AAD 2025 Phase 3 Recap: 7 Trials to Know

An annual showcase of the latest developments and breakthrough for dermatology, the 2025 American Academy of Dermatology annual meeting’s late-breaking sessions served as the stage for new data from more than 2 dozen studies, including 7 phase 3 trials.

To celebrate the close of the AAD’s annual meeting and preview what the rest of the year might hold for the field of dermatology, we’ve created a brief recap of these 7 trials.

Phase 3 Recap from AAD 2025

Ruxolitinib Cream 1.5% for Prurigo Nodularis

Twice-daily ruxolitinib cream 1.5% (Opzelura; Incyte) significantly improved itch in adults with prurigo nodularis within 7 days, according to phase 3 TRuE-PN trial data presented at AAD 2025. The TRuE-PN1 trial showed that 44.6% of patients achieved a 4-point or greater improvement in the Worst Itch Numeric Rating Scale at 12 weeks, compared with 20.6% in the vehicle group (P = .0003). Secondary endpoints, including the Investigator’s Global Assessment for treatment success, also favored ruxolitinib. TRuE-PN2 showed similar trends but did not meet its primary endpoint due to a high placebo response. Incyte considers these findings to reinforce ruxolitinib’s potential as a new topical treatment for prurigo nodularis.

Related: Ruxolitinib Cream 1.5% Shows Promise for Prurigo Nodularis at AAD 2025

Icotrokinra for Plaque Psoriasis

Phase 3 trial results suggest that icotrokinra, a first-in-class oral peptide (Johnson & Johnson), significantly improved moderate to severe plaque psoriasis, with nearly 50% of patients achieving PASI 90 at 24 weeks. In the ICONIC-LEAD trial, 65% of patients reached an Investigator’s Global Assessment score of 0 or 1, compared with 8% in the placebo group (P < .001). Johnson & Johnson announced plans for ICONIC-ASCEND, the first head-to-head trial comparing an oral pill with an injectable biologic in psoriasis. Additional data from ICONIC-ADVANCE 1 and 2 showed that icotrokinra outperformed deucravacitinib. No new safety concerns were reported.

Related: Icotrokinra, Plaque Psoriasis, and ICONIC-LEAD, with Robert Bissonnette, MD

Ivarmacitinib for Severe Alopecia Areata

Phase 3 data presented at AAD 2025 showed that oral ivarmacitinib, a selective JAK1 inhibitor from Jiangsu Hengrui Pharmaceuticals, significantly improved hair regrowth in adults with severe alopecia areata. At 24 weeks, 34.9% of patients receiving 4 mg and 40.6% of those receiving 8 mg achieved a SALT score of 20 or less, compared with 9% in the placebo group. Among patients who switched from placebo, 47% in the 4-mg group and 63% in the 8-mg group reached this threshold by week 52. The safety profile was consistent with that of other JAK inhibitors, with no new safety signals.

Rocatinlimab for Atopic Dermatitis

The phase 3 ROCKET-Horizon trial showed that rocatinlimab, a T-cell rebalancing therapy targeting OX40 from Amgen and Kyowa Kirin, significantly reduced signs and symptoms of moderate to severe atopic dermatitis. At 24 weeks, 32.8% of patients achieved EASI-75 compared with 13.7% in the placebo group (P < .001), and 19.3% reached a validated Investigator’s Global Assessment score of 0 or 1 versus 6.6% with placebo (P < .001). The trial met all coprimary and key secondary endpoints. Additional data from the IGNITE trial reinforced rocatinlimab’s efficacy, with up to 42.3% of patients achieving EASI-75.

Related: AAD 2025: Rocatinlimab, a T-Cell Rebalancing Therapy, for Atopic Dermatitis

Dupilumab for Bullous Pemphigoid

Phase 2/3 LIBERTY-BP ADEPT trial results presented at AAD 2025 showed that dupilumab (Dupixent) significantly improved disease activity and reduced burden in patients with moderate to severe bullous pemphigoid. At 36 weeks, 20% of dupilumab-treated patients achieved sustained remission compared with 4% in the placebo group (P = .0114), with significant reductions in disease severity (40% vs 10%; P = .0003) and itch (40% vs 11%; P = .0006). Dupilumab also reduced corticosteroid use and the need for rescue medication. Regeneron and Sanofi recently submitted a supplemental Biologics License Application for FDA approval, which has a target action date in June 2025

Related: Dupilumab Proves Benefit in Bullous Pemphigoid Ahead of June 2025 FDA Decision

Baricitinib for Pediatric Alopecia Areata

Phase 3 BRAVE-AA-PEDS trial results presented at AAD 2025 showed that baricitinib, which is developed by Eli Lilly and Incyte, significantly improved hair regrowth in adolescents with severe alopecia areata. At 36 weeks, 42.4% of patients receiving 4 mg and 27.4% of those receiving 2 mg achieved at least 80% scalp hair coverage, compared with 4.5% in the placebo group (P = .001). Eyebrow and eyelash regrowth were also significantly greater with baricitinib. Results suggest that adolescents may experience faster hair regrowth than adults. The safety profile was consistent with prior studies, and no major safety concerns were reported.

Related: New Data on Hair Regrowth in Severe Alopecia Areata Using Baricitinib, with Brittany Craiglow, MD

Deucravacitinib in Psoriatic Arthritis

Phase 3 POETYK PsA-2 trial results presented at AAD 2025 showed that deucravacitinib (Sotkytu) significantly improved psoriatic arthritis (PsA) symptoms and quality of life in both biologic-naive and TNF inhibitor-experienced patients. At 16 weeks, 54.2% of deucravacitinib-treated patients achieved ACR20 compared to 39.4% on placebo (P = .0002), with significant PASI 75 improvements and better patient-reported outcomes. Safety data showed a well-tolerated profile, with adverse event rates comparable to apremilast. Bristol Myers Squibb plans to discuss these results with regulators, highlighting deucravacitinib’s potential as a new PsA treatment option.

Related: Deucravacitinib Improves PsA Symptoms and Quality of Life in POETYK PsA-2

References:

1. Incyte. Incyte announces results of phase 3 clinical trials evaluating ruxolitinib cream 1.5% (opzelura®) in patients with prurigo nodularis (PN) at 2025 American Academy of Dermatology Annual Meeting. Business Wire. March 8, 2025. Accessed March 8, 2025. https://www.businesswire.com/news/home/20250308179919/en/Incyte-Announces-Results-of-Phase-3-Clinical-Trials-Evaluating-Ruxolitinib-Cream-1.5-Opzelura%C2%AE-in-Patients-with-Prurigo-Nodularis-PN-at-2025-American-Academy-of-Dermatology-Annual-Meeting.

2. Johnson and Johnson. ICOTROKINRA results show potential to set a new standard of treatment in plaque psoriasis. JNJ.com. March 8, 2025. Accessed March 8, 2025. https://www.jnj.com/media-center/press-releases/icotrokinra-results-show-potential-to-set-a-new-standard-of-treatment-in-plaque-psoriasis.

3. Amgen. Amgen and Kyowa Kirin provide top-line results from ROCATINLIMAB Phase 3 ignite study in adults with moderate to severe atopic dermatitis. Amgen. March 8, 2025. Accessed March 8, 2025. https://www.amgen.com/newsroom/press-releases/2025/03/amgen-and-kyowa-kirin-provide-top-line-results-from-rocatinlimab-phase-3-ignite-study-in-adults-with-moderate-to-severe-atopic-dermatitis.

4. Zhang J. Efficacy and safety of ivarmacitinib, a selective Janus kinase 1 (JAK1) inhibitor, for the treatment of adult with severe alopecia areata (AA): a randomized, double-blind, placebo-controlled phase 3. Presented at 2025 American Academy of Dermatology Annual Meeting. Orlando, FL. March 7-11, 2025.

5. Werth V. Efficacy and Safety of Dupilumab in Patients With Bullous Pemphigoid: Results From LIBERTY-BP ADEPT Phase 2/3 Study. Presented at the 2025 American Academy of Dermatology (ADA) Annual Meeting. Orlando, FL. March 07-11, 2025.

6. Eli Lilly and Company. Lilly's baricitinib delivered high rates of hair regrowth for adolescents with severe alopecia areata in Phase 3 BRAVE-AA-PEDS study. Eli Lilly and Company. March 8, 2025. Accessed March 8, 2025. https://investor.lilly.com/news-releases/news-release-details/lillys-baricitinib-delivered-high-rates-hair-regrowth.

7. Bristol Myers Squibb. Bristol Myers Squibb presents late-breaking data from phase 3 POETYK PSA-2 trial demonstrating superiority of sotyktu (deucravacitinib) compared with placebo in adults with psoriatic arthritis. Bristol Myers Squibb. March 8, 2025. Accessed March 9, 2025. https://news.bms.com/news/corporate-financial/2025/Bristol-Myers-Squibb-Presents-Late-Breaking-Data-from-Phase-3-POETYK-PsA-2-Trial-Demonstrating-Superiority-of-Sotyktu-deucravacitinib-Compared-with-Placebo-in-Adults-with-Psoriatic-Arthritis/default.aspx.