Last reviewed · How we verify

NCT04664153: EMPORIA

Study To Assess Efficacy, Safety, Tolerability And Pharmacokinetics Of PF-07038124 Ointment In Participants With Atopic Dermatitis Or Plaque Psoriasis

Completed Phase 2 Results posted Last updated 26 August 2022
What this trial tests

Phase 2 trial testing PF-07038124 ointment in Atopic Dermatitis in 104 participants. Completed in 18 August 2021.

Timeline
21 December 2020
Primary endpoint
18 August 2021
18 August 2021

Quick facts

Lead sponsorPfizer
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment104
Start date21 December 2020
Primary completion18 August 2021
Estimated completion18 August 2021
Sites29 locations across Canada, United States, Australia, Poland

Drugs / interventions tested

Conditions studied

Sponsor

Pfizer — full company profile →

Who can join

Adults 18 to 70, any sex, with Atopic Dermatitis or Plaque Psoriasis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6 for AD Participants Primary · Baseline, Week 6

EASI evaluated severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to

GroupValue95% CI
AD Vehicle Once Daily (QD)-35.5-48.95 – -22.03
AD PF-07038124 0.01% QD-74.9-88.81 – -61.06
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 6 for Plaque Psoriasis Participants Primary · Baseline, Week 6

Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section\*area score\*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease, where higher scores = greater severity of psoriasis.

GroupValue95% CI
Psoriasis Vehicle QD0.1-1.47 – 1.68
Psoriasis PF-07038124 0.01% QD-4.8-6.21 – -3.37
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 Secondary · Baseline, Week 6

IGA assessed severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared-light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriatio

GroupValue95% CI
AD Vehicle Once Daily (QD)8.83.3 – 19.7
AD PF-07038124 0.01% QD44.430.2 – 59.1
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) Secondary · Baseline, Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)

EASI evaluated severity of participants' AD based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk and lower limbs) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+E

Week 1
GroupValue95% CI
AD Vehicle Once Daily (QD)00.0 – 8.0
AD PF-07038124 0.01% QD8.33.1 – 18.9
Week 2
GroupValue95% CI
AD Vehicle Once Daily (QD)00.0 – 8.2
AD PF-07038124 0.01% QD27.815.9 – 40.9
Week 4
GroupValue95% CI
AD Vehicle Once Daily (QD)11.85.2 – 24.3
AD PF-07038124 0.01% QD33.321.3 – 47.0
Week 6
GroupValue95% CI
AD Vehicle Once Daily (QD)20.611.3 – 34.9
AD PF-07038124 0.01% QD61.147.0 – 74.6
FUP/EOS
GroupValue95% CI
AD Vehicle Once Daily (QD)8.83.3 – 19.7
AD PF-07038124 0.01% QD44.430.2 – 59.1
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 Secondary · Baseline, Weeks 1, 2, 4 and 6

The PP-NRS was a daily patient-reported assessment of intensity of pruritus on an 11-point numerical rating scale, ranging from 0 ('No Itch) to 10 ('Worst Itch Imaginable') with a 24 hour recall period. For the PP-NRS score, baseline was defined as the average of all values recorded between Day -7 and Day -1. In this OM, percentages of AD participants with \>=4 points of reduction in weekly averages of PP-NRS from baseline are reported (percentage based on number of participants with baseline \>=4).

Week 1
GroupValue95% CI
AD Vehicle Once Daily (QD)00.0 – 9.4
AD PF-07038124 0.01% QD8.83.3 – 19.7
Week 2
GroupValue95% CI
AD Vehicle Once Daily (QD)3.40.4 – 14.5
AD PF-07038124 0.01% QD23.512.3 – 37.7
Week 4
GroupValue95% CI
AD Vehicle Once Daily (QD)6.91.8 – 20.0
AD PF-07038124 0.01% QD41.226.9 – 56.7
Week 6
GroupValue95% CI
AD Vehicle Once Daily (QD)13.86.2 – 27.9
AD PF-07038124 0.01% QD41.226.9 – 56.7
Change From Baseline in EASI Total Score at Weeks 1, 2, 4, 6 and FUP/EOS for AD Participants Secondary · Baseline, Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)

EASI evaluated severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<

Week 1
GroupValue95% CI
AD Vehicle Once Daily (QD)-1.7-2.59 – -0.85
AD PF-07038124 0.01% QD-3.4-4.28 – -2.59
Week 2
GroupValue95% CI
AD Vehicle Once Daily (QD)-2.4-3.42 – -1.45
AD PF-07038124 0.01% QD-5.6-6.51 – -4.66
Week 4
GroupValue95% CI
AD Vehicle Once Daily (QD)-2.5-3.63 – -1.31
AD PF-07038124 0.01% QD-7.0-8.06 – -5.90
Week 6
GroupValue95% CI
AD Vehicle Once Daily (QD)-3.3-4.59 – -1.93
AD PF-07038124 0.01% QD-8.2-9.39 – -6.94
FUP/EOS
GroupValue95% CI
AD Vehicle Once Daily (QD)-2.8-4.26 – -1.39
AD PF-07038124 0.01% QD-6.9-8.19 – -5.54
Percentage of AD Participants Achieving IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6 and FUP/EOS Secondary · Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)

IGA assessed severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriati

Week 1
GroupValue95% CI
AD Vehicle Once Daily (QD)2.90.3 – 12.3
AD PF-07038124 0.01% QD11.14.9 – 22.9
Week 2
GroupValue95% CI
AD Vehicle Once Daily (QD)9.13.4 – 20.2
AD PF-07038124 0.01% QD36.122.9 – 50.0
Week 4
GroupValue95% CI
AD Vehicle Once Daily (QD)14.77.3 – 26.9
AD PF-07038124 0.01% QD44.430.2 – 59.1
Week 6
GroupValue95% CI
AD Vehicle Once Daily (QD)17.68.0 – 30.7
AD PF-07038124 0.01% QD52.838.0 – 67.2
FUP/EOS
GroupValue95% CI
AD Vehicle Once Daily (QD)5.91.6 – 16.9
AD PF-07038124 0.01% QD38.925.4 – 53.0
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 Secondary · Baseline, Week 6

The PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). In

GroupValue95% CI
Psoriasis Vehicle QD5.90.6 – 22.5
Psoriasis PF-07038124 0.01% QD17.66.7 – 36.4
Percentage of Psoriasis Participants Achieving PASI 75 (75% or Greater Improvement From Baseline) at Weeks 1, 2, 4, 6 and FUP/EOS Secondary · Baseline, Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)

The PASI quantified the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI was a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score could vary in increments of 0.1 and range from 0.0 to 72.0, with hig

Week 1
GroupValue95% CI
Psoriasis Vehicle QD00.0 – 14.0
Psoriasis PF-07038124 0.01% QD5.90.6 – 22.5
Week 2
GroupValue95% CI
Psoriasis Vehicle QD00.0 – 14.0
Psoriasis PF-07038124 0.01% QD5.90.6 – 22.5
Week 4
GroupValue95% CI
Psoriasis Vehicle QD00.0 – 14.0
Psoriasis PF-07038124 0.01% QD17.66.7 – 36.4
Week 6
GroupValue95% CI
Psoriasis Vehicle QD5.90.6 – 22.5
Psoriasis PF-07038124 0.01% QD35.317.5 – 56.8
FUP/EOS
GroupValue95% CI
Psoriasis Vehicle QD00.0 – 14.0
Psoriasis PF-07038124 0.01% QD23.510.7 – 43.2
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 Secondary · Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)

PSI was a self-administered 8 item questionnaire that measured the severity of psoriasis symptoms over the past 24 hours and the past 7 days. The measure included concepts of itch, pain, burning, stinging, cracking, scaling, flaking, and redness. Participants were asked to respond to each item using a 5 point Likert response scale: 0: not all severe, 1: mild, 2: moderate, 3: severe and 4: very severe. In this OM, percentages of participants with a PSI score of 0 or 1 on every item at weeks 1, 2, 4, 6 and FUP/EOS are reported.

Week 1
GroupValue95% CI
Psoriasis Vehicle QD00.0 – 14.0
Psoriasis PF-07038124 0.01% QD11.83.2 – 31.1
Week 2
GroupValue95% CI
Psoriasis Vehicle QD5.90.6 – 22.5
Psoriasis PF-07038124 0.01% QD18.87.1 – 39.1
Week 4
GroupValue95% CI
Psoriasis Vehicle QD23.510.7 – 43.2
Psoriasis PF-07038124 0.01% QD43.823.5 – 66.7
Week 6
GroupValue95% CI
Psoriasis Vehicle QD29.414.0 – 50.0
Psoriasis PF-07038124 0.01% QD58.836.4 – 77.5
FUP/EOS
GroupValue95% CI
Psoriasis Vehicle QD41.222.5 – 63.6
Psoriasis PF-07038124 0.01% QD41.222.5 – 63.6
Change From Baseline in PASI Scores at Weeks 1, 2, 4 and FUP/EOS Secondary · Baseline, Weeks 1, 2, 4 and FUP/EOS (28-35 days post-last dose)

Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section\*area score\*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease, where higher scores = greater severity of psoriasis.

Week 1
GroupValue95% CI
Psoriasis Vehicle QD-0.6-1.23 – 0.03
Psoriasis PF-07038124 0.01% QD-1.9-2.50 – -1.24
Week 2
GroupValue95% CI
Psoriasis Vehicle QD-0.7-1.51 – 0.11
Psoriasis PF-07038124 0.01% QD-3.2-3.97 – -2.35
Week 4
GroupValue95% CI
Psoriasis Vehicle QD-0.1-1.49 – 1.19
Psoriasis PF-07038124 0.01% QD-4.1-5.44 – -2.80
FUP/EOS
GroupValue95% CI
Psoriasis Vehicle QD0.2-1.59 – 1.97
Psoriasis PF-07038124 0.01% QD-3.7-5.35 – -2.00
Percent Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6 and FUP/EOS Secondary · Baseline, Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)

Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section\*area score\*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease, where higher scores = greater severity of psoriasis.

Week 1
GroupValue95% CI
Psoriasis Vehicle QD-6.8-15.28 – 1.78
Psoriasis PF-07038124 0.01% QD-25.6-34.11 – -17.04
Week 2
GroupValue95% CI
Psoriasis Vehicle QD-9.0-19.14 – 1.09
Psoriasis PF-07038124 0.01% QD-37.8-47.92 – -27.68
Week 4
GroupValue95% CI
Psoriasis Vehicle QD-9.0-22.73 – 4.73
Psoriasis PF-07038124 0.01% QD-49.4-62.93 – -35.79
Week 6
GroupValue95% CI
Psoriasis Vehicle QD-5.4-21.35 – 10.65
Psoriasis PF-07038124 0.01% QD-58.1-73.52 – -42.70
FUP/EOS
GroupValue95% CI
Psoriasis Vehicle QD-8.4-27.02 – 10.25
Psoriasis PF-07038124 0.01% QD-45.6-63.02 – -28.10

Adverse events — posted to ClinicalTrials.gov

Time frame: Day 1 through Week 6. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

AD Vehicle Once Daily (QD)
Serious: 0/34 (0%)
Deaths: 0/34
AD PF-07038124 0.01% QD
Serious: 0/36 (0%)
Deaths: 0/36
Psoriasis Vehicle QD
Serious: 0/17 (0%)
Deaths: 0/17
Psoriasis PF-07038124 0.01% QD
Serious: 0/17 (0%)
Deaths: 0/17
Other adverse events (16 terms — click to expand)

ReactionSystemAD Vehicle Once Daily (QD)AD PF-07038124 0.01% QDPsoriasis Vehicle QDPsoriasis PF-07038124 0.01…
Dermatitis atopicSkin and subcutaneous tissue disorders————
Application site pruritusGeneral disorders————
PsoriasisSkin and subcutaneous tissue disorders————
PruritusSkin and subcutaneous tissue disorders————
Herpes zosterInfections and infestations————
Urinary tract infectionInfections and infestations————
Muscle strainInjury, poisoning and procedural complications————
Blood glucose increasedInvestigations————
SARS-CoV-2 test positiveInvestigations————
HyperglycaemiaMetabolism and nutrition disorders————
HyperkalaemiaMetabolism and nutrition disorders————
ArthralgiaMusculoskeletal and connective tissue disorders————
Back painMusculoskeletal and connective tissue disorders————
Suicidal ideationPsychiatric disorders————
Sinus congestionRespiratory, thoracic and mediastinal disorders————
HypertensionVascular disorders————

Data from ClinicalTrials.gov NCT04664153 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Atopic dermatitis: an expanding therapeutic pipeline for a complex disease.
    Bieber T. · · 2022 · cited 421× · PMID 34417579 · DOI 10.1038/s41573-021-00266-6
  2. Therapeutic Development Based on the Immunopathogenic Mechanisms of Psoriasis.
    Tseng JC, Chang YC, Huang CM, Hsu LC, et al · · 2021 · cited 27× · PMID 34371756 · DOI 10.3390/pharmaceutics13071064
  3. Phosphodiesterase-4 Inhibition in the Management of Psoriasis.
    Crowley EL, Gooderham MJ. · · 2023 · cited 24× · PMID 38258034 · DOI 10.3390/pharmaceutics16010023
  4. Topical anti-inflammatory treatments for eczema: network meta-analysis.
    Lax SJ, Van Vogt E, Candy B, Steele L, et al · · 2024 · cited 22× · PMID 39105474 · DOI 10.1002/14651858.cd015064.pub2
  5. A Review of the Clinical Trial Landscape in Psoriasis: An Update for Clinicians.
    Drakos A, Vender R. · · 2022 · cited 15× · PMID 36319883 · DOI 10.1007/s13555-022-00840-9
  6. Efficacy and Safety of PF-07038124 in Patients With Atopic Dermatitis and Plaque Psoriasis: A Randomized Clinical Trial.
    Eichenfield LF, Tarabar S, Forman S, García-Bello A, et al · · 2024 · cited 12× · PMID 38117526 · DOI 10.1001/jamadermatol.2023.4990
  7. Exploring the Therapeutic Landscape: A Narrative Review on Topical and Oral Phosphodiesterase-4 Inhibitors in Dermatology.
    Carmona-Rocha E, Rusiñol L, Puig L. · · 2025 · cited 11× · PMID 39861739 · DOI 10.3390/pharmaceutics17010091
  8. Topical Management of Pediatric Psoriasis: A Review of New Developments and Existing Therapies.
    Lie E, Choi M, Wang SP, Eichenfield LF. · · 2024 · cited 9× · PMID 37847480 · DOI 10.1007/s40272-023-00592-9

Verify or expand the search:

Other recruiting trials for Atopic Dermatitis

Currently open trials in the same condition.

Other Pfizer trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04664153.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing