Upadacitinib + Topical Corticosteroids for Eczema

(AD Up Trial)

This trial tests the combination of upadacitinib, a pill, and topical corticosteroids (creams) to determine their effectiveness in treating moderate to severe eczema, a skin condition causing itchy, inflamed patches. Researchers aim to assess whether this combination is safe and more effective than other treatments for individuals who haven't found success with creams alone. Participants will be divided into groups, with some receiving different doses of upadacitinib alongside the creams, while others will start with a placebo (inactive pill). This trial suits those aged 12 and up who have had chronic eczema for at least 3 years, with significant skin involvement and itching that hasn't improved with typical treatments. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

The trial requires participants to stop their current atopic dermatitis treatments before joining the study. If you are unable or unwilling to do so, you may not be eligible to participate.

Research has shown that upadacitinib, when combined with topical corticosteroids (TCS), is generally safe for treating moderate to severe atopic dermatitis (AD). Studies have found that both the 15 mg and 30 mg doses of upadacitinib are safe for individuals with this condition. No new safety concerns have emerged, and the safety profile aligns with previous research.

However, upadacitinib can increase the risk of infections, and some individuals may develop infections requiring medical attention. This risk should be considered when deciding to join a trial.

Upadacitinib is unique because it targets a specific enzyme called Janus kinase (JAK), which plays a key role in the inflammatory process associated with eczema. Unlike standard treatments that primarily involve topical corticosteroids or immunosuppressants like cyclosporine, upadacitinib offers a new mechanism of action by directly inhibiting JAK pathways. Researchers are excited about this treatment because it has the potential to offer relief to patients who have not responded well to traditional therapies, and it may provide a more targeted approach with potentially fewer side effects compared to broader immunosuppressive treatments. Additionally, the option to combine upadacitinib with topical corticosteroids could enhance overall effectiveness and flexibility in managing eczema symptoms.

Research has shown that upadacitinib, when combined with topical corticosteroids, effectively treats moderate to severe eczema. In this trial, participants will receive either a 15 mg or 30 mg dose of upadacitinib alongside topical corticosteroids. Studies have found that patients using upadacitinib experience significant improvements, such as reduced itchiness and clearer skin. Specifically, both 15 mg and 30 mg doses of upadacitinib have led to major improvements, with many patients seeing at least a 75% improvement in their symptoms. Additionally, some studies have shown that upadacitinib is more effective than other treatments like Dupixent, offering hope for a better quality of life. These findings suggest that upadacitinib could be a promising treatment option for those dealing with eczema.²³⁶⁷⁸