{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,6]],"date-time":"2026-09-06T06:20:46Z","timestamp":1788675646857,"version":"build-2803163510"},"reference-count":45,"publisher":"Oxford University Press (OUP)","issue":"Supplement_1","license":[{"start":{"date-parts":[[2025,2,3]],"date-time":"2025-02-03T00:00:00Z","timestamp":1738540800000},"content-version":"vor","delay-in-days":2,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,2,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>The therapeutic pipeline for moderate-to-severe hidradenitis suppurativa (HS) is robust. Successes and lessons learned have led to improvements in trial designs aimed at avoiding prior pitfalls, as well as high placebo response in HS, which remains a fundamental threat to drug development.<\/jats:p>\n               <jats:p>Herein, we review the evolutions in HS trials over the last 20\u2005years with respect to overall design, sample size, diversity in enrolment, inclusion criteria, concomitant medications, rescue therapy, endpoints and statistical design analysis plans. Areas of focus that merit future consideration are also highlighted.<\/jats:p>","DOI":"10.1093\/bjd\/ljae318","type":"journal-article","created":{"date-parts":[[2025,2,3]],"date-time":"2025-02-03T09:49:17Z","timestamp":1738576157000},"page":"i15-i21","source":"Crossref","is-referenced-by-count":7,"title":["An evolutionary tale on clinical trials in hidradenitis suppurativa"],"prefix":"10.1093","volume":"192","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3201-4637","authenticated-orcid":false,"given":"Christopher J","family":"Sayed","sequence":"first","affiliation":[{"name":"Department of Dermatology, University of North Carolina at Chapel Hill , Chapel Hill, NC ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2273-2301","authenticated-orcid":false,"given":"Rayad B","family":"Shams","sequence":"additional","affiliation":[{"name":"Department of Dermatology, University of North Carolina at Chapel Hill , Chapel Hill, NC ,","place":["USA"]},{"name":"University of North Carolina Chapel Hill School of Medicine , Chapel Hill, NC ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bria","family":"Midgette","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Northwell Health , New Hyde Park, NY ,","place":["USA"]},{"name":"Donald and Barbara Zucker School of Medicine at Hofstra Northwell , New Hyde Park, NY ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0886-6856","authenticated-orcid":false,"given":"Amit","family":"Garg","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Northwell Health , New Hyde Park, NY ,","place":["USA"]},{"name":"Donald and Barbara Zucker School of Medicine at Hofstra Northwell , New Hyde Park, NY ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2025,2,3]]},"reference":[{"key":"2025020309491115500_ljae318-B1","doi-asserted-by":"crossref","first-page":"797","DOI":"10.1001\/jamadermatol.2019.0164","article-title":"Comparative overall comorbidity burden among patients with hidradenitis suppurativa","volume":"155","author":"Reddy","year":"2019","journal-title":"JAMA Dermatol"},{"key":"2025020309491115500_ljae318-B2","doi-asserted-by":"crossref","first-page":"937","DOI":"10.1016\/j.jaad.2019.06.016","article-title":"All-cause mortality among patients with hidradenitis suppurativa: a population-based cohort study in the United States","volume":"81","author":"Reddy","year":"2019","journal-title":"J Am Acad Dermatol"},{"key":"2025020309491115500_ljae318-B3","doi-asserted-by":"crossref","first-page":"429","DOI":"10.1001\/jamadermatol.2015.6264","article-title":"Risk of major adverse cardiovascular events and all-cause mortality in patients with hidradenitis suppurativa","volume":"152","author":"Egeberg","year":"2016","journal-title":"JAMA Dermatol"},{"issue":"5 Suppl. 1","key":"2025020309491115500_ljae318-B4","doi-asserted-by":"crossref","first-page":"S19","DOI":"10.1016\/j.jaad.2015.07.054","article-title":"The psychosocial impact of hidradenitis suppurativa","volume":"73","author":"Gooderham","year":"2015","journal-title":"J Am Acad Dermatol"},{"key":"2025020309491115500_ljae318-B5","doi-asserted-by":"crossref","first-page":"222","DOI":"10.2340\/00015555-2129","article-title":"Disutility in patients with hidradenitis suppurativa: a cross-sectional study using EuroQoL-5D","volume":"96","author":"Riis","year":"2016","journal-title":"Acta Derm Venereol"},{"key":"2025020309491115500_ljae318-B6","doi-asserted-by":"crossref","first-page":"366","DOI":"10.1016\/j.jaad.2019.06.1301","article-title":"Evaluating patients\u2019 unmet needs in hidradenitis suppurativa: results from the Global Survey Of Impact and Healthcare Needs (VOICE) project","volume":"82","author":"Garg","year":"2020","journal-title":"J Am Acad Dermatol"},{"key":"2025020309491115500_ljae318-B7","doi-asserted-by":"crossref","first-page":"927","DOI":"10.1111\/bjd.21798","article-title":"Factors associated with treatment satisfaction in patients with hidradenitis suppurativa: results from the Global VOICE project","volume":"187","author":"Midgette","year":"2022","journal-title":"Br J Dermatol"},{"key":"2025020309491115500_ljae318-B8","doi-asserted-by":"crossref","first-page":"422","DOI":"10.1056\/NEJMoa1504370","article-title":"Two phase 3 trials of adalimumab for hidradenitis suppurativa","volume":"375","author":"Kimball","year":"2016","journal-title":"N Engl J Med"},{"key":"2025020309491115500_ljae318-B9","doi-asserted-by":"crossref","first-page":"747","DOI":"10.1016\/S0140-6736(23)00022-3","article-title":"Secukinumab in moderate-to-severe hidradenitis suppurativa (SUNSHINE and SUNRISE): week 16 and week 52 results of two identical, multicentre, randomised, placebo-controlled, double-blind phase 3 trials","volume":"401","author":"Kimball","year":"2023","journal-title":"Lancet"},{"key":"2025020309491115500_ljae318-B10","doi-asserted-by":"crossref","first-page":"2504","DOI":"10.1016\/S0140-6736(24)00101-6","article-title":"Efficacy and safety of bimekizumab in patients with moderate-to-severe hidradenitis suppurativa (BE HEARD I and BE HEARD II): two 48-week, randomised, double-blind, placebo-controlled, multicentre phase 3 trials","volume":"403","author":"Kimball","year":"2024","journal-title":"Lancet"},{"key":"2025020309491115500_ljae318-B11","article-title":"ACELYRIN, INC. announces izokibep achieves HiSCR100 responses at 12 weeks in moderate-to-severe hidradenitis suppurativa","author":"ACELYRIN, INC"},{"key":"2025020309491115500_ljae318-B12"},{"key":"2025020309491115500_ljae318-B13","doi-asserted-by":"crossref","first-page":"2098","DOI":"10.1111\/jdv.19252","article-title":"Guselkumab for the treatment of patients with moderate-to-severe hidradenitis suppurativa: a phase 2 randomized study","volume":"37","author":"Kimball","year":"2023","journal-title":"J Eur Acad Dermatol Venereol"},{"key":"2025020309491115500_ljae318-B14","doi-asserted-by":"crossref","first-page":"1099","DOI":"10.1007\/s13555-023-00913-3","article-title":"Efficacy and safety of risankizumab for the treatment of hidradenitis suppurativa: a phase 2, randomized, placebo-controlled trial","volume":"13","author":"Kimball","year":"2023","journal-title":"Dermatol Ther (Heidelb)"},{"key":"2025020309491115500_ljae318-B15","doi-asserted-by":"crossref","first-page":"45","DOI":"10.1016\/j.jaad.2019.05.065","article-title":"Exploring changes in placebo treatment arms in hidradenitis suppurativa randomized clinical trials: a systematic review","volume":"82","author":"Amir Ali","year":"2020","journal-title":"J Am Acad 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double-blind, placebo-controlled randomized clinical trial","volume":"157","author":"Glatt","year":"2021","journal-title":"JAMA Dermatol"},{"key":"2025020309491115500_ljae318-B22","doi-asserted-by":"crossref","first-page":"EVIDoa2300155","DOI":"10.1056\/EVIDoa2300155","article-title":"Brepocitinib, zimlovisertib, and ropsacitinib in hidradenitis suppurativa","volume":"3","author":"Kimball","year":"2024","journal-title":"NEJM Evid"},{"key":"2025020309491115500_ljae318-B23"},{"key":"2025020309491115500_ljae318-B24","doi-asserted-by":"crossref","first-page":"3127","DOI":"10.1038\/s41591-023-02635-7","article-title":"IRAK4 degrader in hidradenitis suppurativa and atopic dermatitis: a phase 1 trial","volume":"29","author":"Ackerman","year":"2023","journal-title":"Nat Med"},{"key":"2025020309491115500_ljae318-B25","doi-asserted-by":"crossref","first-page":"760","DOI":"10.1001\/jamadermatol.2017.0201","article-title":"Sex- and age-adjusted population analysis of prevalence estimates for hidradenitis suppurativa in the United States","volume":"153","author":"Garg","year":"2017","journal-title":"JAMA Dermatol"},{"key":"2025020309491115500_ljae318-B26","doi-asserted-by":"crossref","first-page":"348","DOI":"10.1093\/geront\/gnv118","article-title":"African Americans and clinical research: evidence concerning barriers and facilitators to participation and recruitment recommendations","volume":"57","author":"Hughes","year":"2017","journal-title":"Gerontologist"},{"key":"2025020309491115500_ljae318-B27","doi-asserted-by":"crossref","first-page":"208","DOI":"10.1016\/j.jdin.2020.09.005","article-title":"Quantifying the natural variation in lesion counts over time in untreated hidradenitis suppurativa: implications for outcome measures and trial design","volume":"1","author":"Frew","year":"2020","journal-title":"JAAD Int"},{"key":"2025020309491115500_ljae318-B28","doi-asserted-by":"crossref","first-page":"1399","DOI":"10.1016\/j.jaad.2020.07.108","article-title":"Low prescription of tumor necrosis alpha inhibitors in hidradenitis suppurativa: a cross-sectional analysis","volume":"84","author":"Orenstein","year":"2021","journal-title":"J Am Acad Dermatol"},{"key":"2025020309491115500_ljae318-B29","doi-asserted-by":"crossref","first-page":"689","DOI":"10.1111\/pde.15026","article-title":"A cross-sectional study of pediatric hidradenitis suppurativa and the value of the International Hidradenitis Suppurativa Severity Score System (IHS4) as a pediatric clinical trial inclusion criteria","volume":"39","author":"Bui","year":"2022","journal-title":"Pediatr Dermatol"},{"key":"2025020309491115500_ljae318-B30","doi-asserted-by":"crossref","first-page":"45","DOI":"10.1159\/000526069","article-title":"Demographic gaps and requirements for participation: a systematic review of clinical trial designs in hidradenitis 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