Optimization of placebo use in clinical trials with systemic treatments for atopic dermatitis: an International Eczema Council survey‐based position statement

Author:

Leshem Y.A.12,Bissonnette R.3,Paul C.4,Silverberg J.I.5,Irvine A.D.678,Paller A.S.9,Cork M.J.10,Guttman‐Yassky E.11

Affiliation:

1. Department of Dermatology Beilinson Hospital Rabin Medical Center Petach‐Tikva Israel

2. Sackler School of Medicine Tel‐Aviv University Tel‐Aviv Israel

3. Innovaderm Research Inc Montreal QC Canada

4. Paul Sabatier University Toulouse France

5. Department of Dermatology Department of Preventive Medicine, and Department of Medical Social Sciences Northwestern University Feinberg School of Medicine Chicago IL USA

6. Pediatric Dermatology Our Lady's Children's Hospital Crumlin Dublin Ireland

7. National Children's Research Centre Our Lady's Children's Hospital Crumlin Dublin Ireland

8. Clinical Medicine Trinity College Dublin Dublin Ireland

9. Departments of Dermatology and Pediatrics Northwestern University Feinberg School of Medicine and Ann and Robert H. Lurie Children's Hospital of Chicago Chicago IL USA

10. Sheffield Dermatology Research Department of Infection, Immunity and Cardiovascular Disease The University of Sheffield Sheffield UK

11. Icahn School of Medicine at Mount Sinai New York NY USA

Funder

GlaxoSmithKline

LEO Pharma Research Foundation

MedImmune

Genzyme

AbbVie

Amgen

Celgene

Chugai Pharmaceutical

Galderma

Eli Lilly and Company

Novartis

Les Laboratories Pierre Fabre

Pfizer

Sanofi

Valeant Pharmaceuticals International

Publisher

Wiley

Subject

Infectious Diseases,Dermatology

Reference45 articles.

1. Choice of Control Group and Related Issues in Clinical Trials: ICH. URLhttp://www.ich.org/products/guidelines/efficacy/efficacy-single/article/choice-of-control-group-and-related-issues-in-clinical-trials.html(last accessed: 11 September 2017).

2. Efficacy and safety of lebrikizumab (an anti-IL-13 monoclonal antibody) in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical corticosteroids: A randomized, placebo-controlled phase II trial (TREBLE)

3. WollenbergA HowellMD Guttman‐YasskyEet al.A phase 2b dose‐ranging efficacy and safety study of tralokinumab in adult patients with moderate to severe atopic dermatitis. In:75th Annual Meeting of the American Academy of Dermatology. Orlando Florida;2017.

4. Towards global consensus on outcome measures for atopic eczema research: results of the HOME II meeting

5. The Ethics of Placebo-Controlled Trials — A Middle Ground

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