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

Primary Purpose

Atopic Dermatitis

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PF-07275315
PF-07264660
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Eczema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 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; Moderate to severe AD (defined as having an affected BSA (captured as part of EASI) ≥10%, IGA ≥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). Exclusion Criteria: - 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; Irritable bowel syndrome; Multiple Sclerosis. History of significant allergic reactions, including anaphylaxis and reactions to protein therapeutics, except to single, identified, avoidable allergens (eg, peanut allergy). Any of the following acute or chronic infections or infection history: Active infection (including helminth or parasitic) requiring treatment within 2 weeks prior to the screening; Infection requiring hospitalization or systemic (eg, parenteral, oral) antimicrobial therapy within 60 days prior to Day 1; 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. 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 would 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.

Sites / Locations

  • Allervie Clinical Research
  • Marvel Clinical ResearchRecruiting
  • Sunwise Clinical Research
  • Renaissance Research and Medical Group
  • Florida International Medical ResearchRecruiting
  • Revival ResearchRecruiting
  • Global Health Research Center, Inc.
  • SouthCoast Research Center
  • Floridian Research Institute LlcRecruiting
  • Floridian Research InstituteRecruiting
  • Clinical Neuroscience Solutions, Inc.Recruiting
  • Southern Indiana Clinical Trials
  • Maryland Laser Skin and VeinRecruiting
  • Michigan Center for Research CompanyRecruiting
  • Epic Medical Research-Oklahoma
  • Clinical Partners, LLC
  • Clinical Neuroscience Solutions Inc.Recruiting
  • North Texas Center for Clinical Research
  • Complete Dermatology
  • Virginia Dermatology and Skin Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Stage 1_PF-07275315

Stage 1_PF-07264660

Stage 1_Placebo

Stage 2_PF-07275315 or PF-07264660_Dose A

Stage 2_PF-07275315 or PF-07264660_Dose B

Stage 2_PF-07275315 or PF-07264660_Dose C

Stage 2_PF-07275315 or PF-07264660_Dose D

Stage 2_Placebo

Arm Description

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 Injections on Day 1, Week 1, Week 2, Week 4, Week 6, Week 8, Week 10 and Week 12.

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 Injections on Day 1, Week 4, Week 8 and Week 12.

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 Injections on Day 1, Week 4, Week 8 and Week 12.

Stage 2 PF-07275315 or PF-07264660 Injections on Day 1, Week 4, Week 8 and Week 12.

Stage 2 Placebo Injections on Day 1, Week 4, Week 8 and Week 12.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The number and % of participants achieving IGA 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
IGA 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
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
Percent change from baseline in EASI total score at scheduled time points
The number and % of participants with treatment emergent AEs
Incidence of treatment emergent AEs
The number and % of participants with clinically significant changes in vital signs
Incidence of clinically significant changes in vital signs
The number and % of participants with clinically significant changes in ECG
Incidence of clinically significant changes in ECG
The number and % of participants with clinically significant changes in laboratory tests
Incidence of clinically significant changes in laboratory tests

