Clinical trial NCT05732454: 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
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Atopic Dermatitis
Atopic Dermatitis, Unspecified
Eczema
Eczema, Atopic
Keywords: Systemic Failure
Oral
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-02-17
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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).


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:

1. IGA score ≥3 (on the 0 to 4 IGA scale, in which 3 = moderate and 4 = severe) at screening and baseline (Day 1)
2. BSA ≥10% of AD involvement at screening and baseline (Day 1)
3. Eczema Area and Severity Index (EASI) ≥16 at screening and baseline (Day 1) 4. A participant who has failed a prior systemic therapy for AD, ie, refractory, moderate-to-severe AD that is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.

   5. Willing to apply a topical emollient/moisturizer at least once daily for ≥1 week prior to baseline (Day 1) and willing to maintain consistent (ie, no change in type, frequency, or application) daily application over the course of the study.

   Exclusion Criteria:

   Participants are excluded from the study if any of the following criteria apply:

   Medical Conditions:
   1. Presence of confounding factors:

      * Skin conditions (eg, psoriasis, seborrheic dermatitis) that may interfere with evaluation of AD or assessment of treatment response as deemed by the investigator.
      * Current significant active infection or requiring a treatment for infection that may interfere with the assessment of AD.
   2. Hypersensitivity to etrasimod or any of the excipients.
   3. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

Primary outcomes:
measure: Part 1, DB Period: Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response at Week 16
timeFrame: DB Period: Week 16
measure: Part 1, DB Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (All Causality)
timeFrame: DB Period: From first dose of study drug up to 16 Weeks of treatment
measure: Part 1, DB Period: Number of Participants With TEAEs (All Causality) Leading to Study Treatment Discontinuation
timeFrame: DB Period: From first dose of study drug up to 16 Weeks of treatment
measure: Part 1, DB Period: Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) (All Causality)
timeFrame: DB Period: From first dose of study drug up to 16 Weeks of treatment
measure: Part 1, DB Period: Number of Participants With Treatment Emergent AEs of Special Interest (AESIs) (All Causality)
timeFrame: DB Period: From first dose of study drug up to 16 Weeks of treatment
measure: Part 1, DB Period: Number of Participants With Laboratory Test Abnormalities
timeFrame: DB Period: From first dose of study drug up to 16 Weeks of treatment
measure: Part 1, DB Period: Number of Participants With Markedly Abnormal 12-Lead Electrocardiogram Measurements and AV Blocks
timeFrame: 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
measure: Part 1, DB Period: Number of Participants With Markedly Abnormal Vital Sign
timeFrame: 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
measure: Part 1, OLE Period: Number of Participants With TEAEs (All Causality)
timeFrame: 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)
measure: Part 1, OLE Period: Number of Participants With Treatment Emergent AEs (All Causality) Leading to Study Treatment Discontinuation
timeFrame: 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)
measure: Part 1, OLE Period: Number of Participants With Treatment Emergent SAEs (All Causality)
timeFrame: 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)
measure: Part 1, OLE Period: Number of Participants With Treatment Emergent AESIs (All Causality)
timeFrame: 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)
measure: Part 1, OLE Period: Number of Participants With Laboratory Test Abnormalities
timeFrame: 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)
measure: Part 1, OLE Period: Number of Participants With Markedly Abnormal 12-Lead Electrocardiogram Measurements and AV Blocks
timeFrame: OLE Period: Day 169/Week 24
measure: Part 1, OLE Period: Number of Participants With Markedly Abnormal Vital Sign
timeFrame: OLE Period: Day 141/Week 20; Day 169/Week 24; Day 281/Week 40; Follow Up 1; Follow Up 2
Secondary outcomes:
measure: 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
timeFrame: DB Period: Week 16
measure: Part 1, DB Period: Percent Change From Baseline in EASI Score at Week 16
timeFrame: DB Period: Baseline, Week 16
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: First OC Dermatology Research Inc
state: California
city: Fountain Valley
country: United States
facility: Jared R. Younger, MD (Ophthalmologist)
state: California
city: Laguna Hills
country: United States
facility: Bryan D. Vo. MD (Pulmonologist)
state: California
city: Los Angeles
country: United States
facility: California Allergy and Asthma Medical Group
state: California
city: Los Angeles
country: United States
facility: Dr. Carolyn M. Wong
state: California
city: Los Angeles
country: United States
facility: Dr. Gerald Markovitz
state: California
city: Santa Monica
country: United States
facility: Resolution Advanced Imaging Center
state: California
city: Aventura
country: United States
facility: Ponce PFT & Medical services, INC [for pulmonology examination]
state: Florida
city: Hialeah
country: United States
facility: Advanced Eye Center: Rodrigo Belalcazar, MD
state: Florida
city: Hialeah
country: United States
facility: Direct Helpers Research Center
state: Florida
city: Margate
country: United States
facility: Gsi Clinical Research
state: Florida
city: Margate
country: United States
facility: Randy Burks, MD, FACS
state: Florida
city: Miami
country: United States
facility: D & H National Research Centers, Inc.
state: Florida
city: Miami
country: United States
facility: Imaging - Advanced Health Imaging
state: Florida
city: Miami
country: United States
facility: The Selem Center [Ophthalmologist JOSEPH SELEM]
state: Florida
city: Miami
country: United States
facility: Miami Dermatology and Laser Research
state: Florida
city: Miami
country: United States
facility: Ophthalmology - Dr. Edward Boshnick's Global Vision Rehabilitation Center
state: Florida
city: Miami
country: United States
facility: Pulmonology - Miami Pulmonology Specialists
state: Florida
city: North Miami Beach
country: United States
facility: Pelletier Jesse MD
state: Florida
city: North Miami Beach
country: United States
facility: Santos Carlos R MD
state: Florida
city: North Miami Beach
country: United States
facility: Tory Sullivan, Md Pa
state: Florida
city: Pinellas Park
country: United States
facility: Gateway Radiology
state: Florida
city: Plantation
country: United States
facility: Hull & Hull Medical Specialists
state: Florida
city: Saint Petersburg
country: United States
facility: GCP Research, Global Clinical professionals
state: Florida
city: Saint Petersburg
country: United States
facility: St. Anthonys Hospital
state: Florida
city: Tampa
country: United States
facility: USF Health
state: Florida
city: Lathrup Village
country: United States
facility: Lung and Sleep Disorder Center
state: Michigan
city: Troy
country: United States
facility: Revival Research Institute, LLC
state: Michigan
city: Troy
country: United States
facility: Somerset Opthalmology PC
state: Michigan
city: Tulsa
country: United States
facility: Eye Institute
state: Oklahoma
city: Tulsa
country: United States
facility: Pulmonary and Sleep Center of Oklahoma
state: Oklahoma
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute, PC
state: Oklahoma
city: Rapid City
country: United States
facility: Monument Health Rapid City Hospital
state: South Dakota
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Rapid City
country: United States
facility: In Vision Optical and Eyecare
state: South Dakota
city: Arlington
country: United States
facility: Eye Care Associates of Arlington
state: Texas
city: Arlington
country: United States
facility: Arlington Research Center
state: Texas
city: Arlington
country: United States
facility: Texas Pulmonary
state: Texas
city: Houston
country: United States
facility: Alpesh D. Desai, DO PLLC
state: Texas
city: Houston
country: United States
facility: Becky Fredrickson, MD [Optometrist/Ophthalmologist]
state: Texas
city: Houston
country: United States
facility: Rupesh Vakil, MD [Pulmonologist]
state: Texas
city: Sugar Land
country: United States
facility: Acclaim Dermatology
state: Texas
city: Sugar Land
country: United States
facility: Horizon Eye Care and Optical
state: Texas
city: Sugar Land
country: United States
facility: Sweetwater Pulmonary Associates
state: Texas
city: Edmonton
country: Canada
facility: Rejuvenation Dermatology
state: Alberta
city: Red Deer
country: Canada
facility: CaRe Clinic
state: Alberta
city: Québec
country: Canada
facility: Visique
state: Quebec
city: Quebec
country: Canada
facility: Biron
city: Quebec
country: Canada
facility: Alpha Recherche Clinique
city: Pardubice
country: Czechia
facility: Poliklinika VEKTOR Pardubice
city: Pardubice
country: Czechia
facility: Pratia Pardubice a.s.
city: Praha 5
country: Czechia
facility: Fakultní nemocnice v Motole
city: Wroclaw
country: Poland
facility: Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska
state: Dolnośląskie
city: Wrocław
country: Poland
facility: Artemed Centrum Medyczne
state: Dolnośląskie
city: Wrocław
country: Poland
facility: Specjalistyczna Praktyka Lekarska Joanna Kalinowska
state: Dolnośląskie
city: Wrocław
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska Michał Silber
state: Dolnośląskie
city: Lublin
country: Poland
facility: DERMEDIC Iwona Zdybska
state: Lubelskie
city: Lublin
country: Poland
facility: Eyemed
state: Lubelskie
city: Kraków
country: Poland
facility: Centrum Medyczne ,,All - Med'' Badania Kliniczne
state: Małopolskie
city: Kraków
country: Poland
facility: Centrum Medyczne Dietla 19
state: Małopolskie
city: Bialystok
country: Poland
facility: AUGON Gabinet Okulistyczny
state: Podlaskie
city: Bialystok
country: Poland
facility: Nzoz Specjalistyczny Ośrodek Dermatologiczny "Dermal"
state: Podlaskie
city: Bialystok
country: Poland
facility: Gabinet Alergologiczny IR-med dr n. med. Izabela Roszko-Kirpsza
state: Podlaskie
city: Poznan
country: Poland
facility: Flosmed
state: Wielkopolskie
city: Poznan
country: Poland
facility: Niepubliczny Zakład Opieki Zdrowotnej Zespół Poradni Specjalistycznych "Termedica"
state: Wielkopolskie
city: Poznań
country: Poland
facility: Medoculis
state: Wielkopolskie
city: Szczecin
country: Poland
facility: Medicus
state: Zachodniopomorskie
city: Szczecin
country: Poland
facility: Twoja Przychodnia SCM
state: Zachodniopomorskie
city: Poznan
country: Poland
facility: Gabinety Lekarskie Rivermed
city: Łódź
country: Poland
facility: Centrum Medyczne Szpital Świętej Rodziny
state: Łódzkie
city: Łódź
country: Poland
facility: Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak
state: Łódzkie
city: Łódź
country: Poland
facility: Ekovivus
state: Łódzkie
city: Katowice
country: Poland
facility: Centrum Medyczne Angelius Provita
state: Śląskie
city: Katowice
country: Poland
facility: Centrum Zdrowia Ochaliczówka
state: Śląskie
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: