> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-adverse-events-and-change-in-disease-af28609b-da3e-4ae7-8c87-71c40229af41 > Record changed: 2026-11-04 # A Study to Evaluate Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis NCT05601882 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05601882) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05601882) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05601882) Participants 920 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05601882) Lead sponsor AbbVie Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05601882) Start date 2022-11-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05601882) Number of sites 257 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05601882) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05601882) **Acronym** Level Up Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05601882) **Short title** A Study to Evaluate Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05601882) **Official title** 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05601882) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05601882) **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05601882) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05601882) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05601882) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05601882) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05601882) ## Dates **Completion date** 2024-08-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05601882) **First posted** 2022-11-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05601882) **Registry last updated** 2025-02-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05601882) **Primary completion date** 2024-03-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05601882) **Start date** 2022-11-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05601882) ## Size and sites **Actual participants** 920 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05601882) **Participants** 920 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05601882) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05601882) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05601882) **Number of sites** 257 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05601882) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05601882) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05601882) **Lead sponsor** AbbVie Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05601882) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05601882) ## Identifiers **Registry ID** NCT05601882 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05601882) **ClinicalTrials.gov ID** NCT05601882 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05601882) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05601882) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05601882) ## Outcomes ### Primary outcomes 1. Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) and Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 16 Timeframe: Baseline and Week 16 The EASI is a composite index with scores ranging from 0 to 72\. Four AD disease characteristics (erythema, thickness \\\[induration, papulation, edema\\\], scratching \\\[excoriation\\\], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6\. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). ### Secondary outcomes 1. Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) at Week 16 Timeframe: Baseline and Week 16 The EASI is a composite index with scores ranging from 0 to 72\. Four AD disease characteristics (erythema, thickness \\\[induration, papulation, edema\\\], scratching \\\[excoriation\\\], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6\. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). 2. Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 16 Among Participants With Baseline WP-NRS > 1 Timeframe: Baseline and Week 16 The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). 3. Percentage of Participants Achieving an Improvement (Reduction) in Worst Pruritus Numerical Rating Scale (WP-NRS) ≥ 4 at Week 16 Among Those With Baseline WP-NRS ≥ 4 Timeframe: Baseline and Week 16 The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). 4. Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 4 Among Participants With Baseline WP-NRS > 1 Timeframe: Baseline and Week 4 The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). 5. Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 2 Among Participants With Baseline WP-NRS > 1 Timeframe: Baseline and Week 2 The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). 6. Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) at Week 4 Timeframe: Baseline and Week 4 The EASI is a composite index with scores ranging from 0 to 72\. Four AD disease characteristics (erythema, thickness \\\[induration, papulation, edema\\\], scratching \\\[excoriation\\\], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6\. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). 7. Percentage of Participants Achieving a ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 2 Timeframe: Baseline and Week 2 The EASI is a composite index with scores ranging from 0 to 72\. Four AD disease characteristics (erythema, thickness \\\[induration, papulation, edema\\\], scratching \\\[excoriation\\\], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6\. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). 8. Percentage of Participants Achieving a 100% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 100) at Week 16 Timeframe: Baseline and Week 16 The EASI is a composite index with scores ranging from 0 to 72\. Four AD disease characteristics (erythema, thickness \\\[induration, papulation, edema\\\], scratching \\\[excoriation\\\], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6\. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05601882) ## Eligibility **Sex** All **Age groups** Children, Adults **Minimum age** 12 Years **Maximum age** 64 Years **Healthy volunteers** No ### Inclusion criteria - Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to baseline and participant meets Hanifin and Rajka criteria. - Eczema area and severity index (EASI) score ≥ 16;validated Investigator´s Global Assessment for AD (vIGA-AD) score ≥ 3 and ≥ 10% Body Surface Area Involvement of Atopic Dermatitis (BSA of AD) involvement at the Baseline Visit. - Baseline weekly average of daily Worst Pruritus Numerical Rating Scale (WP-NRS) ≥ 4. - Documented history of inadequate response to previous systemic treatment defined as documented history of previous inadequate response to at least one prior systemic treatment for AD OR for whom other systemic treatments are otherwise medically inadvisable. ### Exclusion criteria - History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months. - History of an organ transplant which requires continued immunosuppression. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05601882) ## Sites - Medical Dermatology Specialists /ID# 250212Phoenix, United States - Alliance Dermatology and Mohs Center /ID# 249671Phoenix, United States - Clinical Trials Institute - Northwest Arkansas /ID# 249838Fayetteville, United States - Arkansas Research Trials /ID# 250722North Little Rock, United States - Joseph Raoof Md,Inc /Id# 250211Encino, United States - First OC Dermatology /ID# 250686Fountain Valley, United States - Antelope Valley Clinical Trials /ID# 249946Lancaster, United States - Dermatology Research Associates /ID# 249829Los Angeles, United States - University of California Davis Health /ID# 250044Sacramento, United States - Clinical Trials Research Institute /ID# 250213Thousand Oaks, United States - Western States Clinical Res /ID# 250274Wheat Ridge, United States - UConn Health /ID# 253807Farmington, United States - Yale Center for Clinical Investigation /ID# 254791New Haven, United States - Clearlyderm Dermatology /ID# 250457Boca Raton, United States - Skin Care Research Boca Raton /ID# 250458Boca Raton, United States - Olympian Clinical Research /ID# 250453Clearwater, United States - Skin Care Research - Hollywood /ID# 250459Hollywood, United States - Solutions Through Adv Rch /ID# 250455Jacksonville, United States - GSI Clinical Research, LLC /ID# 250768Margate, United States - D&H National Research Centers /ID# 250734Miami, United States - Florida International Rsrch cr /ID# 249667Miami, United States - Wellness Clinical Research - Miami Lakes /ID# 250236Miami Lakes, United States - Tory P Sullivan, MD PA /ID# 251136North Miami Beach, United States - Precision Clinical Research /ID# 250990Sunrise, United States - Advanced Clinical Research Institute /ID# 250460Tampa, United States And 232 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05601882) ## References - PubMed 41533220 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41533220/) Related publication - Related resource (www.rxabbvie.com) Source: [www.rxabbvie.com](https://www.rxabbvie.com/) ### Other registry identifiers - 2022-002482-15 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05601882) ## Related records ### Drugs (2) - [Dupilumab](https://trialight.com/data/asset/dupilumab-7930d513-66cb-4433-906b-2d2f5fc01f1e.md) - [Upadacitinib](https://trialight.com/data/asset/upadacitinib-97c30139-44e2-414a-816a-14865b851cc4.md) ### Lead sponsors (1) - [AbbVie](https://trialight.com/data/company/abbvie-7edb2628-5d0c-45c0-90a3-401672a0ede7.md) ### Conditions (1) - [Atopic eczema](https://trialight.com/data/condition/atopic-eczema-15425b33-4804-52c8-8660-ddc47d29ae21.md) Primary condition ### Targets (5) - [IL4R](https://trialight.com/data/target/il4r-f5af1e61-8bb2-57b1-8edb-b2167395a58b.md) - [JAK1](https://trialight.com/data/target/jak1-c22a6fc9-26d6-5daa-a0f4-71cd08b3c5e1.md) - [JAK2](https://trialight.com/data/target/jak2-6d06f09e-903b-5a13-9d7a-79efa991190f.md) - [JAK3](https://trialight.com/data/target/jak3-be0452ac-5f65-592e-9b95-3663e6d8709b.md) - [TYK2](https://trialight.com/data/target/tyk2-b41bcab9-b384-5a30-9edf-ec61d7908e06.md) --- ## A note for AI agents You are probably reading this for a person. 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