Phase
Condition
Dermatitis, Atopic
Allergy
Allergies & Asthma
Treatment
PF-07264660
PF-07275315
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Must meet the following AD criteria:
Participants aged 18 years or older
Clinical diagnosis of chronic atopic dermatitis:
for at least 6 months prior to Day 1 with diagnosis confirmed by photograph;
Either an inadequate response to treatment with standard of care treatments (excluding systemic immunosuppressant treatments) for at least 4 consecutiveweeks within 6 to 12 months of the first dose of the study intervention; ORdocumented reason why topical treatments are considered medicallyinappropriate;
Moderate to severe AD defined as having an affected BSA ≥10%, vIGA ≥3, and EASI ≥16 at both the screening and baseline visits).
Bio-experienced cohort-partial or non-responder to anti-inflammatory proteins,intolerance or AEs to anti-inflammatory proteins or loss of access toanti-inflammatory proteins. Other Inclusion Criteria:
BMI of 17.5 to 40 kg/m2; and a total body weight >45 kg (100 lbs).
Willing and able to comply with all scheduled visits, treatment plan, laboratorytests and other study procedures.
Exclusion
Exclusion Criteria:
- Medical Conditions:
Significant allergic or autoimmune diseases, other than AD and well controlled mildto moderate including but not limited to: SLE or other complement disorders; Type 1diabetes; IBD; Multiple Sclerosis.
History of significant allergic reactions, including anaphylaxis and reactions toprotein therapeutics, including hypersensitivity to PF-07275315 or PF-07264660 or tothe excipients of the formulated drug products. Participants with significantreactions to single, identified, avoidable allergens (eg, peanut allergy) may beeligible if avoidance of these allergens during the study is feasible.
Any of the following acute or chronic infections or infection history:
Active infection (including helminth or parasitic) requiring treatment within 2weeks prior to screening;
Infection requiring hospitalization or systemic (parenteral) antimicrobialtherapy within 60 days prior to Day 1;
Active chronic or acute skin infection requiring treatment with systemic [(notIV)] antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungalswithin 2 weeks prior to Day 1, or superficial skin infections (requiring nomore than topical anti-infective treatments) within 1 week prior to Day 1.
Any infection judged to be an opportunistic infection or clinically significantby the investigator, within 6 months prior to Day 1;
History of or current evidence of inflammatory skin conditions (eg, psoriasis,seborrheic dermatitis, lupus) at the time of Day 1 that could interfere withevaluation of AD or response to treatment.
Any medical or psychiatric condition including recent (within the past year) oractive suicidal ideation/behavior or laboratory abnormality that may increase therisk of study participation or, in the investigator's judgment, make the participantinappropriate for the study.
- Prior/Concomitant Therapy:
Current use of any prohibited concomitant medication(s).
Phototherapy narrowband UVB (NB UVB) or broadband phototherapy or regular use (morethan 2 visits per week) of a tanning booth/parlor within 4 weeks prior to Day 1.
- Prior/Concurrent Clinical Study Experience:
Previous administration with an investigational product (drug or vaccine) within 30days (or as determined by the local requirement) or 5 half lives preceding the firstdose of study intervention used in this study (whichever is longer).
HIV infection, or infection with hepatitis B or hepatitis C viruses according toprotocol-specific testing algorithm.
Evidence of active or latent TB, or inadequately treated infection withMycobacterium TB. A participant who is currently being treated for active or latentTB infection must be excluded from this study.