Full Information

First Posted
July 26, 2023
Last Updated
October 18, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT05995964
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 22, 2023 (Actual)
Primary Completion Date
April 6, 2026 (Anticipated)
Study Completion Date
April 6, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Eczema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
340 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stage 1_PF-07275315
Arm Type
Experimental
Arm Description
Stage 1 PF-07275315 Injections on Day 1, Week 1, Week 2, Week 4, Week 6, Week 8, Week 10 and Week 12.
Arm Title
Stage 1_PF-07264660
Arm Type
Experimental
Arm Description
Stage 1 PF-07264660 Injections on Day 1, Week 1, Week 2, Week 4, Week 6, Week 8, Week 10 and Week 12.
Arm Title
Stage 1_Placebo
Arm Type
Experimental
Arm Description
Stage 1 Placebo Injections on Day 1, Week 1, Week 2, Week 4, Week 6, Week 8, Week 10 and Week 12.
Arm Title
Stage 2_PF-07275315 or PF-07264660_Dose A
Arm Type
Experimental
Arm Description
Stage 2 PF-07275315 or PF-07264660 Injections on Day 1, Week 4, Week 8 and Week 12.
Arm Title
Stage 2_PF-07275315 or PF-07264660_Dose B
Arm Type
Experimental
Arm Description
Stage 2 PF-07275315 or PF-07264660 Injections on Day 1, Week 4, Week 8 and Week 12.
Arm Title
Stage 2_PF-07275315 or PF-07264660_Dose C
Arm Type
Experimental
Arm Description
Stage 2 PF-07275315 or PF-07264660 Injections on Day 1, Week 4, Week 8 and Week 12.
Arm Title
Stage 2_PF-07275315 or PF-07264660_Dose D
Arm Type
Experimental
Arm Description
Stage 2 PF-07275315 or PF-07264660 Injections on Day 1, Week 4, Week 8 and Week 12.
Arm Title
Stage 2_Placebo
Arm Type
Experimental
Arm Description
Stage 2 Placebo Injections on Day 1, Week 4, Week 8 and Week 12.
Intervention Type
Drug
Intervention Name(s)
PF-07275315
Intervention Description
subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
PF-07264660
Intervention Description
subcutaneous injection
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
subcutaneous injection
Primary Outcome Measure Information:
Title
The number of participants achieving ≥75% improvement in EAS175 from baseline at week16.
Description
EASI75 (≥75% improvement from baseline) at Week 16
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
The number and % of participants achieving IGA 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
Description
IGA 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
Time Frame
Screening through study completion, an average of 76 weeks.
Title
The number and % of participants achieving EASI75 (≥75% improvement from baseline) at scheduled time points except Week 16
Description
EASI75 (≥75% improvement from baseline) at scheduled time points except Week 16
Time Frame
All scheduled timepoints other than Week 16, screening through study completion, an average of 76 weeks.
Title
The number and % of participants achieving a Percent change from baseline in EASI total score at scheduled time points
Description
Percent change from baseline in EASI total score at scheduled time points
Time Frame
Screening through study completion, an average of 76 weeks.
Title
The number and % of participants with treatment emergent AEs
Description
Incidence of treatment emergent AEs
Time Frame
Screening - Week 76
Title
The number and % of participants with clinically significant changes in vital signs
Description
Incidence of clinically significant changes in vital signs
Time Frame
Screening - Week 76
Title
The number and % of participants with clinically significant changes in ECG
Description
Incidence of clinically significant changes in ECG
Time Frame
Screening - Week 76
Title
The number and % of participants with clinically significant changes in laboratory tests
Description
Incidence of clinically significant changes in laboratory tests
Time Frame
Screening - Week 76

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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; Moderate to severe AD (defined as having an affected BSA (captured as part of EASI) ≥10%, IGA ≥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). Exclusion Criteria: - 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; Irritable bowel syndrome; Multiple Sclerosis. History of significant allergic reactions, including anaphylaxis and reactions to protein therapeutics, except to single, identified, avoidable allergens (eg, peanut allergy). Any of the following acute or chronic infections or infection history: Active infection (including helminth or parasitic) requiring treatment within 2 weeks prior to the screening; Infection requiring hospitalization or systemic (eg, parenteral, oral) antimicrobial therapy within 60 days prior to Day 1; 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. 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 would 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Allervie Clinical Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Marvel Clinical Research
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Individual Site Status
Recruiting
Facility Name
Sunwise Clinical Research
City
Lafayette
State/Province
California
ZIP/Postal Code
94549
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Renaissance Research and Medical Group
City
Cape Coral
State/Province
Florida
ZIP/Postal Code
33991
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Florida International Medical Research
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Individual Site Status
Recruiting
Facility Name
Revival Research
City
Doral
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Individual Site Status
Recruiting
Facility Name
Global Health Research Center, Inc.
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
SouthCoast Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Floridian Research Institute Llc
City
Miami
State/Province
Florida
ZIP/Postal Code
33179
Country
United States
Individual Site Status
Recruiting
Facility Name
Floridian Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33179
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Individual Site Status
Recruiting
Facility Name
Southern Indiana Clinical Trials
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Maryland Laser Skin and Vein
City
Hunt Valley
State/Province
Maryland
ZIP/Postal Code
21030
Country
United States
Individual Site Status
Recruiting
Facility Name
Michigan Center for Research Company
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Individual Site Status
Recruiting
Facility Name
Epic Medical Research-Oklahoma
City
Chickasha
State/Province
Oklahoma
ZIP/Postal Code
73018
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Clinical Partners, LLC
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Clinical Neuroscience Solutions Inc.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Individual Site Status
Recruiting
Facility Name
North Texas Center for Clinical Research
City
Frisco
State/Province
Texas
ZIP/Postal Code
75034
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Complete Dermatology
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Virginia Dermatology and Skin Cancer Center
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C4531002
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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