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Atopic DermatitisPhase 2/3NCT05732454

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

A Phase 2/3 study testing etrasimod in people with Atopic Dermatitis and Atopic Dermatitis, Unspecified, run by Pfizer at 74 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
etrasimod
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
58 participants
Where
74 sitesin 4 countries
Study dates
18 Jan 2023to 29 Apr 2024
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

74 sites in 4 countries.

74 sites in 4 countries

United States44 sites

  • Eye Care Associates of Arlington

    Arlington, Texas, 76010

  • Arlington Research Center

    Arlington, Texas, 76011

  • Texas Pulmonary

    Arlington, Texas, 76012

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

    Aventura, Florida, 33180

  • First OC Dermatology Research Inc

    Fountain Valley, California, 92708

  • Jared R. Younger, MD (Ophthalmologist)

    Fountain Valley, California, 92708

  • Advanced Eye Center: Rodrigo Belalcazar, MD

    Hialeah, Florida, 33012

  • Direct Helpers Research Center

    Hialeah, Florida, 33012

  • Alpesh D. Desai, DO PLLC

    Houston, Texas, 77008

  • Becky Fredrickson, MD [Optometrist/Ophthalmologist]

    Houston, Texas, 77008

  • Rupesh Vakil, MD [Pulmonologist]

    Houston, Texas, 77008

  • Bryan D. Vo. MD (Pulmonologist)

    Laguna Hills, California, 92653

  • Lung and Sleep Disorder Center

    Lathrup Village, Michigan, 48076

  • California Allergy and Asthma Medical Group

    Los Angeles, California, 90025

  • Dr. Carolyn M. Wong

    Los Angeles, California, 90025

  • Dr. Gerald Markovitz

    Los Angeles, California, 90025

  • Gsi Clinical Research

    Margate, Florida, 33063

  • Randy Burks, MD, FACS

    Margate, Florida, 33063

  • D & H National Research Centers, Inc.

    Miami, Florida, 33155

  • Imaging - Advanced Health Imaging

    Miami, Florida, 33155

  • The Selem Center [Ophthalmologist JOSEPH SELEM]

    Miami, Florida, 33165

  • Miami Dermatology and Laser Research

    Miami, Florida, 33173

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

    Miami, Florida, 33173

  • Pulmonology - Miami Pulmonology Specialists

    Miami, Florida, 33173

  • Pelletier Jesse MD

    North Miami Beach, Florida, 33162

  • Santos Carlos R MD

    North Miami Beach, Florida, 33162

  • Tory Sullivan, Md Pa

    North Miami Beach, Florida, 33162

  • Gateway Radiology

    Pinellas Park, Florida, 33781

  • Hull & Hull Medical Specialists

    Plantation, Florida, 33324

  • Monument Health Rapid City Hospital

    Rapid City, South Dakota, 57701

  • Health Concepts

    Rapid City, South Dakota, 57702

  • In Vision Optical and Eyecare

    Rapid City, South Dakota, 57702

  • Resolution Advanced Imaging Center

    Santa Monica, California, 90404

  • GCP Research, Global Clinical professionals

    St. Petersburg, Florida, 33705

  • St. Anthonys Hospital

    St. Petersburg, Florida, 33705

  • Acclaim Dermatology

    Sugar Land, Texas, 77479

  • Horizon Eye Care and Optical

    Sugar Land, Texas, 77479

  • Sweetwater Pulmonary Associates

    Sugar Land, Texas, 77479

  • USF Health

    Tampa, Florida, 33612

  • Revival Research Institute, LLC

    Troy, Michigan, 48084

  • Somerset Opthalmology PC

    Troy, Michigan, 48084

  • Eye Institute

    Tulsa, Oklahoma, 74136

  • Pulmonary and Sleep Center of Oklahoma

    Tulsa, Oklahoma, 74136

  • Vital Prospects Clinical Research Institute, PC

    Tulsa, Oklahoma, 74136

Other trials in United States

Poland22 sites

  • AUGON Gabinet Okulistyczny

    Bialystok, Podlaskie Voivodeship, 15-427

  • Nzoz Specjalistyczny Ośrodek Dermatologiczny "Dermal"

    Bialystok, Podlaskie Voivodeship, 15-453

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

    Bialystok, Podlaskie Voivodeship, 15-872

  • Centrum Medyczne Angelius Provita

    Katowice, Silesian Voivodeship, 40-611

  • Centrum Zdrowia Ochaliczówka

    Katowice, Silesian Voivodeship, 40-750

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

    Krakow, Lesser Poland Voivodeship, 30-033

  • Centrum Medyczne Dietla 19

    Krakow, Lesser Poland Voivodeship, 31-070

  • Centrum Medyczne Szpital Świętej Rodziny

    Lodz, Łódź Voivodeship, 90-302

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

    Lodz, Łódź Voivodeship, 90-436

  • Ekovivus

    Lodz, Łódź Voivodeship, 91-833

  • DERMEDIC Iwona Zdybska

    Lublin, Lublin Voivodeship, 20-607

  • Eyemed

    Lublin, Lublin Voivodeship, 20-631

  • Flosmed

    Poznan, Greater Poland Voivodeship, 60-192

  • Niepubliczny Zakład Opieki Zdrowotnej Zespół Poradni Specjalistycznych "Termedica"

    Poznan, Greater Poland Voivodeship, 60-681

  • Medoculis

    Poznan, Greater Poland Voivodeship, 61-551

  • Gabinety Lekarskie Rivermed

    Poznan, 61-441

  • Medicus

    Szczecin, West Pomeranian Voivodeship, 70-233

  • Twoja Przychodnia SCM

    Szczecin, West Pomeranian Voivodeship, 71-500

  • Artemed Centrum Medyczne

    Wroclaw, Lower Silesian Voivodeship, 50-450

  • Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska

    Wroclaw, Lower Silesian Voivodeship, 50-566

  • Specjalistyczna Praktyka Lekarska Joanna Kalinowska

    Wroclaw, Lower Silesian Voivodeship, 51-605

  • Indywidualna Specjalistyczna Praktyka Lekarska Michał Silber

    Wroclaw, Lower Silesian Voivodeship, 53-124

Other trials in Poland

Canada5 sites

  • Rejuvenation Dermatology

    Edmonton, Alberta, T5J 3S9

  • Visique

    Québec, Quebec, G2J 0C4

  • Biron

    Québec, G1W 2K9

  • Alpha Recherche Clinique

    Québec, G2J 0C4

  • CaRe Clinic

    Red Deer, Alberta, T4P 1K4

Other trials in Canada

Czechia3 sites

  • Poliklinika VEKTOR Pardubice

    Pardubice, 53002

  • Pratia Pardubice a.s.

    Pardubice, 53002

  • Fakultní nemocnice v Motole

    Prague, 150 06

Other trials in Czechia

About this study

Official title: A PHASE 2/3, TWO-PART STUDY TO EVALUATE THE EFFICACY AND LONG-TERM SAFETY WITH ORAL ETRASIMOD, 2 MG, ONCE DAILY IN ADULT PARTICIPANTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS WITH A HISTORY OF PRIOR SYSTEMIC TREATMENT FAILURE

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:

Read more
  • 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).

Being tested
etrasimod, Placebo
Keywords
Systemic Failure, Oral
Medical subject headings
Dermatitis, Atopic, Eczema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • etrasimodDrug

    Also called APD334, PF-07915503

    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

  • PlaceboDrug

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

Study groups in NCT05732454
Study groupRoleWhat they receive
etrasimodExperimental2 mg, oral tablet, once daily
Receives: Drug: etrasimod
Placebo (Part 1 DB period only)Placebo comparatorOral sham comparator
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: DB Period: Week 16

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

    Measured: 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

  8. 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.

    Measured: 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

  9. 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.

    Measured: 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)

  10. 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.

    Measured: 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)

  11. 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.

    Measured: 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)

  12. 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.

    Measured: 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)

  13. 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.

    Measured: 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)

  14. 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.

    Measured: OLE Period: Day 169/Week 24

  15. 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.

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

Secondary outcomes (2)

  1. 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

    EASI-75 response was defined as a 75% reduction or greater in EASI score from Baseline to Week 16. EASI quantified severity of AD based on severity of lesion clinical signs and percentage (%) of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema [E], induration/papulation [I], excoriation [Ex] and lichenification [L]) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin)] and lower limbs [including buttocks]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; h = head and neck; u = upper limbs; t = trunk; l = lower limbs.

    Measured: DB Period: Week 16

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

    EASI quantified severity of AD based on severity of lesion clinical signs and percentage (%) of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema [E], induration/papulation [I], excoriation [Ex] and lichenification [L]) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin)] and lower limbs [including buttocks]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; h = head and neck; u = upper limbs; t = trunk; l = lower limbs.

    Measured: DB Period: Baseline, Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2023
  2. Study start18 Jan 2023
  3. Primary completion29 Apr 2024
  4. Study completion29 Apr 2024

Why it stopped: Per the results of the planned interim analysis, the study met futility criteria for efficacy so the trial was terminated. This decision was made for efficacy reasons only and is not due to any safety concerns.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05732454
Sponsor's protocol ID
C5041005
Other IDs
2022-003361-37, APD334-314
Status last verified
Apr 2025
First submitted
22 Dec 2022
Last updated
8 May 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing etrasimod in people with Atopic Dermatitis and Atopic Dermatitis, Unspecified, run by Pfizer at 74 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in United States, Poland, Canada, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1, DB Period: Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response at Week 16 (time frame: DB Period: Week 16). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05732454.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025; AzTrials last refreshed its copy on 31 Oct 2026.

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