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

• ClinicalTrials.gov Identifier: NCT05732454
• Recruitment Status: Recruiting
• First Posted: February 17, 2023
• Last Update Posted: June 5, 2023
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

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).

Condition or disease	Intervention/treatment	Phase
Atopic Dermatitis; Atopic Dermatitis, Unspecified; Eczema; Eczema, Atopic	Drug: etrasimod; Drug: Placebo	Phase 2; Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment

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.

• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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.

• Primary Purpose: Treatment
• 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
• Actual Study Start Date: January 18, 2023
• Estimated Primary Completion Date: August 13, 2026
• Estimated Study Completion Date: August 13, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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 [ Time Frame: at Week 16 ]
   To evaluate the efficacy of etrasimod, 2 mg, QD versus placebo
2. 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. [ Time Frame: Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2 ]
   To evaluate the long-term safety of oral etrasimod, 2 mg, QD
3. Part 1 OLE and Part 2: Incidence of clinically significant changes in Hemoglobin (g/dL) [ Time Frame: Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2 ]
   To evaluate the long-term safety of oral etrasimod, 2 mg, QD
4. Part 1 OLE and Part 2: Incidence of clinically significant changes in RBC (x10^6/uL) [ Time Frame: Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2 ]
   To evaluate the long-term safety of oral etrasimod, 2 mg, QD
5. Part 1 OLE and Part 2: Incidence of clinically significant changes in Platelets, WBC, and WBC with Diff (x10^3/uL) [ Time Frame: Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2 ]
   To evaluate the long-term safety of oral etrasimod, 2 mg, QD
6. Part 1 OLE and Part 2: Incidence of clinically significant changes in TBNK panel (abs/uL) [ Time Frame: Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2 ]
   To evaluate the long-term safety of oral etrasimod, 2 mg, QD
7. Part 1 OLE and Part 2: Incidence of clinically significant changes in Hematocrit, WBC with Diff, TBNK with Diff (%) [ Time Frame: Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2 ]
   To evaluate the long-term safety of oral etrasimod, 2 mg, QD
8. Part 1 OLE and Part 2: Incidence of clinically significant changes in Total bilirubin, Urea Nitrogen, Creatinine (mg/dL) [ Time Frame: Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2 ]
   To evaluate the long-term safety of oral etrasimod, 2 mg, QD
9. Part 1 OLE and Part 2: Incidence of clinically significant changes in AP, ALT (SGPT), AST (SGOT) (U/L) [ Time Frame: Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2 ]
   To evaluate the long-term safety of oral etrasimod, 2 mg, QD
10. Part 1 OLE and Part 2: Incidence of clinically significant changes in Total Protein and Albumin-BCG (g/dL) [ Time Frame: Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2 ]
    To evaluate the long-term safety of oral etrasimod, 2 mg, QD
11. Part 1 OLE and Part 2: Incidence of clinically significant changes in Serum Sodium, Serum Potassium (mmol/L) [ Time Frame: Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2 ]
    To evaluate the long-term safety of oral etrasimod, 2 mg, QD
12. Part 1 OLE and Part 2: Incidence of clinically significant changes in urinalysis (pos/neg local dipstick) [ Time Frame: Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2 ]
    To evaluate the long-term safety of oral etrasimod, 2 mg, QD
13. Part 1 OLE and Part 2: Incidence of clinically significant changes in vital sign values (BP) [ Time Frame: Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2 ]
    To evaluate the long-term safety of oral etrasimod, 2 mg, QD
14. Part 1 OLE and Part 2: Incidence of clinically significant changes in vital sign values (pulse rate) [ Time Frame: Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2 ]
    To evaluate the long-term safety of oral etrasimod, 2 mg, QD
15. Part 1 OLE and Part 2: Incidence of clinically significant changes in vital sign values (temperature) [ Time Frame: Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2 ]
    To evaluate the long-term safety of oral etrasimod, 2 mg, QD
16. Part 1 OLE and Part 2: Incidence of clinically significant changes in vital sign values (respiratory rate) [ Time Frame: Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2 ]
    To evaluate the long-term safety of oral etrasimod, 2 mg, QD
17. Part 1 OLE and Part 2: Incidence of clinically significant changes in ECG measurements (QT interval) [ Time Frame: Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2 ]
    To evaluate the long-term safety of oral etrasimod, 2 mg, QD
18. Part 1 OLE and Part 2: Incidence of clinically significant changes in ECG measurements (QTc interval) [ Time Frame: Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2 ]
    To evaluate the long-term safety of oral etrasimod, 2 mg, QD
19. Part 1 OLE and Part 2: Incidence of clinically significant changes in ECG measurements (heart rate) [ Time Frame: Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2 ]
    To evaluate the long-term safety of oral etrasimod, 2 mg, QD
20. Part 1 OLE and Part 2: Incidence of clinically significant changes in ECG measurements (PR interval) [ Time Frame: Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2 ]
    To evaluate the long-term safety of oral etrasimod, 2 mg, QD
21. Part 1 OLE and Part 2: Incidence of clinically significant changes in ECG measurements (QRS complex) [ Time Frame: Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2 ]
    To evaluate the long-term safety of oral etrasimod, 2 mg, QD
22. Part 1 OLE and Part 2: Change from Baseline in Hemoglobin (g/dL) [ Time Frame: Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2 ]
    To evaluate the long-term safety of oral etrasimod, 2 mg, QD
23. Part 1 OLE and Part 2: Change from Baseline in RBC (x10^6/uL) [ Time Frame: Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2 ]
    To evaluate the long-term safety of oral etrasimod, 2 mg, QD
24. Part 1 OLE and Part 2: Change from Baseline in Platelets, WBC, and WBC with diff (x10^3/uL) [ Time Frame: Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2 ]
    To evaluate the long-term safety of oral etrasimod, 2 mg, QD
25. Part 1 OLE and Part 2: Change from Baseline in TBNK Panel (abs/uL) [ Time Frame: Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2 ]
    To evaluate the long-term safety of oral etrasimod, 2 mg, QD
26. Part 1 OLE and Part 2: Change from Baseline in Hematocrit, WBC with diff, TBNK with diff (%) [ Time Frame: Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2 ]
    To evaluate the long-term safety of oral etrasimod, 2 mg, QD
27. Part 1 OLE and Part 2: Change from Baseline in Total bilirubin, Urea Nitrogen, Creatinine (mg/dL) [ Time Frame: Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2 ]
    To evaluate the long-term safety of oral etrasimod, 2 mg, QD
28. Part 1 OLE and Part 2: Change from Baseline in AP, ALT (SGPT), AST (SGOT) (U/L) [ Time Frame: Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2 ]
    To evaluate the long-term safety of oral etrasimod, 2 mg, QD
29. Part 1 OLE and Part 2: Change from Baseline in Total Protein and Albumin-BCG (g/dL) [ Time Frame: Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2 ]
    To evaluate the long-term safety of oral etrasimod, 2 mg, QD
30. Part 1 OLE and Part 2: Change from Baseline in Serum Sodium, Serum Potassium (mmol/L) [ Time Frame: Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2 ]
    To evaluate the long-term safety of oral etrasimod, 2 mg, QD
31. Part 1 OLE and Part 2: Change from Baseline in urinalysis (pos/neg local dipstick) [ Time Frame: Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2 ]
    To evaluate the long-term safety of oral etrasimod, 2 mg, QD
32. Part 1 OLE and Part 2: Change from Baseline in vital sign values (BP) [ Time Frame: Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2 ]
    To evaluate the long-term safety of oral etrasimod, 2 mg, QD
33. Part 1 OLE and Part 2: Change from Baseline in vital sign values (pulse rate) [ Time Frame: Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2 ]
    To evaluate the long-term safety of oral etrasimod, 2 mg, QD
34. Part 1 OLE and Part 2: Change from Baseline in vital sign values (temperature) [ Time Frame: Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2 ]
    To evaluate the long-term safety of oral etrasimod, 2 mg, QD
35. Part 1 OLE and Part 2: Change from Baseline in vital sign values (respiratory rate) [ Time Frame: Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2 ]
    To evaluate the long-term safety of oral etrasimod, 2 mg, QD
36. Part 1 OLE and Part 2: Change from Baseline in ECG values (QT interval) [ Time Frame: Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2 ]
    To evaluate the long-term safety of oral etrasimod, 2 mg, QD
37. Part 1 OLE and Part 2: Change from Baseline in ECG values (QTc interval) [ Time Frame: Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2 ]
    To evaluate the long-term safety of oral etrasimod, 2 mg, QD
38. Part 1 OLE and Part 2: Change from Baseline in ECG values (heart rate) [ Time Frame: Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2 ]
    To evaluate the long-term safety of oral etrasimod, 2 mg, QD
39. Part 1 OLE and Part 2: Change from Baseline in ECG values (PR interval) [ Time Frame: Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2 ]
    To evaluate the long-term safety of oral etrasimod, 2 mg, QD
40. Part 1 OLE and Part 2: Change from Baseline in ECG values (QRS complex) [ Time Frame: Baseline up to 68 weeks in Part 1 and up to 52 weeks in Part 2 ]
    To evaluate the long-term safety of oral etrasimod, 2 mg, QD

Secondary Outcome Measures :

1. Part 1 DB: Proportion of participants achieving a EASI-75 [ Time Frame: at Week 16 ]
   To evaluate the efficacy of etrasimod, 2 mg, QD based on additional measures
2. Part 1 DB: Percent change from baseline in EASI [ Time Frame: at Week 16 ]
   To evaluate the efficacy of etrasimod, 2 mg, QD based on additional measures

Eligibility Criteria

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

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.

Contacts and Locations

Contacts

Contact: Pfizer CT.gov Call Center; 1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Locations

United States, California

First OC Dermatology Research Inc; Recruiting

Fountain Valley, California, United States, 92708

Jared R. Younger, MD (Ophthalmologist); Recruiting

Fountain Valley, California, United States, 92708

Bryan D. Vo. MD (Pulmonologist); Recruiting

Laguna Hills, California, United States, 92653

California Allergy and Asthma Medical Group; Recruiting

Los Angeles, California, United States, 90025

Dr. Carolyn M. Wong; Recruiting

Los Angeles, California, United States, 90025

Dr. Gerald Markovitz; Recruiting

Los Angeles, California, United States, 90025

Acuity Eye Group; Recruiting

Santa Ana, California, United States, 92705

Chest & Critical Care Consultants; Recruiting

Santa Ana, California, United States, 92705

Wolverine Clinical Trials; Recruiting

Santa Ana, California, United States, 92705

Clinical Science Institute; Not yet recruiting

Santa Monica, California, United States, 90404

Providence Saint John's Health Center; Not yet recruiting

Santa Monica, California, United States, 90404

Santa Monica Eye Medical Group; Not yet recruiting

Santa Monica, California, United States, 90404

United States, Florida

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

Aventura, Florida, United States, 33180

Pulmonary Associates; Not yet recruiting

Boca Raton, Florida, United States, 33428

Cohen Laser and Vision Center; Not yet recruiting

Boca Raton, Florida, United States, 33431

Skin Care Research; Not yet recruiting

Boca Raton, Florida, United States, 33486

Advanced Eye Center: Rodrigo Belalcazar, MD; Recruiting

Hialeah, Florida, United States, 33012

Direct Helpers Research Center; Recruiting

Hialeah, Florida, United States, 33012

Gsi Clinical Research; Recruiting

Margate, Florida, United States, 33063

Randy Burks, MD, FACS; Recruiting

Margate, Florida, United States, 33063

D & H National Research Centers, Inc.; Recruiting

Miami, Florida, United States, 33155

Imaging - Advanced Health Imaging; Recruiting

Miami, Florida, United States, 33155

The Selem Center [Ophthalmologist JOSEPH SELEM]; Recruiting

Miami, Florida, United States, 33165

Miami Dermatology and Laser Research; Recruiting

Miami, Florida, United States, 33173

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

Miami, Florida, United States, 33173

Pulmonology - Miami Pulmonology Specialists; Recruiting

Miami, Florida, United States, 33173

Pelletier Jesse MD; Recruiting

North Miami Beach, Florida, United States, 33162

Santos Carlos R MD; Recruiting

North Miami Beach, Florida, United States, 33162

Tory Sullivan, MD PA; Recruiting

North Miami Beach, Florida, United States, 33162

Gateway Radiology; Recruiting

Pinellas Park, Florida, United States, 33781

Akumin Imaging; Not yet recruiting

Plantation, Florida, United States, 33322

Hull & Hull Medical Specialists; Recruiting

Plantation, Florida, United States, 33324

GCP Research, Global Clinical professionals; Recruiting

Saint Petersburg, Florida, United States, 33705

Pulmonology Lung and sleep care inc Dr. Vinubhai C. Pansuriya, MD; Recruiting

Saint Petersburg, Florida, United States, 33713

Akumin Imaging; Recruiting

Tampa, Florida, United States, 33603

Clinical Research Trials of Florida; Recruiting

Tampa, Florida, United States, 33607

Tampa Eye Clinic; Recruiting

Tampa, Florida, United States, 33607

United States, Indiana

Pike Medical Consultants; Recruiting

Indianapolis, Indiana, United States, 46268

Rothbaum Eye & Vision; Recruiting

Noblesville, Indiana, United States, 46062

Physicians Research Group; Recruiting

West Lafayette, Indiana, United States, 47906

United States, Michigan

Great Lakes Research Group, Inc.; Recruiting

Bay City, Michigan, United States, 48706

McLaren Bay Region (Pulmonary Function Testing); Recruiting

Bay City, Michigan, United States, 48708

Lung and Sleep Disorder Center; Recruiting

Lathrup Village, Michigan, United States, 48076

Melisa David, O.D. (Ophthalmology Exam); Recruiting

Saginaw, Michigan, United States, 48603

Revival Research Institute, LLC; Recruiting

Troy, Michigan, United States, 48084

Somerset Opthalmology PC; Recruiting

Troy, Michigan, United States, 48084

United States, Oklahoma

Eye Institute; Recruiting

Tulsa, Oklahoma, United States, 74136

Pulmonary and Sleep Center of Oklahoma; Recruiting

Tulsa, Oklahoma, United States, 74136

Vital Prospects Clinical Research Institute, PC; Recruiting

Tulsa, Oklahoma, United States, 74136

United States, South Dakota

Monument Health Rapid City Hospital; Recruiting

Rapid City, South Dakota, United States, 57701

Health Concepts; Recruiting

Rapid City, South Dakota, United States, 57702

In Vision Optical and Eyecare; Not yet recruiting

Rapid City, South Dakota, United States, 57702

United States, Texas

Eye Care Associates of Arlington; Recruiting

Arlington, Texas, United States, 76010

Arlington Research Center; Recruiting

Arlington, Texas, United States, 76011

Envision Imaging; Recruiting

Arlington, Texas, United States, 76012

Texas Pulmonary; Recruiting

Arlington, Texas, United States, 76012

Alpesh D. Desai, DO PLLC; Recruiting

Houston, Texas, United States, 77008

Becky Fredrickson, MD [Optometrist/Ophthalmologist]; Recruiting

Houston, Texas, United States, 77008

Heights Dermatology & Aesthetic Center; Recruiting

Houston, Texas, United States, 77008

Rupesh Vakil, MD [Pulmonologist]; Recruiting

Houston, Texas, United States, 77008

Canada, Alberta

Rejuvenation Dermatology; Not yet recruiting

Edmonton, Alberta, Canada, T5J 3S9

CARe Clinic; Recruiting

Red Deer, Alberta, Canada, T4P 1K4

Canada, Quebec

Visique; Recruiting

Québec, Quebec, Canada, G2J 0C4

Canada

Biron; Recruiting

Quebec, Canada, G1W 2K9

Centre de Recherche Saint-Louis; Recruiting

Quebec, Canada, G1W 4R4

Alpha Recherche Clinique; Recruiting

Quebec, Canada, G2J 0C4

Czechia

CCR Czech a.s.; Recruiting

Pardubice, Czechia, 53002

MUDr. Katarína Jiráková s.r.o.; Recruiting

Pardubice, Czechia, 53002

Poliklinika VEKTOR Pardubice; Recruiting

Pardubice, Czechia, 53002

Poland

WIP Warsaw IBD Point Profesor Kierkuś; Not yet recruiting

Warsaw, Mazowieckie, Poland, 00-728

Centrum Mikrochirurgii Oka Laser; Not yet recruiting

Warszawa, Mazowieckie, Poland, 00-215

ŚWIAT OKA Centrum Okulistyczne; Recruiting

Warszawa, Mazowieckie, Poland, 02-511

Centrum Radiologii Klinicznej Wilanowska Sp. Z O.O.; Recruiting

Warszawa, Mazowieckie, Poland, 02-665

Klinika Ambroziak Dermatologia; Recruiting

Warszawa, Mazowieckie, Poland, 02-953

Royalderm Agnieszka Nawrocka; Not yet recruiting

Warszawa, Mazowieckie, Poland, 02-962

Centrum Medyczne ,,All - Med'' Badania Kliniczne; Not yet recruiting

Kraków, Małopolskie, Poland, 30-033

Centrum Medyczne ALL-MED; Not yet recruiting

Kraków, Małopolskie, Poland, 30-033

Centrum Medyczne Dietla 19; Not yet recruiting

Kraków, Małopolskie, Poland, 31-070

AUGON Gabinet Okulistyczny; Recruiting

Bialystok, Podlaskie, Poland, 15-427

NZOZ Specjalistyczny Ośrodek Dermatologiczny "DERMAL"; Recruiting

Bialystok, Podlaskie, Poland, 15-453

Gabinet Alergologiczny IR-med dr n. med. Izabela Roszko-Kirpsza; Recruiting

Bialystok, Podlaskie, Poland, 15-872

Flosmed; Recruiting

Poznan, Wielkopolskie, Poland, 60-192

Medoculis; Recruiting

Poznań, Wielkopolskie, Poland, 61-551

Medicus; Not yet recruiting

Szczecin, Zachodniopomorskie, Poland, 70-233

Twoja Przychodnia SCM; Not yet recruiting

Szczecin, Zachodniopomorskie, Poland, 71-434

Gabinety Lekarskie Rivermed; Recruiting

Poznan, Poland, 61-441

Centrum Okulistyczne Instytut Oka; Not yet recruiting

Warsaw, Poland, 02-653

Centrum Dermatologiczne FEBUMED; Not yet recruiting

Warszawa, Poland, 02-777

"DERMED" Centrum Medyczne Sp. z o.o.; Not yet recruiting

Lodz, Łódzkie, Poland, 90-265

Centra Medyczne Medyceusz Sp. z o. o.; Not yet recruiting

Lodz, Łódzkie, Poland, 91-053

Centrum Okulistyczne Contact - Med sp. z o.o.; Not yet recruiting

Lodz, Łódzkie, Poland, 91-464

Centrum Medyczne Szpital Świętej Rodziny; Not yet recruiting

Łódź, Łódzkie, Poland, 90-302

Salve; Not yet recruiting

Łódź, Łódzkie, Poland, 90-420

Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak; Not yet recruiting

Łódź, Łódzkie, Poland, 90-436

Ekovivus; Not yet recruiting

Łódź, Łódzkie, Poland, 91-833

Centrum Medyczne Angelius Provita; Recruiting

Katowice, Śląskie, Poland, 40-611

Centrum Zdrowia Ochaliczówka; Recruiting

Katowice, Śląskie, Poland, 40-750

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

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

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT05732454
• Other Study ID Numbers: C5041005; 2022-003361-37 ( EudraCT Number ); APD334-314 ( Other Identifier: Alias Study Number )
• First Posted: February 17, 2023
• Last Update Posted: June 5, 2023
• Last Verified: June 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:

Systemic Failure; Oral

Additional relevant MeSH terms:

Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases