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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

Primary Purpose

Atopic Dermatitis, Atopic Dermatitis, Unspecified, Eczema

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
etrasimod
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Systemic Failure, Oral

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Placebo Comparator

Arm Label

etrasimod

Placebo (Part 1 DB period only)

Arm Description

2 mg, oral tablet, once daily

Oral sham comparator

Outcomes

Primary Outcome Measures

Part 1 DB: Proportion of participants achieving IGA of clear (0) or almost clear (1) (on a 5-point scale) and a reduction of ≥ 2 points from baseline
To evaluate the efficacy of etrasimod, 2 mg, QD versus placebo
Part 1 OLE and Part 2: Incidence and severity of treatment-emergent adverse events (AEs), AEs leading to study treatment discontinuation, serious AEs, and AEs of special interest.
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
Part 1 OLE and Part 2: Incidence of clinically significant changes in Hemoglobin (g/dL)
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
Part 1 OLE and Part 2: Incidence of clinically significant changes in RBC (x10^6/uL)
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
Part 1 OLE and Part 2: Incidence of clinically significant changes in Platelets, WBC, and WBC with Diff (x10^3/uL)
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
Part 1 OLE and Part 2: Incidence of clinically significant changes in TBNK panel (abs/uL)
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
Part 1 OLE and Part 2: Incidence of clinically significant changes in Hematocrit, WBC with Diff, TBNK with Diff (%)
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
Part 1 OLE and Part 2: Incidence of clinically significant changes in Total bilirubin, Urea Nitrogen, Creatinine (mg/dL)
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
Part 1 OLE and Part 2: Incidence of clinically significant changes in AP, ALT (SGPT), AST (SGOT) (U/L)
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
Part 1 OLE and Part 2: Incidence of clinically significant changes in Total Protein and Albumin-BCG (g/dL)
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
Part 1 OLE and Part 2: Incidence of clinically significant changes in Serum Sodium, Serum Potassium (mmol/L)
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
Part 1 OLE and Part 2: Incidence of clinically significant changes in urinalysis (pos/neg local dipstick)
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
Part 1 OLE and Part 2: Incidence of clinically significant changes in vital sign values (BP)
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
Part 1 OLE and Part 2: Incidence of clinically significant changes in vital sign values (pulse rate)
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
Part 1 OLE and Part 2: Incidence of clinically significant changes in vital sign values (temperature)
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
Part 1 OLE and Part 2: Incidence of clinically significant changes in vital sign values (respiratory rate)
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
Part 1 OLE and Part 2: Incidence of clinically significant changes in ECG measurements (QT interval)
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
Part 1 OLE and Part 2: Incidence of clinically significant changes in ECG measurements (QTc interval)
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
Part 1 OLE and Part 2: Incidence of clinically significant changes in ECG measurements (heart rate)
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
Part 1 OLE and Part 2: Incidence of clinically significant changes in ECG measurements (PR interval)
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
Part 1 OLE and Part 2: Incidence of clinically significant changes in ECG measurements (QRS complex)
To evaluate the long-term safety of oral etrasimod, 2 mg, QD

Secondary Outcome Measures

Part 1 DB: Proportion of participants achieving a EASI-75
To evaluate the efficacy of etrasimod, 2 mg, QD based on additional measures
Part 1 DB: Percent change from baseline in EASI
To evaluate the efficacy of etrasimod, 2 mg, QD based on additional measures

Full Information

First Posted
December 22, 2022
Last Updated
September 15, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT05732454
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2023 (Actual)
Primary Completion Date
August 13, 2026 (Anticipated)
Study Completion Date
August 13, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Atopic Dermatitis, Unspecified, Eczema, Eczema, Atopic
Keywords
Systemic Failure, Oral

