Phase 2
Completed N=104
Study To Assess Efficacy, Safety, Tolerability And Pharmacokinetics Of PF-07038124 Ointment In Participants With Atopic Dermatitis Or Plaque Psoriasis
Source: ClinicalTrials.gov NCT04664153 ↗Enrolled (actual)
104
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcomePrimary: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6 for AD Participants — -35.5; -74.9 Percent Change — p=0.0004
Summary
This study is being conducted to provide data on efficacy, safety, tolerability and PK of PF-07038124 ointment versus vehicle control in the treatment of mild to moderate AD and mild to moderate plaque psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6 for AD Participants |
-35.5; -74.9 | 0.0004 sig |
| PRIMARY Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 6 for Plaque Psoriasis Participants |
0.1; -4.8 | <0.0001 sig |
| SECONDARY Percentage of AD 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 6 |
8.8; 44.4 | — |
| SECONDARY Percentage of AD Participants Achieving EASI 75 (75% Improvement From Baseline) at Weeks 1, 2, 4, 6 and Follow-up (FUP)/End of Study (EOS) |
0; 8.3; 0; 27.8; 11.8; 33.3 | — |
| SECONDARY Percentage of AD Participants Having >=4 Points of Reduction in Weekly Averages of Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 4 and 6 |
0; 8.8; 3.4; 23.5; 6.9; 41.2 | — |
| SECONDARY Change From Baseline in EASI Total Score at Weeks 1, 2, 4, 6 and FUP/EOS for AD Participants |
-1.7; -3.4; -2.4; -5.6; -2.5; -7.0 | — |
| SECONDARY Percentage of AD Participants Achieving IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6 and FUP/EOS |
2.9; 11.1; 9.1; 36.1; 14.7; 44.4 | — |
| SECONDARY Percentage of Psoriasis Participants With Physician Global Assessment (PGA) Score Clear (0) or Almost Clear (1) (on a 5-Point Scale) and >=2 Points Improvement From Baseline at Week 6 |
5.9; 17.6 | — |
| SECONDARY Percentage of Psoriasis Participants Achieving PASI 75 (75% or Greater Improvement From Baseline) at Weeks 1, 2, 4, 6 and FUP/EOS |
0; 5.9; 0; 5.9; 0; 17.6 | — |
| SECONDARY Percentage of Psoriasis Participants Who Achieved a Psoriasis Symptoms Inventory (PSI) Score of 0 (Not at All) or 1 (Mild) on Every Item at Weeks 1, 2, 4, 6 and FUP/EOS |
0; 11.8; 5.9; 18.8; 23.5; 43.8 | — |
| SECONDARY Change From Baseline in PASI Scores at Weeks 1, 2, 4 and FUP/EOS |
-0.6; -1.9; -0.7; -3.2; -0.1; -4.1 | — |
| SECONDARY Percent Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6 and FUP/EOS |
-6.8; -25.6; -9.0; -37.8; -9.0; -49.4 | — |
| SECONDARY Percentage of Psoriasis Participants With PGA Score Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6 and FUP/EOS |
0; 11.8; 0; 17.6; 0; 23.5 | — |
| SECONDARY Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6 and FUP/EOS |
-6.6; -20.2; 2.5; -14.5; -10.5; -32.2 | — |
| SECONDARY Number of Participants With All-Causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
9; 9; 6; 3; 0; 0 | — |
| SECONDARY Number of Participants With Vital Signs Data Meeting Pre-defined Criteria |
2; 1; 0; 2; 1; 0 | — |
| SECONDARY Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria |
0; 1; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Laboratory Test Abnormalities |
0; 1; 0; 0; 0; 1 | — |
| SECONDARY Number of Participants With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP |
33; 35; 17; 17; 0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Atopic Dermatitis (AD): Have been diagnosed with AD for at least 3 months; Have an Investigator's Global Assessment (IGA) score of 2 (mild), or 3 (moderate); Have AD covering 5% to 20% (inclusive) of BSA.
- Plaque psoriasis: Have been diagnosed with plaque psoriasis (psoriasis vulgaris) for at least 6 months; Have a Physician Global Assessment (PGA) score of 2 (mild), or 3 (moderate); Having plaque psoriasis covering 5% to 15% (inclusive) of BSA.
Exclusion Criteria
- Presence of skin comorbidities that would interfere with study assessment or response to treatment.
- Current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurological disease.
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Data sourced from ClinicalTrials.gov (NCT04664153). 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. Informational only — not medical advice.