A Study To Learn About Two Study Medicines (PF-07275315 And PF-07264660) In People Who Have Moderate To Severe Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Interventions
- Registration Number
- NCT05995964
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to learn about the safety and effects of 2 study medicines (PF-07275315 and PF-07264660) for the treatment of atopic dermatitis (AD). AD is a long- lasting itchy red rash, caused by a skin reaction.
This study is seeking participants who:
* are 18 years of age or more.
* Were confirmed to have AD at least 6 months ago.
* Are not having an effective treatment result from medicines that are applied on skin for AD.
* Are considered by their doctors to have moderate to severe AD.
All participants in the study will receive either PF-07275315 or PF-07264660 or placebo. A placebo does not have any medicine in it but looks just like the medicines being studied.
PF-07275315 or PF-07264660 or placebo will be given as multiple shots in the clinic over the course of 12 weeks.
Stage 1 participants will receive shots at the study clinic on Day 1, Week 1, Week 2, Week 4, Week 6, Week 8, Week 10 and Week 12.
Stage 2 participants will receive shots at the study clinic on Day 1, Week 4, Week 8 and Week 12.
The experiences of people receiving PF-07275315 or PF-07264660 will be compared to people who do not. This will help determine if PF-07275315 and PF-07264660 are safe and effective.
Participants will be involved in this study for up to 40 weeks (20 months). During this time, Stage 1 participants will have 16 visits at the study clinic, and Stage 2 participants will have 12 visits at the study clinic.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 340
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 weeks within 6 to 12 months of the first dose of the study intervention; OR documented reason why topical treatments are considered medically inappropriate;
-
Moderate to severe AD defined as having an affected BSA ≥10%, vIGA ≥3, and EASI ≥16 at 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).
- Medical Conditions:
-
Significant allergic or autoimmune diseases, other than AD and well controlled mild to moderate including but not limited to: SLE or other complement disorders; Type 1 diabetes; IBD; Multiple Sclerosis.
-
History of significant allergic reactions, including anaphylaxis and reactions to protein therapeutics, including hypersensitivity to PF-07275315 or PF-07264660 or to the excipients of the formulated drug products. Participants with significant reactions to single, identified, avoidable allergens (eg, peanut allergy) may be eligible 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 2 weeks prior to screening;
- Infection requiring hospitalization or systemic (parenteral) antimicrobial therapy within 60 days prior to Day 1;
- Active chronic or acute skin infection requiring treatment with systemic [(not IV)] antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks prior to Day 1, or superficial skin infections (requiring no more than topical anti-infective treatments) within 1 week prior to Day 1.
- Any infection judged to be an opportunistic infection or clinically significant by 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 with evaluation of AD or response to treatment.
-
Any 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.
- Prior/Concomitant Therapy:
-
Current use of any prohibited concomitant medication(s).
-
Phototherapy narrowband UVB (NB UVB) or broadband phototherapy or regular use (more than 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 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).
-
HIV infection, or infection with hepatitis B or hepatitis C viruses according to protocol-specific testing algorithm.
-
Evidence of active or latent TB, or inadequately treated infection with Mycobacterium TB. A participant who is currently being treated for active or latent TB infection must be excluded from this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stage 1_PF-07275315 PF-07275315 Stage 1 PF-07275315 Injections on Day 1, Week 1, Week 2, Week 4, Week 6, Week 8, Week 10 and Week 12. Stage 1_PF-07264660 PF-07264660 Stage 1 PF-07264660 Injections on Day 1, Week 1, Week 2, Week 4, Week 6, Week 8, Week 10 and Week 12. Stage 1_Placebo Placebo Stage 1 Placebo Injections on Day 1, Week 1, Week 2, Week 4, Week 6, Week 8, Week 10 and Week 12. Stage 2_PF-07275315 or PF-07264660_Dose A PF-07275315 Stage 2 PF-07275315 or PF-07264660 Injections on Day 1, Week 4, Week 8 and Week 12. Stage 2_PF-07275315 or PF-07264660_Dose A PF-07264660 Stage 2 PF-07275315 or PF-07264660 Injections on Day 1, Week 4, Week 8 and Week 12. Stage 2_PF-07275315 or PF-07264660_Dose B PF-07275315 Stage 2 PF-07275315 or PF-07264660 Injections on Day 1, Week 4, Week 8 and Week 12. Stage 2_PF-07275315 or PF-07264660_Dose B PF-07264660 Stage 2 PF-07275315 or PF-07264660 Injections on Day 1, Week 4, Week 8 and Week 12. Stage 2_PF-07275315 or PF-07264660_Dose C PF-07275315 Stage 2 PF-07275315 or PF-07264660 Injections on Day 1, Week 4, Week 8 and Week 12. Stage 2_PF-07275315 or PF-07264660_Dose C PF-07264660 Stage 2 PF-07275315 or PF-07264660 Injections on Day 1, Week 4, Week 8 and Week 12. Stage 2_PF-07275315 or PF-07264660_Dose D PF-07275315 Stage 2 PF-07275315 or PF-07264660 Injections on Day 1, Week 4, Week 8 and Week 12. Stage 2_PF-07275315 or PF-07264660_Dose D PF-07264660 Stage 2 PF-07275315 or PF-07264660 Injections on Day 1, Week 4, Week 8 and Week 12. Stage 2_Placebo Placebo Stage 2 Placebo Injections on Day 1, Week 4, Week 8 and Week 12.
- Primary Outcome Measures
Name Time Method The number of participants achieving ≥75% improvement in EAS175 from baseline at week16. Week 16 EASI75 (≥75% improvement from baseline) at Week 16
- Secondary Outcome Measures
Name Time Method The number and % of participants with clinically significant changes in ECG Screening - Week 36 Incidence of clinically significant changes in ECG
The number and % of participants with clinically significant changes in laboratory tests Screening - Week 36 Incidence of clinically significant changes in laboratory tests
The number and % of participants with clinically significant changes in vital signs Screening - Week 36 Incidence of clinically significant changes in vital signs
The number and % of participants achieving vIGA score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥2 points at all scheduled time points Screening through study completion, an average of 36 weeks. vIGA score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥2 points at all scheduled time points
The number and % of participants achieving EASI75 (≥75% improvement from baseline) at scheduled time points except Week 16 All scheduled timepoints other than Week 16, screening through study completion, an average of 36 weeks. EASI75 (≥75% improvement from baseline) at scheduled time points except Week 16
The number and % of participants achieving a Percent change from baseline in EASI total score at scheduled time points Screening through study completion, an average of 36 weeks. Percent change from baseline in EASI total score at scheduled time points
The number and % of participants with treatment emergent AEs Screening - Week 36 Incidence of treatment emergent AEs
Related Research Topics
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Trial Locations
- Locations (69)
Allervie Clinical Research
🇺🇸Birmingham, Alabama, United States
Medical Dermatology Specialists
🇺🇸Phoenix, Arizona, United States
Banner - University Medicine Dermatology Clinic
🇺🇸Tucson, Arizona, United States
Marvel Clinical Research
🇺🇸Huntington Beach, California, United States
Sunwise Clinical Research
🇺🇸Walnut Creek, California, United States
California Allergy and Asthma Medical Group
🇺🇸Los Angeles, California, United States
Northridge Clinical Trials
🇺🇸Northridge, California, United States
Profound Research LLC
🇺🇸Oceanside, California, United States
Wr-McCr, Llc
🇺🇸San Diego, California, United States
Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
🇺🇸San Diego, California, United States
West Dermatology La Jolla
🇺🇸San Diego, California, United States
AboutSkin Research, LLC
🇺🇸Greenwood Village, Colorado, United States
Renaissance Research and Medical Group
🇺🇸Cape Coral, Florida, United States
Florida Academic Centers Research and Education, LLC
🇺🇸Coral Gables, Florida, United States
Florida International Medical Research
🇺🇸Coral Gables, Florida, United States
Revival Research
🇺🇸Doral, Florida, United States
St. Jude Clinical Research
🇺🇸Doral, Florida, United States
Solutions Through Advanced Research
🇺🇸Jacksonville, Florida, United States
Global Health Research Center, Inc.
🇺🇸Miami Lakes, Florida, United States
SouthCoast Research Center
🇺🇸Miami, Florida, United States
Floridian Research Institute Llc
🇺🇸Miami, Florida, United States
Floridian Research Institute
🇺🇸Miami, Florida, United States
Ziaderm Research LLC
🇺🇸North Miami Beach, Florida, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Orlando, Florida, United States
GCP Research, Global Clinical professionals
🇺🇸Saint Petersburg, Florida, United States
Dawes Fretzin Clinical Research Group, LLC
🇺🇸Indianapolis, Indiana, United States
Southern Indiana Clinical Trials
🇺🇸New Albany, Indiana, United States
Maryland Laser Skin and Vein
🇺🇸Hunt Valley, Maryland, United States
Great Lakes Research Group, Inc.
🇺🇸Bay City, Michigan, United States
Michigan Center for Research Company
🇺🇸Clarkston, Michigan, United States
Revival Research Institute, LLC
🇺🇸Troy, Michigan, United States
Skin Specialists, PC
🇺🇸Omaha, Nebraska, United States
Empire Dermatology
🇺🇸East Syracuse, New York, United States
Private Practice - Dr. Bobby Buka
🇺🇸New York, New York, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Sadick Research Group
🇺🇸New York, New York, United States
Apex Clinical Research Center
🇺🇸Mayfield Heights, Ohio, United States
Epic Medical Research - Oklahoma
🇺🇸Chickasha, Oklahoma, United States
Unity Clinical Research
🇺🇸Oklahoma City, Oklahoma, United States
Vital Prospects Clinical Research Institute, PC
🇺🇸Tulsa, Oklahoma, United States
Velocity Clinical Research, Medford
🇺🇸Medford, Oregon, United States
Paddington Testing Company
🇺🇸Philadelphia, Pennsylvania, United States
Clinical Partners, LLC
🇺🇸Johnston, Rhode Island, United States
Spartanburg Medical Research
🇺🇸Spartanburg, South Carolina, United States
Clinical Neuroscience Solutions Inc.
🇺🇸Memphis, Tennessee, United States
Dermatology Treatment and Research Center
🇺🇸Dallas, Texas, United States
North Texas Center for Clinical Research
🇺🇸Frisco, Texas, United States
Alpesh D. Desai, DO PLLC
🇺🇸Houston, Texas, United States
DCT-Stone Oak, LLC dba Discovery Clinical Trials
🇺🇸San Antonio, Texas, United States
Complete Dermatology
🇺🇸Sugar Land, Texas, United States
Virginia Dermatology and Skin Cancer Center
🇺🇸Norfolk, Virginia, United States
Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
Wiseman Dermatology Research Inc.
🇨🇦Winnipeg, Manitoba, Canada
Lima's Excellence in Allergy and Dermatology Research
🇨🇦Hamilton, Ontario, Canada
DermEdge Research
🇨🇦Mississauga, Ontario, Canada
Medicor Research Inc
🇨🇦Sudbury, Ontario, Canada
Sudbury Skin Clinique
🇨🇦Sudbury, Ontario, Canada
Toronto Research Centre
🇨🇦Toronto, Ontario, Canada
INTERMED Groupe Sante
🇨🇦Chicoutimi, Quebec, Canada
Centre de Recherche Saint-Louis
🇨🇦Quebec, Canada
The First Affiliated Hospital Of Fujian Medical University
🇨🇳Fuzhou, China
Guangdong Province Dermatology Hospital
🇨🇳Guangzhou, Guangdong, China
Huashan Hospital, Fudan University
🇨🇳Shanghai, Shanghai, China
Zhejiang Provincial People's Hospital
🇨🇳Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Nomura Dermatology Clinic
🇯🇵Yokohama-city, Kanagawa, Japan
Medical Corporation Heishinkai OPHAC Hospital
🇯🇵Osaka-shi, Osaka, Japan
Nihonbashi Sakura Clinic
🇯🇵Chuo-ku, Tokyo, Japan
Fukuwa Clinic
🇯🇵Chuo-ku, Tokyo, Japan