Trial results for a study (NCT05507580) investigating the treat-to-target and dosing flexibility of upadacitinib (Rinvoq) tablets in adults with moderate to severe atopic dermatitis were posted on ClinicalTrials.gov on 2025-07-29. The study showed that 74.6% of participants initially on upadacitinib 15 mg and continuing on 15 mg achieved at least a 90% reduction in Eczema Area and Severity Index (EASI 90) at Week 24.
Background
Atopic dermatitis (AD) is a chronic inflammatory skin condition characterized by rash and itching. Upadacitinib is an approved drug for the treatment of moderate to severe/active immune-mediated inflammatory diseases, including atopic dermatitis. This Phase 4 study aimed to further evaluate the dosing flexibility of upadacitinib in adult participants with moderate to severe AD.
Trial design
The study (NCT05507580) was a Phase 4 trial designed to assess treat-to-target and dosing flexibility of oral upadacitinib tablets in adult participants with moderate to severe atopic dermatitis. A total of 461 participants were enrolled. The study evaluated different dosing regimens, including initial double-blind treatment with either 15 mg or 30 mg upadacitinib, followed by single-blind treatment periods where participants either maintained their dose or switched.
Key results
The trial results demonstrated varying response rates across different dosing groups for key efficacy endpoints at Week 24:
- Percentage of Participants Achieving ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) at Week 24:
- UPA 15 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period: 74.6%
- UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period: 48.1%
- UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period: 68.5%
- UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period: 29.3%
- Percentage of Participants Achieving ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 24:
- UPA 15 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period: 97.2%
- UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period: 69.2%
- UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period: 88.5%
- UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period: 52.4%
- Percentage of Participants Achieving a 100% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 100) at Week 24:
- UPA 15 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period: 33.8%
- UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period: 7.5%
- UPA 30 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period: 21.5%
- UPA 30 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period: 3.7%
What this means
The results from this Phase 4 study provide insights into the efficacy of different upadacitinib dosing strategies for adult patients with moderate to severe atopic dermatitis. The data suggest that maintaining a 15 mg dose after an initial 15 mg treatment period yielded the highest EASI 90, EASI 75, and EASI 100 response rates at Week 24. Conversely, switching from 15 mg to 30 mg, or maintaining 30 mg, generally resulted in lower response rates for these endpoints. These findings contribute to understanding the optimal dosing flexibility for upadacitinib in this patient population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05507580, titled "A Study to Assess Treat-to-Target and Dosing Flexibility of Oral Upadacitinib Tablets in Adult Participants With Moderate to Severe Atopic Dermatitis," were posted on 2025-07-29 on clinicaltrials.gov.