A Study to Learn About the Study Medicine Etrasimod in Adults With Moderate to Severe Atopic Dermatitis (AD) Who Have Already Tried Treatments Taken by Mouth or by Injection
Atopic Dermatitis, Atopic Dermatitis, Unspecified, Eczema
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring Systemic Failure, Oral
Eligibility Criteria
Inclusion Criteria: Participants must meet the following key inclusion criteria to be eligible for enrollment into the study: 1. Age 18-80 at screening (or minimum age of consent according to local regulations). 2 Chronic AD (also known as atopic eczema) that was diagnosed at least 1 year prior to Screening and meets Hanifin and Rajka criteria at screening).1 3. Moderate to severe AD: IGA score ≥3 (on the 0 to 4 IGA scale, in which 3 = moderate and 4 = severe) at screening and baseline (Day 1) BSA ≥10% of AD involvement at screening and baseline (Day 1) Eczema Area and Severity Index (EASI) ≥16 at screening and baseline (Day 1) 4. A participant who has failed a prior systemic therapy for AD, ie, refractory, moderate-to-severe AD that is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. 5. Willing to apply a topical emollient/moisturizer at least once daily for ≥1 week prior to baseline (Day 1) and willing to maintain consistent (ie, no change in type, frequency, or application) daily application over the course of the study. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: Medical Conditions: Presence of confounding factors: Skin conditions (eg, psoriasis, seborrheic dermatitis) that may interfere with evaluation of AD or assessment of treatment response as deemed by the investigator. Current significant active infection or requiring a treatment for infection that may interfere with the assessment of AD. Hypersensitivity to etrasimod or any of the excipients. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Sites / Locations
- First OC Dermatology Research IncRecruiting
- Jared R. Younger, MD (Ophthalmologist)Recruiting
- Bryan D. Vo. MD (Pulmonologist)Recruiting
- California Allergy and Asthma Medical GroupRecruiting
- Dr. Carolyn M. WongRecruiting
- Dr. Gerald MarkovitzRecruiting
- Acuity Eye GroupRecruiting
- Chest & Critical Care ConsultantsRecruiting
- Wolverine Clinical TrialsRecruiting
- Clinical Science Institute
- Providence Saint John's Health Center
- Santa Monica Eye Medical Group
- Ponce PFT & Medical services, INC [for pulmonology examination]Recruiting
- Pulmonary AssociatesRecruiting
- Cohen Laser and Vision CenterRecruiting
- Skin Care ResearchRecruiting
- Advanced Eye Center: Rodrigo Belalcazar, MDRecruiting
- Direct Helpers Research CenterRecruiting
- Gsi Clinical ResearchRecruiting
- Randy Burks, MD, FACSRecruiting
- D & H National Research Centers, IncRecruiting
- Imaging - Advanced Health ImagingRecruiting
- The Selem Center [Ophthalmologist JOSEPH SELEM]Recruiting
- Miami Dermatology and Laser ResearchRecruiting
- Ophthalmology - Dr. Edward Boshnick's Global Vision Rehabilitation CenterRecruiting
- Pulmonology - Miami Pulmonology SpecialistsRecruiting
- Pelletier Jesse MDRecruiting
- Santos Carlos R MDRecruiting
- Tory Sullivan, MD PARecruiting
- Ziaderm Research, LLCRecruiting
- Gateway RadiologyRecruiting
- Akumin Imaging
- Hull & Hull Medical SpecialistsRecruiting
- GCP Research, Global Clinical professionalsRecruiting
- St. Anthonys HospitalRecruiting
- Pulmonology Lung and sleep care inc Dr. Vinubhai C. Pansuriya, MDRecruiting
- Akumin ImagingRecruiting
- Clinical Research Trials of FloridaRecruiting
- Tampa Eye ClinicRecruiting
- USF HealthRecruiting
- NorthShore University HealthSystemRecruiting
- NorthShore University HealthSystemRecruiting
- NorthShore University Health SystemRecruiting
- Pike Medical ConsultantsRecruiting
- Rothbaum Eye & VisionRecruiting
- Options Research GroupRecruiting
- Physicians Research GroupRecruiting
- Great Lakes Research Group, Inc.Recruiting
- McLaren Bay Region (Pulmonary Function Testing)Recruiting
- Lung and Sleep Disorder CenterRecruiting
- Melisa David, O.D. (Ophthalmology Exam)Recruiting
- Revival Research Institute, LLCRecruiting
- Somerset Opthalmology PCRecruiting
- Eye InstituteRecruiting
- Pulmonary and Sleep Center of OklahomaRecruiting
- Vital Prospects Clinical Research Institute, PCRecruiting
- Monument Health Rapid City HospitalRecruiting
- Health ConceptsRecruiting
- In Vision Optical and Eyecare
- Eye Care Associates of ArlingtonRecruiting
- Arlington Research CenterRecruiting
- Envision ImagingRecruiting
- Texas PulmonaryRecruiting
- Alpesh D. Desai, DO PLLCRecruiting
- Becky Fredrickson, MD [Optometrist/Ophthalmologist]Recruiting
- Heights Dermatology & Aesthetic CenterRecruiting
- Rupesh Vakil, MD [Pulmonologist]Recruiting
- Acclaim DermatologyRecruiting
- Horizon Eye Care and OpticalRecruiting
- Sweetwater Pulmonary AssociatesRecruiting
- Dermatology Research InstituteRecruiting
- Rejuvenation DermatologyRecruiting
- CARe ClinicRecruiting
- VisiqueRecruiting
- BironRecruiting
- Centre de Recherche Saint-LouisRecruiting
- Alpha Recherche CliniqueRecruiting
- Fakultni nemocnice OstravaRecruiting
- FNORecruiting
- CCR Czech a.s.Recruiting
- MUDr. Katarína Jiráková s.r.o.Recruiting
- Poliklinika VEKTOR PardubiceRecruiting
- Fakultni nemocnice v MotoleRecruiting
- Fakultní nemocnice v MotoleRecruiting
- Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka PartnerskaRecruiting
- Artemed Centrum MedyczneRecruiting
- Specjalistyczna Praktyka Lekarska Joanna KalinowskaRecruiting
- Indywidualna Specjalistyczna Praktyka Lekarska Michał SilberRecruiting
- DERMEDIC Iwona ZdybskaRecruiting
- EyemedRecruiting
- WIP Warsaw IBD Point Profesor Kierkuś
- Centrum Mikrochirurgii Oka LaserRecruiting
- ŚWIAT OKA Centrum OkulistyczneRecruiting
- Centrum Radiologii Klinicznej Wilanowska Sp. Z O.O.Recruiting
- Klinika Ambroziak DermatologiaRecruiting
- Royalderm Agnieszka NawrockaRecruiting
- Centrum Medyczne ,,All - Med'' Badania KliniczneRecruiting
- Centrum Medyczne ALL-MED
- Centrum Medyczne Dietla 19Recruiting
- AUGON Gabinet OkulistycznyRecruiting
- NZOZ Specjalistyczny Ośrodek Dermatologiczny "DERMAL"Recruiting
- Gabinet Alergologiczny IR-med dr n. med. Izabela Roszko-KirpszaRecruiting
- FlosmedRecruiting
- Niepubliczny Zakład Opieki Zdrowotnej Zespół Poradni Specjalistycznych "Termedica"Recruiting
- MedoculisRecruiting
- MedicusRecruiting
- Twoja Przychodnia SCMRecruiting
- Twoja Przychodnia SCMRecruiting
- Gabinety Lekarskie RivermedRecruiting
- Centrum Okulistyczne Instytut Oka
- Centrum Dermatologiczne FEBUMEDRecruiting
- "DERMED" Centrum Medyczne Sp. z o.o.Recruiting
- Centra Medyczne Medyceusz Sp. z o. o.Recruiting
- Centrum Okulistyczne Contact - Med sp. z o.o.Recruiting
- Centrum Medyczne Szpital Świętej RodzinyRecruiting
- Salve
- Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. LesiakRecruiting
- EkovivusRecruiting
- Centrum Medyczne Angelius ProvitaRecruiting
- Centrum Zdrowia OchaliczówkaRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
etrasimod
Placebo (Part 1 DB period only)
2 mg, oral tablet, once daily
Oral sham comparator