PrecISE-a biomarker-stratified adaptive trial of 5 interventions in severe asthma: Final protocol and the baseline cohort - PubMed (original) (raw)

Conflict of interest statement

Disclosure statement The PrecISE study is funded by the National Heart, Lung and Blood Institute, National Institutes of Health (grants U24 HL138998, 1UG1HL139054, 1UG1HL139098, 1UG1HL139106, 1UG1HL139117, 1UG1HL139118, 1UG1HL139119, 1UG1HL139123, 1UG1HL139124, 1UG1HL139125, and 1UG1HL139126). Support for site institutional infrastructure came from National Institutes of Health (Clinical and Translational Science Award grants UL1TR002451 [Harvard], UL1TR000427 [University of Wisconsin], UL1TR002366 [University of Kansas], UL1TR002389 [University of Chicago], UL1TR002489 [University of North Carolina], UL1TR001857 [University of Pittsburgh], UL1TR001442 [University of California, San Diego], and UL1TR001872 [University of California, San Francisco]). The single institutional review board is supported by the Duke/Vanderbilt Trial Innovation Center (grant 5U24TR001608). The following endowed chair positions contributed additional support: Gloria M. and Anthony C. Simboli Distinguished Chair in Asthma Research (to E.I.), William W. and Judith H. Busse Professor of Allergy and Asthma Research (to L.C.D.), and Walter and Carmina Parkes Family Endowed Professorship (to S.N.G.). The study also gratefully acknowledges receiving contributed product from Vitaeris, which is owned and operated by the CSL group (clazakizumab); Vitaflo (MCT); Sun Pharma (imatinib); OM Pharma, a Vifor Pharma Group Company (OM-85, Broncho-Vaxom); Laurel Venture (Cavosonstat); and GlaxoSmithKline (Advair Diskus and Ventolin). Disclosure of potential conflict of interest: The aforementioned companies provided study drugs but did not have any role in study design or access to study data. They will have 1 week of preliminary review for the future articles describing postrandomization study outcomes. The following statements reflect author involvements in the 36 months before submission. L. C. Denlinger has consulted with OM Pharma and received speaker fees from AstraZeneca. E. Israel has received grants from AstraZeneca and PCORI; royalties from UpToDate/Wolters Kluwer; consulting fees from the Allergy and Asthma Network, Amgen, AnaptysBio, Apogee Therapeutics, Arrowhead Pharmaceuticals, AstraZeneca, Chiesi, Generate Biomedicine, GlaxoSmithKline, Jasper Therapeutics, OrbiMed, Regeneron, Sanofi, and Teva; honoraria for presentations to NYU/Grossman, ERS, McMaster University, and North York Hospital; and payment for expert testimony to Danker and Associates. In addition, E. Israel has participated in an advisory board with AnaptysBio and Apogee Therapeutics; is an unpaid member of the coordinating committee for the National Asthma Education and Prevention Program; has stock in Vorso; and has received equipment and study drugs from Circassia, Genetech, Teva, Sun Pharma, Laurel Pharmaceuticals, OM Pharma, Nestle, CSL Behring, Amgen, GlaxoSmithKline, and Sanofi/Regeneron. W. C. Moore has participated in advisory boards for AstraZeneca, GSK, and Sanofi/Regeneron. S. N. Georas reports consulting fees from OM Pharma, AstraZeneca, and GH Research. E. R. Bleecke reports grant support from the National Instituters of Health (NIH) and has participated in clinical trials and contracts with AstraZeneca, Sanofi, Genzyme, and TEVA. K. N. Cahill has consulted with Apogee Therapeutics, Ramble Health, and Deciphera; served on advisory boards for AstraZeneca, Eli Lilly, Boehringer Ingelheim, and Sanofi; received royalties from UpToDate; and received research support from Novo Nordisk. J. C. Cardet has received grant support and honoraria for work on advisory boards and steering committees and giving educational lectures on asthma from Aiolos Bio, Amgen, Apogee, AstraZeneca, Chiesi, Genentech, GSK, and Sanofi. T. F. Carr reports consulting fees from Apogee Therapeutics and royalty payments from Wolters Kluwer Health/UpToDate. M. Castro has received grants/research support from the American Lung Association, AstraZeneca, Gala Therapeutics, Genentech, GSK, the NIH, Novartis, PCORI, PULMATRiX, Sanofi, Shionogi, Teva, Theravance Biopharma, and Uniquity; consultant fees from Allakos, Amgen, Apogee, Apreo, Arrowhead Pharmaceuticals, AstraZeneca, Connect BioPharma, Evommune, Genentech, GSK, Jasper, Merck, Novartis, OM Pharma, Pfizer, Pioneering Medicines, Regeneron Pharmaceuticals, Sanofi, Teva, and Upstream Bio; speaker fees from Amgen, AstraZeneca, Genentech, Regeneron Pharmaceuticals, Sanofi, and Teva; and royalties from Aer Therapeutics and Elsevier. G. L. Chupp reports consultancies for Genentech, AstraZeneca, Sanofi/Genzyme, Regeneron, GSK, Kymera, Amgen, Pliant, and RAPT Therapeutics; DSMB participation for Mannkind, Rein Therapeutics, and Arthrosi; and investigator-initiated research grants from GSK. S. A. A. Comhair had intellectual property related to technology licensed to Vitaflo under an agreement that included potential royalty income; however, she did not receive any royalties and the license has since expired. J. V. Fahy has received grants from the NIH/National Heart, Lung and Blood Institute (NHLBI); received consulting fees from and owns stock in Suzhou Connect Biopharmaceuticals and Aer Therapeutics; received consulting fees from Kymera and AbbVie; and has been issued 2 patents describing thiol-modified saccharides as drugs to treat mucus-associated lung diseases, including asthma. B. M. Gaston is a minority owner of Respiratory Research and Atelerix. D. J. Jackson has received research grants from Regeneron and personal fees for consulting from Apogee, Areteia, GlaxoSmithKline, Regeneron, and Sanofi, and personal fees for DSMB from Astra Zeneca and Upstream Bio outside this work. N. N. Jarjour has received honoraria from GSK, AstraZeneca, and General Medicines for consultations unrelated to the reported study. N. J. Kenyon previously consulted with AstraZeneca. M. Kraft has received funding for research paid to her institution from NIH, ALA, Sanofi, and Areteia; consulting fees from Sanofi, AstraZeneca, Chiesi, Genentech, GSK, Ubiopharma, AbbVie, and Regeneron; speaker fees from Chiesi, Sanofi, GSK, AstraZeneca, and Regeneron; and payment as a section editor for UptoDate. J. A. Krishnan reports research grants from the NHLBI Patient-Centered Outcomes Research Institute, Chronic Obstructive Pulmonary Disease Foundation, American Lung Association, BioVie, and Sanofi, as well as consulting fees from AstraZeneca, DynaMed/EBSCO, Genentech, Inogen, MedImmune, and Verona Pharmaceuticals. R. Kumar has consulted with Sanofi, receives support from the National Institute of Allergy and Infectious Diseases (NIAID), and has several patents pending unrelated to the products studied by PrecISE. N. L. Lugogo has received consulting fees from AbbVie, Amgen, Apogee, AstraZeneca, Avillion, Foresee, Genentech, GSK, Inctye, Niox, Novartis, Regeneron, Sanofi, and Teva; honoraria for non–speakers bureau presentations from GSK, Teva, Sanofi/Regeneron, and AstraZeneca; and travel support from AstraZeneca, Sanofi, Teva, Regeneron, and GSK. In addition, N. L. Lugogo’s institution has received research support from Amgen, AstraZeneca, Avillion, Bellus, Evidera, Gossamer Bio, Genentech, GSK, Janssen, Regeneron, Roche, Sanofi, Novartis, and Teva, and she is an honorary faculty member of Observational and Pragmatic Research Institute but does not receive compensation for this role. F. D. Martinez is a member of a scientific advisory board for OM-Pharma. A. A. Pappalardo currently has research grants from the NIH and the Illinois Department of Public Health (contracted through the Respiratory Health Association), and she recently (within the past 24 months) completed research grant funding from the Agency for Healthcare Research and Quality, American College of Allergy, Asthma and Immunology, American Lung Association, Food Allergy Research and Education (FARE), and the American College of Allergy, Asthma and Immunology; serves as a consultant for OptumRx and the FARE, and recently (also within the past 24 months) served as a consultant to Northwestern University. Also within the past 24 months, A. A. Pappalardo has received honoraria and/or travel expense costs for knowledge dissemination and/or lectures through the American Academy of Allergy, Asthma & Immunology Illinois Critical Access Hospital Network, the American College of Allergy, Asthma and Immunology, FARE, and the American Academy of Pediatrics. D. B. Peden has consulted for Advarra, Inimmune, Sanofi, and Regeneron. W. Phipatanakul has received clinical trial support and fees from Genentech, Novartis, Sanofi, Regeneron, GSK, Astra Zeneca, and Cheiesi for advising and speaking on asthma- and allergy-related therapeutics. S. R. Rosenberg has received speaker fees from GlaxoSmithKline. J. D. Salciccioli reports no conflicts during his contribution to this article while at Harvard; he is currently employed by Upstream Bio. K. Sumino has consulted with AstraZeneca and Teva and received speaker fees from Kyorin Pharmaceuticals. S. J. Szefler has consulted for Astra Zeneca, Eli Lilly, Regeneron, and Sanofi; has received research support from the NIH/NHLBI (grant 4UH3HL151297-04) and the Colorado Department of Public Health and Environment Cancer, Cardiovascular, and Pulmonary Disease Program; and participated in advisory boards with Sanofi. S. E. Wenzel has consulted for Eli Lily and Johnson, serves on the respiratory advisory board for Chiesi, is principal investigator of an investigator-initiated study with Regeneron, has consulted for Regeneron, and is site principal investigator of a multicenter study with Amgen. M. E. Wechsler has received consulting and/or advisory honoraria from AbbVie, Allakos, Apogee, Areteia Therapeutics, Arrowhead Pharmaceutical, Avalo Therapeutics, Belenos Bio, Celldex, Connect Biopharma, Eli Lilly, Enveda Therapeutics, Equillium, General Medicines, Gilead, Jasper Therapeutics, Kinaset, Kymera, Merck, MyBiometry, Pfizer, Pharming, Phylaxis, Pulmatrix, Rapt Therapeutics, recludix Pharma, Roche/Genentech, Sentien, Sound Biologics, Tetherex Pharmaceuticals, Uniquity Bio, Verona Pharma, and Zurabio. In addition, he has received consulting, advising, and/or speaking honoraria from AstraZeneca, Amgen, Regeneron, GlaxoSmithKline, Sanofi/Genzyme and is doing research sponsored by them. In addition, M. E. Wechsler has received stock options from Cellergy Pharma, and he has received consulting honoraria and stock options from and is doing research sponsored by Upstream Bio. S. R. White has received speaker fees from AstraZeneca and Sanofi/Regeneron. A. A. Zeki has received consultant and speaking fees from AstraZeneca, Regeneron, and Sanofi and is also a cofounder, director, and chief sales officer/chief marketing officer of InStatin. L. B. Bacharier is a member of the Global Initiative for Asthma Science Committee; reports grants from NIH/NIAID/NHLBI; has received personal fees from GlaxoSmithKline, Genentech/Novartis, AstraZeneca, Avillion, WebMD/Medscape, Sanofi/Regeneron, Circassia, OM Pharma, Apogee, Excellergy, and Kinaset, AstraZeneca (fees for DSMB), DBV Technologies, Aravax, AbbVie, Horizon, and Vertex; and has received royalties from Elsevier and Up-To-Date outside the submitted work. P. Akuthota has received grant funding from AstraZeneca, Sanofi, 4D Molecular Therapeutics, and Recode and consulting fees from AstraZeneca, Connect Biopharma, Gilead, Sanofi, Regeneron, GSK, Amgen, Vida Ventures, and Enveda. The rest of the authors declare that they have no relevant conflicts of interest.