Study of pharmacodynamics, pharmacokinetics, safety and tolerability of VAY736 in patients with idiopathic pulmonary fibrosis

• Register: EUCTR
• Last refreshed on: 28 February 2019
• Main ID: EUCTR2017-002667-17-FR
• Date of registration: 20/02/2018
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma AG
• Public title: Study of pharmacodynamics, pharmacokinetics, safety and tolerability of VAY736 in patients with idiopathic pulmonary fibrosis
• Scientific title: A subject-, investigator-, and sponsor-blinded, randomized, placebo-controlled, multicenter study to investigate efficacy, safety, and tolerability of VAY736 in patients with idiopathic pulmonary fibrosis
• Date of first enrolment: 06/06/2018
• Target sample size: 84
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-002667-17
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Canada, France, Germany, Ireland, Italy, United Kingdom, United States

Contacts

• Name: Information&Communication Médicales
• Affiliation: Novartis Pharma S.A.S

• Name: Information&Communication Médicales
• Affiliation: Novartis Pharma S.A.S

Key inclusion & exclusion criteria

Inclusion criteria:
•?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

Exclusion criteria:
•?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)


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Idiopathic pulmonary fibrosis
MedDRA version: 20.0 Level: PT Classification code 10021240 Term: Idiopathic pulmonary fibrosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Intervention(s)

Product Code: VAY736
Pharmaceutical Form: Powder for solution for injection/infusion
INN or Proposed INN: not established
Other descriptive name: VAY736
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection/infusion
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

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)

Main Objective: To assess the efficacy of VAY736 in patients with idiopathic pulmonary fibrosis

Secondary Objective: Impact of VAY736 on survival and disease progression.

Other protocol-defined secondary objectives may apply

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: across the 48 weeks of treatment and at the end of study

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)
Other protocol defined endpoints may apply

Secondary ID(s)

2017-002667-17-GB

CVAY736X2207

NCT03287414

Source(s) of Monetary Support

Novartis Pharma AG

Ethics review

Status: Approved
Approval date:
Contact: