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

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05732454
• Other study ID #: C5041005
• Secondary ID: 2022-003361-37AP
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: January 18, 2023
• Est. completion date: April 29, 2024

Study information

• Verified date: May 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 58
• Est. completion date: April 29, 2024
• Est. primary completion date: April 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Eczema, Atopic

Intervention

Drug:
• etrasimod
PART 1 Double Blind one 2 mg tablet once daily for up to 16 weeks PART 1 Open Label Extension one 2 mg tablet once daily for an additional 52 weeks PART 2 Open Label one 2 mg tablet once daily for up 52 weeks
• Placebo
PART 1 DOUBLE BLIND Placebo - one table daily for up to 16 weeks

Locations

Country	Name	City	State
Canada	Dermatology Research Institute	Calgary	Alberta
Canada	Rejuvenation Dermatology	Edmonton	Alberta
Canada	Alpha Recherche Clinique	Quebec
Canada	Biron	Quebec
Canada	Centre de Recherche Saint-Louis	Quebec
Canada	Visique	Québec	Quebec
Canada	CARe Clinic	Red Deer	Alberta
Czechia	Fakultni nemocnice Ostrava	Ostrava	Moravskoslezský KRAJ
Czechia	FNO	Ostrava	Ostrava Mesto
Czechia	CCR Czech a.s.	Pardubice
Czechia	MUDr. Katarína Jiráková s.r.o.	Pardubice
Czechia	Poliklinika VEKTOR Pardubice	Pardubice
Czechia	Fakultni nemocnice v Motole	Praha 5
Czechia	Fakultní nemocnice v Motole	Praha 5
Poland	AUGON Gabinet Okulistyczny	Bialystok	Podlaskie
Poland	Gabinet Alergologiczny IR-med dr n. med. Izabela Roszko-Kirpsza	Bialystok	Podlaskie
Poland	NZOZ Specjalistyczny Osrodek Dermatologiczny "DERMAL"	Bialystok	Podlaskie
Poland	Centrum Medyczne Angelius Provita	Katowice	Slaskie
Poland	Centrum Zdrowia Ochaliczówka	Katowice	Slaskie
Poland	Centrum Medyczne ,,All - Med'' Badania Kliniczne	Kraków	Malopolskie
Poland	Centrum Medyczne ALL-MED	Kraków	Malopolskie
Poland	Centrum Medyczne Dietla 19	Kraków	Malopolskie
Poland	"DERMED" Centrum Medyczne Sp. z o.o.	Lodz	Lódzkie
Poland	Centra Medyczne Medyceusz Sp. z o. o.	Lodz	Lódzkie
Poland	Centrum Okulistyczne Contact - Med sp. z o.o.	Lodz	Lódzkie
Poland	Centrum Medyczne Szpital Swietej Rodziny	Lódz	Lódzkie
Poland	Dermoklinika - Centrum Medyczne spólka cywilna M. Kierstan, J. Narbutt, A. Lesiak	Lódz	Lódzkie
Poland	Ekovivus	Lódz	Lódzkie
Poland	Salve	Lódz	Lódzkie
Poland	DERMEDIC Iwona Zdybska	Lublin	Lubelskie
Poland	Eyemed	Lublin	Lubelskie
Poland	Flosmed	Poznan	Wielkopolskie
Poland	Gabinety Lekarskie Rivermed	Poznan
Poland	Medoculis	Poznan	Wielkopolskie
Poland	Niepubliczny Zaklad Opieki Zdrowotnej Zespól Poradni Specjalistycznych "Termedica"	Poznan	Wielkopolskie
Poland	Medicus	Szczecin	Zachodniopomorskie
Poland	Twoja Przychodnia SCM	Szczecin	Zachodniopomorskie
Poland	Twoja Przychodnia SCM	Szczecin	Zachodniopomorskie
Poland	Centrum Okulistyczne Instytut Oka	Warsaw
Poland	WIP Warsaw IBD Point Profesor Kierkus	Warsaw	Mazowieckie
Poland	Centrum Dermatologiczne FEBUMED	Warszawa
Poland	Centrum Mikrochirurgii Oka Laser	Warszawa	Mazowieckie
Poland	Centrum Radiologii Klinicznej Wilanowska Sp. Z O.O.	Warszawa	Mazowieckie
Poland	Klinika Ambroziak Dermatologia	Warszawa	Mazowieckie
Poland	Royalderm Agnieszka Nawrocka	Warszawa	Mazowieckie
Poland	SWIAT OKA Centrum Okulistyczne	Warszawa	Mazowieckie
Poland	Artemed Centrum Medyczne	Wroclaw	Dolnoslaskie
Poland	Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spólka Partnerska	Wroclaw	Dolnoslaskie
Poland	Indywidualna Specjalistyczna Praktyka Lekarska Michal Silber	Wroclaw	Dolnoslaskie
Poland	Specjalistyczna Praktyka Lekarska Joanna Kalinowska	Wroclaw	Dolnoslaskie
United States	Arlington Research Center	Arlington	Texas
United States	Envision Imaging	Arlington	Texas
United States	Eye Care Associates of Arlington	Arlington	Texas
United States	Texas Pulmonary	Arlington	Texas
United States	Ponce PFT & Medical services, INC [for pulmonology examination]	Aventura	Florida
United States	Great Lakes Research Group, Inc.	Bay City	Michigan
United States	McLaren Bay Region (Pulmonary Function Testing)	Bay City	Michigan
United States	Cohen Laser and Vision Center	Boca Raton	Florida
United States	Pulmonary Associates	Boca Raton	Florida
United States	Skin Care Research	Boca Raton	Florida
United States	First OC Dermatology Research Inc	Fountain Valley	California
United States	Jared R. Younger, MD (Ophthalmologist)	Fountain Valley	California
United States	NorthShore University HealthSystem	Glenview	Illinois
United States	Advanced Eye Center: Rodrigo Belalcazar, MD	Hialeah	Florida
United States	Direct Helpers Research Center	Hialeah	Florida
United States	Alpesh D. Desai, DO PLLC	Houston	Texas
United States	Becky Fredrickson, MD [Optometrist/Ophthalmologist]	Houston	Texas
United States	Heights Dermatology & Aesthetic Center	Houston	Texas
United States	Rupesh Vakil, MD [Pulmonologist]	Houston	Texas
United States	Pike Medical Consultants	Indianapolis	Indiana
United States	Bryan D. Vo. MD (Pulmonologist)	Laguna Hills	California
United States	Lung and Sleep Disorder Center	Lathrup Village	Michigan
United States	California Allergy and Asthma Medical Group	Los Angeles	California
United States	Dr. Carolyn M. Wong	Los Angeles	California
United States	Dr. Gerald Markovitz	Los Angeles	California
United States	Gsi Clinical Research	Margate	Florida
United States	Randy Burks, MD, FACS	Margate	Florida
United States	D & H National Research Centers, Inc.	Miami	Florida
