Funding

The tralokinumab ECZTRA 3 trial was sponsored by LEO Pharma A/S (Ballerup, Denmark).

Conflicts of interest/Competing interests

JIS reports personal fees from AbbVie, Afyx, AnaptysBio, Aobiome, Arena, Asana, Aslan, BioMX, Bluefin, Bodewell, Boehringer Ingelheim, Celgene, Connect Biopharma, Dermavant, Dermira, DS Biopharma, Eli Lilly, Galderma, GlaxoSmithKline, Incyte, Kiniksa, Kymab, LEO Pharma, Luna, Menlo, Novartis, Pfizer, RAPT, Realm, Regeneron, and Sanofi Genzyme, grants and/or personal fees from Galderma, GlaxoSmithKline and Pfizer, and stock/stock options from AbbVie, Arcutis, and Eli Lilly outside the submitted work. DNA has been an investigator, consultant, advisory board member, speaker for and/or received honoraria from AbbVie, Actelion, Amgen, Arcutis, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Coherus, Dermira, Dermavant, Eli Lilly, Galderma, Incyte, Janssen, LEO Pharma, Merck, Novartis, Pfizer, Regeneron, Sanofi Genzyme, Stiefel, Sun Pharma, UCB, and Valeant. MZ is a consultant, investigator, and/or speaker for AbbVie, All Free Care/Sun, Anaptys Bio, Arcutis, Bausch Health, Cara, Concert, Dermavant, Edessa Biotech, Eli Lilly and Company, EPI Health, Fit Bit, Galderma, Genentech, Incyte, LEO Pharma, Level-Ex, L’Oréal, LUUM, Menlo, Novartis, Oculus, Ortho Derm, Peloton, Pfizer, Regeneron, Sanofi, Trevi, and UCB, is a part owner of AsepticMD, and has worked with LEO Pharma and other companies with atopic dermatitis drugs that have received FDA approval or are expected to receive FDA approval in the next year. SK reports consulting for AbbVie, Amgen Inc, Aralez Pharmaceuticals Canada Inc, Bausch Health, Celgene Corporation, Eli Lilly and Company, Galderma SA, Johnson & Johnson, La Roche-Posay, Novartis International AG, Pfizer Inc, Sanofi Genzyme, and UCB; conducting clinical trials that have received funding from AbbVie, Amgen Inc, Bausch Health, Corbus Pharmaceuticals Holdings Inc, Eli Lilly and Company, Janssen Pharmaceuticals, LEO Pharma, Merck & Co, Novartis, Pfizer Inc, and UCB; receiving grant funding from LEO Pharma A/S and Novartis International AG; and serving as co-chair of the Canadian PSOLAR steering committee; and has received salary support from the Michael Smith Foundation for Health Research. JG is a consultant and/or speaker for and/or receives honoraria from AbbVie, Almirall, Eli Lilly, LEO Pharma, Pfizer, Regeneron, and Sanofi Genzyme, and has provided expert testimony to AbbVie and LEO Pharma. AP reports acting as an investigator, speaker, or advisor for AbbVie, Almirall-Hermal, Amgen, Biogen Idec, BioNTec, Boehringer Ingelheim, Celgene, Eli Lilly, Galderma, GlaxoSmithKline, Hexal, Janssen, LEO Pharma, MC2, Medac, Merck Serono, Mitsubishi, MSD, Novartis, Pascoe, Pfizer, Regeneron, Roche, Sandoz Biopharmaceuticals, Sanofi Genzyme, Schering-Plough, Tigercat Pharma, and UCB Pharma. AEP has acted as an advisor/speaker/investigator for or received educational support from AbbVie, Almirall, Amgen, Anaptys Bio, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Galderma, Janssen, La Roche-Posay, LEO Pharma, Lilly, Novartis, Pfizer, Sanofi, and UCB. AC has served as a scientific adviser and/or clinical study investigator for AbbVie, Almirall, Fresenius Kabi, Janssen, LEO Pharma, Lilly, Novartis, Sanofi Genzyme, and UCB Pharma, and as paid speaker for AbbVie, Almirall, Janssen, LEO Pharma, Lilly, Novartis, and Sanofi Genzyme. SB is an investigator or speaker for AbbVie, Almirall, Chiesi, Eli Lilly, Janssen, LEO Pharma, Novartis, Pfizer, Sanofi-Genzyme, UCB Pharma. TM and AMT are employees of and hold stock in LEO Pharma. SW is co-principal investigator of the German atopic eczema registry TREATgermany; has received institutional research grants from La Roche-Posay, LEO Pharma, and Sanofi Deutschland GmbH; has performed consultancies for AbbVie, Almirall, Eli Lilly, GlaxoSmithKline, Kymab, LEO Pharma, Novartis, Pfizer, Regeneron, and Sanofi Genzyme; has lectured at educational events sponsored by AbbVie, Almirall, Eli Lilly, Galderma, LEO Pharma, Pfizer, Novartis, Regeneron, and Sanofi Genzyme; has received work-related travel support from AbbVie, LEO Pharma, and Sanofi Genzyme; and is involved in performing clinical trials with many pharmaceutical industries that manufacture drugs used for the treatment of psoriasis and atopic eczema.

Ethics approval

This randomized study was conducted in accordance with the ethical principles derived from international guidelines including the Declaration of Helsinki and Council for International Organizations of Medical Sciences International Ethical Guidelines and in compliance with International Council for Harmonisation guidelines for Good Clinical Practice. The clinical trial was approved by institutional review boards or ethics committees at each study site. This trial followed the Consolidated Standards of Reporting Trials reporting guideline.

Consent to participate

All patients provided written informed consent.

Consent for publication

NA.

Availability of data and material

Data will be made available, upon request to the study sponsor, following review by the external Patient and Scientific Review Board.

Code availability

NA.

Author contributions

Conceptualization: JIS (equal), DNA (equal), MZ (equal), SK (equal), JG (equal), AP (equal), AEP (equal), AC (equal), SB (equal), TM (equal), AMT (equal), SW (equal); Investigation: JIS (equal), DNA (equal), MZ (equal), SK (equal), JG (equal), AP (equal), AEP (equal), AC (equal), SB (equal), TM (equal), AMT (equal), SW (equal); Data curation: TM (lead); Formal analysis: TM (lead), AMT (supporting); Methodology: TM (equal), AMT (equal); Visualization: AMT (lead); Writing-original draft: JIS (equal), DNA (equal), MZ (equal), SK (equal), JG (equal), AP (equal), AEP (equal), AC (equal), SB (equal), TM (equal), AMT (equal), SW (equal); Writing-review & editing: JIS (equal), DNA (equal), MZ (equal), SK (equal), JG (equal), AP (equal), AEP (equal), AC (equal), SB (equal), TM (equal), AMT (equal), SW (equal).