Phase 2
N=263
A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis.
Atopic Dermatitis · Plaque Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT05375955 ↗Enrolled (actual)
263
Serious AEs
1.1%
Results posted
Oct 2024
Primary outcome: Primary: Percentage of Participants With Investigator's Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of More Than or Equal to (>=) 2 Points at Week 12: Participants With Atopic Dermatitis (AD) Only — 11.4; 23.8; 21.4 Percentage of participants — p=0.0711
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PF-07038124 ointment 0.01% (Drug); Vehicle ointment (Drug); PF-07038124 ointment 0.03% (Drug); PF-07038124 ointment 0.06% (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Investigator's Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of More Than or Equal to (>=) 2 Points at Week 12: Participants With Atopic Dermatitis (AD) Only |
11.4; 23.8; 21.4 | 0.0711 |
| PRIMARY Percentage of Participants With Physician's Global Assessment (PGA) Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Week 12: Participants With Plaque Psoriasis Only |
8.8; 15.2; 37.1; 45.5 | 0.2712 |
| SECONDARY Percentage of Participants With >= 75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Atopic Dermatitis Only |
2.3; 2.4; 4.8; 2.3; 11.9; 7.1 | 0.5701 |
| SECONDARY Percentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis Only |
0; 3.0; 0; 9.1; 0; 9.1 | 0.2578 |
| SECONDARY Percentage of Participants With IGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >= 2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Atopic Dermatitis Only |
2.3; 4.8; 4.8; 2.3; 7.1; 9.5 | 0.3269 |
| SECONDARY Percentage of Participants With PGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Plaque Psoriasis Only |
0; 0; 0; 3.0; 0; 6.1 | 1.0000 |
| SECONDARY Percentage of Participants With IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only |
2.3; 4.8; 4.8; 4.5; 7.1; 11.9 | 0.3269 |
| SECONDARY Percentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only |
0; 0; 2.9; 3.0; 0; 6.1 | 1.0000 |
| SECONDARY Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only |
-10.07; -24.58; -21.07; -20.10; -35.91; -35.35 | — |
| SECONDARY Change From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only |
-0.60; -1.74; -1.69; -2.66; -1.53; -2.75 | — |
| SECONDARY Percentage of Participants With >= 4 Points of Reduction From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (PP-NRS) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only |
2.5; 5.3; 0; 0; 18.4; 14.7 | 0.3255 |
| SECONDARY Percentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only |
4.3; 0; 12.5; 5.3; 4.3; 13.6 | 0.7278 |
| SECONDARY Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque Psoriasis |
-5.70; -7.97; -11.34; -0.57; -11.80; -4.08 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (AEs): Participants With Atopic Dermatitis and Plaque Psoriasis |
20; 28; 19; 9; 13; 11 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs): Participants With Atopic Dermatitis and Plaque Psoriasis |
0; 1; 1; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Changes in Vital Signs: Participants With Atopic Dermatitis and Plaque Psoriasis |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG): Participants With Atopic Dermatitis and Plaque Psoriasis |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities: Participants With Atopic Dermatitis and Plaque Psoriasis |
18; 27; 18; 14; 14; 13 | — |
| SECONDARY Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis |
44; 42; 42; 32; 32; 34 | — |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT05375955). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.