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

Last updated: May 21, 2024
Sponsor: Pfizer
Overall Status: Terminated

Phase

2/3

Condition

Dermatitis, Atopic

Eczema (Atopic Dermatitis)

Allergy

Treatment

Placebo

etrasimod

Clinical Study ID

NCT05732454
C5041005
2022-003361-37
APD334-314
  • Ages 18-80
  • All Genders

Study Summary

The purpose of this study is to learn about the safety and effects of the study medicine called etrasimod for the possible treatment of atopic dermatitis (AD), also called eczema, in adults who have already tried AD treatments taken by mouth or by injection that work all over the body. These adults can have moderate to severe AD.

This study is seeking participants who:

  • have AD for at least 1 year

  • have moderate-to-severe AD

  • have tried treatments that work all over the body and saw no effects

  • are willing to apply a moisturizer at least once daily during the study

This is a 2-part study that is only selecting about 60 participants for Part 1 as of now. In Part 1, half of the participants will receive etrasimod, a pill to be taken by mouth once daily. The other half will receive a placebo, a pill that looks like etrasimod but has no medicine also taken by mouth once daily. No one will know what treatment the participant is taking. The Sponsor will compare participant experiences of those taking etrasimod to those taking placebo for 16 weeks. This will help determine if the study medicine is safe and effective. After the first 16 weeks, some participants may continue the study knowing they are taking etrasimod for an additional 52 weeks.

Those participating for just the first 16-weeks, will need to visit the study clinic at least 6 times during the study (about every 4 weeks), and will have to come for 2 safety follow up visits at 2nd and 4th week after the last dose of study medicine. People who want to and can continue for an additional 52 weeks will need to visit the study clinic for at least 6 more visits making 12 total visits over 68 weeks followed by 2 safety follow up visits at the 2nd and 4th week after the last dose of study medicine.

In Part 2 of the study, around 340 more participants will be participating. Everyone will receive etrasimod pills once daily for 52 weeks. Participants will need to go to the study clinic at least 9 times after which they will have to go for 2 more safety follow up visits at the 2nd and 4th weeks after the last dose of study medicine.

At every study visit in Part 1 and Part 2, the focus will be on signs and symptoms of AD (like lesions, itch, and pain) as well as general health and overall side effects. Blood samples and vital signs will be taken at every visit. Due to the way the study medicine works, the in-study clinic visit will last at least 4 hours on Day 1 (Part 1 and Part 2) and Week 16 (Part 1).

Eligibility Criteria

Inclusion

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:

  1. IGA score ≥3 (on the 0 to 4 IGA scale, in which 3 = moderate and 4 = severe) atscreening and baseline (Day 1)

  2. BSA ≥10% of AD involvement at screening and baseline (Day 1)

  3. Eczema Area and Severity Index (EASI) ≥16 at screening and baseline (Day 1) 4. Aparticipant who has failed a prior systemic therapy for AD, ie, refractory,moderate-to-severe AD that is not adequately controlled with other systemic drugproducts, including biologics, or when use of those therapies is inadvisable.

  4. Willing to apply a topical emollient/moisturizer at least once daily for ≥1week prior to baseline (Day 1) and willing to maintain consistent (ie, nochange in type, frequency, or application) daily application over the course ofthe study.

Exclusion

Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: Medical Conditions:

  1. Presence of confounding factors:
  • Skin conditions (eg, psoriasis, seborrheic dermatitis) that may interferewith evaluation of AD or assessment of treatment response as deemed by theinvestigator.
  • Current significant active infection or requiring a treatment forinfection that may interfere with the assessment of AD.
  1. Hypersensitivity to etrasimod or any of the excipients.

  2. Other medical or psychiatric condition including recent (within the past year)or active suicidal ideation/behavior or laboratory abnormality that mayincrease the risk of study participation or, in the investigator's judgment,make the participant inappropriate for the study.

