A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis.

• ClinicalTrials.gov Identifier: NCT05375955
• Recruitment Status: Active, not recruiting
• First Posted: May 17, 2022
• Last Update Posted: June 1, 2023
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: May 11, 2022
• First Posted Date: May 17, 2022
• Last Update Posted Date: June 1, 2023
• Actual Study Start Date: September 26, 2022
• Estimated Primary Completion Date: July 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 11, 2022)

• Proportion of participants achieving Investigator's Global Assessment (IGA) score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥2 points at Week 12 [ Time Frame: Week 12 ]
  Atopic Dermatitis population only
• Proportion of participants achieving Patient Global Assessment (PGA) score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥2 points at Week 12 [ Time Frame: Week 12 ]
  Plaque Psoriasis population only

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 25, 2022)

• Proportion of participants achieving >=75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline [ Time Frame: Week 1, 2, 4, 6, 8, 10, 12, and Follow-up ]
  Atopic Dermatitis population only
• Proportion of participants achieving >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline [ Time Frame: Week 1, 2, 4, 6, 8, 10, 12, and Follow-up ]
  Plaque Psoriasis population only
• Proportion 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 [ Time Frame: Week 1, 2, 4, 6, 8, 10, and Follow-up ]
  Atopic Dermatitis population only
• Proportion of participants achieving PGA score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥2 points [ Time Frame: Week 1, 2, 4, 6, 8, 10, and Follow-up ]
  Plaque Psoriasis population only
• Proportion of Participants Achieving IGA Score of Clear (0) or Almost Clear (1) [ Time Frame: Week 1, 2, 4, 6, 8, 10, 12, and Follow-up ]
  Atopic Dermatitis population only
• Proportion of Participants Achieving PGA Score of Clear (0) or Almost Clear (1) [ Time Frame: Week 1, 2, 4, 6, 8, 10, 12, and Follow-up ]
  Plaque Psoriasis population only
• Percent Change From Baseline (CFB) in Eczema Area and Severity Index (EASI) total score [ Time Frame: Week 1, 2, 4, 6, 8, 10, 12, and Follow-up ]
  Atopic Dermatitis population only
• Change From Baseline in Psoriasis Area and Severity Index (PASI) total score [ Time Frame: Week 1, 2, 4, 6, 8, 10, 12, and Follow-up ]
  Plaque Psoriasis population only
• Proportion of participants having ≥4 points of reduction from baseline in weekly averages of PP-NRS [ Time Frame: Week 1, 2, 4, 6, 8, 10, 12, and Follow-up ]
  Atopic Dermatitis population only
• Proportion of adult (18-75 years old) participants having ≥4 points of reduction from baseline in weekly averages of Peak Pruritus Numerical Rating Scale (PP-NRS) [ Time Frame: Week 1, 2, 4, 6, 8, 10, 12, and Follow-up ]
  Plaque Psoriasis population only
• Percent CFB in Affected Body Surface Area (BSA) [ Time Frame: Week 1, 2, 4, 6, 8, 10, 12, and Follow-up ]
  Atopic Dermatitis and Plaque Psoriasis population
• Incidence of Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Week 1, 2, 4, 6, 8, 10, 12, and Follow-up ]
  Atopic Dermatitis and Plaque Psoriasis population
• Number of Participants With Clinically Significant Changes in Vital Signs [ Time Frame: Week 1, 2, 4, 6, 8, 10, 12, and Follow-up ]
  Atopic Dermatitis and Plaque Psoriasis population
• Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) [ Time Frame: Week 1, 2, 4, 6, 8, 10, 12, and Follow-up ]
  Atopic Dermatitis and Plaque Psoriasis population
• Number of Participants With Clinically Significant Changes in Laboratory Abnormalities [ Time Frame: Week 1, 2, 4, 6, 8, 10, 12, and Follow-up ]
  Atopic Dermatitis and Plaque Psoriasis population
• Incidence of Increase in Local Tolerability Severity Grades [ Time Frame: Week 1, 2, 4, 6, 8, 10, 12, and Follow-up ]
  Atopic Dermatitis and Plaque Psoriasis population

Original Secondary Outcome Measures (submitted: May 11, 2022)

• Proportion of participants achieving >=75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline [ Time Frame: Week 1, 2, 4, 6, 8, 10, 12, and Follow-up ]
  Atopic Dermatitis population only
• Proportion of participants achieving75% Improvement in Psoriasis Area and Severity Index (PASI-75) Score From Baseline [ Time Frame: Week 1, 2, 4, 6, 8, 10, 12, and Follow-up ]
  Plaque Psoriasis population only
• Proportion 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 [ Time Frame: Week 1, 2, 4, 6, 8, 10, and Follow-up ]
  Atopic Dermatitis population only
• Proportion of participants achieving PGA score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥2 points [ Time Frame: Week 1, 2, 4, 6, 8, 10, and Follow-up ]
  Plaque Psoriasis population only
• Proportion of Participants Achieving IGA Score of Clear (0) or Almost Clear (1) [ Time Frame: Week 1, 2, 4, 6, 8, 10, 12, and Follow-up ]
  Atopic Dermatitis population only
• Proportion of Participants Achieving PGA Score of Clear (0) or Almost Clear (1) [ Time Frame: Week 1, 2, 4, 6, 8, 10, 12, and Follow-up ]
  Plaque Psoriasis population only
• Percent Change From Baseline (CFB) in EASI total score [ Time Frame: Week 1, 2, 4, 6, 8, 10, 12, and Follow-up ]
  Atopic Dermatitis population only
• Change From Baseline in PASI [ Time Frame: Week 1, 2, 4, 6, 8, 10, 12, and Follow-up ]
  Plaque Psoriasis population only
• Proportion of participants having ≥4 points of reduction from baseline in weekly averages of PP-NRS [ Time Frame: Week 1, 2, 4, 6, 8, 10, 12, and Follow-up ]
  Atopic Dermatitis population only
• Proportion of adult (18-75 years old) participants having ≥4 points of reduction from baseline in weekly averages of Peak Pruritus Numerical Rating Scale (PP-NRS) [ Time Frame: Week 1, 2, 4, 6, 8, 10, 12, and Follow-up ]
  Plaque Psoriasis population only
• Percent CFB in Affected Body Surface Area (BSA) [ Time Frame: Week 1, 2, 4, 6, 8, 10, 12, and Follow-up ]
  Atopic Dermatitis and Plaque Psoriasis population
• Incidence of Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Week 1, 2, 4, 6, 8, 10, 12, and Follow-up ]
  Atopic Dermatitis and Plaque Psoriasis population
• Number of Participants With Clinically Significant Changes in Vital Signs [ Time Frame: Week 1, 2, 4, 6, 8, 10, 12, and Follow-up ]
  Atopic Dermatitis and Plaque Psoriasis population
• Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) [ Time Frame: Week 1, 2, 4, 6, 8, 10, 12, and Follow-up ]
  Atopic Dermatitis and Plaque Psoriasis population
• Number of Participants With Clinically Significant Changes in Laboratory Abnormalities [ Time Frame: Week 1, 2, 4, 6, 8, 10, 12, and Follow-up ]
  Atopic Dermatitis and Plaque Psoriasis population
• Incidence of Increase in Local Tolerability Severity Grades [ Time Frame: Week 1, 2, 4, 6, 8, 10, 12, and Follow-up ]
  Atopic Dermatitis and Plaque Psoriasis population

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis.
• Official Title: A PHASE 2B, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF MULTIPLE DOSE LEVELS OF PF-07038124 OINTMENT FOR 12 WEEKS IN PARTICIPANTS 12 YEARS AND OLDER AND WITH MILD-TO-MODERATE ATOPIC DERMATITIS OR MILD-TO-SEVERE PLAQUE PSORIASIS

Brief Summary

The purpose of this clinical trial is to learn about the safety, how well the study medicine works, extent to which side effects can be tolerated, and how the study medicine is changed and eliminated from your body after you apply it on your skin. The study medicine is in ointment form.

This study is seeking participants who

If they have Atopic Dermatitis (AD):

• Have a diagnosis for at least 3 months
• Have a diagnosis of mild or moderate disease assessed using Investigator's Global Assessment (IGA)
• Have percent Body Surface Area (%BSA) covering 5% up to 40%
• A Peak Pruritus Numerical Rating Scale (PP-NRS) average score of ≥2 during the screening period

If they have plaque psoriasis (PsO):

• Have a diagnosis for at least 6 months
• Have a diagnosis of mild, moderate, or severe disease assessed using Physician's Global Assessment (PGA)
• Have percent Body Surface Area (%BSA) covering 2% up to 20%

All participants in this study will receive either 0.01% PF-07038124, 0.03% PF-07038124, or a vehicle ointment. In addition, some participants with PsO will receive 0.06% PF- PF-07038124. Participants will not know which dose level they have received. The participants will be randomly assigned to each dose group.

PF-07038124 ointment will be applied topically to affected areas once daily. We will compare the experiences of people receiving the different dose levels of the ointment to those who receive the vehicle ointment. This will help us determine if PF-07038124 ointment is safe and effective.

Participants will take part in this study for approximately 21 weeks. Participants will apply the study medicine once daily for 12 weeks followed by a safety follow-up period of 4-5 weeks from last application of study medicine to last visit.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Atopic Dermatitis
• Plaque Psoriasis

Intervention

• Drug: PF-07038124 ointment 0.01%
  Atopic Dermatitis and Plaque Psoriasis
• Drug: Vehicle ointment
  Atopic Dermatitis and Plaque Psoriasis
• Drug: PF-07038124 ointment 0.03%
  Atopic Dermatitis and Plaque Psoriasis
• Drug: PF-07038124 ointment 0.06%
  PF-07038124 ointment 0.06% (Plaque Psoriasis only)

Study Arms

• Experimental: Atopic Dermatitis PF-07038124 0.01% ointment
  Atopic Dermatitis
  Intervention: Drug: PF-07038124 ointment 0.01%
• Placebo Comparator: Atopic Dermatitis Vehicle ointment
  Atopic Dermatitis
  Intervention: Drug: Vehicle ointment
• Experimental: Atopic Dermatitis PF-07038124 0.03% ointment
  Atopic Dermatitis
  Intervention: Drug: PF-07038124 ointment 0.03%
• Experimental: Plaque Psoriasis PF-07038124 0.01% ointment
  Plaque Psoriasis
  Intervention: Drug: PF-07038124 ointment 0.01%
• Experimental: Plaque Psoriasis PF-07038124 0.03% ointment
  Plaque Psoriasis
  Intervention: Drug: PF-07038124 ointment 0.03%
• Experimental: Plaque Psoriasis PF-07038124 0.06% ointment
  Plaque Psoriasis
  Intervention: Drug: PF-07038124 ointment 0.06%
• Placebo Comparator: Plaque Psoriasis Vehicle ointment
  Plaque Psoriasis
  Intervention: Drug: Vehicle ointment

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: May 30, 2023): 264
• Original Estimated Enrollment (submitted: May 11, 2022): 240
• Estimated Study Completion Date: July 31, 2023
• Estimated Primary Completion Date: July 31, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria for AD population:

• Diagnosis of Atopic Dermatitis (AD) for at least 3 months
• Investigator's Global Assessment (IGA) score of 2 (mild), or 3 (moderate)
• AD covering 5% and up to 40% of Body Surface Area (BSA)
• A Peak Pruritus Numerical Rating Scale (PP-NRS) average score of ≥2

Inclusion Criteria for Plaque Psoriasis

• Diagnosis of Plaque Psoriasis (PsO) for at least 6 months
• Physician Global Assessment (PGA) score of 2 (mild), 3 (moderate), or 4 (severe)
• PsO covering 2% to 20% (inclusive) of BSA

Exclusion Criteria:

• Presence of skin comorbidities that would interfere with study assessment or response to treatment
• Psychiatric condition including recent or active suicidal ideation or behavior
• Current or recent history of severe, progressive, or uncontrolled disease
• A history of systemic, chronic or acute skin infection requiring hospitalization, parenteral antimicrobial therapy, or is judged clinically significant.
• Recent, significant trauma or major surgery
• History of cancer or have undergone treatment for any type of cancer, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ with no evidence of recurrence.
• History of angioedema or anaphylaxis to topical products or known sensitivity to any of the components of the investigational products.
• Use of any prohibited concomitant medication(s)
• Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
• Participants with an estimated glomerular filtration rate (eGFR) of <40 mL/min/1.73m2 calculated using the serum creatinine-based Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) formula for adults and serum creatinine >1.5 x upper limit of normal (ULN) in adolescents (12-18 years old)
• Participants with total bilirubin ≥2x ULN (≥3 x ULN for Gilbert's disease), aspartate aminotransferase (AST) ≥2.5 x ULN, ALT ≥2.5 x ULN.
• Clinically relevant abnormal baseline standard 12-lead electrocardiogram (ECG) including, but not limited to QTC corrected using Fridericia's Formula (QTcF) interval >450 msec and QRS > 120 msec
• A recent history of alcohol or substance abuse

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, Japan, United Kingdom, United States

Administrative Information

• NCT Number: NCT05375955
• Other Study ID Numbers: C3941005
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: Yes
• 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.
• URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

• Current Responsible Party: Pfizer
• Original Responsible Party: Same as current
• Current Study Sponsor: Pfizer
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: May 2023