Study of Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of VAY736 in Patients With Idiopathic Pulmonary Fibrosis

Study Purpose

This study will investigate the safety and efficacy of VAY736 administered subcutaneously (s.c.) every 4 weeks for 48 weeks. Approximately, 84 subjects will be randomized in a 1:1 ratio on top of local standard of care (SOC), to receive VAY736 or placebo.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 40 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

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 Figure 3, Tables 4-6 of 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 50-90% predicted (inclusive) 6. DLCO, corrected for hemoglobin, 30-79% 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.

Exclusion Criteria:

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 first dose 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) with concurrent negative hepatitis B surface antibody (anti-HBs); or positive total hepatitis B core antibody (anti-HBc) with concurrent negative anti-HBs; 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 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) 12. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test 13. Clinically diagnosed AE-IPF or other significant clinical worsening within 3 months of randomization 14. Other known causes of interstitial lung disease (e.g., domestic or occupational environmental exposures, drug toxicity) or other identifiable interstitial lung disease 15. Definitive diagnosis of a connective tissue disease (such as systemic sclerosis, DM/PM, RA, Sjogren's syndrome, or SLE) 16. Initiation of pulmonary rehabilitation within 60 days of randomization (pulmonary rehabilitation is prohibited during the period of this trial, except for "maintenance" rehabilitation, to be documented with a clinical summary from the Rehabilitation Center) 17. Myocardial Infarction (MI), Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA), or hospitalization for arrhythmia or unstable angina within 6 months 18. New York Heart Association (NYHA) class III/IV Congestive Heart Failure (CHF), Ejection Fraction (EF) <25% 19. Other investigational treatments within 6 months of screening 20. Disability (other than dyspnea) that may limit the completion of 6MWT (angina, claudication, etc.) 21. Current smoker (must have negative cotinine test) 22. Any current treatment for IPF (except for pirfenidone or nintedanib; but not both) 23. Historical (within 6 months of screening) treatment for IPF with experimental or off-label modalities including but not limited to oral corticosteroids, N-Acetylcysteine , cyclophosphamide, mycophenolate, azathioprine, cyclosporine A, etanercept, or plasmapheresis. 24. 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) 25. Receiving any treatment for pulmonary hypertension OR treatment for pulmonary hypertension anticipated during this trial (in other words, treatment for pulmonary hypertension is prohibited during this trial), including but not limited to epoprostanil, iloprostanil, treprostanil, selexipag, bosentan, ambrisentan, macitentan, sildenafil, tadalafil, and riociguat. 26. History of alcohol and/or drug abuse within the last 2 years 27. Elective surgery planned to take place during this trial 28. Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception for 3 months prior to screening, during dosing, and for 4 months after stopping of investigational medication. Highly effective contraception methods include:
  • - Total abstinence from heterosexual intercourse (when this is in line with the preferred and usual lifestyle of the patient).
Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
  • - Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks before taking investigational drug.
In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
  • - Male sterilization (at least 6 months prior to screening).
For female subjects on the study the vasectomized male partner should be the sole partner for that subject.
  • - Use of oral (estrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception.
In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking investigational drug. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03287414
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Novartis Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Canada, France, Germany, Ireland, Italy, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Novartis Investigative Site, Salt Lake City, Utah

Status

Recruiting

Address

Novartis Investigative Site

Salt Lake City, Utah, 84108

Novartis Investigative Site, Nashville, Tennessee

Status

Recruiting

Address

Novartis Investigative Site

Nashville, Tennessee, 37203

Novartis Investigative Site, Pittsburgh, Pennsylvania

Status

Recruiting

Address

Novartis Investigative Site

Pittsburgh, Pennsylvania, 15213

Novartis Investigative Site, Durham, North Carolina

Status

Recruiting

Address

Novartis Investigative Site

Durham, North Carolina, 27710

Novartis Investigative Site, Lebanon, New Hampshire

Status

Recruiting

Address

Novartis Investigative Site

Lebanon, New Hampshire, 03756

Novartis Investigative Site, Saint Louis, Missouri

Status

Recruiting

Address

Novartis Investigative Site

Saint Louis, Missouri, 63110

Novartis Investigative Site, Boston, Massachusetts

Status

Recruiting

Address

Novartis Investigative Site

Boston, Massachusetts, 02115

Novartis Investigative Site, Baltimore, Maryland

Status

Recruiting

Address

Novartis Investigative Site

Baltimore, Maryland, 21224

Novartis Investigative Site, Chicago, Illinois

Status

Recruiting

Address

Novartis Investigative Site

Chicago, Illinois, 60637

Novartis Investigative Site, Miami, Florida

Status

Recruiting

Address

Novartis Investigative Site

Miami, Florida, 33136

Novartis Investigative Site, Aurora, Colorado

Status

Recruiting

Address

Novartis Investigative Site

Aurora, Colorado, 80045

Novartis Investigative Site, Los Angeles, California

Status

Recruiting

Address

Novartis Investigative Site

Los Angeles, California, 90095

Novartis Investigative Site, Birmingham, Alabama

Status

Recruiting

Address

Novartis Investigative Site

Birmingham, Alabama, 35294-0007

International Sites

Novartis Investigative Site, Nottingham, United Kingdom

Status

Recruiting

Address

Novartis Investigative Site

Nottingham, , NG5 1PB

Novartis Investigative Site, Edinburgh, United Kingdom

Status

Recruiting

Address

Novartis Investigative Site

Edinburgh, ,

Novartis Investigative Site, High Heaton, Newcastle Upon Tyne, United Kingdom

Status

Recruiting

Address

Novartis Investigative Site

High Heaton, Newcastle Upon Tyne, NE7 7DN

Novartis Investigative Site, Cambridge, Cambridgeshire, United Kingdom

Status

Recruiting

Address

Novartis Investigative Site

Cambridge, Cambridgeshire, CB23 3RE

Novartis Investigative Site, Siena, Italy

Status

Recruiting

Address

Novartis Investigative Site

Siena, , 53100

Novartis Investigative Site, Roma, Italy

Status

Recruiting

Address

Novartis Investigative Site

Roma, , 00168

Novartis Investigative Site, Modena, Italy

Status

Recruiting

Address

Novartis Investigative Site

Modena, , 41124

Novartis Investigative Site, Milano, MI, Italy

Status

Recruiting

Address

Novartis Investigative Site

Milano, MI, 20123

Novartis Investigative Site, Forli, Forli - Cesena, Italy

Status

Recruiting

Address

Novartis Investigative Site

Forli, Forli - Cesena, 47100

Novartis Investigative Site, Dublin, Ireland

Status

Active, not recruiting

Address

Novartis Investigative Site

Dublin, , DUBLIN 4

Novartis Investigative Site, Hannover, Germany

Status

Recruiting

Address

Novartis Investigative Site

Hannover, , 30625

Novartis Investigative Site, Coswig, Germany

Status

Recruiting

Address

Novartis Investigative Site

Coswig, , 01640

Novartis Investigative Site, Paris, France

Status

Recruiting

Address

Novartis Investigative Site

Paris, , 75018

Novartis Investigative Site, Marseille, France

Status

Recruiting

Address

Novartis Investigative Site

Marseille, , 13015

Novartis Investigative Site, Bobigny cedex, Seine Saint Denis, France

Status

Recruiting

Address

Novartis Investigative Site

Bobigny cedex, Seine Saint Denis, 93009

Novartis Investigative Site, Montpellier cedex 5, Herault, France

Status

Recruiting

Address

Novartis Investigative Site

Montpellier cedex 5, Herault, 34059

Novartis Investigative Site, Besancon Cedex, Doubs, France

Status

Recruiting

Address

Novartis Investigative Site

Besancon Cedex, Doubs, 25030

Novartis Investigative Site, Quebec, Canada

Status

Recruiting

Address

Novartis Investigative Site

Quebec, , GIV 4G5

Novartis Investigative Site, Calgary, Alberta, Canada

Status

Recruiting

Address

Novartis Investigative Site

Calgary, Alberta, T2N 2T9

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