AbbVie’s Pediatric Atopic Dermatitis Study: A Potential Game Changer?

Abbvie ((ABBV)) announced an update on their ongoing clinical study.

AbbVie is currently conducting a Phase 3 clinical study titled A Phase 3, Open-label, Efficacy-Assessor-Blinded Study, Comparing the Safety and Efficacy of Upadacitinib to Dupilumab in Children From 2 to Less Than 12 Years of Age With Moderate to Severe Atopic Dermatitis. The study aims to evaluate adverse events and changes in disease activity when comparing oral upadacitinib to subcutaneous dupilumab in pediatric patients with moderate to severe atopic dermatitis. This research is significant as it addresses the need for effective systemic treatments in younger patients who do not respond adequately to topical therapies.

The interventions being tested are upadacitinib, an oral medication, and dupilumab, a subcutaneous injection. Upadacitinib is already approved for treating atopic dermatitis in patients aged 12 and older, and this study seeks to extend its use to younger children. Dupilumab is administered every 2 or 4 weeks, while upadacitinib is given daily.

The study is designed as an interventional, randomized, parallel assignment with a single-blind approach where the outcomes assessor is masked. The primary purpose is treatment-focused, aiming to determine the safety and efficacy of the drugs in question.

The study began on June 12, 2024, with an estimated primary completion date yet to be determined. The latest update was submitted on September 1, 2025, indicating ongoing recruitment and progress in the study.

This study could potentially impact AbbVie’s stock performance positively if upadacitinib proves effective, as it would expand the drug’s market to younger patients. Competitors in the pediatric atopic dermatitis treatment space may also be affected, depending on the study’s outcomes.

The study is ongoing, with further details available on the ClinicalTrials portal.