Study of pharmacodynamics, pharmacokinetics, safety and tolerability of VAY736 in patients with idiopathic pulmonary fibrosis
- Conditions
- Idiopathic pulmonary fibrosisMedDRA version: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2017-002667-17-IE
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 58
1.Written informed consent must be obtained before any assessment is performed.
2.Male and female subjects 40 to 80 years of age inclusive
3.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)
4.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
5.FVC 40-90% predicted (inclusive)
6.DLCO, corrected for hemoglobin, 25-79% predicted (inclusive)
7.FEV1/FVC >70%
8.Unlikely to die from cause other than IPF within the next 3 years, in the opinion of the investigator
9.Unlikely to undergo lung transplantation during this trial
10.Able to communicate well with the investigator, to understand and comply with the requirements of the study.
Other protocol-defined inclusion/exclusion criteria may apply
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 23
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35
1.Emphysema > fibrosis on screening HRCT (must be confirmed by central reader)
2.Active viral, bacterial or other infections requiring systemic treatment at the time of screening or enrollment, or history of recurrent clinically significant infection or of bacterial infections with encapsulated organisms
3.History of major organ, hematopoietic stem cell or bone marrow transplant
4.History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes (e.g., mAb of IgG1 class) or to any of the constituents of the study drug (sucrose, L-Arginine hydrochloride, L-histidine, polysorbate 80, hydrochloric acid)
5.Receipt of live/attenuated vaccine within a 2 month period before baseline
6.History of primary or secondary immunodeficiency, including a positive Human Immunodeficiency Virus (HIV) (Enzyme-linked Immunosorbent Assay (ELISA) and Western blot) test result
7.History of malignancy of any organ system (other than localized basal cell carcinoma of the skin, in situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
8.Any one of the following screening values of complete blood count laboratory values: Hemoglobin levels below 8.0 g/dL; Total leukocyte count less than 2,000/µL; Platelets <100.0 x 109/L; Absolute neutrophil count (ANC) <1.5 x 109/L
9.Any surgical, medical (e.g., uncontrolled hypertension, heart failure or diabetes), psychiatric or additional physical condition that the Investigator feels may jeopardize the patient in case of participation in this study
10.Positive hepatitis B surface antigen (HBsAg); or positive total hepatitis B core antibody (anti-HBc); or positive hepatitis C antibody (anti-HCV) unless it can be documented that the patient has received highly-effective HCV-specific antiviral therapy, HCV RNA levels are measured, and HCV RNA is undetectable; i.e., any acute latent or chronic infection with hepatitis B or hepatitis C
11.Evidence of active or latent tuberculosis (TB) infection, as determined by Quantiferon test (after anti-TB treatment, patients with history of or latent TB may become eligible according to national guidelines)
Other protocol-defined inclusion/exclusion criteria may apply
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;Secondary Objective: Impact of VAY736 on survival and disease progression.<br><br>Other protocol-defined secondary objectives may apply;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 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-<br>minute walk test and in distance-saturation product; Change from baseline to the end of treatment epoch (Week 48) in resting oxygen<br>saturation (on room air); Immunogenicity of VAY736; To assess the pharmacokinetics Cmin,ss of VAY736 after multiple s.c. doses;<br>Idiopathic Pulmonary Fibrosis (IPF) -related Mortality; Other protocol defined endpoints may apply;Timepoint(s) of evaluation of this end point: across the 48 weeks of treatment and at the end of study