NCT03627767 is a Phase 3 clinical trial of PF-04965842 100 mg in Dermatitis, sponsored by Pfizer.

Who is sponsoring NCT03627767?

NCT03627767 is sponsored by Pfizer.

What drugs are being tested in NCT03627767?

Interventions in NCT03627767: PF-04965842 100 mg, PF-04965842 200 mg, Placebo.

What condition does NCT03627767 study?

NCT03627767 studies Dermatitis, Dermatitis, Atopic, Eczema, Skin Diseases, Skin Diseases, Genetic, Genetic Diseases, Inborn, Skin Diseases, Eczematous, Hypersensitivity, Hypersensitivity, Immediate, Immune System Diseases.

Is NCT03627767 still recruiting?

NCT03627767 is currently completed. Last updated 20 September 2021.

Are results published for NCT03627767?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-09-20 · How we verify

NCT03627767

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects

Completed Phase 3 Results posted Last updated 20 September 2021

What this trial tests

Phase 3 trial testing PF-04965842 100 mg in Dermatitis in 1,235 participants. Completed in 7 October 2020.

Timeline

11 June 2018

Primary endpoint
2 September 2020

7 October 2020

Quick facts

Lead sponsor	Pfizer
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	1,235
Start date	11 June 2018
Primary completion	2 September 2020
Estimated completion	7 October 2020
Sites	235 locations across Italy, Taiwan, Poland, Netherlands, Russia, Belgium, Mexico, Bulgaria

Drugs / interventions tested

PF-04965842 100 mg — full drug profile →
PF-04965842 200 mg — full drug profile →
Placebo

Conditions studied

Dermatitis — all drugs for Dermatitis →
Dermatitis, Atopic — all drugs for Dermatitis, Atopic →
Eczema — all drugs for Eczema →
Skin Diseases — all drugs for Skin Diseases →

Sponsor

Pfizer — full company profile →

Who can join

12 and older, any sex, with Dermatitis or Dermatitis, Atopic. 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.

Percentage of Participants With Loss of Response: Double-blind (DB) Period Primary · From Day 1 of up to Week 40 of double blind period

Percentage of participants with loss of response requiring rescue treatment during double blind period was determined. Loss of response denoted as flare and was define as a loss of at least 50% of EASI total score at Week 12 and with an IGA score of 2 or higher. EASI quantifies severity of participant's atopic dermatitis (AD) based on both severity of lesion clinical signs and % of body surface area (BSA) affected. EASI is a composite scoring by AD clinical evaluator of degree of erythema, induration/papulation, excoriation, and lichenification for each of 4 body regions. EASI total score rang

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	77.5
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	39.6
PF-04965842 200 mg OL to PF-04965842 200 mg DB	16.5

Time to First Loss of Response Based on Investigator's Global Assessment (IGA) Score of 2 or Higher: Double-blind Period Secondary · From date of first dose of randomized treatment until the last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue) (maximum up to Week 40, visit window +/- 7 Days)

Time (in days) to loss of response based on achieving IGA \>=2 (for the first time) as measured from date of first dose of randomized treatment until the last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue). IGA assesses severity of AD on a 5-point scale (0 to 4, higher scores indicated more severity), reflecting global consideration of erythema, induration and scaling. Where, 0 = clear, AD is cleared; 1 = almost clear, AD not entirely cleared, light pink residual lesions; 2 = mild, AD with light red lesions; 3 = moderate, AD with red l

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	27.0	26.0 – 28.0
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	78.0	32.0 – 112.0
PF-04965842 200 mg OL to PF-04965842 200 mg DB	201.0	177.0 – 282.0

Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Weeks 12, 16, 28, 40, and 52: Double-blind Period Secondary · Baseline, Weeks 12, 16, 28, 40 and 52

IGA assessed severity of AD on a 5-point scale (0 to 4, higher scores indicated more severity), reflecting global consideration of erythema, induration and scaling. Where, 0 = clear, AD is cleared; 1 = almost clear, AD not entirely cleared, light pink residual lesions; 2 = mild, AD with light red lesions; 3 = moderate, AD with red lesions; 4 = severe, AD with deep dark red lesions.

Week 12

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	99.6	98.9 – 100.0
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	99.6	98.9 – 100.0
PF-04965842 200 mg OL to PF-04965842 200 mg DB	99.2	98.2 – 100.0

Week 16

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	15.4	11.0 – 19.7
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	55.5	49.5 – 61.5
PF-04965842 200 mg OL to PF-04965842 200 mg DB	77.8	72.8 – 82.8

Week 28

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	10.5	6.8 – 14.2
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	45.0	39.0 – 51.0
PF-04965842 200 mg OL to PF-04965842 200 mg DB	61.8	55.9 – 67.7

Week 40

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	10.6	6.9 – 14.3
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	42.3	36.3 – 48.3
PF-04965842 200 mg OL to PF-04965842 200 mg DB	57.1	51.1 – 63.2

Week 52

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	11.7	7.9 – 15.6
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	36.8	30.9 – 42.7
PF-04965842 200 mg OL to PF-04965842 200 mg DB	54.1	48.0 – 60.2

Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=50% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period Secondary · Baseline, Weeks 12, 16, 28, 40 and 52

EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema \[E\], induration/papulation \[I\], excoriation \[Ex\] and lichenification \[L\]) was scored separately for each of 4 body regions (head and neck \[h\], upper limbs \[u\], trunk \[t\] \[including axillae and groin\] and lower limbs \[l\] \[including buttocks\]) 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 (1

Week 12

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	100.0	98.6 – 100.0
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	100.0	98.6 – 100.0
PF-04965842 200 mg OL to PF-04965842 200 mg DB	100.0	98.6 – 100.0

Week 16

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	40.8	34.9 – 46.7
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	83.3	78.8 – 87.8
PF-04965842 200 mg OL to PF-04965842 200 mg DB	96.2	94.0 – 98.5

Week 28

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	22.8	17.8 – 27.9
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	68.1	62.4 – 73.7
PF-04965842 200 mg OL to PF-04965842 200 mg DB	85.9	81.7 – 90.1

Week 40

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	16.6	12.1 – 21.1
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	57.3	51.3 – 63.3
PF-04965842 200 mg OL to PF-04965842 200 mg DB	74.9	69.6 – 80.2

Week 52

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	15.9	11.5 – 20.3
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	50.8	44.7 – 56.9
PF-04965842 200 mg OL to PF-04965842 200 mg DB	71.2	65.7 – 76.7

Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period Secondary · Baseline, Weeks 12, 16, 28, 40 and 52

EASI quantifies severity of participant's 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

Week 12

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	99.2	98.2 – 100.0
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	100.0	98.6 – 100.0
PF-04965842 200 mg OL to PF-04965842 200 mg DB	99.6	98.9 – 100.0

Week 16

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	27.0	21.6 – 32.3
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	76.0	70.9 – 81.2
PF-04965842 200 mg OL to PF-04965842 200 mg DB	92.5	89.3 – 95.7

Week 28

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	18.0	13.4 – 22.6
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	60.4	54.4 – 66.3
PF-04965842 200 mg OL to PF-04965842 200 mg DB	80.5	75.7 – 85.3

Week 40

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	15.1	10.8 – 19.4
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	54.2	48.2 – 60.3
PF-04965842 200 mg OL to PF-04965842 200 mg DB	71.8	66.3 – 77.3

Week 52

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	14.0	9.8 – 18.2
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	46.5	40.4 – 52.6
PF-04965842 200 mg OL to PF-04965842 200 mg DB	65.8	60.0 – 71.6

Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=90% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period Secondary · Baseline, Weeks 12, 16, 28, 40 and 52

EASI quantifies severity of participant's 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

Week 12

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	84.6	80.2 – 88.9
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	87.1	83.1 – 91.2
PF-04965842 200 mg OL to PF-04965842 200 mg DB	86.4	82.3 – 90.5

Week 16

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	13.9	9.7 – 18.0
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	51.3	45.3 – 57.4
PF-04965842 200 mg OL to PF-04965842 200 mg DB	77.1	72.0 – 82.1

Week 28

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	10.5	6.8 – 14.2
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	46.9	40.9 – 53.0
PF-04965842 200 mg OL to PF-04965842 200 mg DB	64.5	58.7 – 70.3

Week 40

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	12.1	8.2 – 16.0
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	41.5	35.5 – 47.5
PF-04965842 200 mg OL to PF-04965842 200 mg DB	58.7	52.7 – 64.7

Week 52

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	10.6	6.9 – 14.3
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	37.6	31.7 – 43.5
PF-04965842 200 mg OL to PF-04965842 200 mg DB	54.5	48.4 – 60.6

Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=100% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period Secondary · Baseline, Weeks 12, 16, 28, 40 and 52

EASI quantifies severity of participant's 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 12

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	30.5	24.9 – 36.0
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	30.3	24.8 – 35.8
PF-04965842 200 mg OL to PF-04965842 200 mg DB	28.3	22.9 – 33.7

Week 16

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	3.7	1.5 – 6.0
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	15.2	10.9 – 19.5
PF-04965842 200 mg OL to PF-04965842 200 mg DB	28.9	23.5 – 34.4

Week 28

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	4.1	1.7 – 6.5
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	16.5	12.0 – 21.1
PF-04965842 200 mg OL to PF-04965842 200 mg DB	30.2	24.6 – 35.7

Week 40

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	4.5	2.0 – 7.0
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	15.8	11.3 – 20.2
PF-04965842 200 mg OL to PF-04965842 200 mg DB	30.1	24.5 – 35.7

Week 52

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	4.5	2.0 – 7.1
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	18.6	13.9 – 23.4
PF-04965842 200 mg OL to PF-04965842 200 mg DB	28.8	23.3 – 34.3

Percentage of Participants With Greater Than or Equal 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period Secondary · Baseline, Weeks 12, 16, 28, 40 and 52

Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itch) to 10 (worst itch imaginable), where higher scores indicated worse disease status.

