Mild to moderate atopic dermatitis or mild to moderate plaque psoriasis MedDRA version: 21.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858 MedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Interventions
Product Code: PF-07038124
Pharmaceutical Form: Ointment
INN or Proposed INN: PF-07038124
Current Sponsor code: PF-07038124
Other descriptive name: PF-07038124
Concentration unit: mg/g milligram(s)/gra
Sponsors
Pfizer Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: General Inclusion Criteria Applicable for both AD and psoriasis 1.Male or female participants between the ages of 18 and 70 years, inclusive, at Visit 1 (Screening Visit/time of informed consent). •Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants. 2.Body weight =50 kg and Body Mass Index (BMI) =17.5 kg/m2 up to 40 kg/m2 (inclusive). 3.Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol. 4.Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. Refer to Section 5.3 for Lifestyle considerations. AD Specific Inclusion Criteria 1.Have been diagnosed with AD for at least 3 months prior to Day 1; the clinical diagnosis of AD will be confirmed according to the criteria of Hanifin and Rajka7 (Appendix 11). 2.Have an Investigator’s Global Assessment (IGA) score of 2 (mild), or 3 (moderate) at both the Screening and Day 1/Randomization. Note: Refer to Section 8.1.2.2 for the assessment of 5-point IGA. 3.Have AD covering 5% to 20% (inclusive) of BSA (excluding the scalp) at both the Screening and Day 1/Randomization. Note: Refer to Section 8.1.2.3 for detailed methods of calculating treatable BSA. 4.Have an EASI total score of =3 to =21 at Screening and at Day 1/Randomization. Note: Refer to Section 8.1.2.1 for method of calculating EASI scores. 5.Have a Baseline Peak Pruritis Numerical Rating Scale (PP-NRS) average score of =2 assessed at Day 1/Randomization. Psoriasis Specific Inclusion Criteria 1.Participants with a diagnosis of plaque psoriasis (psoriasis vulgaris) for at least 6 months prior to Day 1. 2.Participants with a Physician Global Assessment (PGA) score of 2 (mild), or 3 (moderate) at Screening and Day 1. Note: Refer to Section 8.1.4.2 for the assessment of 5-point PGA. 3.Having plaque psoriasis covering 5% to 15% (inclusive) of BSA (excluding the scalp) at both the Screening and Day 1/Randomization. Note: Refer to Section 8.1.4.3 for detailed methods of calculating treatable BSA. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 83 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: The exclusion criteria for AD and psoriasis are the same. Medical Conditions: 1.Presence of skin comorbidities that would interfere with study assessment or response to treatment. 2.Any psychiatric condition including recent or active suicidal ideation or behavior that meets any of the following criteria at Screening or Day 1: a.Suicidal ideation associated with actual intent and/or plan in the past year: “Yes” answers on items 4 “some intent to act without specific plan” or 5 “specific plan and intent” of the Columbia Suicide Severity Rating Scale (C-SSRS); b.Previous history of suicidal behaviors in the past 5 years: “Yes” answer (for events that occurred in the past 5 years) to any of the suicidal behavior items of the C-SSRS; c.Any lifetime history of serious or recurrent suicidal behavior; d.The presence of any current major psychiatric disorder that is not explicitly permitted in the inclusion/exclusion criteria; e.In the opinion of the investigator or Pfizer (or designee) exclusion is required. 3.Current or recent history (within approximately 3 months prior to Day 1) of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurological disease. 4.A history of systemic (within approximately 3 months prior to Day 1), chronic or acute skin infection (within approximately 2 weeks prior to Day 1) requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator. 5.A known immunodeficiency disorder or a first degree relative with a hereditary immunodeficiency. 6.Undergone significant trauma or major surgery within 1 month prior to screening. 7.Have a history of cancer within 5 years or has 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. 8.Have a history of angioedema or anaphylaxis to topical products or known sensitivity to any of the components of the investigational products. 9.