Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects
Launched by PFIZER · Aug 8, 2018
Trial Information
Current as of August 11, 2025
Completed
Keywords
ClinConnect Summary
Responder criteria for randomization at week 12 are defined as a) achieving an IGA of clear (0) or almost clear (1) (on a 5 point scale), b) a reduction from IGA baseline of 2 or more points, and c) reaching an EASI-75 response compared to baseline. Flare requiring rescue treatment is defined as a loss of at least 50% of the EASI response at Week 12 and an IGA score of 2 or higher.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 12 years of age or older with a minimum body weight of 40 kg
- • Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate to severe disease (\>= the following scores: BSA10%, IGA 3, EASI 16, Pruritus NRS 4)
- • Recent history of inadequate response or inability to tolerate topical AD treatments or require systemic treatments for AD control
- Exclusion Criteria:
- • Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
- • Prior treatment with JAK inhibitors
- • Other active nonAD inflammatory skin diseases or conditions affecting skin
- • Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator
- • Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception
About Pfizer
Pfizer Inc. is a global leader in biopharmaceutical innovation, dedicated to discovering, developing, and delivering advanced therapies that enhance patient outcomes across a wide range of medical conditions. With a rich history of scientific research and a commitment to quality, Pfizer focuses on areas such as oncology, immunology, cardiology, and rare diseases. The company leverages cutting-edge technology and collaborates with healthcare professionals, regulatory bodies, and academic institutions to conduct rigorous clinical trials that ensure the safety and efficacy of its products. Pfizer's mission is to bring breakthroughs that change patients' lives, exemplifying its commitment to health and wellness worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rochester, Minnesota, United States
Brussels, , Belgium
Madrid, , Spain
Madrid, , Spain
Atlanta, Georgia, United States
Barcelona, , Spain
New Orleans, Louisiana, United States
Boston, Massachusetts, United States
Valencia, , Spain
Barcelona, , Spain
Rochester, Minnesota, United States
Oklahoma City, Oklahoma, United States
Essen, , Germany
Hannover, , Germany
Madrid, , Spain
Alicante, , Spain
Orange Park, Florida, United States
Nis, , Serbia
Portland, Oregon, United States
Cordoba, , Spain
Taipei, , Taiwan
Kaohsiung, , Taiwan
Milano, , Italy
Guangzhou, Guangdong, China
Valencia, , Spain
San Diego, California, United States
Badalona, Barcelona, Spain
Tainan, , Taiwan
Rapid City, South Dakota, United States
Edegem, , Belgium
Dresden, , Germany
Haifa, , Israel
Warszawa, , Poland
Edmonton, Alberta, Canada
Windsor, Ontario, Canada
Waterloo, Ontario, Canada
Philadelphia, Pennsylvania, United States
Gera, , Germany
Bay Pines, Florida, United States
Indianapolis, Indiana, United States
Dallas, Texas, United States
Seattle, Washington, United States
Winnipeg, Manitoba, Canada
Markham, Ontario, Canada
Ottawa, Ontario, Canada
Peterborough, Ontario, Canada
Toronto, Ontario, Canada
Barcelona, , Spain
Porto Alegre, Rs, Brazil
Beijing, , China
Belgrade, , Serbia
Sevilla, , Spain
Shanghai, Shanghai, China
Saint Petersburg, , Russian Federation
Erlangen, , Germany
Beijing, Beijing, China
Guangzhou, Guangdong, China
Brussels, , Belgium
Hamburg, , Germany
Essen, , Germany
Changsha, Hunan, China
Oceanside, California, United States
Esplugues De Llobregat, Barcelona, Spain
Shanghai, , China
Ajax, Ontario, Canada
Santiago, Region Metropolitana, Chile
Monterrey, Nuevo Leon, Mexico
Warszawa, , Poland
Fremont, California, United States
Macon, Georgia, United States
Owensboro, Kentucky, United States
Banska Bystrica, , Slovakia
Tarnow, , Poland
Warszawa, , Poland
Hangzhou, Zhejiang, China
Plainfield, Indiana, United States
Pancevo, , Serbia
Quebec, , Canada
La Plata, Buenos Aires, Argentina
Lublin, , Poland
Madrid, , Spain
Changsha, Hunan, China
Haifa, , Israel
Majadahonda, Madrid, Spain
Birmingham, Alabama, United States
Saint Joseph, Missouri, United States
Bonn, , Germany
Miami, Florida, United States
Pilar, Buenos Aires, Argentina
Krakow, , Poland
Coral Gables, Florida, United States
Luebeck, , Germany
Utrecht, , Netherlands
Lodz, , Poland
Cuautitlan Izcalli, Estado De Mexico, Mexico
Saint Louis, Missouri, United States
Petah Tikva, , Israel
Santa Ana, California, United States
Jinan, Shandong, China
Katowice, , Poland
Beer Sheva, , Israel
Barrie, Ontario, Canada
Mississauga, Ontario, Canada
Berlin, , Germany
Birmingham, Alabama, United States
Skokie, Illinois, United States
Warszawa, , Poland
Hamburg, , Germany
Wroclaw, , Poland
San Luis Obispo, California, United States
Hamburg, , Germany
Houston, Texas, United States
Katowice, , Poland
Ramat Gan, , Israel
Tel Aviv, , Israel
New Albany, Indiana, United States
Madrid, Madrid, Communidad Delaware, Spain
Katowice, , Poland
Lodz, , Poland
Ostrowiec Swietokrzyski, , Poland
Warszawa, , Poland
Spokane, Washington, United States
Shanghai, , China
Santa Monica, California, United States
Birmingham, Alabama, United States
Long Beach, California, United States
Boca Raton, Florida, United States
Normal, Illinois, United States
Baton Rouge, Louisiana, United States
Kew Gardens, New York, United States
Rochester, New York, United States
Oklahoma City, Oklahoma, United States
Norfolk, Virginia, United States
Rio De Janeiro, Rj, Brazil
Porto Alegre, Rs, Brazil
Santo Andre, Sp, Brazil
Rio De Janeiro, , Brazil
Dupnitsa, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Calgary, Alberta, Canada
St. John's, Newfoundland And Labrador, Canada
Santiago, Region Metropolitana, Chile
Santiago, Region Metropolitana, Chile
Santiago, Región Metropolitana, Chile
Shenzhen, Guangdong, China
Nanjing, Jiangsu, China
Nanchang, Jiangxi, China
Tianjin, Tianjin, China
Hangzhou, Zhejiang, China
Hangzhou, Zhejiang, China
Hangzhou, Zhejiang, China
Berlin, , Germany
Bielefeld, , Germany
Langenau, , Germany
Stuttgart, , Germany
Rome, , Italy
Riga, , Latvia
Riga, , Latvia
Riga, , Latvia
Ventspils, , Latvia
Cuernavaca, Morelos, Mexico
Krakow, , Poland
Krakow, , Poland
Warszawa, , Poland
Zabrze, , Poland
Brasov, Jud. Brasov, Romania
Cluj Napoca, Jud. Cluj, Romania
Chelyabinsk, , Russian Federation
Kemerovo, , Russian Federation
Kirov, , Russian Federation
Moscow, , Russian Federation
Rostov On Don, , Russian Federation
Ryazan, , Russian Federation
Saint Petersburg, , Russian Federation
Saint Petersburg, , Russian Federation
Saint Petersburg, , Russian Federation
Saint Petersburg, , Russian Federation
Smolensk, , Russian Federation
Bratislava, , Slovakia
Bratislava, , Slovakia
Kosice Saca, , Slovakia
Nitra, , Slovakia
New Taipei City, , Taiwan
Taoyuan City, , Taiwan
Bexley, Ohio, United States
Saint Petersburg, , Russian Federation
Fort Worth, Texas, United States
Chongqing, Chongqing, China
Warszawa, , Poland
Fountain Valley, California, United States
Tampa, Florida, United States
Overland Park, Kansas, United States
Louisville, Kentucky, United States
Louisville, Kentucky, United States
Owensboro, Kentucky, United States
New York, New York, United States
Raleigh, North Carolina, United States
Hurst, Texas, United States
Rosario, Santa Fe, Argentina
C.A.B.A., , Argentina
C.A.B.A., , Argentina
C.A.B.A, , Argentina
Curitiba, Pr, Brazil
Santo Andre, Sp, Brazil
Gabrovo, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Edmonton, Alberta, Canada
Scarborough, Ontario, Canada
Wuhan, Hubei, China
Berlin, , Germany
Halle, , Germany
Hamburg, , Germany
Bologna, Bo, Italy
Chieti, Ch, Italy
Roma, Rm, Italy
Roma, Rome, Italy
Genova, , Italy
Modena, , Italy
Cuauhtemoc, Ciudad De Mexico, Mexico
Aguascalientes, , Mexico
Chihuahua, , Mexico
Bydgoszcz, , Poland
Chorzow, , Poland
Gdansk, , Poland
Gdansk, , Poland
Lodz, , Poland
Lodz, , Poland
Szczecin, , Poland
Wroclaw, , Poland
Bucuresti, , Romania
Moscow, , Russian Federation
Saint Petersburg, , Russian Federation
Bratislava, , Slovakia
Kosice, , Slovakia
Svidnik, , Slovakia
Madrid, , Spain
Taichung City, , Taiwan
Santiago, , Chile
Patients applied
Trial Officials
Pfizer CT.gov Call Center
Study Director
Pfizer
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials