A Study of Oral Vismodegib for the Treatment of Idiopathic Pulmonary Fibrosis (IPF)
Last updated on April 2022Recruitment
- Recruitment Status
- Withdrawn
- Estimated Enrollment
- 129
Inclusion Criteria
- Diagnosis of IPF within the previous 5 years from time of screening and confirmed at baseline
- Diffusion capacity of the lung for carbon dioxide (DLCO) >/=25% of predicted at screening
- Adequate hematopoietic capacity, liver and renal function
- ...
- Diagnosis of IPF within the previous 5 years from time of screening and confirmed at baseline
- Diffusion capacity of the lung for carbon dioxide (DLCO) >/=25% of predicted at screening
- Adequate hematopoietic capacity, liver and renal function
- Patients from countries where a treatment is licensed/approved for IPF must additionally meet at least one of the following criteria to be eligible: (1) be unable to access a licensed therapy for IPF; (2) treatment with a licensed therapy/therapies has been stopped for lack of efficacy or because of safety/tolerability reasons (a washout period will be required); (3) be unwilling to be treated with a licensed therapy and study enrollment considered appropriate.
- Male patients must agree to remain abstinent or use a condom, even after a vasectomy, during sexual intercourse with female partners while being treated with vismodegib/placebo, and for 2 months after completion of study treatment
- Agreement not to donate blood or blood products during the study and for at least 7 months (or as per local requirements) after the last dose of study treatment
- Stable baseline lung function as evidenced by a difference of <10% in absolute FVC measurements (in liters) between screening and Day 1/Visit 2 prior to randomization
- Forced vital capacity (FVC) >/=40% and </=90% of predicted at screening
- Female patients of childbearing potential must use two methods of acceptable contraception, including one highly effective method and a barrier method, during treatment and for 7 months after completion of study treatment (or as per local requirement)
- Adult patients aged >/=40 years at Visit 1
Exclusion Criteria
- Known immunodeficiency, including but not limited to HIV infection
- Evidence of clinically significant lung disease other than IPF
- Any clinically significant medical disease (other than IPF) that is associated with an expected survival of <12 months, likely to require a change in therapy during the study, or likely to impact the ability of the patient to participate in the study in the opinion of the investigator, or impact the study efficacy or safety assessments
- ...
- Known immunodeficiency, including but not limited to HIV infection
- Evidence of clinically significant lung disease other than IPF
- Any clinically significant medical disease (other than IPF) that is associated with an expected survival of <12 months, likely to require a change in therapy during the study, or likely to impact the ability of the patient to participate in the study in the opinion of the investigator, or impact the study efficacy or safety assessments
- Hospitalization due to an exacerbation of IPF within 4 weeks prior to, or during, screening
- Evidence of other known causes of interstitial lung disease
- Class IV New York Heart Association chronic heart failure or historical evidence of left ventricular ejection fraction <35%
- Post bronchodilator forced expiratory volume in 1 second/FVC ratio <0.7 at screening
- Known hypersensitivity to any of the study drug excipients or the drug itself
- Pregnant or lactating
- Substantial emphysema on high resolution computed tomography (HRCT) with degree of emphysema greater than fibrosis
- Prior treatment with vismodegib or any Hh-pathway inhibitor
- Known current malignancy or current evaluation for a potential malignancy
- Lung transplant expected within 12 months of screening
Summary
- Conditions
- Idiopathic Pulmonary Fibrosis
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 40 years and 125 years
- Gender
- Both males and females
Inclusion Criteria
- Diagnosis of IPF within the previous 5 years from time of screening and confirmed at baseline
- Diffusion capacity of the lung for carbon dioxide (DLCO) >/=25% of predicted at screening
- Adequate hematopoietic capacity, liver and renal function
- ...
- Diagnosis of IPF within the previous 5 years from time of screening and confirmed at baseline
- Diffusion capacity of the lung for carbon dioxide (DLCO) >/=25% of predicted at screening
- Adequate hematopoietic capacity, liver and renal function
- Patients from countries where a treatment is licensed/approved for IPF must additionally meet at least one of the following criteria to be eligible: (1) be unable to access a licensed therapy for IPF; (2) treatment with a licensed therapy/therapies has been stopped for lack of efficacy or because of safety/tolerability reasons (a washout period will be required); (3) be unwilling to be treated with a licensed therapy and study enrollment considered appropriate.
- Male patients must agree to remain abstinent or use a condom, even after a vasectomy, during sexual intercourse with female partners while being treated with vismodegib/placebo, and for 2 months after completion of study treatment
- Agreement not to donate blood or blood products during the study and for at least 7 months (or as per local requirements) after the last dose of study treatment
- Stable baseline lung function as evidenced by a difference of <10% in absolute FVC measurements (in liters) between screening and Day 1/Visit 2 prior to randomization
- Forced vital capacity (FVC) >/=40% and </=90% of predicted at screening
- Female patients of childbearing potential must use two methods of acceptable contraception, including one highly effective method and a barrier method, during treatment and for 7 months after completion of study treatment (or as per local requirement)
- Adult patients aged >/=40 years at Visit 1
Exclusion Criteria
- Known immunodeficiency, including but not limited to HIV infection
- Evidence of clinically significant lung disease other than IPF
- Any clinically significant medical disease (other than IPF) that is associated with an expected survival of <12 months, likely to require a change in therapy during the study, or likely to impact the ability of the patient to participate in the study in the opinion of the investigator, or impact the study efficacy or safety assessments
- ...
- Known immunodeficiency, including but not limited to HIV infection
- Evidence of clinically significant lung disease other than IPF
- Any clinically significant medical disease (other than IPF) that is associated with an expected survival of <12 months, likely to require a change in therapy during the study, or likely to impact the ability of the patient to participate in the study in the opinion of the investigator, or impact the study efficacy or safety assessments
- Hospitalization due to an exacerbation of IPF within 4 weeks prior to, or during, screening
- Evidence of other known causes of interstitial lung disease
- Class IV New York Heart Association chronic heart failure or historical evidence of left ventricular ejection fraction <35%
- Post bronchodilator forced expiratory volume in 1 second/FVC ratio <0.7 at screening
- Known hypersensitivity to any of the study drug excipients or the drug itself
- Pregnant or lactating
- Substantial emphysema on high resolution computed tomography (HRCT) with degree of emphysema greater than fibrosis
- Prior treatment with vismodegib or any Hh-pathway inhibitor
- Known current malignancy or current evaluation for a potential malignancy
- Lung transplant expected within 12 months of screening
Tracking Information
- NCT #
- NCT02168530
- Collaborators
- Not Provided
- Investigators
- Study Director: Clinical Trials Hoffmann-La Roche