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NCT03903822

Dose Ranging Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of PF-06700841 Topical Cream in Participants With Mild or Moderate Atopic Dermatitis

Completed Phase 2 Results posted Last updated 29 March 2021
What this trial tests

Phase 2 trial testing PF-06700841 in Atopic Dermatitis in 292 participants. Completed in 7 May 2020.

Timeline
13 May 2019
Primary endpoint
7 May 2020
7 May 2020

Quick facts

Lead sponsorPfizer
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment292
Start date13 May 2019
Primary completion7 May 2020
Estimated completion7 May 2020
Sites76 locations across Denmark, Japan, Germany, Hungary, Poland, Canada, Bulgaria, Australia

Drugs / interventions tested

Conditions studied

Sponsor

Pfizer — full company profile →

Who can join

Adults 12 to 75, any sex, with Atopic Dermatitis. 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: Multiple Imputation Primary · Baseline, Week 6

EASI evaluates severity of participant's 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 \[including buttocks\]) on4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each 4 body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (

GroupValue95% CI
Vehicle Cream Once Daily (QD)-44.4-57.3 – -31.6
PF-06700841 0.1% Cream QD-58.3-71.2 – -45.5
PF-06700841 0.3% Cream QD-64.6-77.1 – -52.1
PF-06700841 1.0% Cream QD-70.1-82.1 – -58.0
PF-06700841 3.0% Cream QD-67.9-80.6 – -55.3
Vehicle Cream Twice Daily (BID)-47.6-57.5 – -37.7
PF-06700841 0.3% Cream BID-58.6-67.5 – -49.7
PF-06700841 1.0% Cream BID-75.0-83.8 – -66.2
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 Secondary · Baseline, Week 6

IGA assesses severity of participant's AD on a 5 point scale. 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, excoriation and slight oozing/crusting and 4= seve

GroupValue95% CI
Vehicle Cream Once Daily (QD)10.84.8 – 22.2
PF-06700841 0.1% Cream QD29.718.5 – 43.3
PF-06700841 0.3% Cream QD33.321.3 – 47.0
PF-06700841 1.0% Cream QD40.528.0 – 54.4
PF-06700841 3.0% Cream QD44.430.2 – 59.1
Vehicle Cream Twice Daily (BID)13.96.9 – 25.4
PF-06700841 0.3% Cream BID33.321.3 – 47.0
PF-06700841 1.0% Cream BID27.015.5 – 40.2
Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6: Multiple Imputation Secondary · Baseline, Week 6

EASI evaluates severity of participant's 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 \[including buttocks\]) on4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each 4 body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (

GroupValue95% CI
Vehicle Cream Once Daily (QD)-3.2-4.1 – -2.3
PF-06700841 0.1% Cream QD-4.5-5.4 – -3.6
PF-06700841 0.3% Cream QD-4.6-5.5 – -3.7
PF-06700841 1.0% Cream QD-4.8-5.7 – -3.9
PF-06700841 3.0% Cream QD-5.5-6.4 – -4.7
Vehicle Cream Twice Daily (BID)-3.6-4.3 – -3.0
PF-06700841 0.3% Cream BID-4.4-5.0 – -3.8
PF-06700841 1.0% Cream BID-5.3-5.9 – -4.7
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 Secondary · Baseline, Weeks 1, 2, 3, 4 and 6

The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants at specified time points were asked the following question: "How would you rate your itch due to AD at the worst moment during the previous 24 hours?" The scale ranged from 0-10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.

