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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 40 Years and Over
Gender All
More Inclusion & Exclusion 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 if completely excised. 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.
  • - 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), COVID-19 or Hepatitis C virus (HCV).
  • - Occurrence of serious illness requiring hospitalization within 90 days prior to study start.
  • - Use of nintedanib or pirfenidone for greater than 60 days.
Subjects must not have taken nintedanib or pirfenidone for 14 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 such as methotrexate, azathioprine, systemic or inhaled glucocorticosteroids used as a treatment for IPF.
  • - Regular use of phosphodiesterase type-5 inhibitor, occasional use for erectile dysfunction will be allowed.
  • - Use of drugs that are known strong CYP3A4/5 inhibitors, inducers, or substrates 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 30 days after their final dose.
  • - Females that are pregnant or lactating.
  • - Females and males that are unwilling to refrain from blood or blood product donation for the duration of the study or for 30 days after their final study dose.
  • - Males who are unwilling to refrain from sperm donation for the duration of the study or for 30 days 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04968574
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Endeavor Biomedicines, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Srikanth Pendyala, M.D.
Principal Investigator Affiliation Endeavor Biomedicines
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis
Arms & Interventions

Arms

Experimental: ENV-101

taladegib, 200 mg tablet, once daily for 12 weeks

Placebo Comparator: placebo

placebo, tablet, once daily for 12 weeks

Interventions

Drug: - taladegib

hedgehog pathway inhibitor dosed once daily

Drug: - placebo

identical tablets to the experimental arm with no active ingredient

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Research Site, Liverpool, New South Wales, Australia

Status

Not yet recruiting

Address

Research Site

Liverpool, New South Wales, 1871

Site Contact

Endeavor Clinical Trials

ebmclinical@endeavorbiomedicines.com

1-858-727-3199

Research Site, Benowa, Queensland, Australia

Status

Not yet recruiting

Address

Research Site

Benowa, Queensland, 4217

Site Contact

Endeavor Clinical Trials

ebmclinical@endeavorbiomedicines.com

1-858-727-3199

Research Site, Box Hill, Victoria, Australia

Status

Recruiting

Address

Research Site

Box Hill, Victoria, 3128

Site Contact

Endeavor Clinical Trials

ebmclinical@endeavorbiomedicines.com

1-858-727-3199

Research Site, Clayton, Victoria, Australia

Status

Not yet recruiting

Address

Research Site

Clayton, Victoria, 3168

Site Contact

Endeavor Clinical Trials

ebmclinical@endeavorbiomedicines.com

1-858-727-3199