Clinical trial NCT05995964: A Study To Learn About Two Study Medicines (PF-07275315 And PF-07264660) In People Who Have Moderate To Severe Atopic Dermatitis
Official title: A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF PF-07275315 AND PF-07264660 IN ADULT PARTICIPANTS WITH MODERATE-SEVERE ATOPIC DERMATITIS
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: Eczema
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-08-16
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

Must meet the following AD criteria:

1. Clinical diagnosis of chronic atopic dermatitis for at least 6 months prior to Day 1;
2. 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;
3. 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:
4. BMI of 17.5 to 40 kg/m2; and a total body weight \>45 kg (100 lbs).

Exclusion Criteria:

- Medical Conditions:

1. 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.
2. 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.
3. Any of the following acute or chronic infections or infection history:

   1. Active infection (including helminth or parasitic) requiring treatment within 2 weeks prior to screening;
   2. Infection requiring hospitalization or systemic (parenteral) antimicrobial therapy within 60 days prior to Day 1;
   3. 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.
   4. Any infection judged to be an opportunistic infection or clinically significant by the investigator, within 6 months prior to Day 1;
4. 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.
5. 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:
6. Current use of any prohibited concomitant medication(s).
7. 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:
8. 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).
9. HIV infection, or infection with hepatitis B or hepatitis C viruses according to protocol-specific testing algorithm.
10. 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.

Primary outcomes:
measure: The number of participants achieving ≥75% improvement in EAS175 from baseline at week16.
timeFrame: Week 16
Secondary outcomes:
measure: 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
timeFrame: Screening through study completion, an average of 36 weeks.
measure: The number and % of participants achieving EASI75 (≥75% improvement from baseline) at scheduled time points except Week 16
timeFrame: All scheduled timepoints other than Week 16, screening through study completion, an average of 36 weeks.
measure: The number and % of participants achieving a Percent change from baseline in EASI total score at scheduled time points
timeFrame: Screening through study completion, an average of 36 weeks.
measure: The number and % of participants with treatment emergent AEs
timeFrame: Screening - Week 36
measure: The number and % of participants with clinically significant changes in vital signs
timeFrame: Screening - Week 36
measure: The number and % of participants with clinically significant changes in ECG
timeFrame: Screening - Week 36
measure: The number and % of participants with clinically significant changes in laboratory tests
timeFrame: Screening - Week 36
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Allervie Clinical Research
state: Alabama
city: Phoenix
country: United States
facility: Medical Dermatology Specialists
state: Arizona
city: Tucson
country: United States
facility: Banner - University Medicine Dermatology Clinic
state: Arizona
city: Huntington Beach
country: United States
facility: Marvel Clinical Research
state: California
city: Lafayette
country: United States
facility: Sunwise Clinical Research
state: California
city: Los Angeles
country: United States
facility: California Allergy and Asthma Medical Group
state: California
city: Northridge
country: United States
facility: Northridge Clinical Trials
state: California
city: Oceanside
country: United States
facility: Profound Research LLC
state: California
city: San Diego
country: United States
facility: Wr-McCr, Llc
state: California
city: San Diego
country: United States
facility: Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
state: California
city: San Diego
country: United States
facility: West Dermatology La Jolla
state: California
city: Walnut Creek
country: United States
facility: Sunwise Clinical Research
state: California
city: Greenwood Village
country: United States
facility: AboutSkin Research, LLC
state: Colorado
city: Cape Coral
country: United States
facility: Renaissance Research and Medical Group
state: Florida
city: Coral Gables
country: United States
facility: Florida Academic Centers Research and Education, LLC
state: Florida
city: Coral Gables
country: United States
facility: Florida International Medical Research
state: Florida
city: Doral
country: United States
facility: Revival Research
state: Florida
city: Doral
country: United States
facility: St. Jude Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Solutions Through Advanced Research
state: Florida
city: Miami Lakes
country: United States
facility: Global Health Research Center, Inc.
state: Florida
city: Miami
country: United States
facility: SouthCoast Research Center
state: Florida
city: Miami
country: United States
facility: Floridian Research Institute Llc
state: Florida
city: Miami
country: United States
facility: Floridian Research Institute
state: Florida
city: North Miami Beach
country: United States
facility: Ziaderm Research LLC
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Saint Petersburg
country: United States
facility: GCP Research, Global Clinical professionals
state: Florida
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: New Albany
country: United States
facility: Southern Indiana Clinical Trials
state: Indiana
city: Hunt Valley
country: United States
facility: Maryland Laser Skin and Vein
state: Maryland
city: Bay City
country: United States
facility: Great Lakes Research Group, Inc.
state: Michigan
city: Clarkston
country: United States
facility: Michigan Center for Research Company
state: Michigan
city: Troy
country: United States
facility: Revival Research Institute, LLC
state: Michigan
city: Omaha
country: United States
facility: Skin Specialists, PC
state: Nebraska
city: East Syracuse
country: United States
facility: Empire Dermatology
state: New York
city: New York
country: United States
facility: Private Practice - Dr. Bobby Buka
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Sadick Research Group
state: New York
city: Mayfield Heights
country: United States
facility: Apex Clinical Research Center
state: Ohio
city: Chickasha
country: United States
facility: Epic Medical Research - Oklahoma
state: Oklahoma
city: Oklahoma City
country: United States
facility: Unity Clinical Research
state: Oklahoma
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute, PC
state: Oklahoma
city: Medford
country: United States
facility: Velocity Clinical Research, Medford
state: Oregon
city: Philadelphia
country: United States
facility: Paddington Testing Company
state: Pennsylvania
city: Philadelphia
country: United States
facility: Paddington Testing Company
state: Pennsylvania
city: Johnston
country: United States
facility: Clinical Partners, LLC
state: Rhode Island
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions Inc.
state: Tennessee
city: Dallas
country: United States
facility: Dermatology Treatment and Research Center
state: Texas
city: Frisco
country: United States
facility: North Texas Center for Clinical Research
state: Texas
city: Houston
country: United States
facility: Alpesh D. Desai, DO PLLC
state: Texas
city: San Antonio
country: United States
facility: DCT-Stone Oak, LLC dba Discovery Clinical Trials
state: Texas
city: Sugar Land
country: United States
facility: Complete Dermatology
state: Texas
city: Norfolk
country: United States
facility: Virginia Dermatology and Skin Cancer Center
state: Virginia
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research Inc.
state: Manitoba
city: Hamilton
country: Canada
facility: Lima's Excellence in Allergy and Dermatology Research
state: Ontario
city: Mississauga
country: Canada
facility: DermEdge Research
state: Ontario
city: Sudbury
country: Canada
facility: Medicor Research Inc
state: Ontario
city: Sudbury
country: Canada
facility: Sudbury Skin Clinique
state: Ontario
city: Sudbury
country: Canada
facility: Sudbury Skin Clinique
state: Ontario
city: Toronto
country: Canada
facility: Toronto Research Centre
state: Ontario
city: Chicoutimi
country: Canada
facility: INTERMED Groupe Sante
state: Quebec
city: Quebec
country: Canada
facility: Centre de Recherche Saint-Louis
city: Fuzhou
country: China
facility: The First Affiliated Hospital Of Fujian Medical University
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Province Dermatology Hospital
state: Guangdong
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University
state: Shanghai
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Fuzhou
country: China
facility: The First Affiliated Hospital Of Fujian Medical University
city: Yokohama-city
country: Japan
facility: Nomura Dermatology Clinic
state: Kanagawa
city: Osaka-shi
country: Japan
facility: Medical Corporation Heishinkai OPHAC Hospital
state: Osaka
city: Chuo-ku
country: Japan
facility: Nihonbashi Sakura Clinic
state: Tokyo
city: Chuo-ku
country: Japan
facility: Fukuwa Clinic
state: Tokyo
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: