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

NCT05732454 | Terminated Phase 2 Results DMC FDA Drug

• 3 other identifiers: C50410052022-003361-37APD334-314
• Study Type: interventional
• Target: 58
• Locations: 4 countries
• Sites: 74

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

Keywords

Systemic Failure; Oral

Outcome Measures

Primary Outcomes (15)

• Part 1, DB Period: Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response at Week 16

  IGA measured AD severity, based on a 5-point scale (0-4); 0= AD is clear, 1= AD is almost clear, 2= mild AD, 3= moderate AD and 4= severe AD. IGA response was defined as participants achieving IGA 0 (clear) or 1 (almost clear) and a reduction of \>=2 points from baseline.

  DB Period: Week 16

• Part 1, DB Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (All Causality)

  An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent are events between first dose of study drug and up to last dose that were absent before treatment or that worsened relative to pretreatment state.

  DB Period: From first dose of study drug up to 16 Weeks of treatment

• Part 1, DB Period: Number of Participants With TEAEs (All Causality) Leading to Study Treatment Discontinuation

  An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent are events between first dose of study drug and up to last dose that were absent before treatment or that worsened relative to pretreatment state.

  DB Period: From first dose of study drug up to 16 Weeks of treatment

• Part 1, DB Period: Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) (All Causality)

  An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent are events between first dose of study drug and up to last dose that were absent before treatment or that worsened relative to pretreatment state. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of death); new or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or other medical events judged by investigator.

  DB Period: From first dose of study drug up to 16 Weeks of treatment

• Part 1, DB Period: Number of Participants With Treatment Emergent AEs of Special Interest (AESIs) (All Causality)

  An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent are events between first dose of study drug and up to last dose that were absent before treatment or that worsened relative to pretreatment state. AESIs included here were cardiovascular events (i.e., bradycardia, Atrioventricular (AV) conduction delay, and hypertension); macular edema, pulmonary events (airflow obstruction or decreased gas exchange); infections (severe infections, opportunistic infections \[including progressive multifocal leukoencephalopathy (PML)\], Herpes simplex and Herpes zoster); liver injury (liver transaminase elevation and bilirubin elevation); posterior reversible encephalopathy syndrome (PRES) and malignancies.

  DB Period: From first dose of study drug up to 16 Weeks of treatment

• Part 1, DB Period: Number of Participants With Laboratory Test Abnormalities

  Laboratory assessments included hematology, clinical chemistry, urinalysis, other parameters and reflex tests. Number of participants with abnormalities in any of laboratory parameters is reported.

  DB Period: From first dose of study drug up to 16 Weeks of treatment

• Part 1, DB Period: Number of Participants With Markedly Abnormal 12-Lead Electrocardiogram Measurements and AV Blocks

  Standard 12-lead ECGs utilizing limb leads were used to measure PR interval, QT interval, QTc corrected using Fridericia's formula (QTcF), and QRS complex. Number of participants with non-zero ECG abnormalities and AV blocks are reported in this outcome measure.

  DB Period: Pre-dose and 4 hours (hrs) post-dose on Day 1/Week 0; Pre-dose and 4 hrs post-dose on Day 113/Week 16

• Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign

  Vital signs evaluation included systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse rate. Number of participants with non-zero vital signs abnormalities are reported in this outcome measure.

  DB Period: Pre-dose and 1, 2, 3, 4 hours (hrs) post-dose on Day 1/Week 0; Day 29/Week 4; Day 57/Week 8; Day 85/Week 12; Pre-dose and 1, 2, 3, 4, 5 and 6 hrs post-dose on Day 113/Week 16

• Part 1, OLE Period: Number of Participants With TEAEs (All Causality)

  An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent are events between first dose of study drug and up to last dose that were absent before treatment or that worsened relative to pretreatment state.

