AAD 2025 Preview: 5 Phase 3 Trials to Watch

Few fields have welcomed as much advancement and change in recent years as dermatology. With insights into disease pathophysiology ushering in a new era of treatment for many dermatologic conditions, including psoriasis, atopic dermatitis, alopecia, and others, dermatologists have been tasked with staying informed on what many fields would consider decades’ worth of breakthroughs and clinically applicable updates.

The stage for debuting many of these advancements in recent years is often the American Academy of Dermatology (AAD) annual meeting. With the 2024 meeting billed as the largest in the organization’s history, with nearly 20,000 attendees, dermatologists and care providers with an interest in dermatology are now looking forward to the 2025 AAD annual meeting, which is taking place in Orlando, Florida from March 7-11, 2025, for the same reasons.

This year’s programming includes a pair of late-breaking sessions, spotlighting 30 pieces of data spanning a variety of dermatologic conditions and several novel therapies. As part of our coverage of dermatology, we’ve compiled a list of 5 phase 3 trials to watch at the upcoming AAD annual meeting.

5 Phase 3 Trials to Watch at AAD 2025

Efficacy and Safety of Ruxolitinib Cream in Patients With Prurigo Nodularis: Results From a Phase 3, Randomized, Vehicle-Controlled Study (TRuE-PN1)

Presentation Time: Saturday, March 8, 2025, from 09:24-09:36 AM ET
Presenter: Shawn Kwatra, MD
Description: The TRuE-PN1 trial is a double-blind, vehicle-controlled trial assessing the safety and tolerability of ruxolitinib cream (Opzelura) in patients with prurigo nodularis. The 204-person trial’s primary outcome was a 4-point or greater improvement in Worst-Itch Numeric Rating Scale score at 12 weeks.

During the 12-week, double-blind treatment period, all prurigo nodularis-affected areas at baseline received treatment. This was followed by a 40-week open-label extension period during which only active prurigo nodularis-affected areas were treated.

Icotrokinra, a Targeted Oral Peptide That Selectively Blocks the Interleukin-23–Receptor, for the Treatment of Moderate-to-Severe Plaque Psoriasis

Presentation Time: Saturday, March 8, 2025, from 11:24-11:36 AM ET
Presenter: Robert Bissonnette, MD, MSc
Description: ICONIC LEAD is a phase 3 examining icotrokinra, which Johnson and Johnson bill as the first targeted oral peptide selectively blocking the IL-23 receptor, in adults and adolescents 12 years of age and older with moderate to severe plaque psoriasis. The 66-person trial’s coprimary endpoints were Psoriasis Area and Severity Index 90 and Investigator’s Global Assessment response of 0 or 1 at week 16 and response rates continued to improve through week 24.

Johnson and Johnson announced the trial had met its co-primary endpoints on November 18, 2024.

Rocatinlimab Significantly Improved Clinical Signs and Symptoms by Targeting OX40R+ T cells in Patients with Moderate-to-Severe Atopic Dermatitis: Results from the Phase 3 ROCKET HORIZON Trial

Presentation Time: Saturday, March 8, 2025, from 02:00-02:12 PM ET
Presenter: Emma Gutman, MD, PhD
Description: ROCKET HORIZON is a phase 3 trial assessing the efficacy, safety, and tolerability of rocatinlimab monotherapy against placebo in adults with moderate to severe atopic dermatitis. The 726-person trial’s coprimary endpoints were achievement of a Validated Investigator Global Assessment for Atopic Dermatitis score of 0 or 1 with a 2-point or greater reduction from baseline at week 24 and achievement of 75% or greater reduction from baseline in Eczema Area and Severity Index score at week 24.

The first of 8 trials in the ROCKET program, Kyowa Kirin announced positive topline results from this trial in a press release on September 25, 2024.

Efficacy and Safety of Dupilumab in Patients With Bullous Pemphigoid: Results From LIBERTY-BP ADEPT Phase 2/3 Study

Presentation Time: Saturday, March 8, 2025, from 02:48-03:00 PM ET
Presenter: Frederic Faux, PhD
Description: Billed by Regeneron asthe first randomized, controlled trial designed to evaluate the efficacy and safety of dupilumab (Dupixent) in patients with moderate-to-severe bullous pemphigoid relative to placebo therapy. The 98-person trial’s primary outcome is the proportion of patients achieving sustained remission at week 36.

In September 2024, Sanofi announced the trial had met the primary and all key secondary endpoints and would be used to support regulatory submissions before the end of the year.

Baricitinib Provides Significant Hair Regrowth In Adolescents With Severe Alopecia Areata: 36-Week Efficacy and Safety Results From A Phase 3 Randomized, Controlled Trial

Presentation Time: Saturday, March 8, 2025, from 03:48-04:00 PM ET
Presenter: Thierry Passeron, MD, PhD
Description: The BRAVE-AA-PEDS trial is designed to assess the safety and efficacy of baricitinib, which already boasts an FDA approval for adults with severe alopecia areata, for treatment of severe or very severe alopecia areata in children from 6 years to less than 18 years of age. The 595-person trial’s primary outcome is percentage of patients achieving an absolute SALT score of 20 or less at 36 weeks.^6,7

References:

1. American Academy of Dermatology. Stellar, inspiring, motivating, and mind-blowing! AAD DermWorld. April 12, 2024. Accessed March 3, 2025. https://www.aadmeetingnews.org/2024-aad-annual-meeting/article/22890698/stellar-inspiring-motivating-and-mindblowing.

2. ClinicalTrials.gov. A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN) (TRuE-PN1). Clinicaltrials.gov. November 7, 2024. Accessed March 3, 2025. https://clinicaltrials.gov/study/NCT05755438.

3. Johnson & Johnson. ICOTROKINRA delivered an industry-leading combination of significant skin clearance with demonstrated tolerability in a once daily pill in phase 3 topline results. JNJ.com. November 18, 2024. Accessed March 3, 2025. https://www.jnj.com/media-center/press-releases/icotrokinra-delivered-an-industry-leading-combination-of-significant-skin-clearance-with-demonstrated-tolerability-in-a-once-daily-pill-in-phase-3-topline-results.

4. Kyowa Kirin US. Kyowa Kirin announces top-line data from Rocatinlimab Phase 3 rocket horizon trial for adults with moderate to severe atopic dermatitis. Kyowa Kirin US. September 25, 2024. Accessed March 3, 2025. https://www.kkna.kyowakirin.com/media-center/kyowa-kirin-announces-top-line-data-from-rocatinlimab-phase-3-rocket-horizon-trial-for-adults-with-moderate-to-severe-atopic-dermatitis/.

5. Sanofi. Press release: Dupixent is the first and only biologic to achieve significant improvements in disease remission and symptoms in bullous pemphigoid positive pivotal study. Sanofi. September 11, 2024. Accessed March 3, 2025. https://www.sanofi.com/en/media-room/press-releases/2024/2024-09-11-05-00-00-2944237.

6. Clinicaltrials.gov. A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata (BRAVE-AA-PEDS). Clinicaltrials.gov. February 25, 2025. Accessed March 3, 2025. https://clinicaltrials.gov/study/NCT05723198.

7. Eli Lilly and Company. FDA approves Lilly and Incyte’s OLUMIANT® (baricitinib) as First and only systemic medicine for adults with severe alopecia areata. Eli Lilly and Company. June 13, 2022. Accessed March 03, 2025. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lilly-and-incytes-olumiantr-baricitinib-first-and.