Idiopathic Pulmonary FibrosisPhase 2NCT04968574
A Study Evaluating the Safety and Efficacy of ENV-101 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
A Phase 2 study testing taladegib in people with Idiopathic Pulmonary Fibrosis, run by Endeavor Biomedicines, Inc. at 24 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- taladegib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 24 sitesin 5 countries
- Study dates
- 26 Aug 2021to 30 Nov 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
- Prior history of in situ basal or squamous cell skin cancer that was successfully treated with curative therapies.
- Subjects with other malignancies if they have been continuously disease free for at least 5 years prior to study start.
- 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.
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- 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:
- N-acetylcysteine
- endothelin receptor antagonist
- riociguat
- prostacyclin or prostacyclin analogue
- Warfarin for IPF
- Cytotoxic agents (e.g., colchicine if used for IPF)
- Radiation to the lungs
- Pulmonary rehabilitation
- Investigational agent for IPF
- Immunosuppressive medications (e.g., methotrexate, azathioprine)
- Systemic or inhaled glucocorticosteroids
- 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.
Trial locations and contacts
24 sites in 5 countries.
24 sites in 5 countries
Mexico8 sites
Research Site
Chihuahua City, 31203
Research Site
Mexico City, 03100
Research Site
Mexico City, 14080
Research Site
Monterrey, Nuevo León, 64060
Research Site
Monterrey, Nuevo León, 64718
Research Site
Oaxaca City, 68000
Research Site
Puebla City, 72180
Research Site
San Nicolás de los Garza, Nuevo León, 66465
Malaysia5 sites
Research Site
Batu Caves, 68100
Research Site
Kota Bharu, 15200
Research Site
Kuala Lumpur, 53000
Research Sire
Kuala Lumpur, 56000
Research Site
Kuala Lumpur, 59100
South Korea5 sites
Research Site (Namdong District)
Incheon
Research Site (Bundang District)
Seongnam
Research Site (Gangnam District)
Seoul
Research Site (Seongbuk District)
Seoul
Research Site (Songpa District)
Seoul
Australia4 sites
Research Site
Benowa, Queensland, 4217
Research Site
Box Hill, Victoria, 3128
Research Site
Clayton, Victoria, 3168
Research Site
Liverpool, New South Wales, 1871
Canada2 sites
Research Site
Sherbrooke, Quebec, J1H 5N4
Research Site
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: A Phase 2, Multi-Center Study Evaluating the Safety and Efficacy of ENV-101 (Taladegib) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
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.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- taladegib, placebo
- Keywords
- hedgehog, smoothened, pulmonary fibrosis
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taladegibDrug
hedgehog pathway inhibitor dosed once daily
placeboDrug
identical tablets to the experimental arm with no active ingredient
| Study group | Role | What they receive |
|---|---|---|
| ENV-101 | Experimental | taladegib, 200 mg tablet, once daily for 12 weeks Receives: Drug: taladegib |
| placebo | Placebo comparator | placebo, tablet, once daily for 12 weeks Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in frequency of adverse events (AEs)
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.
Measured: Baseline to Week 18
Change from baseline in severity of AEs
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.
Measured: Baseline to Week 18
Change from baseline in vital sign measurements - pulse
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.
Measured: Baseline to Week 18
Change from baseline in vital sign measurements - blood pressure
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.
Measured: Baseline to Week 18
Change from baseline in vital sign measurements - respiration rate
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.
Measured: Baseline to Week 18
Change from baseline in vital sign measurements - temperature
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.
Measured: Baseline to Week 18
Change from baseline in blood oxygen saturation level
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.
Measured: Baseline to Week 18
Incidence of clinical laboratory abnormalities
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.
Measured: Baseline to Week 18
Severity of clinical laboratory abnormalities
Assessment of the severity (defined as either clinically significant or not clinically significant) for the clinical laboratory abnormalities observed during the study.
Measured: Baseline to Week 18
Number of hospitalizations
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.
Measured: Baseline to Week 18
Secondary outcomes (3)
Change from baseline of FVC (forced vital capacity)
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.
Measured: Baseline and Week 12
Change from baseline of DLCO (diffusing capacity of the lungs for carbon monoxide)
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.
