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A Study Evaluating the Safety and Efficacy of ENV-101 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

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 evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04968574
Recruitment Status : Recruiting
First Posted : July 20, 2021
Last Update Posted : July 7, 2023
Sponsor:
Information provided by (Responsible Party):
Endeavor Biomedicines, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: taladegib Drug: placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Multi-Center Study Evaluating the Safety and Efficacy of ENV-101 (Taladegib) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Actual Study Start Date : August 26, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ENV-101
taladegib, 200 mg tablet, once daily for 12 weeks
 Drug: taladegib
hedgehog pathway inhibitor dosed once daily
Placebo Comparator: placebo
placebo, tablet, once daily for 12 weeks
 Drug: placebo
identical tablets to the experimental arm with no active ingredient


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.


Secondary Outcome Measures :
  1. Change from baseline of FVC (forced vital capacity) [ Time Frame: Baseline and Week 12 ]
    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.

  2. Change from baseline of DLCO (diffusing capacity of the lungs for carbon monoxide) [ Time Frame: Baseline and Week 12 ]
    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.

  3. 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 ]
    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).


Other Outcome Measures:
  1. Change from baseline of FVC [ Time Frame: Baseline and Week 6 ]
  2. Change from baseline of FVC [ Time Frame: Baseline and Week 18 ]
  3. Change from baseline of DLCO [ Time Frame: Baseline and Week 6 ]
  4. Change from baseline of DLCO [ Time Frame: Baseline and Week 18 ]
  5. Change from baseline of patient reported outcomes by the UCSD SOBQ [ Time Frame: Baseline and Week 6 ]
  6. Change from baseline of patient reported outcomes by the UCSD SOBQ [ Time Frame: Baseline and Week 18 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04968574


Contacts
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Contact: Endeavor Clinical Trials 1-858-727-3199 ebmclinical@endeavorbiomedicines.com

Locations
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Australia, New South Wales
Research Site Recruiting
Liverpool, New South Wales, Australia, 1871
Contact: Endeavor Clinical Trials    1-858-727-3199    ebmclinical@endeavorbiomedicines.com   
Australia, Queensland
Research Site Recruiting
Benowa, Queensland, Australia, 4217
Contact: Endeavor Clinical Trials    1-858-727-3199    ebmclinical@endeavorbiomedicines.com   
Australia, Victoria
Research Site Recruiting
Box Hill, Victoria, Australia, 3128
Contact: Endeavor Clinical Trials    1-858-727-3199    ebmclinical@endeavorbiomedicines.com   
Research Site Recruiting
Clayton, Victoria, Australia, 3168
Contact: Endeavor Clinical Trials    1-858-727-3199    ebmclinical@endeavorbiomedicines.com   
Canada, British Columbia
Research Site Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Endeavor Clinical Trials    1-858-727-3199    ebmclinical@endeavorbiomedicines.com   
Canada, Quebec
Research Site Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Endeavor Clinical Trials    1-858-727-3199    ebmclinical@endeavorbiomedicines.com   
Korea, Republic of
Research Site (Namdong District) Recruiting
Incheon, Korea, Republic of
Contact: Endeavor Clinical Trials    1-858-727-3199    ebmclinical@endeavorbiomedicines.com   
Research Site (Bundang District) Recruiting
Seongnam, Korea, Republic of
Contact: Endeavor Clinical Trials    1-858-727-3199    ebmlinical@endeavorbiomedicines.com   
Research Site (Gangnam District) Recruiting
Seoul, Korea, Republic of
Contact: Endeavor Clinical Trials    1-858-727-3199    ebmclinical@endeavorbiomedicines.com   
Research Site (Seongbuk District) Recruiting
Seoul, Korea, Republic of
Contact: Endeavor Clinical Trials    1-858-727-3199    ebmclinical@endeavorbiomedicines.com   
Research Site (Songpa District) Recruiting
Seoul, Korea, Republic of
Contact: Endeavor Clinical Trials    1-858-727-3199    ebmclinical@endeavorbiomedicines.com   
Malaysia
Research Site Recruiting
Batu Caves, Malaysia, 68100
Contact: Endeavor Clinical Trials    1-858-727-3199    ebmclinical@endeavorbiomedicines.com   
Research Site Recruiting
Kota Bharu, Malaysia, 15200
Contact: Endeavor Clinical Trials    1-858-727-3199    ebmclinical@endeavorbiomedicines.com   
Research Site Recruiting
Kuala Lumpur, Malaysia, 53000
Contact: Endeavor Clinical Trials    1-858-727-3199    ebmclinical@endeavorbiomedicines.com   
Research Sire Recruiting
Kuala Lumpur, Malaysia, 56000
Contact: Endeavor Clinical Trials    1-858-727-3199    ebmclinical@endeavorbiomedicines.com   
Research Site Recruiting
Kuala Lumpur, Malaysia, 59100
Contact: Endeavor Clinical Trials    1-858-727-3199    ebmclinical@endeavorbiomedicines.com   
Mexico
Research Site Recruiting
Monterrey, Nuevo Leon, Mexico, 64060
Contact: Endeavor Clinical Trials    1-858-727-3199    ebmclinical@endeavorbiomedicines.com   
Research Site Recruiting
Monterrey, Nuevo Leon, Mexico, 64718
Contact: Endeavor Clinical Trials    1-858-727-3199    ebmclinical@endeavorbiomedicines.com   
Research Site Not yet recruiting
San Nicolás De Los Garza, Nuevo Leon, Mexico, 66465
Contact: Endeavor Clinical Trials    1-858-727-3199    ebmclinical@endeavorbiomedicines.com   
Research Site Recruiting
Chihuahua, Mexico, 31203
Contact: Endeavor Clinical Trials    1-858-727-3199    ebmclinical@endeavorbiomedicines.com   
Research Site Recruiting
Mexico City, Mexico, 03100
Contact: Endeavor Clinical Trials    1-858-727-3199    ebmclinical@endeavorbiomedicines.com   
Research Site Recruiting
Mexico City, Mexico, 14080
Contact: Endeavor Clinical Trials    1-858-727-3199    ebmclinical@endeavorbiomedicines.com   
Research Site Recruiting
Oaxaca, Mexico, 68000
Contact: Endeavor Clinical Trials    1-858-727-3199    ebmclinical@endeavorbiomedicines.com   
Research Site Not yet recruiting
Puebla, Mexico, 72180
Contact: Endeavor Clinical Trials    1-858-727-3199    ebmclinical@endeavorbiomedicines.com   
Sponsors and Collaborators
Endeavor Biomedicines, Inc.
Investigators
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Study Director: Srikanth Pendyala, M.D. Endeavor Biomedicines
More Information
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Responsible Party: Endeavor Biomedicines, Inc.
ClinicalTrials.gov Identifier: NCT04968574    
Other Study ID Numbers: ENV-IPF-101
First Posted: July 20, 2021    Key Record Dates
Last Update Posted: July 7, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Endeavor Biomedicines, Inc.:
hedgehog
smoothened
pulmonary fibrosis
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
 Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases