Advertisement

AAD 2026 Preview: Late Breaking Data to Watch

Published on: 

This preview highlights key data to watch out for during the 2026 American Academy of Dermatology (AAD) meeting in Denver, Colorado.

The 2026 American Academy of Dermatology (AAD) Annual Meeting arrives at a pivotal moment for the field, with a slate of late-breaking data poised to reshape treatment paradigms across some of dermatology's most challenging conditions.

From atopic dermatitis and plaque psoriasis to hidradenitis suppurativa (HS) and dermatomyositis, this year's program is headlined by phase 3 readouts that represent years of clinical development, and in several cases, potential first-in-class approvals that could redefine the standard of care.

Taken together, the sessions reflect a broader maturation of the dermatology pipeline, one increasingly defined by oral precision therapies, novel biologic mechanisms, and a growing willingness to tackle rare and historically underserved diseases head-on.

SESSION 1

Efficacy and Safety of Monotherapy Amlitelimab, a Non-Depleting Anti-OX40 Ligand Antibody, in Moderate-to-Severe Atopic Dermatitis: 24-Week Results From the Pivotal COAST 1 and COAST 2 Phase 3 Trials and Efficacy and Safety of Amlitelimab, a Non-Depleting Anti-OX40 Ligand Antibody, in Combination With Topical Therapy in Participants With Moderate-to-Severe Atopic Dermatitis: 24-Week Results From the SHORE Phase 3 Trial

Session 1, 9:00 AM

Presenter: Eric Lawrence Simpson, MD, FAAD

Sanofi’s amlitelimab, a non-depleting anti-OX40 ligand monoclonal antibody, consolidates 24-week data from three pivotal phase 3 studies. COAST 1 (n=601) met all primary and key secondary endpoints across Q4W and Q12W dosing. SHORE met all EU estimand primary and key secondary endpoints in combination with topical corticosteroids. COAST 2 met the US estimand co-primary endpoint, narrowly missing EU co-primary endpoints.1 Global regulatory submissions are planned for H2 2026.

Efficacy and Safety of Abrocitinib in Patients with Chronic Hand Eczema: A Randomized, Double-Blind, Multicenter, Placebo-Controlled Trial

Session 1, 9:36 AM

Presenter: Robert Bissonnette, MSc, MD, FAAD

Pfizer’s abrocitinib (Cibinqo), an oral selective JAK1 inhibitor approved for moderate-to-severe atopic dermatitis, presents phase 3 results from the first randomized, placebo-controlled trial dedicated to chronic hand eczema (CHE). Prior phase 2b data (HAWK) established proof-of-concept for JAK1 inhibition in CHE.2 A positive outcome would support a label expansion for Cibinqo, positioning abrocitinib as the first oral JAK inhibitor with dedicated pivotal evidence in this indication. AAD 2026 marks the first public disclosure of the full trial results.

Envudeucitinib (ESK-001) in moderate-to-severe plaque psoriasis: 24-week results from the randomized, double-blind, active comparator- and placebo-controlled, Phase 3 ONWARD 1 and 2 studies

Session 1, 11:12 AM

Presenter: Andrew Blauvelt, MD, FAAD

Alumis’ envudeucitinib, a highly selective oral TYK2 inhibitor, met all co-primary and ranked secondary endpoints in both phase 3 ONWARD studies (total n > 1,700), with superiority over placebo and apremilast (P < .0001). Across both trials, 74% of patients achieved PASI 75 at week 16; by week 24, approximately 65% achieved PASI 90 and more than 40% achieved PASI 100, with no new safety signals.3 Full 24-week data will be presented publicly for the first time at AAD 2026. An NDA filing is planned for H2 2026.

Efficacy and Safety of Upadacitinib in Adolescents and Adults for Treatment of Non-Segmental Vitiligo: Results of Two Phase 3 Studies (Viti-Up)

Session 1, 11:36 AM

Presenter: Thierry Passeron, MD, PhD

AbbVie’s upadacitinib (Rinvoq) 15 mg once daily met both co-primary endpoints across two replicate phase 3 Viti-Up studies (combined n≈614) in adults and adolescents ≥12 years with non-segmental vitiligo. T-VASI 50 at week 48 was achieved by 19.4% and 21.5% of treated patients versus 5.9% on placebo; F-VASI 75 by 25.2% and 23.4% versus 5.9% and 6.9%.4 Regulatory submissions have been filed with the FDA and EMA. If approved, upadacitinib would be the first systemic therapy indicated for vitiligo.

SESSION 2

Concomitant therapy with ixekizumab plus tirzepatide in adults with psoriatic arthritis and overweight or obesity demonstrated superior disease control compared to ixekizumab alone: results from the Ph3b TOGETHER-PsA trial

Session 2, 1:00 PM

Presenter: Joseph Merola, MD, MSc, FAAD

Eli Lilly’s TOGETHER-PsA is the first randomized trial to test whether co-treating obesity alongside a biologic improves psoriatic arthritis outcomes. In the phase 3b study (n=271), 31.7% of patients receiving ixekizumab (Taltz) plus tirzepatide (Zepbound) achieved the composite primary endpoint of ACR50 plus ≥10% weight reduction at week 36 versus 0.8% on ixekizumab alone (P < .001). ACR50 alone also favored the combination (33.5% vs. 20.4%; P < .05).5

Once-daily Oral Zasocitinib Demonstrates Rapid and Reproducible Skin Clearance with a Consistent Safety Profile in Moderate-to-Severe Plaque Psoriasis: Results from Two Randomized Phase 3 Trials (LATITUDE-PsO-3001 and 3002)

Session 2, 1:24 PM

Presenter: Melinda Gooderham, MD, FAAD

Takeda’s zasocitinib, an oral once-daily TYK2 inhibitor with more than one-million-fold selectivity for TYK2 over other JAK enzymes, met all primary and all 44 ranked secondary endpoints in both phase 3 LATITUDE studies (n=693 and n=1108), with superiority over placebo and apremilast. More than half of treated patients achieved PASI 90 and approximately 30% achieved PASI 100 at week 16.6 Full 24-week data will be presented for the first time at AAD 2026. Takeda plans to file an NDA in fiscal year 2026.

Povorcitinib in Patients With Moderate to Severe Hidradenitis Suppurativa: 54-Week Efficacy and Safety Results From the STOP-HS1 & STOP-HS2 Phase 3 Studies

Session 2, 1:48 PM

Presenter: Martina J. Porter, MD, FAAD

Incyte’s povorcitinib (INCB54707), a selective oral JAK1 inhibitor, met the primary endpoint of HiSCR50 at week 12 in both phase 3 STOP-HS studies (~600 patients each), with 40.2–42.3% responding versus 28.6–29.7% on placebo.7 The 54-week dataset at AAD 2026 represents the most comprehensive durability evidence yet for any oral therapy in hidradenitis suppurativa, and is expected to support Incyte’s planned US regulatory submission in early 2026. No MACE events or deaths were observed through week 24.

Sonelokimab in moderate-to-severe HS: Long-term results through Week 40 of two Phase 3 trials

Session 2, 2:00 PM

Presenter: Alexandra Boer Kimball, MD, MPH, FAAD

MoonLake Immunotherapeutics’ sonelokimab, a trivalent Nanobody targeting IL-17A and IL-17F, will present long-term data through week 40 from the VELA phase 3 program (n=838). VELA was the first phase 3 HS program to use HiSCR75 as its primary endpoint. VELA-1 met statistical significance at week 16; VELA-2 narrowly missed, attributed to an elevated placebo response.8 The week 40 data at AAD 2026 — the longest follow-up from any phase 3 HS trial — are pivotal for assessing durability and informing MoonLake’s regulatory path.

Brepocitinib Achieves Rapid and Sustained Control of Cutaneous Disease Activity, Itch, and Skin-Related Quality of Life in Dermatomyositis: Results From the Phase 3 VALOR Trial

Session 2, 3:36 PM

Presenter: Ruth Ann Vleugels, MD, MBA, MPH, FAAD

Priovant Therapeutics’ brepocitinib, an oral dual TYK2/JAK1 inhibitor, is the first therapy to demonstrate efficacy in a randomized, placebo-controlled phase 3 trial in dermatomyositis. VALOR (n=241) met its primary endpoint with a mean Total Improvement Score of 46.5 versus 31.2 for placebo at week 52 (P= .0006), with all nine key secondary endpoints met and steroid-sparing effects demonstrated.9 The FDA has accepted the NDA and granted Priority Review. If approved, brepocitinib would be the first targeted therapy for dermatomyositis.

References

  1. Sanofi. Sanofi’s amlitelimab confirms its potential in atopic dermatitis. GlobeNewswire. Published January 23, 2026. Accessed March 18, 2026. https://www.globenewswire.com/news-release/2026/01/23/3224400/0/en/Press-Release-Sanofi-s-amlitelim…
  2. King B, Silverberg JI, Gimenez-Arnau AM, et al. Abrocitinib monotherapy in adults with chronic hand eczema (HAWK): a randomised, double-blind, placebo-controlled phase 2b trial. Lancet. 2023;401(10386):1423-1434. Accessed March 18, 2026. https://doi.org/10.1016/S0140-6736(23)00296-X
  3. Alumis Inc. Alumis’ envudeucitinib delivers leading skin clearance among next-generation oral plaque psoriasis therapies in phase 3 program. BusinessWire. Published January 6, 2026. Accessed March 18, 2026. https://investors.alumis.com/news-releases/news-release-details/alumis-envudeucitinib-delivers-lead…
  4. AbbVie Inc. AbbVie announces positive topline results from phase 3 pivotal studies evaluating upadacitinib (RINVOQ) in adults and adolescents with vitiligo. Published October 29, 2025. Accessed March 18, 2026. https://news.abbvie.com/2025-10-29-AbbVie-Announces-Positive-Topline-Results-from-Phase-3-Pivotal-S…
  5. Eli Lilly and Company. Lilly’s Taltz (ixekizumab) and Zepbound (tirzepatide) used together demonstrated superior disease control compared to ixekizumab alone: results from the Ph3b TOGETHER-PsA trial. Published January 8, 2026. Accessed March 18, 2026. https://investor.lilly.com/news-releases/news-release-details/lillys-taltz-ixekizumab-and-zepbound-…
  6. Takeda Pharmaceutical Company. Takeda’s zasocitinib delivers landmark data from two phase 3 studies in plaque psoriasis. Published December 18, 2025. Accessed March 18, 2026. https://www.takeda.com/newsroom/newsreleases/2025/takeda-zasocitinib-phase-3-plaque-psoriasis-data-…
  7. Incyte Corporation. Incyte announces positive topline results from two phase 3 clinical trials of povorcitinib in patients with hidradenitis suppurativa. BusinessWire. Published March 17, 2025. Accessed March 18, 2026. https://www.businesswire.com/news/home/20250317947508/en/Incyte-Announces-Positive-Topline-Results-…
  8. MoonLake Immunotherapeutics AG. MoonLake announces topline results from the VELA phase 3 program evaluating sonelokimab in hidradenitis suppurativa. GlobeNewswire. Published 2025. Accessed March 18, 2026. https://investors.moonlakeim.com/
  9. Roivant Sciences Ltd / Priovant Therapeutics Inc. Roivant and Priovant announce positive phase 3 VALOR study results for brepocitinib in dermatomyositis. GlobeNewswire. Published September 17, 2025. Accessed March 18, 2026. https://investor.roivant.com/news-releases/news-release-details/roivant-and-priovant-announce-posit…

Advertisement
Advertisement