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
etrasimod
Arm Type
Experimental
Arm Description
2 mg, oral tablet, once daily
Arm Title
Placebo (Part 1 DB period only)
Arm Type
Placebo Comparator
Arm Description
Oral sham comparator
Intervention Type
Drug
Intervention Name(s)
etrasimod
Other Intervention Name(s)
APD334, PF-07915503
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
PART 1 DOUBLE BLIND Placebo - one table daily for up to 16 weeks
Primary Outcome Measure Information:
Title
Part 1 DB: Proportion of participants achieving IGA of clear (0) or almost clear (1) (on a 5-point scale) and a reduction of ≥ 2 points from baseline
Description
To evaluate the efficacy of etrasimod, 2 mg, QD versus placebo
Time Frame
at Week 16
Title
Part 1 OLE and Part 2: Incidence and severity of treatment-emergent adverse events (AEs), AEs leading to study treatment discontinuation, serious AEs, and AEs of special interest.
Description
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
Time Frame
Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2
Title
Part 1 OLE and Part 2: Incidence of clinically significant changes in Hemoglobin (g/dL)
Description
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
Time Frame
Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2
Title
Part 1 OLE and Part 2: Incidence of clinically significant changes in RBC (x10^6/uL)
Description
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
Time Frame
Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2
Title
Part 1 OLE and Part 2: Incidence of clinically significant changes in Platelets, WBC, and WBC with Diff (x10^3/uL)
Description
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
Time Frame
Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2
Title
Part 1 OLE and Part 2: Incidence of clinically significant changes in TBNK panel (abs/uL)
Description
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
Time Frame
Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2
Title
Part 1 OLE and Part 2: Incidence of clinically significant changes in Hematocrit, WBC with Diff, TBNK with Diff (%)
Description
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
Time Frame
Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2
Title
Part 1 OLE and Part 2: Incidence of clinically significant changes in Total bilirubin, Urea Nitrogen, Creatinine (mg/dL)
Description
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
Time Frame
Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2
Title
Part 1 OLE and Part 2: Incidence of clinically significant changes in AP, ALT (SGPT), AST (SGOT) (U/L)
Description
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
Time Frame
Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2
Title
Part 1 OLE and Part 2: Incidence of clinically significant changes in Total Protein and Albumin-BCG (g/dL)
Description
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
Time Frame
Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2
Title
Part 1 OLE and Part 2: Incidence of clinically significant changes in Serum Sodium, Serum Potassium (mmol/L)
Description
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
Time Frame
Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2
Title
Part 1 OLE and Part 2: Incidence of clinically significant changes in urinalysis (pos/neg local dipstick)
Description
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
Time Frame
Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2
Title
Part 1 OLE and Part 2: Incidence of clinically significant changes in vital sign values (BP)
Description
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
Time Frame
Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2
Title
Part 1 OLE and Part 2: Incidence of clinically significant changes in vital sign values (pulse rate)
Description
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
Time Frame
Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2
Title
Part 1 OLE and Part 2: Incidence of clinically significant changes in vital sign values (temperature)
Description
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
Time Frame
Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2
Title
Part 1 OLE and Part 2: Incidence of clinically significant changes in vital sign values (respiratory rate)
Description
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
Time Frame
Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2
Title
Part 1 OLE and Part 2: Incidence of clinically significant changes in ECG measurements (QT interval)
Description
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
Time Frame
Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2
Title
Part 1 OLE and Part 2: Incidence of clinically significant changes in ECG measurements (QTc interval)
Description
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
Time Frame
Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2
Title
Part 1 OLE and Part 2: Incidence of clinically significant changes in ECG measurements (heart rate)
Description
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
Time Frame
Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2
Title
Part 1 OLE and Part 2: Incidence of clinically significant changes in ECG measurements (PR interval)
Description
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
Time Frame
Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2
Title
Part 1 OLE and Part 2: Incidence of clinically significant changes in ECG measurements (QRS complex)
Description
To evaluate the long-term safety of oral etrasimod, 2 mg, QD
Time Frame
Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2
Secondary Outcome Measure Information:
Title
Part 1 DB: Proportion of participants achieving a EASI-75
Description
To evaluate the efficacy of etrasimod, 2 mg, QD based on additional measures
Time Frame
at Week 16
Title
Part 1 DB: Percent change from baseline in EASI
Description
To evaluate the efficacy of etrasimod, 2 mg, QD based on additional measures
Time Frame
at Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
First OC Dermatology Research Inc
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Individual Site Status
Recruiting
Facility Name
Jared R. Younger, MD (Ophthalmologist)
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Individual Site Status
Recruiting
Facility Name
Bryan D. Vo. MD (Pulmonologist)
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Individual Site Status
Recruiting
Facility Name
California Allergy and Asthma Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Individual Site Status
Recruiting
Facility Name
Dr. Carolyn M. Wong
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Individual Site Status
Recruiting
Facility Name
Dr. Gerald Markovitz
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Individual Site Status
Recruiting
Facility Name
Acuity Eye Group
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Individual Site Status
Recruiting
Facility Name
Chest & Critical Care Consultants
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Individual Site Status
Recruiting
Facility Name
Wolverine Clinical Trials
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Science Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Providence Saint John's Health Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Santa Monica Eye Medical Group
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Ponce PFT & Medical services, INC [for pulmonology examination]
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Individual Site Status
Recruiting
Facility Name
Pulmonary Associates
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33428
Country
United States
Individual Site Status
Recruiting
Facility Name
Cohen Laser and Vision Center
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33431
Country
United States
Individual Site Status
Recruiting
Facility Name
Skin Care Research
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Eye Center: Rodrigo Belalcazar, MD
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Individual Site Status
Recruiting
Facility Name
Direct Helpers Research Center
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Individual Site Status
Recruiting
Facility Name
Gsi Clinical Research
City
Margate
State/Province
Florida
ZIP/Postal Code
33063
Country
United States
Individual Site Status
Recruiting
Facility Name
Randy Burks, MD, FACS
City
Margate
State/Province
Florida
ZIP/Postal Code
33063
Country
United States
Individual Site Status
Recruiting
Facility Name
D & H National Research Centers, Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Name
Imaging - Advanced Health Imaging
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Name
The Selem Center [Ophthalmologist JOSEPH SELEM]
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Individual Site Status
Recruiting
Facility Name
Miami Dermatology and Laser Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Individual Site Status
Recruiting
Facility Name
Ophthalmology - Dr. Edward Boshnick's Global Vision Rehabilitation Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Individual Site Status
Recruiting
Facility Name
Pulmonology - Miami Pulmonology Specialists
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Individual Site Status
Recruiting
Facility Name
Pelletier Jesse MD
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Individual Site Status
Recruiting
Facility Name
Santos Carlos R MD
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Individual Site Status
Recruiting
Facility Name
Tory Sullivan, MD PA
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Individual Site Status
Recruiting
Facility Name
Ziaderm Research, LLC
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Individual Site Status
Recruiting
Facility Name
Gateway Radiology
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Individual Site Status
Recruiting
Facility Name
Akumin Imaging
City
Plantation
State/Province
Florida
ZIP/Postal Code
33322
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Hull & Hull Medical Specialists
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Individual Site Status
Recruiting
Facility Name
GCP Research, Global Clinical professionals
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Individual Site Status
Recruiting
Facility Name
St. Anthonys Hospital
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Individual Site Status
Recruiting
Facility Name
Pulmonology Lung and sleep care inc Dr. Vinubhai C. Pansuriya, MD
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33713
Country
United States
Individual Site Status
Recruiting
Facility Name
Akumin Imaging
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Trials of Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Individual Site Status
Recruiting
Facility Name
Tampa Eye Clinic
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Individual Site Status
Recruiting
Facility Name
USF Health
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Name
NorthShore University HealthSystem
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60026
Country
United States
Individual Site Status
Recruiting
Facility Name
NorthShore University HealthSystem
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Individual Site Status
Recruiting
Facility Name
NorthShore University Health System
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Individual Site Status
Recruiting
Facility Name
Pike Medical Consultants
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46268
Country
United States
Individual Site Status
Recruiting
Facility Name
Rothbaum Eye & Vision
City
Noblesville
State/Province
Indiana
ZIP/Postal Code
46062
Country
United States
Individual Site Status
Recruiting
Facility Name
Options Research Group
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47906
Country
United States
Individual Site Status
Recruiting
Facility Name
Physicians Research Group
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47906
Country
United States
Individual Site Status
Recruiting
Facility Name
Great Lakes Research Group, Inc.
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Individual Site Status
Recruiting
Facility Name
McLaren Bay Region (Pulmonary Function Testing)
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48708
Country
United States
Individual Site Status
Recruiting
Facility Name
Lung and Sleep Disorder Center
City
Lathrup Village
State/Province
Michigan
ZIP/Postal Code
48076
Country
United States
Individual Site Status
Recruiting
Facility Name
Melisa David, O.D. (Ophthalmology Exam)
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48603
Country
United States
Individual Site Status
Recruiting
Facility Name
Revival Research Institute, LLC
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Individual Site Status
Recruiting
Facility Name
Somerset Opthalmology PC
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Individual Site Status
Recruiting
Facility Name
Eye Institute
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Individual Site Status
Recruiting
Facility Name
Pulmonary and Sleep Center of Oklahoma
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Individual Site Status
Recruiting
Facility Name
Vital Prospects Clinical Research Institute, PC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Individual Site Status
Recruiting
Facility Name
Monument Health Rapid City Hospital
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Individual Site Status
Recruiting
Facility Name
Health Concepts
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Individual Site Status
Recruiting
Facility Name
In Vision Optical and Eyecare
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Eye Care Associates of Arlington
City
Arlington
State/Province
Texas
ZIP/Postal Code
76010
Country
United States
Individual Site Status
Recruiting
Facility Name
Arlington Research Center
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Individual Site Status
Recruiting
Facility Name
Envision Imaging
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Pulmonary
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Individual Site Status
Recruiting
Facility Name
Alpesh D. Desai, DO PLLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Individual Site Status
Recruiting
Facility Name
Becky Fredrickson, MD [Optometrist/Ophthalmologist]
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Individual Site Status
Recruiting
Facility Name
Heights Dermatology & Aesthetic Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Individual Site Status
Recruiting
Facility Name
Rupesh Vakil, MD [Pulmonologist]
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Individual Site Status
Recruiting
Facility Name
Acclaim Dermatology
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Individual Site Status
Recruiting
Facility Name
Horizon Eye Care and Optical
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Individual Site Status
Recruiting
Facility Name
Sweetwater Pulmonary Associates
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Individual Site Status
Recruiting
Facility Name
Dermatology Research Institute
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2J 7E1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Rejuvenation Dermatology
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5J 3S9
Country
Canada
Individual Site Status
Recruiting
Facility Name
CARe Clinic
City
Red Deer
State/Province
Alberta
ZIP/Postal Code
T4P 1K4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Visique
City
Québec
State/Province
Quebec
ZIP/Postal Code
G2J 0C4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Biron
City
Quebec
ZIP/Postal Code
G1W 2K9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centre de Recherche Saint-Louis
City
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Alpha Recherche Clinique
City
Quebec
ZIP/Postal Code
G2J 0C4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava
State/Province
Moravskoslezský KRAJ
ZIP/Postal Code
708 52
Country
Czechia
Individual Site Status
Recruiting
Facility Name
FNO
City
Ostrava
State/Province
Ostrava Město
ZIP/Postal Code
708 52
Country
Czechia
Individual Site Status
Recruiting
Facility Name
CCR Czech a.s.
City
Pardubice
ZIP/Postal Code
53002
Country
Czechia
Individual Site Status
Recruiting
Facility Name
MUDr. Katarína Jiráková s.r.o.
City
Pardubice
ZIP/Postal Code
53002
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Poliklinika VEKTOR Pardubice
City
Pardubice
ZIP/Postal Code
53002
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice v Motole
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultní nemocnice v Motole
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska
City
Wroclaw
State/Province
Dolnośląskie
ZIP/Postal Code
50-566
Country
Poland
Individual Site Status
Recruiting
Facility Name
Artemed Centrum Medyczne
City
Wrocław
State/Province
Dolnośląskie
ZIP/Postal Code
50-450
Country
Poland
Individual Site Status
Recruiting
Facility Name
Specjalistyczna Praktyka Lekarska Joanna Kalinowska
City
Wrocław
State/Province
Dolnośląskie
ZIP/Postal Code
51-605
Country
Poland
Individual Site Status
Recruiting
Facility Name
Indywidualna Specjalistyczna Praktyka Lekarska Michał Silber
City
Wrocław
State/Province
Dolnośląskie
ZIP/Postal Code
53-124
Country
Poland
Individual Site Status
Recruiting
Facility Name
DERMEDIC Iwona Zdybska
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-607
Country
Poland
Individual Site Status
Recruiting
Facility Name
Eyemed
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-631
Country
Poland
Individual Site Status
Recruiting
Facility Name
WIP Warsaw IBD Point Profesor Kierkuś
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
00-728
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Centrum Mikrochirurgii Oka Laser
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
00-215
Country
Poland
Individual Site Status
Recruiting
Facility Name
ŚWIAT OKA Centrum Okulistyczne
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-511
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Radiologii Klinicznej Wilanowska Sp. Z O.O.
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-665
Country
Poland
Individual Site Status
Recruiting
Facility Name
Klinika Ambroziak Dermatologia
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-953
Country
Poland
Individual Site Status
Recruiting
Facility Name
Royalderm Agnieszka Nawrocka
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-962
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne ,,All - Med'' Badania Kliniczne
City
Kraków
State/Province
Małopolskie
ZIP/Postal Code
30-033
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne ALL-MED
City
Kraków
State/Province
Małopolskie
ZIP/Postal Code
30-033
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Centrum Medyczne Dietla 19
City
Kraków
State/Province
Małopolskie
ZIP/Postal Code
31-070
Country
Poland
Individual Site Status
Recruiting
Facility Name
AUGON Gabinet Okulistyczny
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-427
Country
Poland
Individual Site Status
Recruiting
Facility Name
NZOZ Specjalistyczny Ośrodek Dermatologiczny "DERMAL"
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-453
Country
Poland
Individual Site Status
Recruiting
Facility Name
Gabinet Alergologiczny IR-med dr n. med. Izabela Roszko-Kirpsza
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-872
Country
Poland
Individual Site Status
Recruiting
Facility Name
Flosmed
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
60-192
Country
Poland
Individual Site Status
Recruiting
Facility Name
Niepubliczny Zakład Opieki Zdrowotnej Zespół Poradni Specjalistycznych "Termedica"
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
60-681
Country
Poland
Individual Site Status
Recruiting
Facility Name
Medoculis
City
Poznań
State/Province
Wielkopolskie
ZIP/Postal Code
61-551
Country
Poland
Individual Site Status
Recruiting
Facility Name
Medicus
City
Szczecin
State/Province
Zachodniopomorskie
ZIP/Postal Code
70-233
Country
Poland
Individual Site Status
Recruiting
Facility Name
Twoja Przychodnia SCM
City
Szczecin
State/Province
Zachodniopomorskie
ZIP/Postal Code
71-434
Country
Poland
Individual Site Status
Recruiting
Facility Name
Twoja Przychodnia SCM
City
Szczecin
State/Province
Zachodniopomorskie
ZIP/Postal Code
71-500
Country
Poland
Individual Site Status
Recruiting
Facility Name
Gabinety Lekarskie Rivermed
City
Poznan
ZIP/Postal Code
61-441
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Okulistyczne Instytut Oka
City
Warsaw
ZIP/Postal Code
02-653
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Centrum Dermatologiczne FEBUMED
City
Warszawa
ZIP/Postal Code
02-777
Country
Poland
Individual Site Status
Recruiting
Facility Name
"DERMED" Centrum Medyczne Sp. z o.o.
City
Lodz
State/Province
Łódzkie
ZIP/Postal Code
90-265
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centra Medyczne Medyceusz Sp. z o. o.
City
Lodz
State/Province
Łódzkie
ZIP/Postal Code
91-053
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Okulistyczne Contact - Med sp. z o.o.
City
Lodz
State/Province
Łódzkie
ZIP/Postal Code
91-464
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Szpital Świętej Rodziny
City
Łódź
State/Province
Łódzkie
ZIP/Postal Code
90-302
Country
Poland
Individual Site Status
Recruiting
Facility Name
Salve
City
Łódź
State/Province
Łódzkie
ZIP/Postal Code
90-420
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak
City
Łódź
State/Province
Łódzkie
ZIP/Postal Code
90-436
Country
Poland
Individual Site Status
Recruiting
Facility Name
Ekovivus
City
Łódź
State/Province
Łódzkie
ZIP/Postal Code
91-833
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Angelius Provita
City
Katowice
State/Province
Śląskie
ZIP/Postal Code
40-611
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Zdrowia Ochaliczówka
City
Katowice
State/Province
Śląskie
ZIP/Postal Code
40-750
Country
Poland
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C5041005
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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