Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy
NCT03720470
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Male or female subjects aged 18 years or older at the time of informed consent
- Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate to severe disease (>= the following scores: BSA 10%, IGA 3, EASI 16, Pruritus NRS severity 4)
- Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with medicated topical therapy for AD for at least 4 weeks, or who have required systemic therapies for control of their disease.
- Must be willing and able to comply with standardized background topical therapy, as per protocol guidelines throughout the study
- Female subjects who are of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:
1. Female subjects of childbearing potential must have a confirmed negative pregnancy test prior to randomization;
2. Female subjects of childbearing potential must agree to use a highly effective method of contraception for the duration of the active treatment period and for at least 28 days after the last dose of investigational product.
- Female subjects of non-childbearing potential must meet at least 1 of the following criteria:
- Have undergone a documented hysterectomy and/or bilateral oophorectomy;
- Have medically confirmed ovarian failure; or
- Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and have a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.
All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.
-If receiving concomitant medications for any reason other than AD, must be on a stable regimen prior to Day 1 and through the duration of the study
- Other acute or chronic medical or psychiatric condition including recent (within the
past year) or active suicidal ideation or behavior or laboratory abnormality that may
increase the risk associated with study participation or investigational product
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the subject inappropriate for entry into this
study
- 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
- Unwilling to discontinue current AD medications prior to the study or require
treatment with prohibited medications during the study
- Other active nonAD inflammatory skin diseases or conditions affecting skin
- Prior treatment with JAK inhibitors
- Previous treatment with dupilumab
- Unwilling to discontinue current AD medications prior to the study or require
treatment with prohibited medications during the study
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Caba,
- Bonn,
- Stuttgart,
- Kirov,
- Birmingham, Alabama
- Birmingham, Alabama
- Birmingham, Alabama
- Fountain Valley, California
- Long Beach, California
- Oceanside, California
- San Luis Obispo, California
- Santa Ana, California
- Santa Monica, California
- Bay Pines, Florida
- Boca Raton, Florida
- Coral Gables, Florida
- Miami, Florida
- Orange Park, Florida
- Tampa, Florida
- Macon, Georgia
- Normal, Illinois
- Skokie, Illinois
- Indianapolis, Indiana
- Indianapolis, Indiana
- Indianapolis, Indiana
- New Albany, Indiana
- Plainfield, Indiana
- Overland Park, Kansas
- Louisville, Kentucky
- Louisville, Kentucky
- Louisville, Kentucky
- Owensboro, Kentucky
- Owensboro, Kentucky
- Baton Rouge, Louisiana
- New Orleans, Louisiana
- Boston, Massachusetts
- Rochester, Minnesota
- Saint Joseph, Missouri
- Saint Louis, Missouri
- Saint Louis, Missouri
- Forest Hills, New York
- Rochester, New York
- Raleigh, North Carolina
- Bexley, Ohio
- Oklahoma City, Oklahoma
- Oklahoma City, Oklahoma
- Portland, Oregon
- Philadelphia, Pennsylvania
- Rapid City, South Dakota
- Dallas, Texas
- Fort Worth, Texas
- Houston, Texas
- Hurst, Texas
- Norfolk, Virginia
- Seattle, Washington
- Spokane, Washington
- La Plata, Buenos Aires
- Pilar, Buenos Aires
- Rosario, Santa FE
- C.a.b.a.,
- C.a.b.a.,
- C.a.b.a,
- Brussels,
- Bruxelles,
- Edegem,
- Curitiba, PR
- Rio de Janeiro, RJ
- Rio de Janeiro, RJ
- Rio de Janeiro, RJ
- Porto Alegre, RS
- Porto Alegre, RS
- Santo Andre, SP
- Santo Andre, SP
- Santo Andre, SP
- Sao Bernardo do Campo, SP
- Dupnitsa,
- Gabrovo,
- Sofia,
- Sofia,
- Sofia,
- Sofia,
- Varna,
- Calgary, Alberta
- Edmonton, Alberta
- Edmonton, Alberta
- Winnipeg, Manitoba
- St. John's, Newfoundland and Labrador
- Ajax, Ontario
- Barrie, Ontario
- Markham, Ontario
- Mississauga, Ontario
- Ottawa, Ontario
- Peterborough, Ontario
- Scarborough, Ontario
- Toronto, Ontario
- Waterloo, Ontario
- Windsor, Ontario
- Quebec,
- Santiago, Region Metropolitana ,
- Santiago, Region Metropolitana
- Santiago, Region Metropolitana
- Santiago, Region Metropolitana
- Santiago, Region Metropolitana
- Santiago, Region Metropolitana
- Santiago, Región Metropolitana
- Beijing, Beijing
- Chongqing, Chongqing
- Guangzhou, Guangdong
- Guangzhou, Guangdong
- Shenzhen, Guangdong
- Wuhan, Hubei
- Changsha, Hunan
- Changsha, Hunan
- Nanjing, Jiangsu
- Nanchang, Jiangxi
- Jinan, Shandong
- Shanghai, Shanghai
- Tianjin, Tianjin
- Hangzhou, Zhejiang
- Hangzhou, Zhejiang
- Hangzhou, Zhejiang
- Hangzhou, Zhejiang
- Beijing,
- Shanghai,
- Shanghai,
- Berlin,
- Berlin,
- Berlin,
- Bielefeld,
- Dresden,
- Erlangen,
- Essen,
- Gera,
- Halle,
- Hamburg,
- Hamburg,
- Hamburg,
- Hamburg,
- Hannover,
- Langenau,
- Luebeck,
- Beer Sheva,
- Haifa,
- Petah Tikva,
- Ramat-Gan,
- Tel-Aviv,
- Bologna, BO
- Modena, MO
- Roma, RM
- Chieti,
- Genova,
- Milano,
- Roma,
- Rome,
- Riga,
- Riga,
- Riga,
- Ventspils,
- Cuauhtemoc, Ciudad DE Mexico
- Cuautitlan Izcalli, Estado DE Mexico
- Cuernavaca, Morelos
- Monterrey, Nuevo LEON
- Aguascalientes,
- Chihuahua,
- Utrecht,
- Bydgoszcz,
- Gdansk,
- Gdansk,
- Katowice,
- Katowice,
- Katowice,
- Katowice,
- Krakow,
- Krakow,
- Krakow,
- Lodz,
- Lodz,
- Lodz,
- Lodz,
- Lublin,
- Ostrowiec Swietokrzyski,
- Szczecin,
- Tarnow,
- Warszawa,
- Warszawa,
- Warszawa,
- Warszawa,
- Warszawa,
- Warszawa,
- Warszawa,
- Wroclaw,
- Wroclaw,
- Zabrze,
- Brasov, JUD. Brasov
- Cluj-Napoca, Jud. Cluj
- Bucuresti,
- Chelyabinsk,
- Kemerovo,
- Kirov,
- Moscow,
- Moscow,
- Rostov-on-Don,
- Ryazan,
- Saint-Petersburg,
- Saint-Petersburg,
- Saint-Petersburg,
- Saint-Petersburg,
- Saint-Petersburg,
- Saint-Petersburg,
- Saint-Petersburg,
- Smolensk,
- Belgrade,
- Nis,
- Pancevo,
- Banska Bystrica,
- Bratislava,
- Bratislava,
- Bratislava,
- Kosice-Saca,
- Kosice,
- Nitra,
- Svidnik,
- Badalona, Barcelona
- Esplugues de Llobregat, Barcelona
- Majadahonda, Madrid
- Alicante,
- Barcelona,
- Barcelona,
- Cordoba,
- Madrid,
- Madrid,
- Madrid,
- Madrid,
- Madrid,
- Sevilla,
- Valencia,
- Valencia,
- Kaohsiung,
- New Taipei City,
- Taichung,
- Tainan,
- Taipei,
- Taoyuan,
- Pardubice,
- Pardubice,
- Sidcup, Kent
- Shipley, WEST Yorkshire
- Birmingham, Alabama
- Birmingham, Alabama
- Huntington Beach, California
- Laguna Hills, California
- Long Beach, California
- Los Alamitos, California
- Mission Viejo, California
- Murrieta, California
- San Diego, California
- Santa Monica, California
- Santa Rosa, California
- Centennial, Colorado
- Cape Coral, Florida
- Coral Gables, Florida
- Coral Gables, Florida
- Doral, Florida
- Hialeah, Florida
- Jacksonville, Florida
- Largo, Florida
- Miami, Florida
- Tampa, Florida
- West Palm Beach, Florida
- West Palm Beach, Florida
- Columbus, Georgia
- Sandy Springs, Georgia
- Eagle, Idaho
- Nampa, Idaho
- Chicago, Illinois
- Normal, Illinois
- Skokie, Illinois
- Springfield, Illinois
- West Dundee, Illinois
- Plainfield, Indiana
- Louisville, Kentucky
- Baton Rouge, Louisiana
- Glenn Dale, Maryland
- Rockville, Maryland
- Rockville, Maryland
- Clarkston, Michigan
- Plymouth, Minnesota
- Hackensack, New Jersey
- Forest Hills, New York
- New York, New York
- Oceanside, New York
- Cary, North Carolina
- Cary, North Carolina
- Greensboro, North Carolina
- Statesville, North Carolina
- Winston-Salem, North Carolina
- Winston-Salem, North Carolina
- Cleveland, Ohio
- Oklahoma City, Oklahoma
- Tulsa, Oklahoma
- Clackamas, Oregon
- Medford, Oregon
- Medford, Oregon
- Portland, Oregon
- Philadelphia, Pennsylvania
- Anderson, South Carolina
- Charleston, South Carolina
- Greer, South Carolina
- Rapid City, South Dakota
- Arlington, Texas
- Austin, Texas
- Houston, Texas
- Webster, Texas
- West Jordan, Utah
- Franklin, Virginia
- Morgantown, West Virginia
- Phillip, Australian Capital Territory
- Maroubra, New South Wales
- Benowa, Queensland
- Woolloongabba, Queensland
- Box Hill, Victoria
- Carlton, Victoria
- East Melbourne, Victoria
- Parkville, Victoria
- Camberwell,
- Hectorville, South Australia,
- Pleven,
- Sofia,
- Sofia,
- Sofia,
- Sofia,
- Sofia,
- Sofia,
- Stara Zagora,
- Varna,
- Vancouver, British Columbia
- Winnipeg, Manitoba
- London, Ontario
- Markham, Ontario
- North Bay, Ontario
- Peterborough, Ontario
- Toronto, Ontario
- Toronto, Ontario
- Toronto, Ontario
- Montreal, Quebec
- Regina, Saskatchewan
- Santiago, Region Metropolitana
- Santiago, Region Metropolitana
- Santiago, Region Metropolitana
- Santiago, Región Metropolitana
- Brno 2,
- Brno,
- Nachod,
- Nachod,
- Ostrava,
- Ostrava,
- Pardubice,
- Pardubice,
- Praha 10,
- Praha 1,
- Praha 2,
- Praha 2,
- Praha 2,
- Praha 3,
- Besancon,
- Bordeaux,
- Le Mans,
- Augsburg, Bavaria
- Leipzig, Saxony
- Bad Bentheim,
- Berlin,
- Bielefeld,
- Bonn,
- Dresden,
- Dresden,
- Frankfurt,
- Halle,
- Kiel,
- Langenau,
- Luebeck,
- Mahlow,
- Marburg,
- Muenster,
- Budapest,
- Debrecen,
- Debrecen,
- Gyula,
- Nyíregyháza,
- Püspökladány,
- Szeged,
- Veszprem,
- Zalaegerszeg,
- Modena, MO
- Roma,
- Ichikawa, Chiba
- Obihiro, Hokkaido
- Kobe, Hyogo
- Kamimashiki-gun, Kumamoto
- Habikino, Osaka
- Sakai, Osaka
- Chiyoda-ku, Tokyo
- Chuo-ku, Tokyo
- Shinjyuku-ku, Tokyo
- Fukuoka,
- Fukuoka,
- Saitama,
- Ansan-si, Gyeonggi-do
- Bucheon-si, Gyeonggi-do
- Daejeon,
- Incheon,
- Seoul,
- Seoul,
- Seoul,
- Riga,
- Riga,
- Riga,
- Riga,
- Ventspils,
- Cuauhtemoc, Mexico CITY
- Cuauhtemoc, Mexico CITY
- Monterrey, Nuevo LEON
- Monterrey, Nuevo LEON
- Queretaro,
- Bialystok,
- Chorzow,
- Czestochowa,
- Gdansk,
- Gdansk,
- Gdansk,
- Gdynia,
- Grodzisk Mazowiecki,
- Katowice,
- Katowice,
- Katowice,
- Katowice,
- Kielce,
- Krakow,
- Krakow,
- Krakow,
- Krakow,
- Ksawerow,
- Lodz,
- Lodz,
- Lublin,
- Lublin,
- Ostrowiec Swietokrzyski,
- Poznan,
- Poznan,
- Rybnik,
- Rzeszow,
- Rzeszow,
- Szczecin,
- Warszawa,
- Warszawa,
- Warszawa,
- Warszawa,
- Warszawa,
- Warszawa,
- Warszawa,
- Warszawa,
- Wroclaw,
- Wroclaw,
- Wroclaw,
- Wroclaw,
- Bratislava,
- Kosice-Saca,
- Kosice,
- Nove Zamky,
- Svidnik,
- Badalona, Barcelona
- Alcorcon, Madrid
- Majadahonda, Madrid
- Majadahonda, Madrid
- Madrid,
- Valencia,
- Taipei, Taiwan (r.o.c)
- Taichung City,
- Taichung,
- Tainan,
- Taipei,
- Taipei,
- Wokingham, Berkshire
- Plymouth, Devon
- Romford, Essex
- London, Greater London
- Northwood, Middlesex
- Corby, Northamptonshire
- Yaxley, Peterborough
- Kenilworth, Warwickshire
- Glasgow,
Descriptive Information | |||||||
---|---|---|---|---|---|---|---|
Brief Title ICMJE | Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy | ||||||
Official Title ICMJE | A PHASE 3 RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY AND SAFETY OF PF-04965842 AND DUPILUMAB IN COMPARISON WITH PLACEBO IN ADULT SUBJECTS ON BACKGROUND TOPICAL THERAPY, WITH MODERATE TO SEVERE ATOPIC DERMATITIS | ||||||
Brief Summary | B7451029 is a Phase 3 study to investigate PF-04965842 in adult patients who have moderate to severe atopic dermatitis and use background topical therapy. The efficacy of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily will be evaluated relative to placebo over 12 weeks. The efficacy of the two dosage strengths of PF-04965842 will be compared with dupilumab in terms of pruritus relief at 2 weeks. The two dosage strengths of PF-04965842 and dupilumab 300 mg injected subcutaneously once every two weeks (with a loading dose of 600 mg injected on the first day) will also be evaluated relative to placebo over 16 weeks. The safety of the investigational products will be evaluated over the duration of the study. Subjects will use non-medicated emollient at least twice a day and medicated topical therapy such as corticosteroids, calcineurin inhibitors or PDE4 inhibitors, as per protocol guidance, to treat active lesions during the study. Subjects who are randomized to receive one of the two dosage strengths of PF-04965842 will also receive placebo injectable study drug every two weeks until Week 16 and then will continue on receiving only the oral study drug for 4 weeks. Subjects who are randomized to receive dupilumab injections every two weeks will also receive oral placebo to be taken once daily until Week 16 and will then continue to receive only the oral placebo for 4 weeks. Subjects who are randomized to the placebo arms, will receive both daily oral placebo and injectable placebo every two weeks until Week 16, after which they will receive either 100 mg or 200 mg of PF-04965842 taken orally once daily for 4 weeks, dependent upon which arm they have been allocated to. Eligible subjects will have an option to enter a long-term extension study after completing 20 weeks of treatment. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | ||||||
Condition ICMJE |
| ||||||
Intervention ICMJE |
| ||||||
Study Arms ICMJE |
| ||||||
Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE | 838 | ||||||
Original Estimated Enrollment ICMJE | 700 | ||||||
Actual Study Completion Date ICMJE | March 6, 2020 | ||||||
Actual Primary Completion Date | December 27, 2019 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential. -If receiving concomitant medications for any reason other than AD, must be on a stable regimen prior to Day 1 and through the duration of the study Exclusion Criteria:
| ||||||
Sex/Gender ICMJE |
| ||||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Australia, Bulgaria, Canada, Chile, Czechia, Germany, Hungary, Italy, Japan, Korea, Republic of, Latvia, Mexico, Poland, Slovakia, Spain, Taiwan, United Kingdom, United States | ||||||
Removed Location Countries | France | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03720470 | ||||||
Other Study ID Numbers ICMJE | B7451029 COMPARE ( Other Identifier: Alias Study Number ) 2018-002573-21 ( EudraCT Number ) | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
| ||||||
IPD Sharing Statement ICMJE |
| ||||||
Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
| ||||||
PRS Account | Pfizer | ||||||
Verification Date | December 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |