Phase
Condition
Skin Infections/disorders
Skin Wounds
Eczema (Atopic Dermatitis - Pediatric)
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:
Clinical diagnosis of chronic atopic dermatitis for at least 6 months prior to Day 1;
Either an inadequate response to treatment with standard of care treatments (excluding systemic immunosuppressant treatments) for at least 4 consecutive weekswithin 6 to 12 months of the first dose of the study intervention; OR documentedreason why topical treatments are considered medically inappropriate;
Moderate to severe AD defined as having an affected BSA ≥10%, vIGA ≥3, and EASI ≥16at both the screening and baseline visits). Other Inclusion Criteria:
BMI of 17.5 to 40 kg/m2; and a total body weight >45 kg (100 lbs).
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
Box Hill Hospital
Box Hill, Victoria 3128
AustraliaSite Not Available
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba R3M 3Z4
CanadaSite Not Available
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 P3E 5M4
CanadaSite Not Available
Toronto Research Centre
Toronto, Ontario M3H 5Y8
CanadaSite Not Available
INTERMED Groupe Sante
Chicoutimi, Quebec G7H 7Y8
CanadaActive - Recruiting
Centre de Recherche Saint-Louis
Quebec, G1W 4R4
CanadaActive - Recruiting
The First Affiliated Hospital Of Fujian Medical University
Fuzhou, Fujian 350005
ChinaSite Not Available
Guangdong Province Dermatology Hospital
Guangzhou, Guangdong 510018
ChinaSite Not Available
Huashan Hospital, Fudan University
Shanghai, Shanghai 200040
ChinaSite Not Available
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang 310016
ChinaSite Not Available
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang 310014
ChinaSite Not Available
Nomura Dermatology Clinic
Yokohama-city, Kanagawa 221-0825
JapanSite Not Available
Medical Corporation Heishinkai OPHAC Hospital
Osaka-shi, Osaka 532-0003
JapanSite Not Available
Fukuwa Clinic
Chuo-ku, Tokyo 104-0031
JapanSite Not Available
Nihonbashi Sakura Clinic
Chuo-ku, Tokyo 103-0025
JapanSite Not Available
Allervie Clinical Research
Birmingham, Alabama 35209
United StatesActive - Recruiting
Medical Dermatology Specialists
Phoenix, Arizona 85006
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 StatesActive - Recruiting
California Allergy and Asthma Medical Group
Los Angeles, California 90025
United StatesActive - Recruiting
Northridge Clinical Trials
Northridge, California 91325
United StatesActive - Recruiting
Profound Research LLC
Oceanside, California 92056
United StatesSite Not Available
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 StatesActive - Recruiting
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
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
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 StatesSite Not Available
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 StatesActive - Recruiting
Paddington Testing Company
Philadelphia, Pennsylvania 19103
United StatesActive - Recruiting
Clinical Partners, LLC
Johnston, Rhode Island 02919
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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