below: * Mild - Events require minimal or no treatment and do not interfere with the subject's daily activities. * Moderate - Events result in a low level of inconvenience or concern with the therapeutic measures. Moderate events may cause some interference with functioning. * Severe - Events interrupt a subject's usual daily activity and may require systemic drug therapy or other treatment. Severe events are usually potentially life-threatening or incapacitating.
Timepoint [2] 0 0
Baseline to Week 18
Primary outcome [3] 0 0
Change from baseline in vital sign measurements - pulse
Assessment method [3] 0 0
Comparison of a subject's pulse rate at the beginning of the study to that subject's pulse rate at the completion of the study.
Timepoint [3] 0 0
Baseline to Week 18
Primary outcome [4] 0 0
Change from baseline in vital sign measurements - blood pressure
Assessment method [4] 0 0
Comparison of a subject's blood pressure at the beginning of the study to that subject's blood pressure at the completion of the study.
Timepoint [4] 0 0
Baseline to Week 18
Primary outcome [5] 0 0
Change from baseline in vital sign measurements - respiration rate
Assessment method [5] 0 0
Comparison of a subject's respiration rate (number of breaths taken per minute while at rest) at the beginning of the study to that subject's respiration rate at the completion of the study.
Timepoint [5] 0 0
Baseline to Week 18
Primary outcome [6] 0 0
Change from baseline in vital sign measurements - temperature
Assessment method [6] 0 0
Comparison of a subject's body temperature at the beginning of the study to that subject's body temperature at the completion of the study.
Timepoint [6] 0 0
Baseline to Week 18
Primary outcome [7] 0 0
Change from baseline in blood oxygen saturation level
Assessment method [7] 0 0
Comparison of a subject's blood oxygen saturation level (measured at rest using a pulse oximeter) at the beginning of the study to that subject's blood oxygen saturation level at the completion of the study.
Timepoint [7] 0 0
Baseline to Week 18
Primary outcome [8] 0 0
Incidence of clinical laboratory abnormalities
Assessment method [8] 0 0
Assessment of the clinical laboratory measurements (chemistry, hematology, urinalysis parameters) that are above or below the laboratory normal ranges. Incidence of clinical laboratory abnormalities is determined by dividing the total number of clinical laboratory abnormalities by the total number of subjects in the study.
Timepoint [8] 0 0
Baseline to Week 18
Primary outcome [9] 0 0
Severity of clinical laboratory abnormalities
Assessment method [9] 0 0
Assessment of the severity (defined as either clinically significant or not clinically significant) for the clinical laboratory abnormalities observed during the study.
Timepoint [9] 0 0
Baseline to Week 18
Primary outcome [10] 0 0
Number of hospitalizations
Assessment method [10] 0 0
Assessment of the number of hospitalizations for any reason observed among all subjects from the beginning of the study to the completion of the study.
Timepoint [10] 0 0
Baseline to Week 18
Secondary outcome [1] 0 0
Change from baseline of FVC (forced vital capacity)
Assessment method [1] 0 0
FVC is the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible, as measured during a spirometry test.
Timepoint [1] 0 0
Baseline and Week 12
Secondary outcome [2] 0 0
Change from baseline of DLCO (diffusing capacity of the lungs for carbon monoxide)
Assessment method [2] 0 0
DLCO is a measurement of the ease of transfer for carbon monoxide molecules from alveolar gas to the hemoglobin of the red blood cells in the pulmonary circulation.
Timepoint [2] 0 0
Baseline and Week 12
Secondary outcome [3] 0 0
Change from baseline of patient reported outcomes by the University of California-San Diego (UCSD) Shortness of Breath Questionnaire (SOBQ)
Assessment method [3] 0 0
The UCSD SOBQ consists of 24 questions (21 assess severity of shortness of breath during specific activities of daily living; 3 additional items ask about limitations due to: shortness of breath, fear of harm from overexertion and fear of shortness of breath). Each question has a 6-point scale (0 = "not at all" to 5 = "maximal or unable to do because of breathlessness"), resulting in a total score ranging from 0 to 120 (a higher score represents a worse outcome).
Timepoint [3] 0 0
Baseline and Week 12

Eligibility
Key inclusion criteria
* IPF diagnosis based upon American Thoracic Association, Japanese Respiratory Society, European Respiratory Society, Latin American Thoracic Association guidelines within the last 7 years. Diagnosis will be confirmed to be consistent with IPF by centrally read high resolution computed tomography (HRCT).
* Ability to successfully perform lung function tests.
* Subjects are willing to remain on study treatment for the duration of the study.
* Subjects have a full understanding of the informed consent.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Evidence of other known causes of interstitial lung disease (ILD) (e.g., domestic, and occupational environmental exposures, connective tissue disease [CTD], and drug toxicity), lung transplant expected within 12 months of screening or evidence of clinically significant lung disease other than IPF including but not limited to asthma, chronic obstructive pulmonary disease (COPD), uncontrolled pulmonary hypertension and emphysema where computed tomography (CT)-assessed extent of emphysema is greater than extent of fibrosis.
* History of malignancy, including carcinoma during the preceding 5 years. With the following exceptions:

1. Prior history of in situ basal or squamous cell skin cancer that was successfully treated with curative therapies.
2. Subjects with other malignancies if they have been continuously disease free for at least 5 years prior to study start.
3. Subjects with prostate cancer that are managed by surveillance are also eligible.
* Current use of supplemental oxygen for any condition unless prior approval is received from the Sponsor.
* Smoking within 6 months of study start, current smoker, or unwillingness to refrain from smoking during the clinical trial duration.
* Presence of active infection at study start or confirmed active human immunodeficiency virus (HIV), Hepatitis B virus (HBV) or Hepatitis C virus (HCV).
* Occurrence of serious illness requiring hospitalization within 90 days prior to study start.
* Current or previous use (within 30 days prior to study start) of the following:

1. N-acetylcysteine
2. endothelin receptor antagonist
3. riociguat
4. prostacyclin or prostacyclin analogue
5. Warfarin for IPF
6. Cytotoxic agents (e.g., colchicine if used for IPF)
7. Radiation to the lungs
8. Pulmonary rehabilitation
9. Investigational agent for IPF
10. Immunosuppressive medications (e.g., methotrexate, azathioprine)
11. Systemic or inhaled glucocorticosteroids
12. Antifibrotic therapy (e.g., nintedanib, pirfenidone)
* Regular use of phosphodiesterase type-5 inhibitor, occasional use for erectile dysfunction will be allowed.
* Use of drugs that are known moderate or stronger CYP3A4 inhibitors or inducers within 12 days prior to study start.
* Males and females of reproductive potential who are sexually active and unwilling to use birth control for the duration of the study and for 3 months after their final dose.
* Females that are pregnant or nursing.
* Females and males that are unwilling to refrain from blood or blood product donation for the duration of the study and for 30 days after their final study dose.
* Males who are unwilling to refrain from sperm donation and females who are unwilling to refrain from egg donation for the duration of the study and for 3 months after their final study dose.
* Subjects with a history of a severe allergic reaction or anaphylactic reaction or known hypersensitivity to any component of ENV-101.
* Subjects who are immediate family members (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study investigative site or the study Sponsor.

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/11/2023
Sample size
Target
Accrual to date
Final
41
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Research Site - Liverpool
Recruitment hospital [2] 0 0
Research Site - Benowa
Recruitment hospital [3] 0 0
Research Site - Box Hill
Recruitment hospital [4] 0 0
Research Site - Clayton
Recruitment postcode(s) [1] 0 0
1871 - Liverpool
Recruitment postcode(s) [2] 0 0
4217 - Benowa
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
British Columbia
Country [2] 0 0
Canada
State/province [2] 0 0
Quebec
Country [3] 0 0
Korea, Republic of
State/province [3] 0 0
Incheon
Country [4] 0 0
Korea, Republic of
State/province [4] 0 0
Seongnam
Country [5] 0 0
Korea, Republic of
State/province [5] 0 0
Seoul
Country [6] 0 0
Malaysia
State/province [6] 0 0
Batu Caves
Country [7] 0 0
Malaysia
State/province [7] 0 0
Kota Bharu
Country [8] 0 0
Malaysia
State/province [8] 0 0
Kuala Lumpur
Country [9] 0 0
Mexico
State/province [9] 0 0
Nuevo Leon
Country [10] 0 0
Mexico
State/province [10] 0 0
Chihuahua
Country [11] 0 0
Mexico
State/province [11] 0 0
Mexico City
Country [12] 0 0
Mexico
State/province [12] 0 0
Oaxaca
Country [13] 0 0
Mexico
State/province [13] 0 0
Puebla

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Endeavor Biomedicines, Inc.
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
John Huetsch, M.D.
Address 0 0
Endeavor Biomedicines
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


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/NCT04968574