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. Prior/Concomitant Therapy: 10.Has received any of the prohibited medications/therapies that may alter the course of the diseases under study without the required minimum washout period or anticipated concomitant use of any of the prohibited medications/therapy (see Appendix 10). Prior/Concurrent Clinical Study Experience: 11.Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Note: Any investigational or experimental therapy taken or procedure performed for AD, psoriasis, psoriatic arthritis or rheumatoid arthritis in the previous 1 year should be discussed with the Pfizer Medical Monitor (or designee). Participants cannot participate in studies of other investigational or experimental therapies or procedures at any time during their participation in this study. Diagnostic Assessments: 12.Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may affect par
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Atopic dermatitis •Percent change from baseline in EASI total score at Week 6. Plaque psoriasis •Change from baseline in PASI score at Week 6.;Timepoint(s) of evaluation of this end point: Atopic dermatitis •Week 6. Plaque psoriasis •Week 6.;Main Objective: Atopic dermatitis •To compare the efficacy of PF 07038124 versus vehicle on percent change from baseline in Eczema Area and Severity Index (EASI) in participants with mild or moderate atopic dermatitis (AD). Plaque psoriasis •To compare the efficacy of PF 07038124 versus vehicle on change from baseline in Psoriasis Area and Severity Index (PASI) score in participants with mild to moderate plaque psoriasis. ;Secondary Objective: Atopic dermatitis •To compare the efficacy of PF 07038124 versus vehicle, using Investigator’s Global Assessment (IGA) score assessment as endpoint in participants with mild or moderate AD. •To compare the efficacy of PF 07038124 versus vehicle, using measures of disease severity and symptoms as endpoints in participants with mild or moderate AD. For a full list see protocol section 3. Plaque psoriasis •To compare the efficacy of PF 07038124 versus vehicle on Physician Global Assessment (PGA) score in participants with mild to moderate plaque psoriasis. •To compare the efficacy of PF 07038124 versus vehicle on the proportion of participants with mild to moderate plaque psoriasis achieving PASI 75. For a full list see protocol section 3. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Atopic dermatitis •Week 1 to 6. As per Schedule of Activities - see protocol section 1.3 Plaque psoriasis •Week 1 to 6. As per Schedule of Activities - see protocol section 1.3;Secondary end point(s): Atopic dermatitis •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 at Week 6. •Proportion of participants achieving EASI 75 (75% improvement from baseline) at study visit time points specified in the SoA. •Proportion of participants having =4 points of reduction in weekly averages of Peak Pruritus Numerical Rating Scale (PP NRS) from baseline at study visit time points specified in the SoA. •Change from baseline in EASI total score at study visit time points specified in the SoA. •Proportion of participants achieving IGA score of clear (0) or almost clear (1) at study visit time points specified in the SoA. •Percent change from baseline in affected Body Surface Area (BSA) at study visit time points specified in the SoA. •Incidence of treatment emergent adverse events (AEs) and serious adverse events (SAEs), clinically significant changes in vital signs, electrocardiogram (ECG), and laboratory tests. •Incidence of severity grades in skin tolerability at times indicated in SoA. Plaque psoriasis •Proportion of participants with PGA score clear (0) or almost clear (1) (on a 5-point scale) and =2 points improvement from baseline at Week 6. •Proportion of participants achieving PASI 75 (75% or greater improvement from baseline) at study visit time points specified in the SoA. •Proportion of participants who achieved a Psoriasis Symptoms Inventory (PSI) score of 0 (not at all) or 1 (mild) on every item at study visit time points specified in the SoA. •Change from baseline in PASI scores at study visit time points specified in the SoA (except Week 6). •Percent change from baseline in PASI scores at study visit time | — |
Countries
Australia, Canada, Poland, United States
Contacts
Public ContactClinical Trials.gov Call Centre
Pfizer Inc.
Outcome results
None listed