Eczema (Atopic Dermatitis),Psoriasis
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Eczema (Atopic Dermatitis),Psoriasis
C3941005 Enrolling

Atopic Dermatitis or Plaque Psoriasis Clinical Trial (21 Weeks)


Treatment: Topical Age: 12 Years

Individuals from 12 years of age and older diagnosed with atopic dermatitis (AD) for at least 3 months, OR plaque psoriasis (PsO) for at least 6 months, may qualify for this research trial.  Participants with AD must have mild to moderate disease that covers 5% and up to 40% of the body surface area (excluding the hair-bearing scalp).  For participants with PsO, there must be mild, moderate or severe disease that covers 2% to 20% (inclusive) of the body surface area (excluding the hair-bearing scalp, palms, soles, finger nails and toe nails).

Participants will receive investigational topical ointment (active study drug) or placebo (vehicle ointment).  Study medication and study-related assessments will be provided at no cost.  Reimbursement for study-related expenses will also be provided.

Total study duration lasts approximately 21 weeks and involves about 10 visits to the study centre.


The following information is from ClinicalTrials.gov

Last Update Posted: January 29, 2023

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

ClinicalTrials.gov ID

NCT05375955

Sponsor

Pfizer

Study Description

  • 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:

    Atopic Dermatitis

  • Intervention/Treatment:

    Drug: PF-07038124 ointment 0.01%
    Drug: Vehicle ointment
    Drug: PF-07038124 ointment 0.03%
    Drug: PF-07038124 ointment 0.01%
    Drug: PF-07038124 ointment 0.03%
    Drug: PF-07038124 ointment 0.06%
    Drug: Vehicle ointment
  • Phase:

    Phase 2

  • Ages Eligible for Study:

    12 Years and older (Child)

  • Sexes Eligible for Study:

    All

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


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.


Participating Locations

COUNTRY
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Canada

Participating Experts

Dr. Alim Devani

Dermatologist

Dr. Vimal Prajapati

Dermatologist

Dr. Melinda Gooderham

Dermatologist

Dr. Mark Lomaga

Dermatologist

Dr. Charles Lynde

Dermatologist

Dr. Marni Wiseman

Dermatologist

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