Phase 2
Completed N=292
Dose Ranging Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of PF-06700841 Topical Cream in Participants With Mild or Moderate Atopic Dermatitis
Source: ClinicalTrials.gov NCT03903822 ↗Enrolled (actual)
292
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcomePrimary: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6: Multiple Imputation — -44.4; -58.3; -64.6; -70.1 Percent change — p=0.1040
Summary
This study is being conducted to provide data on efficacy, safety, tolerability and PK of multiple topical formulation concentrations of PF-06700841 topical cream in the treatment of mild to moderate atopic dermatitis (AD). The study is intended to enable selection of the dose and dosing regimen (once daily [QD] vs twice daily [BID] application) for the future clinical development of topical PF-06700841.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6: Multiple Imputation |
-44.4; -58.3; -64.6; -70.1; -67.9; -47.6 | 0.1040 |
| SECONDARY Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score Clear (0) or Almost Clear (1) and a Reduction From Baseline of Greater Than or Equal to ( >=2) Points at Week 6: Non-responder Imputation |
10.8; 29.7; 33.3; 40.5; 44.4; 13.9 | 0.0244 sig |
| SECONDARY Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6: Multiple Imputation |
-3.2; -4.5; -4.6; -4.8; -5.5; -3.6 | 0.0488 sig |
| SECONDARY Percentage of Participants Achieving >=2 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4 and 6: Non-responder Imputation |
16.2; 16.7; 20.0; 29.7; 44.4; 13.9 | 0.5246 |
| SECONDARY Percentage of Participants Achieving >=4 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4, 6 and Follow-up Visit: Non-responder Imputation |
0.0; 3.3; 3.1; 16.1; 10.7; 3.3 | 0.2450 |
| SECONDARY Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 3, 4, 6 and Follow-up Visit |
-2.4; -2.9; -16.2; -19.9; -23.0; 8.5 | 0.4781 |
| SECONDARY Percentage of Participants Achieving >=75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline at Weeks 1, 2, 3, 4 and 6: Non-responder Imputation |
5.4; 0.0; 19.4; 5.4; 16.7; 0.0 | 0.8964 |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
18; 17; 11; 12; 10; 17 | — |
| SECONDARY Number of Participants With Pre-defined Criteria For Vital Signs |
0; 0; 1; 2; 0; 0 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities |
26; 22; 23; 22; 16; 21 | — |
| SECONDARY Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings |
0; 0; 0; 0; 1; 0 | — |
| SECONDARY Change From Baseline in Clinical Chemistry-Lactate Dehydrogenase Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit |
0.4; -7.4; -5.3; -9.3; -18.4; -8.0 | — |
| SECONDARY Change From Baseline in Clinical Chemistry- Protein and Albumin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit |
-0.01; -0.04; -0.14; -0.04; -0.03; -0.10 | — |
| SECONDARY Change From Baseline in Clinical Chemistry- Urea Nitrogen, Urate, Calcium and Glucose Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit |
0.9; 0.6; 0.1; 1.0; 1.0; 0.2 | — |
| SECONDARY Change From Baseline in Clinical Chemistry- Sodium, Potassium, Chloride and Bicarbonate Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit |
0.1; -0.0; -0.7; -0.6; -0.4; 0.4 | — |
| SECONDARY Change From Baseline in Hematology- Hemoglobin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit |
-0.01; -0.22; -0.36; -0.12; -0.26; -0.19 | — |
| SECONDARY Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit |
0.2; -0.8; -1.3; -0.4; -0.8; -0.5 | — |
| SECONDARY Change From Baseline in Hematology- Erythrocytes and Reticulocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit |
0.03; -0.07; -0.12; -0.04; -0.08; -0.08 | — |
| SECONDARY Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit |
0.9; 6.8; -3.3; 1.0; 8.5; 6.6 | — |
| SECONDARY Change From Baseline in Lipids Profile Values at Week 6 |
-2.8; 0.1; -1.3; 2.7; 1.9; 0.0 | — |
| SECONDARY Change From Baseline in Ratio of LDL Cholesterol to HDL Cholesterol Lipids Profile at Week 6 |
0.0; -0.1; -0.2; -0.0; -0.3; -0.0 | — |
| SECONDARY Change From Baseline in Electrocardiogram (ECG) Parameter- Heart Rate at Weeks 2 and 6 |
66.8; 66.9; 68.4; 64.9; 64.9; 66.9 | — |
| SECONDARY Change From Baseline in PR, QRS, QTCF and QT Interval at Weeks 2 and 6 |
161.9; 160.2; 161.4; 162.5; 160.7; 156.4 | — |
| SECONDARY Change From Baseline in Vital Signs- Blood Pressure (BP) at Weeks 2 and 6 |
123.3; 123.2; 123.0; 119.7; 122.6; 123.1 | — |
| SECONDARY Change From Baseline in Vital Signs- Pulse Rate at Weeks 2 and 6 |
69.6; 69.5; 72.9; 67.9; 68.8; 69.4 | — |
| SECONDARY Change From Baseline in Vital Signs- Temperature at Weeks 2 and 6 |
36.5; 36.5; 36.6; 36.6; 36.5; 36.5 | — |
| SECONDARY Number of Participants With Each Severity Grade in Local Tolerability Assessments |
35; 35; 31; 33; 36; 35 | — |
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of Atopic Dermatitis for at least 3 months
- Investigator's Global Assessment (IGA) Score of 2 or 3
- Eczema Area Severity Index (EASI) score of 3-21
- Body Surface Area (BSA) of 2-20%
- Peak pruritus-Numerical Rating Scale (PPNRS) of Grade 2 or more
Exclusion Criteria
- Other forms of dermatological diseases (other than atopic dermatitis)
- Fitzpatrick skin type score greater than 5
- Clinically significant abnormal ECG, vital signs, and laboratory values
- Infection with HBV, HCV, herpes zoster or tuberculosis
Data sourced from ClinicalTrials.gov (NCT03903822). 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.