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Idiopathic Pulmonary FibrosisPhase 2NCT02168530

A Study of Oral Vismodegib for the Treatment of Idiopathic Pulmonary Fibrosis (IPF)

A Phase 2 study testing vismodegib in people with Idiopathic Pulmonary Fibrosis, run by Hoffmann-La Roche.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a randomized, multicenter, double-blind, placebo-controlled, parallel-group study of vismodegib in patients with IPF. Eligible patients will be randomized in a 2:1 ratio to one of two treatment arms: vismodegib or placebo. The duration of treatment will be 52 weeks. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Idiopathic Pulmonary Fibrosis
What is being tested?
vismodegib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
Oct 2014to Jan 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients aged >/=40 years at Visit 1
  • 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
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  • 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

Who cannot join

  • 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
  • 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
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  • 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

About this study

This is a randomized, multicenter, double-blind, placebo-controlled, parallel-group study of vismodegib in patients with IPF. Eligible patients will be randomized in a 2:1 ratio to one of two treatment arms: vismodegib or placebo. The duration of treatment will be 52 weeks. Study drug will be administered daily by the oral route. An 8-week safety follow-up period is included for all patients who receive at least one dose of study drug.

Being tested
placebo, vismodegib
Medical subject headings
Idiopathic Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • placeboDrug

    matching placebo administered daily orally

  • vismodegibDrug

    vismodegib 150 mg administered daily orally

Study groups in NCT02168530
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Drug: placebo
VismodegibExperimentalNot described
Receives: Drug: vismodegib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in forced vital capacity (FVC) percent predicted

    Measured: From baseline to Week 52

Secondary outcomes (6)

  1. Change in diffusion capacity of the lung for carbon dioxide (DLCO)

    Measured: From baseline to Week 52

  2. Annualized rate of change in FVC

    Measured: Week 52

  3. Progression-free survival

    Measured: Week 52

  4. Time from randomization to first event of acute IPF exacerbation

    Measured: Up to 52 weeks

  5. Change in Quality of Life measurements

    Measured: From baseline to Week 52

  6. Safety: Incidence of adverse events (AEs)

    Measured: Approximately 60 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionJan 2017 (estimated)
  4. Study completionJan 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02168530
Sponsor's protocol ID
GB29298
Other IDs
2014-000963-42, 2014
Status last verified
Nov 2016
First submitted
18 Jun 2014
Last updated
2 Nov 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing vismodegib in people with Idiopathic Pulmonary Fibrosis, run by Hoffmann-La Roche.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in forced vital capacity (FVC) percent predicted (time frame: From baseline to Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02168530.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.

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