The Tralokinumab Pre-Filled Pen Improved Atopic Dermatitis Signs and Symptoms and Was Well Tolerated in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis: A 16-Week, Open-Label, Single-Arm Phase 3 Study (INJECZTRA)

Conflicts of Interest

Jennifer Soung reports payment for participation in research, participation in advisory boards, or giving lectures or presentations from Amgen, Bristol Myers Squibb, Johnson & Johnson, Incyte, Union Chimique Belge (UCB), Eli Lilly, Abbvie, Pfizer, LEO Pharma A/S, Regeneron, Sanofi, Arcutis, Dermavant, Novartis, and Coval. Vivian Laquer reports payment for participation in research from Abbvie, Acelyrin, Acrotech, Amgen, Argenx, Arcutis, Aslan, Biofrontera, Bristol Meyers Squibb, Cara, Dermavant, Eli Lilly, Galderma, Horizon Therapeutics, Incyte, Janssen, LEO Pharma A/S, Novartis, Padagis, Pfizer, Q32 Bio, Rapt Therapeutics, Sun, UCB, and Ventyx. Matthew Zirwas reports consulting fees from Abbvie, Aldeyra, Advanced Derm Solutions, All Free Clear/Sun, Apogee, Arcutis, Bausch and Lomb, Cara, Castle Biosciences, Dermavant, Novan, Genentech, Galderma, Novartis, Incyte, Janssen, L’Oreal, LEO Pharma A/S, Level-Ex, Eli Lilly, LUUM, Meta, Pfizer, Regeneron, Sanofi, Trevi, Trifecta, and Verrica; payment for participation in research from Abbvie, Acrotech, Aldeyra, Amgen, Anaptys Bio, Arcutis, Biocon, Bristol Myers Squibb, Cara, Concert, Dermavant, Edessa Biotech, Novan, Evelo, Galderma, Incyte, LEO Pharma A/S, Eli Lilly, Nimbus, Pfizer, Regeneron, Sanofi, and UCB; and payment for giving lectures or presentations from Abbvie, Advanced Derm Solutions, Dermavant, Novan, Incyte, LEO Pharma A/S, Eli Lilly, Pfizer, Regeneron, and Sanofi. Peter van Iperen, John C. Stinson, and Katrine Lykke Albertsen are employees and shareholders of LEO Pharma A/S. Linda Stein Gold reports payment for participation in research, participation in advisory boards, or giving lectures or presentations from LEO Pharma A/S, Eli Lilly, Sanofi, Regeneron, Dermavant, Arcutis, Incyte, Amgen, Pfizer, and Abbvie.

Ethical Approval

The study protocol was approved by all relevant ethics committees and institutional review boards (by Advarra® IRB, 6100 Merriwhether Dr. Suite 600, Columbia, MD, 21044, USA). The study was conducted according to the principles of the Declaration of Helsinki and the International Council for Harmonization guidelines for Good Clinical Practice and conformed with all laws and regulations in the USA. Written informed consent for participation in the study was provided by adult patients or legal representatives of adolescent patients. Consent for the publication of patient photographs or other identifiable material was obtained as part of the informed consent process. All patients gave consent with the understanding that this information may become publicly available.

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