Plaque Psoriasis PF-07038124 0.06% ointment for Atopic Dermatitis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Atopic Dermatitis+1 MorePF-07038124 ointment 0.06% - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this clinical trial is to learn about how the safety, how well the study medicine works, extent to which side affects 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.

Eligible Conditions
  • Plaque Psoriasis
  • Atopic Dermatitis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 19 Secondary · Reporting Duration: Week 1, 2, 4, 6, 8, 10, 12, and Follow-up

Week 1
Change From Baseline in PASI
Change From Baseline in Psoriasis Area and Severity Index (PASI) total score
Incidence of Increase in Local Tolerability Severity Grades
Incidence of Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)
Number of Participants With Clinically Significant Changes in Laboratory Abnormalities
Number of Participants With Clinically Significant Changes in Vital Signs
Percent CFB in Affected Body Surface Area (BSA)
Percent Change From Baseline (CFB) in EASI total score
Percent Change From Baseline (CFB) in Eczema Area and Severity Index (EASI) total score
Proportion of Participants Achieving IGA Score of Clear (0) or Almost Clear (1)
Proportion of Participants Achieving PGA Score of Clear (0) or Almost Clear (1)
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)
Proportion of participants achieving >=75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline
Proportion of participants achieving >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline
Proportion of participants achieving75% Improvement in Psoriasis Area and Severity Index (PASI-75) Score From Baseline
Proportion of participants having ≥4 points of reduction from baseline in weekly averages of PP-NRS
Week 1
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
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
Week 12
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
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

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

7 Treatment Groups

Plaque Psoriasis PF-07038124 0.06% ointment
1 of 7
Atopic Dermatitis PF-07038124 0.01% ointment
1 of 7
Plaque Psoriasis PF-07038124 0.03% ointment
1 of 7
Plaque Psoriasis PF-07038124 0.01% ointment
1 of 7
Atopic Dermatitis PF-07038124 0.03% ointment
1 of 7
Plaque Psoriasis Vehicle ointment
1 of 7
Atopic Dermatitis Vehicle ointment
1 of 7

Experimental Treatment

Non-Treatment Group

240 Total Participants · 7 Treatment Groups

Primary Treatment: Plaque Psoriasis PF-07038124 0.06% ointment · Has Placebo Group · Phase 2

Plaque Psoriasis PF-07038124 0.06% ointment
Drug
Experimental Group · 1 Intervention: PF-07038124 ointment 0.06% · Intervention Types: Drug
Atopic Dermatitis PF-07038124 0.01% ointment
Drug
Experimental Group · 1 Intervention: PF-07038124 ointment 0.01% · Intervention Types: Drug
Plaque Psoriasis PF-07038124 0.03% ointment
Drug
Experimental Group · 1 Intervention: PF-07038124 ointment 0.03% · Intervention Types: Drug
Plaque Psoriasis PF-07038124 0.01% ointment
Drug
Experimental Group · 1 Intervention: PF-07038124 ointment 0.01% · Intervention Types: Drug
Atopic Dermatitis PF-07038124 0.03% ointment
Drug
Experimental Group · 1 Intervention: PF-07038124 ointment 0.03% · Intervention Types: Drug
Plaque Psoriasis Vehicle ointment
Drug
PlaceboComparator Group · 1 Intervention: Vehicle ointment · Intervention Types: Drug
Atopic Dermatitis Vehicle ointment
Drug
PlaceboComparator Group · 1 Intervention: Vehicle ointment · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 1, 2, 4, 6, 8, 10, 12, and follow-up

Who is running the clinical trial?

PfizerLead Sponsor
4,310 Previous Clinical Trials
7,111,365 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,281 Previous Clinical Trials
4,820,636 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a diagnosis of Atopic Dermatitis (AD) for at least 3 months.
You have a score of 2 or 3 on the Investigator's Global Assessment (IGA).
You have a score of at least 2 on the PP-NRS.
You have plaque psoriasis for at least 6 months.
The patient has a PGA score of 2 (mild), 3 (moderate), or 4 (severe).