A Study To Learn About The Safety, Efficacy and Tolerability of PF-07038124 Ointment In Participants With Mild-To-Moderate Atopic Dermatitis Or Mild-To-Severe Plaque Psoriasis

JRCT ID: jRCT2031220347

Registered date:22/09/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Atopic Dermatitis Plaque Psoriasis
• Date of first enrollment: 10/11/2022
• Target sample size: 240
• Countries of recruitment: US,Japan,Canada,Japan,United Kingdom,Japan
• Study type: Interventional

Intervention(s)

PF-07038124 ointment 0.01% [Atopic Dermatitis and Plaque Psoriasis]
PF-07038124 ointment 0.03% [Atopic Dermatitis and Plaque Psoriasis]
PF-07038124 ointment 0.06% [Plaque Psoriasis]
Vehicle ointment [Atopic Dermatitis and Plaque Psoriasis]

Outcome(s)

Primary Outcome

Atopic Dermatitis: 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
Plaque Psoriasis: 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

Secondary Outcome

Atopic Dermatitis:
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]
2. 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]
3. 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]
4. 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]
5. 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]
6. Percent CFB in Affected Body Surface Area (BSA) [Time Frame: Week 1, 2, 4, 6, 8, 10, 12, and Follow-up]
Plaque Psoriasis population:
7. 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]
8. 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]
9. 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]
10. 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]
11. 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]
12. Percent CFB in Affected Body Surface Area (BSA) [Time Frame: Week 1, 2, 4, 6, 8, 10, 12, and Follow-up]
Both diseases:
13. Incidence of Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
14. Number of Participants With Clinically Significant Changes in Vital Signs
15. Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)
16. Number of Participants With Clinically Significant Changes in Laboratory Abnormalities
17. Incidence of Increase in Local Tolerability Severity Grades

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude criteria

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

Related Information

• Primary Sponsor: Kawai Norisuke
• Secondary ID(s): NCT05375955