At Week 1
GroupValue95% CI
Vehicle Cream Once Daily (QD)16.27.3 – 29.3
PF-06700841 0.1% Cream QD16.77.5 – 30.2
PF-06700841 0.3% Cream QD20.011.0 – 33.8
PF-06700841 1.0% Cream QD29.718.5 – 43.3
PF-06700841 3.0% Cream QD44.430.2 – 59.1
Vehicle Cream Twice Daily (BID)13.96.9 – 25.4
PF-06700841 0.3% Cream BID28.616.4 – 41.9
PF-06700841 1.0% Cream BID25.715.4 – 39.2
At Week 2
GroupValue95% CI
Vehicle Cream Once Daily (QD)24.314.5 – 37.0
PF-06700841 0.1% Cream QD30.618.9 – 44.0
PF-06700841 0.3% Cream QD42.930.0 – 58.1
PF-06700841 1.0% Cream QD48.634.3 – 63.0
PF-06700841 3.0% Cream QD61.147.0 – 74.6
Vehicle Cream Twice Daily (BID)25.014.9 – 38.0
PF-06700841 0.3% Cream BID45.731.7 – 60.8
PF-06700841 1.0% Cream BID37.123.6 – 52.2
At Week 3
GroupValue95% CI
Vehicle Cream Once Daily (QD)21.611.2 – 34.3
PF-06700841 0.1% Cream QD38.925.4 – 53.0
PF-06700841 0.3% Cream QD48.633.8 – 63.5
PF-06700841 1.0% Cream QD59.545.6 – 72.0
PF-06700841 3.0% Cream QD58.344.0 – 71.0
Vehicle Cream Twice Daily (BID)33.321.3 – 47.0
PF-06700841 0.3% Cream BID51.436.5 – 66.2
PF-06700841 1.0% Cream BID57.141.9 – 70.0
At Week 4
GroupValue95% CI
Vehicle Cream Once Daily (QD)35.122.2 – 49.3
PF-06700841 0.1% Cream QD38.925.4 – 53.0
PF-06700841 0.3% Cream QD51.436.5 – 66.2
PF-06700841 1.0% Cream QD62.248.0 – 75.2
PF-06700841 3.0% Cream QD58.344.0 – 71.0
Vehicle Cream Twice Daily (BID)30.618.9 – 44.0
PF-06700841 0.3% Cream BID60.044.8 – 74.0
PF-06700841 1.0% Cream BID60.044.8 – 74.0
At Week 6
GroupValue95% CI
Vehicle Cream Once Daily (QD)40.528.0 – 54.4
PF-06700841 0.1% Cream QD41.729.0 – 56.0
PF-06700841 0.3% Cream QD51.436.5 – 66.2
PF-06700841 1.0% Cream QD56.843.2 – 70.7
PF-06700841 3.0% Cream QD61.147.0 – 74.6
Vehicle Cream Twice Daily (BID)30.618.9 – 44.0
PF-06700841 0.3% Cream BID60.044.8 – 74.0
PF-06700841 1.0% Cream BID60.044.8 – 74.0
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 Secondary · Baseline, Weeks 1, 2, 3, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)

The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants at specified time points were asked the following question: "How would you rate your itch due to AD at the worst moment during the previous 24 hours?" The scale ranged from 0-10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.

At Week 1
GroupValue95% CI
Vehicle Cream Once Daily (QD)0.00.0 – 8.2
PF-06700841 0.1% Cream QD3.30.4 – 14.0
PF-06700841 0.3% Cream QD3.10.3 – 13.1
PF-06700841 1.0% Cream QD16.18.1 – 29.7
PF-06700841 3.0% Cream QD10.74.0 – 23.8
Vehicle Cream Twice Daily (BID)3.30.4 – 14.0
PF-06700841 0.3% Cream BID3.30.4 – 14.0
PF-06700841 1.0% Cream BID11.14.2 – 24.8
At Week 2
GroupValue95% CI
Vehicle Cream Once Daily (QD)9.13.4 – 20.2
PF-06700841 0.1% Cream QD10.03.7 – 22.1
PF-06700841 0.3% Cream QD9.43.5 – 20.7
PF-06700841 1.0% Cream QD19.48.8 – 32.7
PF-06700841 3.0% Cream QD25.013.9 – 40.0
Vehicle Cream Twice Daily (BID)10.03.7 – 22.1
PF-06700841 0.3% Cream BID13.35.9 – 27.9
PF-06700841 1.0% Cream BID33.320.4 – 50.0
At Week 3
GroupValue95% CI
Vehicle Cream Once Daily (QD)12.15.4 – 25.1
PF-06700841 0.1% Cream QD23.312.9 – 37.6
PF-06700841 0.3% Cream QD15.67.8 – 28.7
PF-06700841 1.0% Cream QD32.318.7 – 48.2
PF-06700841 3.0% Cream QD32.119.7 – 47.3
Vehicle Cream Twice Daily (BID)10.03.7 – 22.1
PF-06700841 0.3% Cream BID20.09.1 – 33.9
PF-06700841 1.0% Cream BID37.022.1 – 54.7
At Week 4
GroupValue95% CI
Vehicle Cream Once Daily (QD)18.28.2 – 31.3
PF-06700841 0.1% Cream QD26.714.0 – 41.6
PF-06700841 0.3% Cream QD28.117.0 – 43.3
PF-06700841 1.0% Cream QD35.521.3 – 51.8
PF-06700841 3.0% Cream QD50.033.3 – 66.7
Vehicle Cream Twice Daily (BID)10.03.7 – 22.1
PF-06700841 0.3% Cream BID30.018.2 – 45.5
PF-06700841 1.0% Cream BID37.022.1 – 54.7
At Week 6
GroupValue95% CI
Vehicle Cream Once Daily (QD)18.28.2 – 31.3
PF-06700841 0.1% Cream QD30.018.2 – 45.5
PF-06700841 0.3% Cream QD34.420.7 – 50.0
PF-06700841 1.0% Cream QD45.229.7 – 60.1
PF-06700841 3.0% Cream QD50.033.3 – 66.7
Vehicle Cream Twice Daily (BID)16.78.3 – 30.8
PF-06700841 0.3% Cream BID33.319.3 – 49.2
PF-06700841 1.0% Cream BID40.724.8 – 58.3
At Follow-up visit
GroupValue95% CI
Vehicle Cream Once Daily (QD)9.13.4 – 20.2
PF-06700841 0.1% Cream QD30.018.2 – 45.5
PF-06700841 0.3% Cream QD21.912.1 – 36.2
PF-06700841 1.0% Cream QD19.48.8 – 32.7
PF-06700841 3.0% Cream QD21.49.8 – 36.6
Vehicle Cream Twice Daily (BID)20.09.1 – 33.9
PF-06700841 0.3% Cream BID20.09.1 – 33.9
PF-06700841 1.0% Cream BID7.42.0 – 20.4
Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 3, 4, 6 and Follow-up Visit Secondary · Baseline, Weeks 1, 2, 3, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)

4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% fo

At Week 1
GroupValue95% CI
Vehicle Cream Once Daily (QD)-2.4-12.2 – 7.4
PF-06700841 0.1% Cream QD-2.9-12.5 – 6.8
PF-06700841 0.3% Cream QD-16.2-26.2 – -6.2
PF-06700841 1.0% Cream QD-19.9-29.6 – -10.2
PF-06700841 3.0% Cream QD-23.0-32.8 – -13.1
Vehicle Cream Twice Daily (BID)8.5-8.3 – 25.3
PF-06700841 0.3% Cream BID-16.5-32.9 – -0.1
PF-06700841 1.0% Cream BID-17.0-33.5 – -0.5
At Week 2
GroupValue95% CI
Vehicle Cream Once Daily (QD)-15.3-28.0 – -2.6
PF-06700841 0.1% Cream QD-7.2-20.2 – 5.8
PF-06700841 0.3% Cream QD-38.1-51.0 – -25.2
PF-06700841 1.0% Cream QD-43.6-56.5 – -30.8
PF-06700841 3.0% Cream QD-39.0-52.1 – -26.0
Vehicle Cream Twice Daily (BID)-2.5-14.0 – 9.1
PF-06700841 0.3% Cream BID-34.2-45.4 – -22.9
PF-06700841 1.0% Cream BID-43.1-54.5 – -31.6
At Week 3
GroupValue95% CI
Vehicle Cream Once Daily (QD)-17.1-31.0 – -3.1
PF-06700841 0.1% Cream QD-13.1-27.4 – 1.1
PF-06700841 0.3% Cream QD-50.6-64.4 – -36.7
PF-06700841 1.0% Cream QD-55.9-69.7 – -42.0
PF-06700841 3.0% Cream QD-49.2-63.2 – -35.1
Vehicle Cream Twice Daily (BID)-25.2-39.2 – -11.1
PF-06700841 0.3% Cream BID-39.8-53.0 – -26.6
PF-06700841 1.0% Cream BID-44.0-57.1 – -30.9
At Week 4
GroupValue95% CI
Vehicle Cream Once Daily (QD)-25.9-39.8 – -12.0
PF-06700841 0.1% Cream QD-20.1-34.4 – -5.7
PF-06700841 0.3% Cream QD-55.8-69.5 – -42.1
PF-06700841 1.0% Cream QD-57.9-71.7 – -44.0
PF-06700841 3.0% Cream QD-56.7-70.8 – -42.7
Vehicle Cream Twice Daily (BID)-34.7-46.1 – -23.3
PF-06700841 0.3% Cream BID-46.4-56.9 – -35.9
PF-06700841 1.0% Cream BID-57.7-68.2 – -47.2
At Week 6
GroupValue95% CI
Vehicle Cream Once Daily (QD)-21.6-38.0 – -5.3
PF-06700841 0.1% Cream QD-39.4-56.1 – -22.7
PF-06700841 0.3% Cream QD-59.4-75.4 – -43.5
PF-06700841 1.0% Cream QD-63.6-79.5 – -47.6
PF-06700841 3.0% Cream QD-60.3-76.4 – -44.1
Vehicle Cream Twice Daily (BID)-31.2-42.5 – -20.0
PF-06700841 0.3% Cream BID-48.9-59.3 – -38.6
PF-06700841 1.0% Cream BID-65.0-75.3 – -54.7
At Follow-up visit
GroupValue95% CI
Vehicle Cream Once Daily (QD)-23.6-39.5 – -7.6
PF-06700841 0.1% Cream QD-24.5-41.0 – -8.0
PF-06700841 0.3% Cream QD-42.7-58.1 – -27.2
PF-06700841 1.0% Cream QD-37.0-52.6 – -21.4
PF-06700841 3.0% Cream QD-55.2-71.8 – -38.6
Vehicle Cream Twice Daily (BID)-26.3-47.5 – -5.2
PF-06700841 0.3% Cream BID-31.6-52.0 – -11.3
PF-06700841 1.0% Cream BID-24.6-45.2 – -4.1
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 Secondary · Baseline, Weeks 1, 2, 3, 4 and 6

EASI evaluates severity of participant's 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 \[including buttocks\]) on4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each 4 body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (

At Week 1
GroupValue95% CI
Vehicle Cream Once Daily (QD)5.41.4 – 15.5
PF-06700841 0.1% Cream QD0.00.0 – 7.3
PF-06700841 0.3% Cream QD19.410.7 – 32.8
PF-06700841 1.0% Cream QD5.41.4 – 15.5
PF-06700841 3.0% Cream QD16.77.5 – 30.2
Vehicle Cream Twice Daily (BID)0.00.0 – 7.5
PF-06700841 0.3% Cream BID13.96.9 – 25.4
PF-06700841 1.0% Cream BID21.611.2 – 34.3
At Week 2
GroupValue95% CI
Vehicle Cream Once Daily (QD)8.13.0 – 18.5
PF-06700841 0.1% Cream QD10.84.8 – 22.2
PF-06700841 0.3% Cream QD27.815.9 – 40.9
PF-06700841 1.0% Cream QD24.314.5 – 37.0
PF-06700841 3.0% Cream QD38.925.4 – 53.0
Vehicle Cream Twice Daily (BID)13.96.9 – 25.4
PF-06700841 0.3% Cream BID25.014.9 – 38.0
PF-06700841 1.0% Cream BID32.420.6 – 46.4
At Week 3
GroupValue95% CI
Vehicle Cream Once Daily (QD)5.41.4 – 15.5
PF-06700841 0.1% Cream QD16.27.3 – 29.3
PF-06700841 0.3% Cream QD36.122.9 – 50.0
PF-06700841 1.0% Cream QD43.229.3 – 56.8
PF-06700841 3.0% Cream QD41.729.0 – 56.0
Vehicle Cream Twice Daily (BID)19.410.7 – 32.8
PF-06700841 0.3% Cream BID19.410.7 – 32.8
PF-06700841 1.0% Cream BID43.229.3 – 56.8
At Week 4
GroupValue95% CI
Vehicle Cream Once Daily (QD)24.314.5 – 37.0
PF-06700841 0.1% Cream QD21.611.2 – 34.3
PF-06700841 0.3% Cream QD38.925.4 – 53.0
PF-06700841 1.0% Cream QD43.229.3 – 56.8
PF-06700841 3.0% Cream QD50.035.3 – 64.7
Vehicle Cream Twice Daily (BID)22.211.6 – 35.3
PF-06700841 0.3% Cream BID36.122.9 – 50.0
PF-06700841 1.0% Cream BID48.634.3 – 63.0
At Week 6
GroupValue95% CI
Vehicle Cream Once Daily (QD)35.122.2 – 49.3
PF-06700841 0.1% Cream QD32.420.6 – 46.4
PF-06700841 0.3% Cream QD52.838.0 – 67.2
PF-06700841 1.0% Cream QD54.140.2 – 68.2
PF-06700841 3.0% Cream QD50.035.3 – 64.7
Vehicle Cream Twice Daily (BID)16.77.5 – 30.2
PF-06700841 0.3% Cream BID36.122.9 – 50.0
PF-06700841 1.0% Cream BID51.437.0 – 65.7
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Secondary · Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)

An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. Treatment-emergent were events between first dose of investigational product and up to 28 days after the last dose of investigational product

TEAEs
GroupValue95% CI
Vehicle Cream Once Daily (QD)18
PF-06700841 0.1% Cream QD17
PF-06700841 0.3% Cream QD11
PF-06700841 1.0% Cream QD12
PF-06700841 3.0% Cream QD10
Vehicle Cream Twice Daily (BID)17
PF-06700841 0.3% Cream BID9
PF-06700841 1.0% Cream BID14
SAEs
GroupValue95% CI
Vehicle Cream Once Daily (QD)0
PF-06700841 0.1% Cream QD0
PF-06700841 0.3% Cream QD0
PF-06700841 1.0% Cream QD0
PF-06700841 3.0% Cream QD0
Vehicle Cream Twice Daily (BID)0
PF-06700841 0.3% Cream BID0
PF-06700841 1.0% Cream BID0
Number of Participants With Pre-defined Criteria For Vital Signs Secondary · Baseline up to Week 6

Pre-defined criteria included: 1) Diastolic blood pressure (DBP), a) sitting DBP: change of \>= 20 millimeter of mercury (mmHg) increase, b) sitting DBP: change of \>=20mmHg decrease, c) supine DBP: less than (\<) 50 mmHg, d) supine DBP: change of \>= 20mmHg increase, e) supine DBP: change of \>= 20mmHg decrease; 2) Systolic blood pressure (SBP), a) sitting SBP: \<90 mmHg, b) sitting SBP: change of \>=30mmHg increase, c) sitting SBP: change of \>=30mmHg decrease, d) supine SBP: change of \>=30mmHg increase, e) supine SBP: change of \>=30mmHg decrease and f) Supine SBP: value \<90mmHg.

Sitting DBP: Change >= 20 mm Hg increase
GroupValue95% CI
Vehicle Cream Once Daily (QD)0
PF-06700841 0.1% Cream QD0
PF-06700841 0.3% Cream QD1
PF-06700841 1.0% Cream QD2
PF-06700841 3.0% Cream QD0
Vehicle Cream Twice Daily (BID)0
PF-06700841 0.3% Cream BID0
PF-06700841 1.0% Cream BID0
Sitting DBP: Change >= 20mmHg decrease
GroupValue95% CI
Vehicle Cream Once Daily (QD)1
PF-06700841 0.1% Cream QD0
PF-06700841 0.3% Cream QD0
PF-06700841 1.0% Cream QD1
PF-06700841 3.0% Cream QD0
Vehicle Cream Twice Daily (BID)1
PF-06700841 0.3% Cream BID0
PF-06700841 1.0% Cream BID0
Supine DBP: Value <50 mmHg
GroupValue95% CI
Vehicle Cream Once Daily (QD)0
PF-06700841 0.1% Cream QD0
PF-06700841 0.3% Cream QD0
PF-06700841 1.0% Cream QD0
PF-06700841 3.0% Cream QD0
Vehicle Cream Twice Daily (BID)1
PF-06700841 0.3% Cream BID0
PF-06700841 1.0% Cream BID0
Supine DBP: Change >= 20mmHg increase
GroupValue95% CI
Vehicle Cream Once Daily (QD)0
PF-06700841 0.1% Cream QD1
PF-06700841 0.3% Cream QD1
PF-06700841 1.0% Cream QD2
PF-06700841 3.0% Cream QD1
Vehicle Cream Twice Daily (BID)0
PF-06700841 0.3% Cream BID1
PF-06700841 1.0% Cream BID0
Supine DBP: Change >= 20mmHg decrease
GroupValue95% CI
Vehicle Cream Once Daily (QD)0
PF-06700841 0.1% Cream QD0
PF-06700841 0.3% Cream QD0
PF-06700841 1.0% Cream QD0
PF-06700841 3.0% Cream QD0
Vehicle Cream Twice Daily (BID)0
PF-06700841 0.3% Cream BID1
PF-06700841 1.0% Cream BID0
Sitting SBP: <90mmHg
GroupValue95% CI
Vehicle Cream Once Daily (QD)0
PF-06700841 0.1% Cream QD0
PF-06700841 0.3% Cream QD0
PF-06700841 1.0% Cream QD1
PF-06700841 3.0% Cream QD0
Vehicle Cream Twice Daily (BID)0
PF-06700841 0.3% Cream BID0
PF-06700841 1.0% Cream BID0
Sitting SBP: change >= 30mmHg increase
GroupValue95% CI
Vehicle Cream Once Daily (QD)0
PF-06700841 0.1% Cream QD0
PF-06700841 0.3% Cream QD0
PF-06700841 1.0% Cream QD1
PF-06700841 3.0% Cream QD0
Vehicle Cream Twice Daily (BID)0
PF-06700841 0.3% Cream BID0
PF-06700841 1.0% Cream BID1
Sitting SBP: change >= 30mmHg decrease
GroupValue95% CI
Vehicle Cream Once Daily (QD)0
PF-06700841 0.1% Cream QD0
PF-06700841 0.3% Cream QD0
PF-06700841 1.0% Cream QD0
PF-06700841 3.0% Cream QD1
Vehicle Cream Twice Daily (BID)0
PF-06700841 0.3% Cream BID0
PF-06700841 1.0% Cream BID0
Number of Participants With Laboratory Abnormalities Secondary · Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)

Hemoglobin (HGB),hematocrit,erythrocytes (ery.),HDL cholesterol (chl.)\<0.8\*lower limit of normal(LLN);reticulocytes (ret.), ret./ery. (%)\<0.5\*LLN,\>1.5\*upper limit of normal (ULN);ery. mean corpuscular (EMC) volume,EMC HGB,EMC HGB concentration,potassium,chloride,calcium,bicarbonate\<0.9\*LLN,\>1.1\*ULN;platelets\<0.5\*LLN,\>1.75\*ULN;leukocytes (leu.),glucose\<0.6\*LLN,\>1.5\*ULN;lymphocytes (lym.), lym./leu.(%), neutrophils (neu.), neu./leu. (%), protein,albumin \<0.8\*LLN,\>1.2\*ULN;basophils (bas.), bas./leu.(%), eosinophils (eos.), eos./leu., monocytes (mon.), mon./leu.(%), urate \>1

GroupValue95% CI
Vehicle Cream Once Daily (QD)26
PF-06700841 0.1% Cream QD22
PF-06700841 0.3% Cream QD23
PF-06700841 1.0% Cream QD22
PF-06700841 3.0% Cream QD16
Vehicle Cream Twice Daily (BID)21
PF-06700841 0.3% Cream BID24
PF-06700841 1.0% Cream BID24
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings Secondary · Baseline up to Week 6

Clinically significant ECG criteria included PR interval: value greater than (\>) 280 millisecond (msec), percentage change greater than equal to (\>=) 25/50 percentage, QRS interval: value \>120 msec, percentage change \>= 50% and QT interval corrected using the Fridericia's formula (QTCF) value 450 msec and 30\<=change\<60.

PR interval : value >280 msec
GroupValue95% CI
Vehicle Cream Once Daily (QD)0
PF-06700841 0.1% Cream QD0
PF-06700841 0.3% Cream QD0
PF-06700841 1.0% Cream QD0
PF-06700841 3.0% Cream QD1
Vehicle Cream Twice Daily (BID)0
PF-06700841 0.3% Cream BID0
PF-06700841 1.0% Cream BID0
PR interval : %change>=25/50%
GroupValue95% CI
Vehicle Cream Once Daily (QD)0
PF-06700841 0.1% Cream QD1
PF-06700841 0.3% Cream QD1
PF-06700841 1.0% Cream QD0
PF-06700841 3.0% Cream QD1
Vehicle Cream Twice Daily (BID)0
PF-06700841 0.3% Cream BID2
PF-06700841 1.0% Cream BID0
QRS interval: value >120 msec
GroupValue95% CI
Vehicle Cream Once Daily (QD)0
PF-06700841 0.1% Cream QD0
PF-06700841 0.3% Cream QD0
PF-06700841 1.0% Cream QD0
PF-06700841 3.0% Cream QD0
Vehicle Cream Twice Daily (BID)0
PF-06700841 0.3% Cream BID1
PF-06700841 1.0% Cream BID1
QRS interval: %Change>=50%
GroupValue95% CI
Vehicle Cream Once Daily (QD)0
PF-06700841 0.1% Cream QD0
PF-06700841 0.3% Cream QD0
PF-06700841 1.0% Cream QD0
PF-06700841 3.0% Cream QD0
Vehicle Cream Twice Daily (BID)1
PF-06700841 0.3% Cream BID0
PF-06700841 1.0% Cream BID0
QTCF: 450 msec
GroupValue95% CI
Vehicle Cream Once Daily (QD)0
PF-06700841 0.1% Cream QD0
PF-06700841 0.3% Cream QD1
PF-06700841 1.0% Cream QD1
PF-06700841 3.0% Cream QD0
Vehicle Cream Twice Daily (BID)1
PF-06700841 0.3% Cream BID0
PF-06700841 1.0% Cream BID0
QTCF: 30<=Change<60
GroupValue95% CI
Vehicle Cream Once Daily (QD)0
PF-06700841 0.1% Cream QD1
PF-06700841 0.3% Cream QD1
PF-06700841 1.0% Cream QD1
PF-06700841 3.0% Cream QD1
Vehicle Cream Twice Daily (BID)2
PF-06700841 0.3% Cream BID1
PF-06700841 1.0% Cream BID0
Change From Baseline in Clinical Chemistry-Lactate Dehydrogenase Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit Secondary · Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Change at week 1
GroupValue95% CI
Vehicle Cream Once Daily (QD)0.4± 25.99
PF-06700841 0.1% Cream QD-7.4± 30.20
PF-06700841 0.3% Cream QD-5.3± 16.99
PF-06700841 1.0% Cream QD-9.3± 22.65
PF-06700841 3.0% Cream QD-18.4± 33.42
Vehicle Cream Twice Daily (BID)-8.0± 34.51
PF-06700841 0.3% Cream BID-8.0± 19.37
PF-06700841 1.0% Cream BID-4.3± 29.08
Change at week 2
GroupValue95% CI
Vehicle Cream Once Daily (QD)-8.8± 21.56
PF-06700841 0.1% Cream QD-7.8± 27.99
PF-06700841 0.3% Cream QD-1.9± 18.18
PF-06700841 1.0% Cream QD-8.8± 23.70
PF-06700841 3.0% Cream QD-15.8± 42.19
Vehicle Cream Twice Daily (BID)-0.3± 22.81
PF-06700841 0.3% Cream BID-8.0± 22.31
PF-06700841 1.0% Cream BID-4.9± 24.49
Change at week 4
GroupValue95% CI
Vehicle Cream Once Daily (QD)-8.6± 23.93
PF-06700841 0.1% Cream QD-5.4± 22.87
PF-06700841 0.3% Cream QD-9.3± 19.61
PF-06700841 1.0% Cream QD-12.1± 28.54
PF-06700841 3.0% Cream QD-16.3± 33.97
Vehicle Cream Twice Daily (BID)-1.0± 29.29
PF-06700841 0.3% Cream BID-19.5± 19.94
PF-06700841 1.0% Cream BID-3.7± 24.96
Change at week 6
GroupValue95% CI
Vehicle Cream Once Daily (QD)-8.8± 18.25
PF-06700841 0.1% Cream QD-8.1± 32.02
PF-06700841 0.3% Cream QD-1.5± 32.42
PF-06700841 1.0% Cream QD-6.4± 28.53
PF-06700841 3.0% Cream QD-18.2± 33.86
Vehicle Cream Twice Daily (BID)-9.7± 20.68
PF-06700841 0.3% Cream BID-11.2± 22.34
PF-06700841 1.0% Cream BID-7.0± 24.65
Change at follow-up visit
GroupValue95% CI
Vehicle Cream Once Daily (QD)-12.3± 24.82
PF-06700841 0.1% Cream QD-12.0± 28.83
PF-06700841 0.3% Cream QD4.0± 43.45
PF-06700841 1.0% Cream QD-2.7± 26.27
PF-06700841 3.0% Cream QD-15.1± 38.23
Vehicle Cream Twice Daily (BID)-11.3± 29.39
PF-06700841 0.3% Cream BID-13.3± 25.37
PF-06700841 1.0% Cream BID0.2± 16.48

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Vehicle Cream Once Daily (QD)
Serious: 0/37 (0%)
Deaths: 0/37
PF-06700841 0.1% Cream QD
Serious: 0/37 (0%)
Deaths: 0/37
PF-06700841 0.3% Cream QD
Serious: 0/36 (0%)
Deaths: 0/36
PF-06700841 1.0% Cream QD
Serious: 0/37 (0%)
Deaths: 0/37
PF-06700841 3.0% Cream QD
Serious: 0/36 (0%)
Deaths: 0/36
Vehicle Cream Twice Daily (BID)
Serious: 0/36 (0%)
Deaths: 0/36
PF-06700841 0.3% Cream BID
Serious: 0/36 (0%)
Deaths: 0/36
PF-06700841 1.0% Cream BID
Serious: 0/37 (0%)
Deaths: 0/37
Other adverse events (86 terms — click to expand)

ReactionSystemVehicle Cream Once Daily (…PF-06700841 0.1% Cream QDPF-06700841 0.3% Cream QDPF-06700841 1.0% Cream QDPF-06700841 3.0% Cream QDVehicle Cream Twice Daily …PF-06700841 0.3% Cream BIDPF-06700841 1.0% Cream BID
NasopharyngitisInfections and infestations
Application site pruritusGeneral disorders
Dermatitis atopicSkin and subcutaneous tissue disorders
Application site erythemaGeneral disorders
InfluenzaInfections and infestations
Urinary tract infectionInfections and infestations
CoughRespiratory, thoracic and mediastinal disorders
Oropharyngeal painRespiratory, thoracic and mediastinal disorders
PruritusSkin and subcutaneous tissue disorders
Swelling of eyelidEye disorders
Ulcerative keratitisEye disorders
DyspepsiaGastrointestinal disorders
NauseaGastrointestinal disorders
Administration site warmthGeneral disorders
Application site acneGeneral disorders
Application site painGeneral disorders
ChillsGeneral disorders
Injection site painGeneral disorders
Oedema peripheralGeneral disorders
PainGeneral disorders
PyrexiaGeneral disorders
Vessel puncture site haematomaGeneral disorders
Allergy to arthropod stingImmune system disorders
Cockroach allergyImmune system disorders
Mite allergyImmune system disorders
Bacterial allergyInfections and infestations
BronchitisInfections and infestations
ConjunctivitisInfections and infestations
CystitisInfections and infestations
Eczema infectedInfections and infestations
FolliculitisInfections and infestations
FuruncleInfections and infestations
GastroenteritisInfections and infestations
Gastroenteritis viralInfections and infestations
GingivitisInfections and infestations
Herpes simplexInfections and infestations
Kaposi's varicelliform eruptionInfections and infestations
LaryngitisInfections and infestations
Oral herpesInfections and infestations
PharyngitisInfections and infestations

Data from ClinicalTrials.gov NCT03903822 adverse events section.

Sponsor's own description

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.

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. Janus kinase-targeting therapies in rheumatology: a mechanisms-based approach.
    Tanaka Y, Luo Y, O'Shea JJ, Nakayamada S. · · 2022 · cited 329× · PMID 34987201 · DOI 10.1038/s41584-021-00726-8
  3. JAK inhibitors in the treatment of atopic dermatitis.
    Chovatiya R, Paller AS. · · 2021 · cited 258× · PMID 34437922 · DOI 10.1016/j.jaci.2021.08.009
  4. JAK-STAT signaling pathway in the pathogenesis of atopic dermatitis: An updated review.
    Huang IH, Chung WH, Wu PC, Chen CB. · · 2022 · cited 195× · PMID 36569854 · DOI 10.3389/fimmu.2022.1068260
  5. Targeting the Janus Kinase Family in Autoimmune Skin Diseases.
    Howell MD, Kuo FI, Smith PA. · · 2019 · cited 180× · PMID 31649667 · DOI 10.3389/fimmu.2019.02342
  6. Selectivity, efficacy and safety of JAKinibs: new evidence for a still evolving story.
    Bonelli M, Kerschbaumer A, Kastrati K, Ghoreschi K, et al · · 2024 · cited 95× · PMID 37923366 · DOI 10.1136/ard-2023-223850
  7. Mendelian randomization and clinical trial evidence supports TYK2 inhibition as a therapeutic target for autoimmune diseases.
    Yuan S, Wang L, Zhang H, Xu F, et al · · 2023 · cited 61× · PMID 36842216 · DOI 10.1016/j.ebiom.2023.104488
  8. Allosteric TYK2 inhibition: redefining autoimmune disease therapy beyond JAK1-3 inhibitors.
    Jensen LT, Attfield KE, Feldmann M, Fugger L. · · 2023 · cited 45× · PMID 37863021 · DOI 10.1016/j.ebiom.2023.104840

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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/NCT03903822.

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