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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
23/02/2024

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)
Timepoint [1] 0 0
Baseline to Week 18
Primary outcome [2] 0 0
Change from baseline in severity of AEs
Timepoint [2] 0 0
Baseline to Week 18
Primary outcome [3] 0 0
Change from baseline in vital sign measurements - pulse
Timepoint [3] 0 0
Baseline to Week 18
Primary outcome [4] 0 0
Change from baseline in vital sign measurements - blood pressure
Timepoint [4] 0 0
Baseline to Week 18
Primary outcome [5] 0 0
Change from baseline in vital sign measurements - respiration rate
Timepoint [5] 0 0
Baseline to Week 18
Primary outcome [6] 0 0
Change from baseline in vital sign measurements - temperature
Timepoint [6] 0 0
Baseline to Week 18
Primary outcome [7] 0 0
Change from baseline in blood oxygen saturation level
Timepoint [7] 0 0
Baseline to Week 18
Primary outcome [8] 0 0
Incidence of clinical laboratory abnormalities
Timepoint [8] 0 0
Baseline to Week 18
Primary outcome [9] 0 0
Severity of clinical laboratory abnormalities
Timepoint [9] 0 0
Baseline to Week 18
Primary outcome [10] 0 0
Number of hospitalizations
Timepoint [10] 0 0
Baseline to Week 18
Secondary outcome [1] 0 0
Change from baseline of FVC (forced vital capacity)
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)
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)
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.
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT04968574
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul Frohna, M.D., Ph.D.
Address 0 0
Endeavor Biomedicines
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04968574