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

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ClinicalTrials.gov Identifier: NCT05375955
Recruitment Status : Recruiting
First Posted : May 17, 2022
Last Update Posted : March 20, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.


Condition or disease Intervention/treatment Phase
Atopic Dermatitis Plaque Psoriasis Drug: PF-07038124 ointment 0.01% Drug: Vehicle ointment Drug: PF-07038124 ointment 0.03% Drug: PF-07038124 ointment 0.06% Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 26, 2022
Estimated Primary Completion Date : August 4, 2023
Estimated Study Completion Date : August 4, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Psoriasis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Atopic Dermatitis PF-07038124 0.01% ointment
Atopic Dermatitis
 Drug: PF-07038124 ointment 0.01%
Atopic Dermatitis and Plaque Psoriasis
Placebo Comparator: Atopic Dermatitis Vehicle ointment
Atopic Dermatitis
 Drug: Vehicle ointment
Atopic Dermatitis and Plaque Psoriasis
Experimental: Atopic Dermatitis PF-07038124 0.03% ointment
Atopic Dermatitis
 Drug: PF-07038124 ointment 0.03%
Atopic Dermatitis and Plaque Psoriasis
Experimental: Plaque Psoriasis PF-07038124 0.01% ointment
Plaque Psoriasis
 Drug: PF-07038124 ointment 0.01%
Atopic Dermatitis and Plaque Psoriasis
Experimental: Plaque Psoriasis PF-07038124 0.03% ointment
Plaque Psoriasis
 Drug: PF-07038124 ointment 0.03%
Atopic Dermatitis and Plaque Psoriasis
Experimental: Plaque Psoriasis PF-07038124 0.06% ointment
Plaque Psoriasis
 Drug: PF-07038124 ointment 0.06%
PF-07038124 ointment 0.06% (Plaque Psoriasis only)
Placebo Comparator: Plaque Psoriasis Vehicle ointment
Plaque Psoriasis
 Drug: Vehicle ointment
Atopic Dermatitis and Plaque Psoriasis


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05375955


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05375955    
Other Study ID Numbers: C3941005
First Posted: May 17, 2022    Key Record Dates
Last Update Posted: March 20, 2023
Last Verified: March 2023
Individual Participant Data (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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Eczema
topical
Additional relevant MeSH terms:
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Dermatitis, Atopic
Psoriasis
Dermatitis
Eczema
Skin Diseases, Papulosquamous
Skin Diseases
 Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases