Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
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
Titles & IDs
Public title
A Study Evaluating the Safety and Efficacy of ENV-101 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Query!
Scientific title
A Phase 2, Multi-Center Study Evaluating the Safety and Efficacy of ENV-101 (Taladegib) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Query!
Secondary ID [1]
0
0
ENV-IPF-101
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis
0
0
Query!
Condition category
Condition code
Respiratory
0
0
0
0
Query!
Other respiratory disorders / diseases
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Connective tissue diseases
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Change from baseline in frequency of adverse events (AEs)
Query!
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.
Query!
Timepoint [1]
0
0
Baseline to Week 18
Query!
Primary outcome [2]
0
0
Change from baseline in severity of AEs
Query!
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.
Query!
Timepoint [2]
0
0
Baseline to Week 18
Query!
Primary outcome [3]
0
0
Change from baseline in vital sign measurements - pulse
Query!
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.
Query!
Timepoint [3]
0
0
Baseline to Week 18
Query!
Primary outcome [4]
0
0
Change from baseline in vital sign measurements - blood pressure
Query!
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.
Query!
Timepoint [4]
0
0
Baseline to Week 18
Query!
Primary outcome [5]
0
0
Change from baseline in vital sign measurements - respiration rate
Query!
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.
Query!
Timepoint [5]
0
0
Baseline to Week 18
Query!
Primary outcome [6]
0
0
Change from baseline in vital sign measurements - temperature
Query!
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.
Query!
Timepoint [6]
0
0
Baseline to Week 18
Query!
Primary outcome [7]
0
0
Change from baseline in blood oxygen saturation level
Query!
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.
Query!
Timepoint [7]
0
0
Baseline to Week 18
Query!
Primary outcome [8]
0
0
Incidence of clinical laboratory abnormalities
Query!
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.
Query!
Timepoint [8]
0
0
Baseline to Week 18
Query!
Primary outcome [9]
0
0
Severity of clinical laboratory abnormalities
Query!
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.
Query!
Timepoint [9]
0
0
Baseline to Week 18
Query!
Primary outcome [10]
0
0
Number of hospitalizations
Query!
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.
Query!
Timepoint [10]
0
0
Baseline to Week 18
Query!
Secondary outcome [1]
0
0
Change from baseline of FVC (forced vital capacity)
Query!
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.
Query!
Timepoint [1]
0
0
Baseline and Week 12
Query!
Secondary outcome [2]
0
0
Change from baseline of DLCO (diffusing capacity of the lungs for carbon monoxide)
Query!
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.
Query!
Timepoint [2]
0
0
Baseline and Week 12
Query!
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)
Query!
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).
Query!
Timepoint [3]
0
0
Baseline and Week 12
Query!
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.
Query!
Minimum age
40
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
26/08/2021
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
30/11/2023
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
41
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Query!
Recruitment hospital [1]
0
0
Research Site - Liverpool
Query!
Recruitment hospital [2]
0
0
Research Site - Benowa
Query!
Recruitment hospital [3]
0
0
Research Site - Box Hill
Query!
Recruitment hospital [4]
0
0
Research Site - Clayton
Query!
Recruitment postcode(s) [1]
0
0
1871 - Liverpool
Query!
Recruitment postcode(s) [2]
0
0
4217 - Benowa
Query!
Recruitment postcode(s) [3]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [4]
0
0
3168 - Clayton
Query!
Recruitment outside Australia
Country [1]
0
0
Canada
Query!
State/province [1]
0
0
British Columbia
Query!
Country [2]
0
0
Canada
Query!
State/province [2]
0
0
Quebec
Query!
Country [3]
0
0
Korea, Republic of
Query!
State/province [3]
0
0
Incheon
Query!
Country [4]
0
0
Korea, Republic of
Query!
State/province [4]
0
0
Seongnam
Query!
Country [5]
0
0
Korea, Republic of
Query!
State/province [5]
0
0
Seoul
Query!
Country [6]
0
0
Malaysia
Query!
State/province [6]
0
0
Batu Caves
Query!
Country [7]
0
0
Malaysia
Query!
State/province [7]
0
0
Kota Bharu
Query!
Country [8]
0
0
Malaysia
Query!
State/province [8]
0
0
Kuala Lumpur
Query!
Country [9]
0
0
Mexico
Query!
State/province [9]
0
0
Nuevo Leon
Query!
Country [10]
0
0
Mexico
Query!
State/province [10]
0
0
Chihuahua
Query!
Country [11]
0
0
Mexico
Query!
State/province [11]
0
0
Mexico City
Query!
Country [12]
0
0
Mexico
Query!
State/province [12]
0
0
Oaxaca
Query!
Country [13]
0
0
Mexico
Query!
State/province [13]
0
0
Puebla
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Endeavor Biomedicines, Inc.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This is a Phase 2, randomized, placebo controlled, multi-center study in subjects with mild to moderate IPF. Eligible subjects will be randomized to receive placebo or ENV-101 as a daily oral dose for 12 consecutive weeks of treatment. Following treatment, subjects will be observed for an additional 6 weeks.
Query!
Trial website
https://clinicaltrials.gov/study/NCT04968574
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Paul Frohna, M.D., Ph.D.
Query!
Address
0
0
Endeavor Biomedicines
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
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