Study Design

Total Participants: 58
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2/3
Study Start date:
January 18, 2023
Estimated Completion Date:
April 29, 2024

Connect with a study center

  • Dermatology Research Institute

    Calgary, Alberta T2J 7E1
    Canada

    Site Not Available

  • Rejuvenation Dermatology

    Edmonton, Alberta T5J 3S9
    Canada

    Site Not Available

  • CARe Clinic

    Red Deer, Alberta T4P 1K4
    Canada

    Site Not Available

  • Visique

    Québec, Quebec G2J 0C4
    Canada

    Site Not Available

  • Alpha Recherche Clinique

    Quebec, G2J 0C4
    Canada

    Site Not Available

  • Biron

    Quebec, G1W 2K9
    Canada

    Site Not Available

  • Centre de Recherche Saint-Louis

    Quebec, G1W 4R4
    Canada

    Site Not Available

  • Fakultni nemocnice Ostrava

    Ostrava, Moravskoslezský KRAJ 708 52
    Czechia

    Site Not Available

  • FNO

    Ostrava, Ostrava Město 708 52
    Czechia

    Site Not Available

  • CCR Czech a.s.

    Pardubice, 53002
    Czechia

    Site Not Available

  • MUDr. Katarína Jiráková s.r.o.

    Pardubice, 53002
    Czechia

    Site Not Available

  • Poliklinika VEKTOR Pardubice

    Pardubice, 53002
    Czechia

    Site Not Available

  • Fakultni nemocnice v Motole

    Praha 5, 150 06
    Czechia

    Site Not Available

  • Fakultní nemocnice v Motole

    Praha 5, 150 06
    Czechia

    Site Not Available

  • Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska

    Wroclaw, Dolnośląskie 50-566
    Poland

    Site Not Available

  • Artemed Centrum Medyczne

    Wrocław, Dolnośląskie 50-450
    Poland

    Site Not Available

  • Indywidualna Specjalistyczna Praktyka Lekarska Michał Silber

    Wrocław, Dolnośląskie 53-124
    Poland

    Site Not Available

  • Specjalistyczna Praktyka Lekarska Joanna Kalinowska

    Wrocław, Dolnośląskie 51-605
    Poland

    Site Not Available

  • DERMEDIC Iwona Zdybska

    Lublin, Lubelskie 20-607
    Poland

    Site Not Available

  • Eyemed

    Lublin, Lubelskie 20-631
    Poland

    Site Not Available

  • WIP Warsaw IBD Point Profesor Kierkuś

    Warsaw, Mazowieckie 00-728
    Poland

    Site Not Available

  • Centrum Mikrochirurgii Oka Laser

    Warszawa, Mazowieckie 00-215
    Poland

    Site Not Available

  • Centrum Radiologii Klinicznej Wilanowska Sp. Z O.O.

    Warszawa, Mazowieckie 02-665
    Poland

    Site Not Available

  • Klinika Ambroziak Dermatologia

    Warszawa, Mazowieckie 02-953
    Poland

    Site Not Available

  • Royalderm Agnieszka Nawrocka

    Warszawa, Mazowieckie 02-962
    Poland

    Site Not Available

  • ŚWIAT OKA Centrum Okulistyczne

    Warszawa, Mazowieckie 02-511
    Poland

    Site Not Available

  • Centrum Medyczne ,,All - Med'' Badania Kliniczne

    Kraków, Małopolskie 30-033
    Poland

    Site Not Available

  • Centrum Medyczne ALL-MED

    Kraków, Małopolskie 30-033
    Poland

    Site Not Available

  • Centrum Medyczne Dietla 19

    Kraków, Małopolskie 31-070
    Poland

    Site Not Available

  • AUGON Gabinet Okulistyczny

    Bialystok, Podlaskie 15-427
    Poland

    Site Not Available

  • Gabinet Alergologiczny IR-med dr n. med. Izabela Roszko-Kirpsza

    Bialystok, Podlaskie 15-872
    Poland

    Site Not Available

  • NZOZ Specjalistyczny Ośrodek Dermatologiczny "DERMAL"

    Bialystok, Podlaskie 15-453
    Poland

    Site Not Available

  • Flosmed

    Poznan, Wielkopolskie 60-192
    Poland

    Site Not Available

  • Niepubliczny Zakład Opieki Zdrowotnej Zespół Poradni Specjalistycznych "Termedica"

    Poznan, Wielkopolskie 60-681
    Poland

    Site Not Available

  • Medoculis

    Poznań, Wielkopolskie 61-551
    Poland

    Site Not Available

  • Medicus

    Szczecin, Zachodniopomorskie 70-233
    Poland

    Site Not Available

  • Twoja Przychodnia SCM

    Szczecin, Zachodniopomorskie 71-434
    Poland

    Site Not Available

  • "DERMED" Centrum Medyczne Sp. z o.o.

    Lodz, Łódzkie 90-265
    Poland

    Site Not Available

  • Centra Medyczne Medyceusz Sp. z o. o.

    Lodz, Łódzkie 91-053
    Poland

    Site Not Available

  • Centrum Okulistyczne Contact - Med sp. z o.o.

    Lodz, Łódzkie 91-464
    Poland

    Site Not Available

  • Centrum Medyczne Szpital Świętej Rodziny

    Łódź, Łódzkie 90-302
    Poland

    Site Not Available

  • Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak

    Łódź, Łódzkie 90-436
    Poland

    Site Not Available

  • Ekovivus

    Łódź, Łódzkie 91-833
    Poland

    Site Not Available

  • Salve

    Łódź, Łódzkie 90-420
    Poland

    Site Not Available

  • Centrum Medyczne Angelius Provita

    Katowice, Śląskie 40-611
    Poland

    Site Not Available

  • Centrum Zdrowia Ochaliczówka

    Katowice, Śląskie 40-750
    Poland

    Site Not Available

  • Gabinety Lekarskie Rivermed

    Poznan, 61-441
    Poland

    Site Not Available

  • Centrum Okulistyczne Instytut Oka

    Warsaw, 02-653
    Poland

    Site Not Available

  • Centrum Dermatologiczne FEBUMED

    Warszawa, 02-777
    Poland

    Site Not Available

  • First OC Dermatology Research Inc

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Jared R. Younger, MD (Ophthalmologist)

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Bryan D. Vo. MD (Pulmonologist)

    Laguna Hills, California 92653
    United States

    Site Not Available

  • California Allergy and Asthma Medical Group

    Los Angeles, California 90025
    United States

    Site Not Available

  • Dr. Carolyn M. Wong

    Los Angeles, California 90025
    United States

    Site Not Available

  • Dr. Gerald Markovitz

    Los Angeles, California 90025
    United States

    Site Not Available

  • Acuity Eye Group

    Santa Ana, California 92705
    United States

    Site Not Available

  • Chest & Critical Care Consultants

    Santa Ana, California 92705
    United States

    Site Not Available

  • Wolverine Clinical Trials

    Santa Ana, California 92705
    United States

    Site Not Available

  • Clinical Science Institute

    Santa Monica, California 90404
    United States

    Site Not Available

  • Providence Saint John's Health Center

    Santa Monica, California 90404
    United States

    Site Not Available

  • Resolution Advanced Imaging Center

    Santa Monica, California 90404
    United States

    Site Not Available

  • Santa Monica Eye Medical Group

    Santa Monica, California 90404
    United States

    Site Not Available

  • Ponce PFT & Medical services, INC [for pulmonology examination]

    Aventura, Florida 33180
    United States

    Site Not Available

  • Cohen Laser and Vision Center

    Boca Raton, Florida 33431
    United States

    Site Not Available

  • Pulmonary Associates

    Boca Raton, Florida 33428
    United States

    Site Not Available

  • Skin Care Research

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • Advanced Eye Center: Rodrigo Belalcazar, MD

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Direct Helpers Research Center

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Gsi Clinical Research

    Margate, Florida 33063
    United States

    Site Not Available

  • Randy Burks, MD, FACS

    Margate, Florida 33063
    United States

    Site Not Available

  • D & H National Research Centers, Inc

    Miami, Florida 33155
    United States

    Active - Recruiting

  • D & H National Research Centers, Inc.

    Miami, Florida 33155
    United States

    Site Not Available

  • Imaging - Advanced Health Imaging

    Miami, Florida 33155
    United States

    Site Not Available

  • Miami Dermatology and Laser Research

    Miami, Florida 33173
    United States

    Site Not Available

  • Ophthalmology - Dr. Edward Boshnick's Global Vision Rehabilitation Center

    Miami, Florida 33173
    United States

    Site Not Available

  • Pulmonology - Miami Pulmonology Specialists

    Miami, Florida 33173
    United States

    Site Not Available

  • The Selem Center [Ophthalmologist JOSEPH SELEM]

    Miami, Florida 33165
    United States

    Site Not Available

  • Pelletier Jesse MD

    North Miami Beach, Florida 33162
    United States

    Site Not Available

  • Santos Carlos R MD

    North Miami Beach, Florida 33162
    United States

    Site Not Available

  • Tory Sullivan, MD PA

    North Miami Beach, Florida 33162
    United States

    Site Not Available

  • Ziaderm Research, LLC

    North Miami Beach, Florida 33162
    United States

    Site Not Available

  • Gateway Radiology

    Pinellas Park, Florida 33781
    United States

    Site Not Available

  • Akumin Imaging

    Plantation, Florida 33322
    United States

    Site Not Available

  • Hull & Hull Medical Specialists

    Plantation, Florida 33324
    United States

    Site Not Available

  • GCP Research, Global Clinical professionals

    Saint Petersburg, Florida 33705
    United States

    Site Not Available

  • Pulmonology Lung and sleep care inc Dr. Vinubhai C. Pansuriya, MD

    Saint Petersburg, Florida 33713
    United States

    Site Not Available

  • St. Anthonys Hospital

    Saint Petersburg, Florida 33705
    United States

    Site Not Available

  • Akumin Imaging

    Tampa, Florida 33603
    United States

    Site Not Available

  • Clinical Research Trials of Florida

    Tampa, Florida 33607
    United States

    Site Not Available

  • Tampa Eye Clinic

    Tampa, Florida 33607
    United States

    Site Not Available

  • USF Health

    Tampa, Florida 33612
    United States

    Site Not Available

  • NorthShore University HealthSystem

    Glenview, Illinois 60026
    United States

    Site Not Available

  • NorthShore University Health System

    Skokie, Illinois 60077
    United States

    Site Not Available

  • NorthShore University HealthSystem

    Skokie, Illinois 60076
    United States

    Site Not Available

  • Pike Medical Consultants

    Indianapolis, Indiana 46268
    United States

    Site Not Available

  • Rothbaum Eye & Vision

    Noblesville, Indiana 46062
    United States

    Site Not Available

  • Options Research Group

    West Lafayette, Indiana 47906
    United States

    Site Not Available

  • Physicians Research Group

    West Lafayette, Indiana 47906
    United States

    Site Not Available

  • Great Lakes Research Group, Inc.

    Bay City, Michigan 48706
    United States

    Site Not Available

  • McLaren Bay Region (Pulmonary Function Testing)

    Bay City, Michigan 48708
    United States

    Site Not Available

  • Lung and Sleep Disorder Center

    Lathrup Village, Michigan 48076
    United States

    Site Not Available

  • Melisa David, O.D. (Ophthalmology Exam)

    Saginaw, Michigan 48603
    United States

    Site Not Available

  • Revival Research Institute, LLC

    Troy, Michigan 48084
    United States

    Site Not Available

  • Somerset Opthalmology PC

    Troy, Michigan 48084
    United States

    Site Not Available

  • Eye Institute

    Tulsa, Oklahoma 74136
    United States

    Site Not Available

  • Pulmonary and Sleep Center of Oklahoma

    Tulsa, Oklahoma 74136
    United States

    Site Not Available

  • Vital Prospects Clinical Research Institute, PC

    Tulsa, Oklahoma 74136
    United States

    Site Not Available

  • Health Concepts

    Rapid City, South Dakota 57702
    United States

    Site Not Available

  • In Vision Optical and Eyecare

    Rapid City, South Dakota 57702
    United States

    Site Not Available

  • Monument Health Rapid City Hospital

    Rapid City, South Dakota 57701
    United States

    Site Not Available

  • Arlington Research Center

    Arlington, Texas 76011
    United States

    Site Not Available

  • Envision Imaging

    Arlington, Texas 76012
    United States

    Site Not Available

  • Eye Care Associates of Arlington

    Arlington, Texas 76010
    United States

    Site Not Available

  • Texas Pulmonary

    Arlington, Texas 76012
    United States

    Site Not Available

  • Alpesh D. Desai, DO PLLC

    Houston, Texas 77008
    United States

    Site Not Available

  • Becky Fredrickson, MD [Optometrist/Ophthalmologist]

    Houston, Texas 77008
    United States

    Site Not Available

  • Heights Dermatology & Aesthetic Center

    Houston, Texas 77008
    United States

    Site Not Available

  • Rupesh Vakil, MD [Pulmonologist]

    Houston, Texas 77008
    United States

    Site Not Available

  • Acclaim Dermatology

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • Horizon Eye Care and Optical

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • Sweetwater Pulmonary Associates

    Sugar Land, Texas 77479
    United States

    Site Not Available

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