A Study To Learn About Two Study Medicines (PF-07275315 And PF-07264660) In People Who Have Moderate To Severe Atopic Dermatitis

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05995964
• Other study ID #: C4531002
• Status: Recruiting
• Phase: Phase 2
• Start date: August 22, 2023
• Est. completion date: February 26, 2026

Study information

• Verified date: May 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 340
• Est. completion date: February 26, 2026
• Est. primary completion date: February 26, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 topical medications (for at least 4 consecutive weeks within 1 year 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, except to single, identified, avoidable allergens (eg, peanut allergy).

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• PF-07275315
subcutaneous injection
• PF-07264660
subcutaneous injection

Other:
• Placebo
subcutaneous injection

Locations

Country	Name	City	State
Canada	INTERMED Groupe Sante	Chicoutimi	Quebec
Canada	Lima's Excellence in Allergy and Dermatology Research	Hamilton	Ontario
Canada	DermEdge Research	Mississauga	Ontario
Canada	Centre de Recherche Saint-Louis	Quebec
Canada	Medicor Research Inc	Sudbury	Ontario
Canada	Sudbury Skin Clinique	Sudbury	Ontario
Canada	Sudbury Skin Clinique	Sudbury	Ontario
Canada	Wiseman Dermatology Research Inc.	Winnipeg	Manitoba
United States	Great Lakes Research Group, Inc.	Bay City	Michigan
United States	Allervie Clinical Research	Birmingham	Alabama
United States	Renaissance Research and Medical Group	Cape Coral	Florida
United States	Epic Medical Research - Oklahoma	Chickasha	Oklahoma
United States	Michigan Center for Research Company	Clarkston	Michigan
United States	Florida Academic Centers Research and Education, LLC	Coral Gables	Florida
United States	Florida International Medical Research	Coral Gables	Florida
United States	Dermatology Treatment and Research Center	Dallas	Texas
United States	Revival Research	Doral	Florida
United States	St. Jude Clinical Research	Doral	Florida
United States	North Texas Center for Clinical Research	Frisco	Texas
United States	AboutSkin Research, LLC	Greenwood Village	Colorado
United States	Alpesh D. Desai, DO PLLC	Houston	Texas
United States	Maryland Laser Skin and Vein	Hunt Valley	Maryland
United States	Marvel Clinical Research	Huntington Beach	California
United States	Clinical Partners, LLC	Johnston	Rhode Island
United States	Sunwise Clinical Research	Lafayette	California
United States	California Allergy and Asthma Medical Group	Los Angeles	California
United States	Velocity Clinical Research, Medford	Medford	Oregon
United States	Clinical Neuroscience Solutions Inc.	Memphis	Tennessee
United States	Floridian Research Institute	Miami	Florida
United States	Floridian Research Institute Llc	Miami	Florida
United States	SouthCoast Research Center	Miami	Florida
United States	Global Health Research Center, Inc.	Miami Lakes	Florida
United States	Southern Indiana Clinical Trials	New Albany	Indiana
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Private Practice - Dr. Bobby Buka	New York	New York
United States	Sadick Research Group	New York	New York
United States	Virginia Dermatology and Skin Cancer Center	Norfolk	Virginia
United States	Tory Sullivan, Md Pa	North Miami Beach	Florida
United States	Northridge Clinical Trials	Northridge	California
United States	Unity Clinical Research	Oklahoma City	Oklahoma
United States	Skin Specialists, PC	Omaha	Nebraska
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	Paddington Testing Company	Philadelphia	Pennsylvania
United States	GCP Research, Global Clinical professionals	Saint Petersburg	Florida
United States	DCT-Stone Oak, LLC dba Discovery Clinical Trials	San Antonio	Texas
United States	Spartanburg Medical Research	Spartanburg	South Carolina
United States	Complete Dermatology	Sugar Land	Texas
United States	Revival Research Institute, LLC	Troy	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of participants achieving =75% improvement in EAS175 from baseline at week16.	EASI75 (=75% improvement from baseline) at Week 16	Week 16
Secondary	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	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 76 weeks.
Secondary	The number and % of participants achieving EASI75 (=75% improvement from baseline) at scheduled time points except Week 16	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 76 weeks.
Secondary	The number and % of participants achieving a Percent change from baseline in EASI total score at scheduled time points	Percent change from baseline in EASI total score at scheduled time points	Screening through study completion, an average of 76 weeks.
Secondary	The number and % of participants with treatment emergent AEs	Incidence of treatment emergent AEs	Screening - Week 76
Secondary	The number and % of participants with clinically significant changes in vital signs	Incidence of clinically significant changes in vital signs	Screening - Week 76
Secondary	The number and % of participants with clinically significant changes in ECG	Incidence of clinically significant changes in ECG	Screening - Week 76
Secondary	The number and % of participants with clinically significant changes in laboratory tests	Incidence of clinically significant changes in laboratory tests	Screening - Week 76

External Links

•   To obtain contact information for a study center near you, click here.