A Study of Oral Vismodegib for the Treatment of Idiopathic Pulmonary Fibrosis (IPF)
NCT ID: NCT02168530
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE2
INTERVENTIONAL
2014-10-31
2017-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
placebo
matching placebo administered daily orally
Vismodegib
vismodegib
vismodegib 150 mg administered daily orally
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
placebo
matching placebo administered daily orally
vismodegib
vismodegib 150 mg administered daily orally
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosis of IPF within the previous 5 years from time of screening and confirmed at baseline
* 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.
* Forced vital capacity (FVC) \>/=40% and \</=90% of predicted at screening
* 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
* Diffusion capacity of the lung for carbon dioxide (DLCO) \>/=25% of predicted at screening
* Adequate hematopoietic capacity, liver and renal function
* 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)
* 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
Exclusion Criteria
* Known hypersensitivity to any of the study drug excipients or the drug itself
* Prior treatment with vismodegib or any Hh-pathway inhibitor
* Evidence of other known causes of interstitial lung disease
* Hospitalization due to an exacerbation of IPF within 4 weeks prior to, or during, screening
* Lung transplant expected within 12 months of 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
* Post bronchodilator forced expiratory volume in 1 second/FVC ratio \<0.7 at screening
* Class IV New York Heart Association chronic heart failure or historical evidence of left ventricular ejection fraction \<35%
* Known current malignancy or current evaluation for a potential malignancy
* Known immunodeficiency, including but not limited to HIV infection
* 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
40 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2014-000963-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GB29298
Identifier Type: -
Identifier Source: org_study_id