United States	Imaging - Advanced Health Imaging	Miami	Florida
United States	Miami Dermatology and Laser Research	Miami	Florida
United States	Ophthalmology - Dr. Edward Boshnick's Global Vision Rehabilitation Center	Miami	Florida
United States	Pulmonology - Miami Pulmonology Specialists	Miami	Florida
United States	The Selem Center [Ophthalmologist JOSEPH SELEM]	Miami	Florida
United States	Rothbaum Eye & Vision	Noblesville	Indiana
United States	Pelletier Jesse MD	North Miami Beach	Florida
United States	Santos Carlos R MD	North Miami Beach	Florida
United States	Tory Sullivan, MD PA	North Miami Beach	Florida
United States	Ziaderm Research, LLC	North Miami Beach	Florida
United States	Gateway Radiology	Pinellas Park	Florida
United States	Akumin Imaging	Plantation	Florida
United States	Hull & Hull Medical Specialists	Plantation	Florida
United States	Health Concepts	Rapid City	South Dakota
United States	In Vision Optical and Eyecare	Rapid City	South Dakota
United States	Monument Health Rapid City Hospital	Rapid City	South Dakota
United States	Melisa David, O.D. (Ophthalmology Exam)	Saginaw	Michigan
United States	GCP Research, Global Clinical professionals	Saint Petersburg	Florida
United States	Pulmonology Lung and sleep care inc Dr. Vinubhai C. Pansuriya, MD	Saint Petersburg	Florida
United States	St. Anthonys Hospital	Saint Petersburg	Florida
United States	Acuity Eye Group	Santa Ana	California
United States	Chest & Critical Care Consultants	Santa Ana	California
United States	Wolverine Clinical Trials	Santa Ana	California
United States	Clinical Science Institute	Santa Monica	California
United States	Providence Saint John's Health Center	Santa Monica	California
United States	Resolution Advanced Imaging Center	Santa Monica	California
United States	Santa Monica Eye Medical Group	Santa Monica	California
United States	NorthShore University Health System	Skokie	Illinois
United States	NorthShore University HealthSystem	Skokie	Illinois
United States	Acclaim Dermatology	Sugar Land	Texas
United States	Horizon Eye Care and Optical	Sugar Land	Texas
United States	Sweetwater Pulmonary Associates	Sugar Land	Texas
United States	Akumin Imaging	Tampa	Florida
United States	Clinical Research Trials of Florida	Tampa	Florida
United States	Tampa Eye Clinic	Tampa	Florida
United States	USF Health	Tampa	Florida
United States	Revival Research Institute, LLC	Troy	Michigan
United States	Somerset Opthalmology PC	Troy	Michigan
United States	Eye Institute	Tulsa	Oklahoma
United States	Pulmonary and Sleep Center of Oklahoma	Tulsa	Oklahoma
United States	Vital Prospects Clinical Research Institute, PC	Tulsa	Oklahoma
United States	Options Research Group	West Lafayette	Indiana
United States	Physicians Research Group	West Lafayette	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	at Week 16
Primary	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	Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2
Primary	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	Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2
Primary	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	Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2
Primary	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	Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2
Primary	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	Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2
Primary	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	Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2
Primary	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	Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2
Primary	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	Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2
Primary	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	Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2
Primary	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	Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2
Primary	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	Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2
Primary	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	Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2
Primary	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	Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2
Primary	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	Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2
Primary	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	Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2
Primary	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	Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2
Primary	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	Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2
Primary	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	Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2
Primary	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	Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2
Primary	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	Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2
Secondary	Part 1 DB: Proportion of participants achieving a EASI-75	To evaluate the efficacy of etrasimod, 2 mg, QD based on additional measures	at Week 16
Secondary	Part 1 DB: Percent change from baseline in EASI	To evaluate the efficacy of etrasimod, 2 mg, QD based on additional measures	at Week 16

External Links

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