AAD 2023: Incyte Presentations and Posters

Presented at the American Academy of Dermatology (AAD) Annual Meeting

March 17-21, 2023; New Orleans, LA

Relapse and Maintenance of Clinical Response In the Randomized Withdrawal Arm of the TRuE-VLong-Term Extension Phase 3 Study of Ruxolitinib Cream in Vitiligo

John E. Harris, MD, PhD,1 Kim Papp, MD, PhD,2,3 Seth B. Forman, MD,4 Jacek Zdybski, MD,5

Amit G. Pandya, MD,6,7 Julien Seneschal, MD, PhD,8 Deanna Kornacki, PhD,9 Kathleen Butler, MD,9

Shaoceng Wei, PhD,9 Thierry Passeron, MD, PhD10,11

1University of Massachusetts Chan Medical School, Worcester, MA, USA; 2Alliance Clinical Trials and Probity Medical Research, Waterloo, ON, Canada; 3Division of Dermatology, Department of Medicine, University of Toronto, Toronto, ON, Canada; 4ForCare Clinical Research, Tampa, FL, USA; 5Klinika Zdybski - Dermedic, Ostrowiec Swietokrzyski, Poland; 6Palo Alto Foundation Medical Group, Mountain View, CA, USA; 7University of Texas Southwestern Medical Center, Dallas, TX, USA; 8Department of Dermatology and Pediatric Dermatology, National Reference Center for Rare Skin Disorders, Hôpital Saint-André, CNRS, UMR-5164, ImmunoConcEpT, F-33000, Bordeaux, France; 9Incyte Corporation, Wilmington, DE, USA; 10Centre Hospitalier Universitaire de Nice, Université Côte d'Azur, Nice, France; 11INSERM U1065, C3M, Université Côte d'Azur, Nice, France

1

Presenting Author Disclosures

• Consultant for AbbVie, Aclaris Therapeutics, BiologicsMD, EMD Serono, Genzyme/Sanofi, Incyte Corporation, Janssen, Pfizer, Rheos Medicines, Sun Pharmaceuticals, TeVido BioDevices, The Expert Institute, 3rd Rock Ventures, and Villaris Therapeutics
• Investigator for Aclaris Therapeutics, Celgene, Dermira, EMD Serono, Genzyme/Sanofi, Incyte Corporation, LEO Pharma, Pfizer, Rheos Medicines, Stiefel/GlaxoSmithKline, Sun Pharmaceuticals, TeVido BioDevices, and Villaris Therapeutics
• Holds equity in Aldena Therapeutics, NIRA Biosciences, Rheos Medicines, TeVido BioDevices, and Villaris Therapeutics
• A scientific founder of Aldena Therapeutics, NIRA Biosciences, and Villaris Therapeutics
• Has patents pending for IL-15 blockade for treatment of vitiligo, JAK inhibition with light therapy for vitiligo, and CXCR3 antibody depletion for treatment of vitiligo

2

JAK-Targeted Therapy for Vitiligo

• Vitiligo is a chronic autoimmune disease that targets melanocytes, causing skin depigmentation1

• A cream formulation of ruxolitinib, a JAK1/JAK2 inhibitor, is approved by the US FDA for the topical treatment of nonsegmental vitiligo in adult and pediatric patients ≥12 years of age,2 a milestone in vitiligo therapy
• In 2 randomized, double-blind,vehicle-controlled phase 3 studies of adults and adolescents with vitiligo (TRuE-V1 [NCT04052425]; TRuE-V2 [NCT04057573]), ruxolitinib cream was statistically superior to vehicle at Week 24 in the primary and all key secondary efficacy endpoints, with continued improvement in outcomes through Week 523

Patient Who Achieved F-VASI90 at Week 52 in the TRuE-V Studies

FDA, US Food and Drug Administration; F-VASI90, ≥90% improvement from baseline in facial Vitiligo Area Scoring Index; JAK, Janus kinase; TRuE-V, Topical Ruxolitinib Evaluation in Vitiligo trials.

1. Rodrigues M, et al. J Am Acad Dermatol. 2017;77:1-13; 2. OPZELURA™ (ruxolitinib) cream). Full Prescribing Information. Incyte Corporation; July 2022; 3. Rosmarin D, et al. N

Engl J Med. 2022;387:1445-1455.

3

Objectives

• To evaluate the time to relapse (a response of<> among adolescents and adults with nonsegmental vitiligo who achieved almost complete facial repigmentation (F-VASI90) in the TRuE-V parent studies and were randomized to vehicle (ruxolitinib cream withdrawal) in the
  TRuE-Vlong-term extension (LTE) study (NCT04530344)
• To evaluate the duration of F-VASI90 response maintenance in patients randomized to vehicle or ruxolitinib cream

F-VASI75, ≥75% improvement from baseline facial Vitiligo Area Scoring Index.	4

TRuE-V LTE Study Design

TRuE-V

Studies1

Nonsegmental

vitiligo

Adolescent and adult

patients

aged ≥12 years randomized 2:1

Cohort

Enrollment

Cohort A: ≥F-VASI90

Cohort B: <>

LTE

(52 weeks)

1.5% Ruxolitinib Cream BID

Vehicle* BID (ie, withdrawal arm)

1.5% Ruxolitinib Cream BID

Follow-Up

(30 days)

Follow-Up

Week 0 through Week 52

Week 52 56 60 64

68

80

92

104

End of Study

BID, twice daily.
* Patients randomized to vehicle who relapsed (ie, <> could apply 1.5% ruxolitinib cream BID rescue treatment for the remainder of the LTE period.
1. Rosmarin D, et al. N Engl J Med. 2022;387:1445-1455.	5