A Phase 3b/4 Randomized, Open-label, Efficacy Assessor Blinded Study, Comparing the Safety and Assessor Blinded Efficacy of Upadacitinib to Dupilumab in Subjects With Moderate to Severe Atopic Dermatitis (Level-Up)
A Phase 3b/4 Randomized, Open-label, Efficacy Assessor Blinded Study, Comparing the Safety and Assessor Blinded Efficacy of Upadacitinib to Dupilumab in Subjects With Moderate to Severe Atopic Dermatitis (Level-Up)
Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study compares upadacitinib to dupilumab in adolescent and adult participants with moderate to severe AD who have inadequate response to systemic therapies. Adverse events and change in the disease activity will be assessed.
Upadacitinib and dupilumab are approved drugs for the treatment of moderate to severe atopic dermatitis (AD). The study is comprised of a 35-day Screening Period, a 16-week treatment Period 1 and a 16-week treatment Period 2. Participants are randomly assigned to 1 of 2 groups called treatment arms to receive upadacitinib Dose A or dupilumab in Period 1. There is a 30-day or 12-week follow-up visit for those on upadacitinib or dupilumab respectively, who will not enter Period 2. In Period 2, participants will receive upadacitinib Dose A or Dose B for 16 weeks, followed by a 30-day follow-up visit. Approximately 880 adolescent and adult participants ages 12 to 64 with moderate to severe AD who are candidates for systemic therapy will be enrolled at up to 330 sites worldwide.
There may be higher treatment burden for participants in this trial compared to their standard of care . Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Inclusion Criteria:
Exclusion Criteria:
Fayetteville, Arkansas 72703, United States
Lincoln, Nebraska 68505-2343, United States
Tulsa, Oklahoma 74136-7049, United States
Charleston, South Carolina 29425-8903, United States
Murfreesboro, Tennessee 37130-2450, United States
Houston, Texas 77065, United States
Woluwe-Saint-Lambert, Brussels Capital 1200, Belgium
Pleven, Smolyan 5800, Bulgaria
Sofiya, Sofia 1431, Bulgaria
Sofia, 1407, Bulgaria
Québec, Quebec G1V 4X7, Canada
Guangzhou, Guangdong 510260, China
Wuhan, Hubei 430022, China
Hangzhou, Zhejiang 310009, China
Grad Zagreb, City of Zagreb 10000, Croatia
Zagreb, City of Zagreb 10000, Croatia
Copenhagen NV, Capital Region 2400, Denmark
Blankenfelde-Mahlow, Brandenburg 15831, Germany
Bramsche, Lower Saxony 49565, Germany
Bad Bentheim, Saarland 48455, Germany
Lübeck, Schleswig-Holstein 23538, Germany
Pecs, Nógrád megye 7624, Hungary
Rome, Roma 00144, Italy
Perugia, 06156, Italy
Kawasaki-shi, Kanagawa 211-0063, Japan
Sagamihara-shi, Kanagawa 252-0392, Japan
Yokohama, Kanagawa 220-6208, Japan
Habikino-shi, Osaka 583-8588, Japan
Sakai-shi, Osaka 5938324, Japan
Setagaya-ku, Tokyo 158-0097, Japan
Cracow, Lesser Poland Voivodeship 30-438, Poland
Krakow, Lesser Poland Voivodeship 31-011, Poland
Iwonicz-Zdrój, Podkarpackie Voivodeship 38-440, Poland
Gdansk, Pomeranian Voivodeship 80-546, Poland
Elblag, Warmian-Masurian Voivodeship 82-300, Poland
Guimarães, Braga District 4839-008, Portugal
Lisboa, Madeira 1998-018, Portugal
Porto, Madeira 4099-001, Portugal
CAPE TOWN Milnerton, Western Cape 7441, South Africa
Dongjak-gu, Gyeonggido 06973, South Korea
Taipei City, Taipei 100, Taiwan
Gaziantep, Adana 27310, Turkey (Türkiye)