Recruitment

Recruitment Status
Withdrawn
Estimated Enrollment
129

Inclusion Criteria

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
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.
...
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
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.
Adequate hematopoietic capacity, liver and renal function
Forced vital capacity (FVC) >/=40% and </=90% of predicted at screening
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
Adult patients aged >/=40 years at Visit 1
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)
Diffusion capacity of the lung for carbon dioxide (DLCO) >/=25% of predicted at screening
Diagnosis of IPF within the previous 5 years from time of screening and confirmed at baseline

Exclusion Criteria

Pregnant or lactating
Known hypersensitivity to any of the study drug excipients or the drug itself
Prior treatment with vismodegib or any Hh-pathway inhibitor
...
Pregnant or lactating
Known hypersensitivity to any of the study drug excipients or the drug itself
Prior treatment with vismodegib or any Hh-pathway inhibitor
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
Class IV New York Heart Association chronic heart failure or historical evidence of left ventricular ejection fraction <35%
Known immunodeficiency, including but not limited to HIV infection
Hospitalization due to an exacerbation of IPF within 4 weeks prior to, or during, screening
Evidence of clinically significant lung disease other than IPF
Substantial emphysema on high resolution computed tomography (HRCT) with degree of emphysema greater than fibrosis
Lung transplant expected within 12 months of screening
Known current malignancy or current evaluation for a potential malignancy
Evidence of other known causes of interstitial lung disease
Post bronchodilator forced expiratory volume in 1 second/FVC ratio <0.7 at 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

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
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.
...
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
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.
Adequate hematopoietic capacity, liver and renal function
Forced vital capacity (FVC) >/=40% and </=90% of predicted at screening
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
Adult patients aged >/=40 years at Visit 1
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)
Diffusion capacity of the lung for carbon dioxide (DLCO) >/=25% of predicted at screening
Diagnosis of IPF within the previous 5 years from time of screening and confirmed at baseline

Exclusion Criteria

Pregnant or lactating
Known hypersensitivity to any of the study drug excipients or the drug itself
Prior treatment with vismodegib or any Hh-pathway inhibitor
...
Pregnant or lactating
Known hypersensitivity to any of the study drug excipients or the drug itself
Prior treatment with vismodegib or any Hh-pathway inhibitor
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
Class IV New York Heart Association chronic heart failure or historical evidence of left ventricular ejection fraction <35%
Known immunodeficiency, including but not limited to HIV infection
Hospitalization due to an exacerbation of IPF within 4 weeks prior to, or during, screening
Evidence of clinically significant lung disease other than IPF
Substantial emphysema on high resolution computed tomography (HRCT) with degree of emphysema greater than fibrosis
Lung transplant expected within 12 months of screening
Known current malignancy or current evaluation for a potential malignancy
Evidence of other known causes of interstitial lung disease
Post bronchodilator forced expiratory volume in 1 second/FVC ratio <0.7 at screening

Tracking Information

NCT #
NCT02168530
Collaborators
Not Provided
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
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