Study of pharmacodynamics, pharmacokinetics, safety and tolerability of VAY736 in patients with idiopathic pulmonary fibrosis
- Conditions
- Idiopathic pulmonary fibrosisMedDRA version: 20.0 Level: PT Classification code 10021240 Term: Idiopathic pulmonary fibrosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2017-002667-17-FR
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 84
•?A diagnosis of definite or probable IPF within 5 years of the screening visit, as defined by the ATS/ERS/JRS/ALAT Diagnostic Guidelines (Raghu et al 2011)
•?Seropositive at screening for at least one of the following auto-antibodies: RF, ANA, anti-dsDNA, anti-CCP, Scl-70, SSA (anti-Ro), SSB (anti-La), anti-RNP, anti-Smith, Jo-1, PL-7, PL-12, EJ, OJ, SRP, Ku, Mi-2, anti-PM/Scl;
OR
Presence of hilar/mediastinal adenopathy (>1cm in short-axis diameter), identified by screening HRCT scan of the chest
•?FVC 50-90% predicted (inclusive)
•?DLCO, corrected for hemoglobin, 30-79% predicted (inclusive)
•?FEV1/FVC >70%
•?Unlikely to die from cause other than IPF within the next 3 years, in the opinion of the investigator
•?Unlikely to undergo lung transplantation during this trial
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 34
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
•?Emphysema > fibrosis on screening HRCT (must be confirmed by central reader)
•?History of major organ, hematopoietic stem cell or bone marrow transplant
•?Findings on screening HRCT that are inconsistent with IPF, suggest the possibility of AEIPF
(new ground-glass opacities (GGO) or consolidation), or any new concerning
pulmonary nodules (central reader)
•?Clinically diagnosed AE-IPF or other significant clinical worsening within 3 months of
randomization
•?class III/IV Congestive Heart Failure (CHF), Ejection Fraction (EF) <25%
•?Current smoker (must have negative cotinine test)
•?Prior use of any B-cell depleting therapy (e.g., rituximab, ofatumumab, or other anti-CD20
mAb, anti-CD40, anti-CD19,anti-CD22 mAb, anti-CD52 mAb, or anti-BAFF mAb)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the efficacy of VAY736 in patients with idiopathic pulmonary fibrosis;<br> Secondary Objective: Impact of VAY736 on survival and disease progression.<br> <br> Other protocol-defined secondary objectives may apply<br> ;Primary end point(s): Change from baseline to end of treatment epoch (48 weeks of treatment) in Forced Vital Capacity (FVC).;Timepoint(s) of evaluation of this end point: end of treatment epoch (48 weeks of treatment)
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): All-Cause mortality; Progression-free survival (PFS); Disease progression; Composite Endpoint; Change from baseline to end of treatment epoch (Week 48) in Diffusing Capacity of the Lungs (DLCO); Change from baseline to the end of treatment epoch (Week 48) in 6-minute walk test and in distance-saturation product; Change from baseline to the end of treatment epoch (Week 48) in resting oxygen saturation (on room air); Immunogenicity of VAY736; To assess the pharmacokinetics Cmin,ss of VAY736 after multiple s.c. doses; Idiopathic Pulmonary Fibrosis (IPF) -related Mortality; Change from baseline to end of treatment epoch (Week 48) in Total Lung Capacity (TLC)<br> Other protocol defined endpoints may apply<br> ;Timepoint(s) of evaluation of this end point: across the 48 weeks of treatment and at the end of study