Measured: Baseline and Week 12
Change from baseline of patient reported outcomes by the University of California-San Diego (UCSD) Shortness of Breath Questionnaire (SOBQ)
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).
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start26 Aug 2021
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Biomedicines, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Huetsch, M.D., Study director, Endeavor Biomedicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968574
- Sponsor's protocol ID
- ENV-IPF-101
- Status last verified
- Nov 2024
- First submitted
- 29 Jun 2021
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maher TM, Goldin JG, Hood J, Pitman J, de Los Rios M, Hobbs BP, Yu-Lin AB, Buendia-Roldan I, Thien F, Song JW, Perea PC, Ramirez-Rivera A, DiFrancesco A. Taladegib for the treatment of idiopathic pulmonary fibrosis (ENV-IPF-101): a multicentre, randomised, double-blind, placebo-controlled, phase 2a trial. Lancet Respir Med. 2025 Nov;13(11):1001-1010. doi: 10.1016/S2213-2600(25)00239-5. Epub 2025 Sep 30.
PubMed 41043447
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multi-Center Study Evaluating the Safety and Efficacy of ENV-101 (Taladegib) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
- ClinicalTrials.gov ID
- NCT04968574
- Acronym / sponsor ID
- ENV-IPF-101
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- hedgehog, smoothened, pulmonary fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Endeavor Biomedicines, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Aug 2021 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 20 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ENV-101 | Experimental | Drug: taladegibtaladegib, 200 mg tablet, once daily for 12 weeks |
| placebo | Placebo comparator | Drug: placeboplacebo, tablet, once daily for 12 weeks |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (30 listed)
- 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:
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| taladegibhedgehog pathway inhibitor dosed once daily | Drug | ENV-101 |
| placeboidentical tablets to the experimental arm with no active ingredient | Drug | placebo |
Primary outcome
Change from baseline in frequency of adverse events (AEs)
Time frame: Baseline to Week 18
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.
Change from baseline in severity of AEs
Time frame: Baseline to Week 18
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.
Change from baseline in vital sign measurements - pulse
Time frame: Baseline to Week 18
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.
Change from baseline in vital sign measurements - blood pressure
Time frame: Baseline to Week 18
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.
Change from baseline in vital sign measurements - respiration rate
Time frame: Baseline to Week 18
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.
Change from baseline in vital sign measurements - temperature
Time frame: Baseline to Week 18
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.
Change from baseline in blood oxygen saturation level
Time frame: Baseline to Week 18
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.
Incidence of clinical laboratory abnormalities
Time frame: Baseline to Week 18
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.
Severity of clinical laboratory abnormalities
Time frame: Baseline to Week 18
Assessment of the severity (defined as either clinically significant or not clinically significant) for the clinical laboratory abnormalities observed during the study.
Number of hospitalizations
Time frame: Baseline to Week 18
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.
3 secondary outcomes
Change from baseline of FVC (forced vital capacity)
Time frame: Baseline and Week 12
Change from baseline of DLCO (diffusing capacity of the lungs for carbon monoxide)
Time frame: Baseline and Week 12
Change from baseline of patient reported outcomes by the University of California-San Diego (UCSD) Shortness of Breath Questionnaire (SOBQ)
Time frame: Baseline and Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Derived from this study: PubMed 41043447Maher TM, Goldin JG, Hood J, Pitman J, de Los Rios M, Hobbs BP, Yu-Lin AB, Buendia-Roldan I, Thien F, Song JW, Perea PC, Ramirez-Rivera A, DiFrancesco A. Taladegib for the treatment of idiopathic pulmonary fibrosis (ENV-IPF-101): a multicentre, randomised, double-blind, placebo-controlled, phase 2a trial. Lancet Respir Med. 2025 Nov;13(11):1001-1010. doi: 10.1016/S2213-2600(25)00239-5. Epub 2025 Sep 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Huetsch, M.D. study director
Endeavor Biomedicines
24 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing taladegib in people with Idiopathic Pulmonary Fibrosis, run by Endeavor Biomedicines, Inc. at 24 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Mexico, Malaysia, South Korea, Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in frequency of adverse events (AEs) (time frame: Baseline to Week 18). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04968574, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.