  OLE Period: First dose of study drug in OLE period up to 4 weeks after last dose in OLE period (up to maximum of 56 Weeks)

• Part 1, OLE Period: Number of Participants With Treatment Emergent AEs (All Causality) Leading to Study Treatment Discontinuation

  An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent are events between first dose of study drug and up to last dose that were absent before treatment or that worsened relative to pretreatment state.

  OLE Period: First dose of study drug in OLE period up to 4 weeks after last dose in OLE period (up to maximum of 56 Weeks)

• Part 1, OLE Period: Number of Participants With Treatment Emergent SAEs (All Causality)

  An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent are events between first dose of study drug and up to last dose that were absent before treatment or that worsened relative to pretreatment state. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of death); new or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or other medical events judged by investigator.

  OLE Period: First dose of study drug in OLE period up to 4 weeks after last dose in OLE period (up to maximum of 56 Weeks)

• Part 1, OLE Period: Number of Participants With Treatment Emergent AESIs (All Causality)

  An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent are events between first dose of study drug and up to last dose that were absent before treatment or that worsened relative to pretreatment state. AESIs included here were cardiovascular events (i.e., bradycardia, AV conduction delay, and hypertension); macular edema, pulmonary events (airflow obstruction or decreased gas exchange); infections (severe infections, opportunistic infections \[including PML\], Herpes simplex and Herpes zoster); liver injury (liver transaminase elevation and/or bilirubin elevation); PRES and malignancies.

  OLE Period: First dose of study drug in OLE period up to 4 weeks after last dose in OLE period (up to maximum of 56 Weeks)

• Part 1, OLE Period: Number of Participants With Laboratory Test Abnormalities

  Laboratory assessments included hematology, clinical chemistry, urinalysis, other parameters and reflex tests. Number of participants with abnormalities in any of laboratory parameters is reported.

  OLE Period: First dose of study drug in OLE period up to 4 weeks after last dose in OLE period (up to maximum of 56 Weeks)

• Part 1, OLE Period: Number of Participants With Markedly Abnormal 12-Lead Electrocardiogram Measurements and AV Blocks

  Standard 12-lead ECGs utilizing limb leads were used to measure PR interval, QT interval, QTcF, and QRS complex. Number of participants with non-zero ECG abnormalities and AV blocks are reported in this outcome measure.

  OLE Period: Day 169/Week 24

• Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign

  Vital signs evaluation included SBP, DBP, pulse rate. Number of participants with non-zero vital signs abnormalities are reported in this outcome measure.

  OLE Period: Day 141/Week 20; Day 169/Week 24; Day 281/Week 40; Follow Up 1; Follow Up 2

Secondary Outcomes (2)

• Part 1, DB Period: Percentage of Participants Who Achieved >=75% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-75) at Week 16

  DB Period: Week 16

• Part 1, DB Period: Percent Change From Baseline in EASI Score at Week 16

  DB Period: Baseline, Week 16

Study Arms (2)

etrasimod

EXPERIMENTAL

2 mg, oral tablet, once daily

Drug: etrasimod

Placebo (Part 1 DB period only)

PLACEBO COMPARATOR

Oral sham comparator

Drug: Placebo

Interventions

etrasimod 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

Also known as: APD334, PF-07915503

etrasimod

Placebo DRUG

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

Placebo (Part 1 DB period only)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age 18-80 at screening (or minimum age of consent according to local regulations).
• 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.
• \. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (74)

First OC Dermatology Research Inc

Fountain Valley, California, 92708, United States

Location

Jared R. Younger, MD (Ophthalmologist)

Fountain Valley, California, 92708, United States

Location

Bryan D. Vo. MD (Pulmonologist)

Laguna Hills, California, 92653, United States

Location

California Allergy and Asthma Medical Group

Los Angeles, California, 90025, United States

Location

Dr. Carolyn M. Wong

Los Angeles, California, 90025, United States

Location

Dr. Gerald Markovitz

Los Angeles, California, 90025, United States

Location

Resolution Advanced Imaging Center

Santa Monica, California, 90404, United States

Location

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

Aventura, Florida, 33180, United States

Location

Advanced Eye Center: Rodrigo Belalcazar, MD

Hialeah, Florida, 33012, United States

Location

Direct Helpers Research Center

Hialeah, Florida, 33012, United States

Location

Gsi Clinical Research

Margate, Florida, 33063, United States

Location

Randy Burks, MD, FACS

Margate, Florida, 33063, United States

Location

D & H National Research Centers, Inc.

