A phase II study to assess vismodegib in the treatment of idiopathic pulmonary fibrosis

• Conditions: Idiopathic pulmonary fibrosis; MedDRA version: 17.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-000963-42-DE
• Lead Sponsor: F. Hoffmann-La Roche Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-13
• Last Update Posted: 7 September 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

- Age > or equal to 40 years at Visit 1
- Have a diagnosis of IPF based upon the ATS/ERS/JRS/ALAT consensus statement on IPF (Raghu et al. 2011) within the previous 5 years from time of screening and confirmed at baseline Have a central review assessment of HRCT performed during the screening period or < or equal to 12 months prior to the start of screening
- Patients from countries where a treatment is licensed/approved for IPF must additionally meet at least one of the following criteria to be eligible;
- Be unable to access a licensed therapy for IPF
- Treatment with a licensed therapy/therapies has been stopped for lack of efficacy or because of safety/tolerability reasons (a period of washout will be required; refer to Section 4.1.2)
- Be unwilling to be treated with a licensed/approved therapy and after having reviewed all available treatment options, the investigator and patient consider enrollment into the study appropriate
- FVC = 40% and < or equal to 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
- DLco > or equal to 25% of predicted at screening
- Adequate hematopoietic capacity, defined as the following:
- Hemoglobin > 8.5 g/dL
- ANC > or equal to 1000/microlitre
- Platelet count > or equal to 75,000/microlitre
- Adequate liver function, defined as the following:
- AST and ALT < or equal to 3 times the upper limit of normal (ULN)
- Total bilirubin < or equal to 1.5 x ULN or < 3 x ULN for patients with documented Gilbert syndrome
- Women of childbearing potential must use two methods of acceptable contraception including one highly effective method and a barrier method as directed by their physician during treatment 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 64
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 65

Exclusion Criteria

- Prior treatment with vismodegib or any Hh pathway inhibitor
- Evidence of other known causes of ILD
- 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 HRCT with degree of emphysema greater than fibrosis
- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified