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

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

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 80 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.

Study Overview

• Status: Recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: PF-07275315; Drug: PF-07264660; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 340
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• Canada
  • Quebec, Canada, G1W 4R4
    • Not yet recruiting
    • Centre de Recherche Saint-Louis
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 7Y8
      • Not yet recruiting
      • Intermed groupe santé
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Recruiting
      • Allervie Clinical Research
  • California
    • Huntington Beach, California, United States, 92647
      • Recruiting
      • Marvel Clinical Research
    • Lafayette, California, United States, 94549
      • Recruiting
      • Sunwise Clinical Research
    • Los Angeles, California, United States, 90025
      • Recruiting
      • California Allergy and Asthma Medical Group
    • Northridge, California, United States, 91325
      • Recruiting
      • Northridge Clinical Trials
  • Colorado
    • Greenwood Village, Colorado, United States, 80111
      • Recruiting
      • AboutSkin Research, LLC
  • Florida
    • Cape Coral, Florida, United States, 33991
      • Recruiting
      • Renaissance Research and Medical Group
    • Coral Gables, Florida, United States, 33134
      • Not yet recruiting
      • Florida Academic Centers Research and Education, LLC
    • Coral Gables, Florida, United States, 33134
      • Recruiting
      • Florida International Medical Research
    • Doral, Florida, United States, 33122
      • Recruiting
      • Revival Research
    • Doral, Florida, United States, 33172
      • Not yet recruiting
      • St. Jude Clinical Research
    • Miami, Florida, United States, 33136
      • Recruiting
      • SouthCoast Research Center
    • Miami, Florida, United States, 33179
      • Recruiting
      • Floridian Research Institute Llc
    • Miami, Florida, United States, 33179
      • Recruiting
      • Floridian Research Institute
    • Miami Lakes, Florida, United States, 33016
      • Recruiting
      • Global Health Research Center, Inc.
    • North Miami Beach, Florida, United States, 33162
      • Recruiting
      • Tory Sullivan, Md Pa
    • Orlando, Florida, United States, 32801
      • Recruiting
      • Clinical Neuroscience Solutions, Inc.
    • Saint Petersburg, Florida, United States, 33705
      • Recruiting
      • GCP Research, Global Clinical professionals
  • Indiana
    • New Albany, Indiana, United States, 47150
      • Recruiting
      • Southern Indiana Clinical Trials
  • Maryland
    • Hunt Valley, Maryland, United States, 21030
      • Recruiting
      • Maryland Laser Skin and Vein
  • Michigan
    • Bay City, Michigan, United States, 48706
      • Not yet recruiting
      • Great Lakes Research Group, Inc.
    • Clarkston, Michigan, United States, 48346
      • Recruiting
      • Michigan Center for Research Company
    • Troy, Michigan, United States, 48084
      • Recruiting
      • Revival Research Institute, LLC
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Recruiting
      • Skin Specialists, PC
  • New York
    • New York, New York, United States, 10075
      • Recruiting
      • Sadick Research Group
    • New York, New York, United States, 10012
      • Not yet recruiting
      • Private Practice - Dr. Bobby Buka
  • Oklahoma
    • Chickasha, Oklahoma, United States, 73018
      • Recruiting
      • Epic Medical Research - Oklahoma
    • Oklahoma City, Oklahoma, United States, 73118
      • Recruiting
      • Unity Clinical Research
  • Oregon
    • Medford, Oregon, United States, 97504
      • Not yet recruiting
      • Velocity Clinical Research, Medford
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Not yet recruiting
      • Paddington Testing Company
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Recruiting
      • Clinical Partners, LLC
  • South Carolina
    • Spartanburg, South Carolina, United States, 29303
      • Recruiting
      • Spartanburg Medical Research
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Recruiting
      • Clinical Neuroscience Solutions Inc.
  • Texas
    • Dallas, Texas, United States, 75230
      • Recruiting
      • Dermatology Treatment and Research Center
    • Frisco, Texas, United States, 75034
      • Recruiting
      • North Texas Center for Clinical Research
    • Houston, Texas, United States, 77008
      • Recruiting
      • Alpesh D. Desai, DO PLLC
    • San Antonio, Texas, United States, 78258
      • Recruiting
      • DCT-Stone Oak, LLC dba Discovery Clinical Trials
    • Sugar Land, Texas, United States, 77479
      • Recruiting
      • Complete Dermatology
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Recruiting
      • Virginia Dermatology and Skin Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 (captured as part of EASI) ≥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; Irritable bowel syndrome; 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 the screening;
   2. Infection requiring hospitalization or systemic (eg, parenteral, oral) antimicrobial therapy within 60 days prior to Day 1;
   3. Active chronic or acute skin infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks prior to Day 1, or superficial skin infections 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 would 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stage 1_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.	Drug: PF-07275315; subcutaneous injection
Experimental: Stage 1_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.	Drug: PF-07264660; subcutaneous injection
Experimental: Stage 1_Placebo; Stage 1 Placebo Injections on Day 1, Week 1, Week 2, Week 4, Week 6, Week 8, Week 10 and Week 12.	Other: Placebo; subcutaneous injection
Experimental: Stage 2_PF-07275315 or PF-07264660_Dose A; Stage 2 PF-07275315 or PF-07264660 Injections on Day 1, Week 4, Week 8 and Week 12.	Drug: PF-07275315; subcutaneous injection; Drug: PF-07264660; subcutaneous injection
Experimental: Stage 2_PF-07275315 or PF-07264660_Dose B; Stage 2 PF-07275315 or PF-07264660 Injections on Day 1, Week 4, Week 8 and Week 12.	Drug: PF-07275315; subcutaneous injection; Drug: PF-07264660; subcutaneous injection
Experimental: Stage 2_PF-07275315 or PF-07264660_Dose C; Stage 2 PF-07275315 or PF-07264660 Injections on Day 1, Week 4, Week 8 and Week 12.	Drug: PF-07275315; subcutaneous injection; Drug: PF-07264660; subcutaneous injection
Experimental: Stage 2_PF-07275315 or PF-07264660_Dose D; Stage 2 PF-07275315 or PF-07264660 Injections on Day 1, Week 4, Week 8 and Week 12.	Drug: PF-07275315; subcutaneous injection; Drug: PF-07264660; subcutaneous injection
Experimental: Stage 2_Placebo; Stage 2 Placebo Injections on Day 1, Week 4, Week 8 and Week 12.	Other: Placebo; subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of participants achieving ≥75% improvement in EAS175 from baseline at week16.	EASI75 (≥75% improvement from baseline) at Week 16	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
The number and % of participants with treatment emergent AEs	Incidence of treatment emergent AEs	Screening - Week 76
The number and % of participants with clinically significant changes in vital signs	Incidence of clinically significant changes in vital signs	Screening - Week 76
The number and % of participants with clinically significant changes in ECG	Incidence of clinically significant changes in ECG	Screening - Week 76
The number and % of participants with clinically significant changes in laboratory tests	Incidence of clinically significant changes in laboratory tests	Screening - Week 76
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.

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2023
• Primary Completion (Estimated): February 13, 2026
• Study Completion (Estimated): February 13, 2026

Study Registration Dates

• First Submitted: July 26, 2023
• First Submitted That Met QC Criteria: August 10, 2023
• First Posted (Actual): August 16, 2023

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Eczema
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: C4531002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No