A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Efficacy and Safety of Upadacitinib in Adult and Adolescent Subjects With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy
A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Efficacy and Safety of Upadacitinib in Adult and Adolescent Subjects With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy
Hidradenitis suppurativa (HS) is an inflammatory skin disease that causes painful lesions in the axilla (underarm), inguinal (groin) and anogenital (anal/genital) regions. This study will assess how safe and effective upadacitinib is in treating adult and adolescent participants with moderate to severe HS who have failed to respond to or are intolerant of anti-tumor necrosis factor (TNF) therapy. Adverse events and change in disease activity will be assessed.
Upadacitinib is an approved drug for ulcerative colitis, atopic dermatitis, rheumatoid arthritis, psoriatic arthritis, and axial spondylarthritis and is being developed for the treatment of HS. This study is "double-blinded", meaning that neither the trial participants nor the study doctors will know who will be given upadacitinib and who will be given placebo. This study is comprised of 3 periods. In Period 1, participants are randomized into 2 groups called treatment arms where each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. In Period 2, participants are placed into 6 different groups depending on their placement and results in Period 1. Period 3 is the long-term extension period where participants will continue treatment from Period 2. Approximately 1328 adult and adolescent participants diagnosed with HS will be enrolled in approximately 300 sites worldwide.
Participants will receive oral tablets of upadacitinib or placebo once daily for 36 weeks in Period 1 and Period 2. Eligible participants from Period 1 and Period 2 will enter Period 3 and receive oral tablets of upadacitinib or placebo once daily for 68 weeks. Participants will be followed up for approximately 30 days.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular outpatient visits during the study. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
Inclusion Criteria:
Exclusion Criteria:
Fountain Hills, Arizona 85268, United States
Fayetteville, Arkansas 72703, United States
Chicago, Illinois 60611-2927, United States
Worcester, Massachusetts 01655, United States
Clarkston, Michigan 48346, United States
Lee's Summit, Missouri 64064-2301, United States
St Louis, Missouri 63130, United States
Charlotte, North Carolina 28277-3816, United States
Hershey, Pennsylvania 17033-2360, United States
Grapevine, Texas 76051-3580, United States
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D. 1055, Argentina
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D. 1425, Argentina
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D. 1425, Argentina
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D. 1428, Argentina
Buenos Aires, 1061, Argentina
CABA, C1199ABB, Argentina
Anderlecht, Brussels Capital 1070, Belgium
Macaé, Rio de Janeiro 27910-190, Brazil
Ribeirão Preto, São Paulo 14049-900, Brazil
São Paulo, São Paulo 04020-060, Brazil
São Paulo, 05403-000, Brazil
Sofiya, Sofia 1407, Bulgaria
Sofiya, Sofia 1463, Bulgaria
Santiago, Region Metropolitana Santiago 8420383, Chile
Barranquilla, Atlántico 80002, Colombia
Bogotá, Cundinamarca 110221, Colombia
Zagreb, City of Zagreb 10000, Croatia
Ivanić-Grad, Zagreb County 10310, Croatia
Bordeaux, Gironde 33000, France
Nantes, Pays de la Loire Region 44000, France
Bramsche, Lower Saxony 49565, Germany
Cona, Ferrara 44124, Italy
Rome, Roma 00168, Italy
Nishinomiya-shi, Hyōgo 663-8186, Japan
Kyoto, Kyoto 602-8566, Japan
Ginowan-shi, Okinawa 901-2725, Japan
Sakai-shi, Osaka 590-0197, Japan
Itabashi-ku, Tokyo 173-8610, Japan
Minato-ku, Tokyo 105-8470, Japan
Porto, 4099-001, Portugal
Riyadh, Riyadh Region 11211, Saudi Arabia
Riyadh, Riyadh Region 11426, Saudi Arabia
Bratislava, Bratislava Region 821 01, Slovakia
Seoul, Seoul Teugbyeolsi 07441, South Korea
Ankara, Antalya 06010, Turkey (Türkiye)
Istanbul, 34098, Turkey (Türkiye)
London, Greater London SW17 0QT, United Kingdom
Southampton, Hampshire SO16 6YD, United Kingdom