Status:
COMPLETED
A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis.
Lead Sponsor:
Pfizer
Conditions:
Atopic Dermatitis
Plaque Psoriasis
Eligibility:
All Genders
12+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2023
Estimated Enrollment :
263 Patients enrolled
Trial Details
Trial ID
NCT05375955
Start Date
September 26 2022
End Date
July 31 2023
Last Update
October 2 2024
Active Locations (39)
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1
California Dermatology & Clinical Research Institute
Encinitas, California, United States, 92024
2
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
3
Renaissance Research and Medical Group
Cape Coral, Florida, United States, 33991
4
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville, Florida, United States, 32256