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, 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:

• 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).

Study Overview

• Status: Active, not recruiting
• Conditions: Eczema; Atopic Dermatitis; Eczema, Atopic; Atopic Dermatitis, Unspecified
• Intervention / Treatment: Drug: etrasimod; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: etrasimod; 2 mg, oral tablet, once daily	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; Other Names: APD334; PF-07915503
Placebo Comparator: Placebo (Part 1 DB period only); Oral sham comparator	Drug: Placebo; PART 1 DOUBLE BLIND Placebo - one table daily for up to 16 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2023
• Primary Completion (Estimated): April 23, 2024
• Study Completion (Estimated): April 23, 2024

Study Registration Dates

• First Submitted: December 22, 2022
• First Submitted That Met QC Criteria: February 7, 2023
• First Posted (Actual): February 17, 2023

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Oral; Systemic Failure
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: C5041005; 2022-003361-37 (EudraCT Number); APD334-314 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No