Miami, Florida, 33155, United States

Location

Imaging - Advanced Health Imaging

Miami, Florida, 33155, United States

Location

The Selem Center [Ophthalmologist JOSEPH SELEM]

Miami, Florida, 33165, United States

Location

Miami Dermatology and Laser Research

Miami, Florida, 33173, United States

Location

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

Miami, Florida, 33173, United States

Location

Pulmonology - Miami Pulmonology Specialists

Miami, Florida, 33173, United States

Location

Pelletier Jesse MD

North Miami Beach, Florida, 33162, United States

Location

Santos Carlos R MD

North Miami Beach, Florida, 33162, United States

Location

Tory Sullivan, Md Pa

North Miami Beach, Florida, 33162, United States

Location

Gateway Radiology

Pinellas Park, Florida, 33781, United States

Location

Hull & Hull Medical Specialists

Plantation, Florida, 33324, United States

Location

GCP Research, Global Clinical professionals

St. Petersburg, Florida, 33705, United States

Location

St. Anthonys Hospital

St. Petersburg, Florida, 33705, United States

Location

USF Health

Tampa, Florida, 33612, United States

Location

Lung and Sleep Disorder Center

Lathrup Village, Michigan, 48076, United States

Location

Revival Research Institute, LLC

Troy, Michigan, 48084, United States

Location

Somerset Opthalmology PC

Troy, Michigan, 48084, United States

Location

Eye Institute

Tulsa, Oklahoma, 74136, United States

Location

Pulmonary and Sleep Center of Oklahoma

Tulsa, Oklahoma, 74136, United States

Location

Vital Prospects Clinical Research Institute, PC

Tulsa, Oklahoma, 74136, United States

Location

Monument Health Rapid City Hospital

Rapid City, South Dakota, 57701, United States

Location

Health Concepts

Rapid City, South Dakota, 57702, United States

Location

In Vision Optical and Eyecare

Rapid City, South Dakota, 57702, United States

Location

Eye Care Associates of Arlington

Arlington, Texas, 76010, United States

Location

Arlington Research Center

Arlington, Texas, 76011, United States

Location

Texas Pulmonary

Arlington, Texas, 76012, United States

Location

Alpesh D. Desai, DO PLLC

Houston, Texas, 77008, United States

Location

Becky Fredrickson, MD [Optometrist/Ophthalmologist]

Houston, Texas, 77008, United States

Location

Rupesh Vakil, MD [Pulmonologist]

Houston, Texas, 77008, United States

Location

Acclaim Dermatology

Sugar Land, Texas, 77479, United States

Location

Horizon Eye Care and Optical

Sugar Land, Texas, 77479, United States

Location

Sweetwater Pulmonary Associates

Sugar Land, Texas, 77479, United States

Location

Rejuvenation Dermatology

Edmonton, Alberta, T5J 3S9, Canada

Location

CaRe Clinic

Red Deer, Alberta, T4P 1K4, Canada

Location

Visique

Québec, Quebec, G2J 0C4, Canada

Location

Biron

Québec, G1W 2K9, Canada

Location

Alpha Recherche Clinique

Québec, G2J 0C4, Canada

Location

Poliklinika VEKTOR Pardubice

Pardubice, 53002, Czechia

Location

Pratia Pardubice a.s.

Pardubice, 53002, Czechia

Location

Fakultní nemocnice v Motole

Prague, 150 06, Czechia

Location

Flosmed

Poznan, Greater Poland Voivodeship, 60-192, Poland

Location

Niepubliczny Zakład Opieki Zdrowotnej Zespół Poradni Specjalistycznych "Termedica"

Poznan, Greater Poland Voivodeship, 60-681, Poland

Location

Medoculis

Poznan, Greater Poland Voivodeship, 61-551, Poland

Location

Centrum Medyczne ,,All - Med'' Badania Kliniczne

Krakow, Lesser Poland Voivodeship, 30-033, Poland

Location

Centrum Medyczne Dietla 19

Krakow, Lesser Poland Voivodeship, 31-070, Poland

Location

Artemed Centrum Medyczne

Wroclaw, Lower Silesian Voivodeship, 50-450, Poland

Location

Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska

Wroclaw, Lower Silesian Voivodeship, 50-566, Poland

Location

Specjalistyczna Praktyka Lekarska Joanna Kalinowska

Wroclaw, Lower Silesian Voivodeship, 51-605, Poland

Location

Indywidualna Specjalistyczna Praktyka Lekarska Michał Silber

Wroclaw, Lower Silesian Voivodeship, 53-124, Poland

Location

DERMEDIC Iwona Zdybska

Lublin, Lublin Voivodeship, 20-607, Poland

Location

Eyemed

Lublin, Lublin Voivodeship, 20-631, Poland

Location

AUGON Gabinet Okulistyczny

Bialystok, Podlaskie Voivodeship, 15-427, Poland

Location

Nzoz Specjalistyczny Ośrodek Dermatologiczny "Dermal"

Bialystok, Podlaskie Voivodeship, 15-453, Poland

Location

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

Bialystok, Podlaskie Voivodeship, 15-872, Poland

Location

Centrum Medyczne Angelius Provita

Katowice, Silesian Voivodeship, 40-611, Poland

Location

Centrum Zdrowia Ochaliczówka

Katowice, Silesian Voivodeship, 40-750, Poland

Location

Medicus

Szczecin, West Pomeranian Voivodeship, 70-233, Poland

Location

Twoja Przychodnia SCM

Szczecin, West Pomeranian Voivodeship, 71-500, Poland

Location

Gabinety Lekarskie Rivermed

Poznan, 61-441, Poland

Location

Centrum Medyczne Szpital Świętej Rodziny

Lodz, Łódź Voivodeship, 90-302, Poland

Location

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

Lodz, Łódź Voivodeship, 90-436, Poland

Location

Ekovivus

Lodz, Łódź Voivodeship, 91-833, Poland

Location

Related Links

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

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

etrasimod

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Pfizer Clinical Trials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

18007181021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: PART 1 Double Blind portion (Day 1 through Week 16): all parties are blinded to treatment. PART 1 Open Label Extension portion: All parties will be aware participant is taking etrasimod for up to an additional 52 weeks. PART 2 Open Label All parties will be aware participant is taking etrasimod for 52 weeks.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1: Approximately 60 participants with moderate-to-severe AD with a history of prior systemic treatment failure will be randomized (1:1 ratio) in a double blind (DB) manner to receive etrasimod 2 mg or placebo orally, once daily, for 16 weeks. Randomization will be stratified by disease severity as measured by IGA score (3 \[moderate AD\], 4 \[severe AD\]) at baseline. After DB period, participants may be given the option to continue in an open label extension (OLE) phase whereby they will receive etrasimod 2 mg (tablet) for up to an additional 52 weeks. Part 2: Approximately 340 additional participants will be enrolled to receive etrasimod 2 mg orally, once daily, for 52 weeks in an open-label manner.

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: February 17, 2023
• Study Start: January 18, 2023
• Primary Completion: April 29, 2024
• Study Completion: April 29, 2024
• Last Updated: May 8, 2025
• Results First Posted: May 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

PL (22); US (44); CZ (3); CA (5)