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

NCT ID: NCT05732454

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-18
• Study Completion Date: 2024-04-29

Brief 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).

Conditions

Atopic Dermatitis; Atopic Dermatitis, Unspecified; Eczema; Eczema, Atopic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

etrasimod

2 mg, oral tablet, once daily

Group Type: EXPERIMENTAL

etrasimod

Intervention Type: DRUG

PART 1 Double Blind one 2 mg tablet once daily for up to 16 weeks PART 1 Open Label Extension one 2 mg tablet once daily for an additional 52 weeks PART 2 Open Label one 2 mg tablet once daily for up 52 weeks

Placebo (Part 1 DB period only)

Oral sham comparator

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

PART 1 DOUBLE BLIND Placebo - one table daily for up to 16 weeks

Interventions

etrasimod

PART 1 Double Blind one 2 mg tablet once daily for up to 16 weeks PART 1 Open Label Extension one 2 mg tablet once daily for an additional 52 weeks PART 2 Open Label one 2 mg tablet once daily for up 52 weeks

Intervention Type: DRUG

Placebo

PART 1 DOUBLE BLIND Placebo - one table daily for up to 16 weeks

Intervention Type: DRUG

Other Intervention Names

APD334; PF-07915503

Eligibility Criteria

Inclusion Criteria

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) at screening 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. 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:

1. 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.

2. Hypersensitivity to etrasimod or any of the excipients.

3. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

First OC Dermatology Research Inc

Fountain Valley, California, United States

Jared R. Younger, MD (Ophthalmologist)

Fountain Valley, California, United States

Bryan D. Vo. MD (Pulmonologist)

Laguna Hills, California, United States

California Allergy and Asthma Medical Group

Los Angeles, California, United States

Dr. Carolyn M. Wong

Los Angeles, California, United States

Dr. Gerald Markovitz

Los Angeles, California, United States

Resolution Advanced Imaging Center

Santa Monica, California, United States

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

Aventura, Florida, United States

Advanced Eye Center: Rodrigo Belalcazar, MD

Hialeah, Florida, United States

Direct Helpers Research Center

Hialeah, Florida, United States

Gsi Clinical Research

Margate, Florida, United States

Randy Burks, MD, FACS

Margate, Florida, United States

D & H National Research Centers, Inc.

Miami, Florida, United States

Imaging - Advanced Health Imaging

Miami, Florida, United States

The Selem Center [Ophthalmologist JOSEPH SELEM]

Miami, Florida, United States

Miami Dermatology and Laser Research

Miami, Florida, United States

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

Miami, Florida, United States

Pulmonology - Miami Pulmonology Specialists

Miami, Florida, United States

Pelletier Jesse MD

North Miami Beach, Florida, United States

Santos Carlos R MD

North Miami Beach, Florida, United States

Tory Sullivan, Md Pa

North Miami Beach, Florida, United States

Gateway Radiology

Pinellas Park, Florida, United States

Hull & Hull Medical Specialists

Plantation, Florida, United States

GCP Research, Global Clinical professionals

St. Petersburg, Florida, United States

St. Anthonys Hospital

St. Petersburg, Florida, United States

USF Health

Tampa, Florida, United States

Lung and Sleep Disorder Center

Lathrup Village, Michigan, United States

Revival Research Institute, LLC

Troy, Michigan, United States

Somerset Opthalmology PC

Troy, Michigan, United States

Eye Institute

Tulsa, Oklahoma, United States

Pulmonary and Sleep Center of Oklahoma

Tulsa, Oklahoma, United States

Vital Prospects Clinical Research Institute, PC

Tulsa, Oklahoma, United States

Monument Health Rapid City Hospital

Rapid City, South Dakota, United States

Health Concepts

Rapid City, South Dakota, United States

In Vision Optical and Eyecare

Rapid City, South Dakota, United States

Eye Care Associates of Arlington

Arlington, Texas, United States

Arlington Research Center

Arlington, Texas, United States

Texas Pulmonary

Arlington, Texas, United States

Alpesh D. Desai, DO PLLC

Houston, Texas, United States

Becky Fredrickson, MD [Optometrist/Ophthalmologist]

Houston, Texas, United States

Rupesh Vakil, MD [Pulmonologist]

Houston, Texas, United States

Acclaim Dermatology

Sugar Land, Texas, United States

Horizon Eye Care and Optical

Sugar Land, Texas, United States

Sweetwater Pulmonary Associates

Sugar Land, Texas, United States

Rejuvenation Dermatology

Edmonton, Alberta, Canada

CaRe Clinic

Red Deer, Alberta, Canada

Visique

Québec, Quebec, Canada

Biron

Québec, , Canada

Alpha Recherche Clinique

Québec, , Canada

Poliklinika VEKTOR Pardubice

Pardubice, , Czechia

Pratia Pardubice a.s.

Pardubice, , Czechia

Fakultní nemocnice v Motole

Prague, , Czechia

Flosmed

Poznan, Greater Poland Voivodeship, Poland

Niepubliczny Zakład Opieki Zdrowotnej Zespół Poradni Specjalistycznych "Termedica"

Poznan, Greater Poland Voivodeship, Poland

Medoculis

Poznan, Greater Poland Voivodeship, Poland

Centrum Medyczne ,,All - Med'' Badania Kliniczne

Krakow, Lesser Poland Voivodeship, Poland

Centrum Medyczne Dietla 19

Krakow, Lesser Poland Voivodeship, Poland

Artemed Centrum Medyczne

Wroclaw, Lower Silesian Voivodeship, Poland

Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska

Wroclaw, Lower Silesian Voivodeship, Poland

Specjalistyczna Praktyka Lekarska Joanna Kalinowska

Wroclaw, Lower Silesian Voivodeship, Poland

Indywidualna Specjalistyczna Praktyka Lekarska Michał Silber

Wroclaw, Lower Silesian Voivodeship, Poland

DERMEDIC Iwona Zdybska

Lublin, Lublin Voivodeship, Poland

Eyemed

Lublin, Lublin Voivodeship, Poland

AUGON Gabinet Okulistyczny

Bialystok, Podlaskie Voivodeship, Poland

Nzoz Specjalistyczny Ośrodek Dermatologiczny "Dermal"

Bialystok, Podlaskie Voivodeship, Poland

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

Bialystok, Podlaskie Voivodeship, Poland

Centrum Medyczne Angelius Provita

Katowice, Silesian Voivodeship, Poland

Centrum Zdrowia Ochaliczówka

Katowice, Silesian Voivodeship, Poland

Medicus

Szczecin, West Pomeranian Voivodeship, Poland

Twoja Przychodnia SCM

Szczecin, West Pomeranian Voivodeship, Poland

Gabinety Lekarskie Rivermed

Poznan, , Poland

Centrum Medyczne Szpital Świętej Rodziny

Lodz, Łódź Voivodeship, Poland

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

Lodz, Łódź Voivodeship, Poland

Ekovivus

Lodz, Łódź Voivodeship, Poland

Countries

United States; Canada; Czechia; Poland

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=C5041005

To obtain contact information for a study center near you, click here.

Other Identifiers

2022-003361-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

APD334-314

Identifier Type: OTHER

Identifier Source: secondary_id

C5041005

Identifier Type: -

Identifier Source: org_study_id