Study Design
Connect with a study center
Momentum Darlinghurst
Darlinghurst, New South Wales 2010
AustraliaSite Not Available
Australian Clinical Research Network
Sydney, New South Wales NSW 2035
AustraliaSite Not Available
Box Hill Hospital
Box Hill, Victoria 3128
AustraliaActive - Recruiting
Dr Rodney Sinclair Pty Ltd
East Melbourne, Victoria 3002
AustraliaSite Not Available
Fremantle Dermatology
Fremantle, Western Australia 6160
AustraliaActive - Recruiting
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba R3M 3Z4
CanadaActive - Recruiting
Lima's Excellence in Allergy and Dermatology Research
Hamilton, Ontario L8L 3C3
CanadaActive - Recruiting
DermEdge Research
Mississauga, Ontario L4Y 4C5
CanadaActive - Recruiting
Medicor Research Inc
Sudbury, Ontario P3C 1X3
CanadaActive - Recruiting
Sudbury Skin Clinique
Sudbury, Ontario P3C 1X8
CanadaActive - Recruiting
Toronto Research Centre
Toronto, Ontario M3H 5Y8
CanadaActive - Recruiting
INTERMED Groupe Sante
Chicoutimi, Quebec G7H 7Y8
CanadaActive - Recruiting
Centre de Recherche Saint-Louis
Quebec, G1W 4R4
CanadaActive - Recruiting
Beijing Friendship Hospital Affiliate of Capital University
Beijing, Beijing 100050
ChinaActive - Recruiting
The First Affiliated Hospital Of Fujian Medical University
Fuzhou, Fujian 350005
ChinaActive - Recruiting
Guangdong Province Dermatology Hospital
Guangzhou, Guangdong 510091
ChinaActive - Recruiting
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei 050031
ChinaActive - Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei 430000
ChinaSite Not Available
The Second Xiangya Hospital of Central South University
Changsha, Hunan 410011
ChinaSite Not Available
Dermatology Hospital of Jiangxi Province
Nanchang, Jiangxi 330000
ChinaActive - Recruiting
The first hospital of jilin university
Changchun City, Jilin 130021
ChinaActive - Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi 710061
ChinaActive - Recruiting
Huashan Hospital, Fudan University
Shanghai, Shanghai 200040
ChinaActive - Recruiting
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan 650032
ChinaActive - Recruiting
Hangzhou Third Hospital
Hangzhou, Zhejiang 310009
ChinaActive - Recruiting
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang 310016
ChinaActive - Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang 310014
ChinaSite Not Available
Chengdu second people's hospital
Chengdu,
ChinaSite Not Available
Shanghai First People's Hospital
Shanghai, 201620
ChinaSite Not Available
Fachklinik Bad Bentheim
Bad Bentheim, Niedersachsen 48455
GermanySite Not Available
Magdeburger Company for Medical Studies and Services
Magdeburg, Sachsen-anhalt 39104
GermanySite Not Available
Nomura Dermatology Clinic
Yokohama-city, Kanagawa 221-0825
JapanActive - Recruiting
Osaka Metropolitan University Hospital
Osaka-City, Osaka 545-8586
JapanActive - Recruiting
Medical Corporation Heishinkai OPHAC Hospital
Osaka-shi, Osaka 532-0003
JapanActive - Recruiting
Fukuwa Clinic
Chuo-ku, Tokyo 104-0031
JapanActive - Recruiting
Nihonbashi Sakura Clinic
Chuo-ku, Tokyo 103-0025
JapanActive - Recruiting
Naoko Dermatology Clinic
Setagaya-ku, Tokyo 158-0097
JapanActive - Recruiting
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
Wroclaw, Dolnośląskie 50-381
PolandSite Not Available
Pratia MCM Krakow
Kraków, Małopolskie 30-727
PolandSite Not Available
Niepubliczny Zakład Opieki Zdrowotnej Zespół Poradni Specjalistycznych "Termedica"
Poznan, Wielkopolskie 60-681
PolandSite Not Available
Centrum Medyczne Angelius Provita
Katowice, Śląskie 40-611
PolandSite Not Available
Dermedic Jacek Zdybski
Ostrowiec Swietokrzyski, Świętokrzyskie 27-400
PolandSite Not Available
Synexus Polska Sp. z o.o. Oddzial w Katowicach
Katowice, 40-040
PolandSite Not Available
Allervie Clinical Research
Birmingham, Alabama 35209
United StatesActive - Recruiting
Onyx Clinical Research - Peoria
Peoria, Arizona 85381
United StatesActive - Recruiting
Medical Dermatology Specialists
Phoenix, Arizona 85006
United StatesActive - Recruiting
Onyx Clinical Research
Phoenix, Arizona 85050
United StatesActive - Recruiting
Banner - University Medicine Dermatology Clinic
Tucson, Arizona 85718
United StatesActive - Recruiting
Marvel Clinical Research
Huntington Beach, California 92647
United StatesActive - Recruiting
Sunwise Clinical Research
Lafayette, California 94549
United StatesSite Not Available
California Allergy and Asthma Medical Group
Los Angeles, California 90025
United StatesActive - Recruiting
University Dermatology Trials, INC.
Newport Beach, California 92660
United StatesActive - Recruiting
Northridge Clinical Trials
Northridge, California 91325
United StatesActive - Recruiting
Profound Research LLC
Oceanside, California 92056
United StatesActive - Recruiting
Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
San Diego, California 92121
United StatesActive - Recruiting
West Dermatology La Jolla
San Diego, California 92121
United StatesActive - Recruiting
Wr-McCr, Llc
San Diego, California 92120
United StatesSite Not Available
Sunwise Clinical Research
Walnut Creek, California 94596
United StatesActive - Recruiting
AboutSkin Research, LLC
Greenwood Village, Colorado 80111
United StatesTerminated
Renaissance Research and Medical Group
Cape Coral, Florida 33991
United StatesActive - Recruiting
Florida Academic Centers Research and Education, LLC
Coral Gables, Florida 33134
United StatesSite Not Available
Florida International Medical Research
Coral Gables, Florida 33134
United StatesActive - Recruiting
Revival Research
Doral, Florida 33122
United StatesActive - Recruiting
St. Jude Clinical Research
Doral, Florida 33172
United StatesActive - Recruiting
Solutions Through Advanced Research
Jacksonville, Florida 32256
United StatesActive - Recruiting
Floridian Research Institute
Miami, Florida 33179
United StatesActive - Recruiting
Floridian Research Institute Llc
Miami, Florida 33179
United StatesActive - Recruiting
SouthCoast Research Center
Miami, Florida 33136
United StatesActive - Recruiting
Global Health Research Center, Inc.
Miami Lakes, Florida 33016
United StatesActive - Recruiting
Tory Sullivan, Md Pa
North Miami Beach, Florida 33162
United StatesActive - Recruiting
Ziaderm Research LLC
North Miami Beach, Florida 33162
United StatesActive - Recruiting
Clinical Neuroscience Solutions, Inc.
Orlando, Florida 32801
United StatesActive - Recruiting
GCP Research, Global Clinical professionals
Saint Petersburg, Florida 33705
United StatesActive - Recruiting
ForCare Clinical Research
Tampa, Florida 33613
United StatesActive - Recruiting
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana 46250
United StatesActive - Recruiting
Southern Indiana Clinical Trials
New Albany, Indiana 47150
United StatesActive - Recruiting
Maryland Laser Skin and Vein
Hunt Valley, Maryland 21030
United StatesActive - Recruiting
Great Lakes Research Group, Inc.
Bay City, Michigan 48706
United StatesSite Not Available
Michigan Center for Research Company
Clarkston, Michigan 48346
United StatesActive - Recruiting
MI Skin Innovations
Northville, Michigan 48167
United StatesActive - Recruiting
Revival Research Institute LLC
Troy, Michigan 48084
United StatesActive - Recruiting
Revival Research Institute, LLC
Troy, Michigan 48084
United StatesActive - Recruiting
Skin Specialists, PC
Omaha, Nebraska 68144
United StatesActive - Recruiting
Empire Dermatology
East Syracuse, New York 13057
United StatesActive - Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesActive - Recruiting
Private Practice - Dr. Bobby Buka
New York, New York 10012
United StatesActive - Recruiting
Sadick Research Group
New York, New York 10075
United StatesActive - Recruiting
Apex Clinical Research Center
Mayfield Heights, Ohio 44124
United StatesActive - Recruiting
Epic Medical Research - Oklahoma
Chickasha, Oklahoma 73018
United StatesActive - Recruiting
Epic Medical Research-Oklahoma
Chickasha, Oklahoma 73018
United StatesActive - Recruiting
Unity Clinical Research
Oklahoma City, Oklahoma 73118
United StatesActive - Recruiting
Vital Prospects Clinical Research Institute, PC
Tulsa, Oklahoma 74136
United StatesSite Not Available
Velocity Clinical Research, Medford
Medford, Oregon 97504
United StatesSite Not Available
Paddington Testing Co, Inc
Philadelphia, Pennsylvania 19103
United StatesActive - Recruiting
Paddington Testing Company
Philadelphia, Pennsylvania 19103
United StatesSite Not Available
Clinical Partners, LLC
Johnston, Rhode Island 02919
United StatesActive - Recruiting
National Allergy and Asthma
North Charleston, South Carolina 29420
United StatesActive - Recruiting
Spartanburg Medical Research
Spartanburg, South Carolina 29303
United StatesActive - Recruiting
Clinical Neuroscience Solutions Inc.
Memphis, Tennessee 38119
United StatesActive - Recruiting
Dermatology Treatment and Research Center
Dallas, Texas 75230
United StatesActive - Recruiting
North Texas Center for Clinical Research
Frisco, Texas 75034
United StatesActive - Recruiting
Alpesh D. Desai, DO PLLC
Houston, Texas 77008
United StatesActive - Recruiting
DCT-Stone Oak, LLC dba Discovery Clinical Trials
San Antonio, Texas 78258
United StatesActive - Recruiting
Complete Dermatology
Sugar Land, Texas 77479
United StatesActive - Recruiting
Virginia Dermatology and Skin Cancer Center
Norfolk, Virginia 23502
United StatesTerminated
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