Week 12

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	82.2	77.2 – 87.1
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	84.0	79.3 – 88.6
PF-04965842 200 mg OL to PF-04965842 200 mg DB	81.9	76.9 – 86.9

Week 16

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	15.9	11.4 – 20.4
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	54.6	48.4 – 60.7
PF-04965842 200 mg OL to PF-04965842 200 mg DB	75.6	70.3 – 80.9

Week 28

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	11.6	7.7 – 15.5
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	45.0	38.9 – 51.2
PF-04965842 200 mg OL to PF-04965842 200 mg DB	66.9	61.0 – 72.8

Week 40

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	10.1	6.4 – 13.8
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	39.4	33.4 – 45.4
PF-04965842 200 mg OL to PF-04965842 200 mg DB	55.7	49.5 – 61.9

Week 52

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	8.3	4.9 – 11.7
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	27.6	21.7 – 33.6
PF-04965842 200 mg OL to PF-04965842 200 mg DB	49.0	42.2 – 55.9

Percent Change From Baseline in Body Surface Area (BSA) at Weeks 12, 16, 28, 40 and 52: Double-blind Period Secondary · Baseline, Weeks 12, 16, 28, 40 and 52

4 body regions evaluated: head and neck, upper limbs, trunk (including axillae, groin/genitals), lower limbs (including buttocks) excluding scalp, palms, soles. BSA calculated by handprint method. Number (No) of handprints (size of participant's hand with fingers in closed position) fitting in affected area of a body region was estimated. Maximum No of handprints were 10, 20, 30, 40 for head and neck, upper limbs, trunk, and lower limbs respectively. Surface area (SA) of body region equivalent to 1 handprint: 1 handprint=10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for l

Change at Week 12

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	-95.6	-100.0 – -88.5
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	-96.7	-100.0 – -91.5
PF-04965842 200 mg OL to PF-04965842 200 mg DB	-96.7	-100.0 – -89.2

Change at Week 16

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	-68.5	-89.8 – -37.5
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	-90.9	-97.6 – -78.3
PF-04965842 200 mg OL to PF-04965842 200 mg DB	-96.3	-100.0 – -88.7

Change at Week 28

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	-85.2	-95.8 – -63.5
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	-93.8	-99.5 – -81.4
PF-04965842 200 mg OL to PF-04965842 200 mg DB	-96.4	-100.0 – -85.7

Change at Week 40

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	-91.2	-100.0 – -77.9
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	-95.8	-100.0 – -83.5
PF-04965842 200 mg OL to PF-04965842 200 mg DB	-96.8	-100.0 – -88.8

Change at Week 52

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	-91.5	-100.0 – -77.9
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	-96.9	-100.0 – -83.4
PF-04965842 200 mg OL to PF-04965842 200 mg DB	-96.9	-100.0 – -88.2

Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period Secondary · Baseline, Weeks 12, 16, 28, 40 and 52

SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3); severity scores added to give B (0-18). C: pruritus and sleep loss, each of these 2 were scored by participa

Change at Week 12

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	-84.0	-94.7 – -73.5
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	-84.4	-95.2 – -74.9
PF-04965842 200 mg OL to PF-04965842 200 mg DB	-84.4	-93.8 – -74.2

Change at Week 16

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	-50.4	-68.3 – -32.1
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	-71.7	-87.8 – -60.5
PF-04965842 200 mg OL to PF-04965842 200 mg DB	-83.6	-95.1 – -70.6

Change at Week 28

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	-63.4	-81.9 – -48.3
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	-77.8	-90.2 – -62.6
PF-04965842 200 mg OL to PF-04965842 200 mg DB	-83.8	-97.4 – -66.4

Change at Week 40

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	-74.4	-89.5 – -60.6
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	-77.1	-94.1 – -64.3
PF-04965842 200 mg OL to PF-04965842 200 mg DB	-84.6	-98.6 – -68.4

Change at Week 52

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	-73.3	-89.8 – -58.0
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	-82.5	-97.7 – -64.1
PF-04965842 200 mg OL to PF-04965842 200 mg DB	-83.2	-100.0 – -69.1

Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period Secondary · Baseline, Weeks 12, 16, 28, 40 and 52

SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region-head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver

Pruritus VAS: Change at Week 12

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	-6.1	-6.3 – -5.9
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	-6.1	-6.3 – -5.9
PF-04965842 200 mg OL to PF-04965842 200 mg DB	-6.1	-6.3 – -5.9

Pruritus VAS: Change at Week 16

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	3.4	3.0 – 3.7
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	1.2	1.0 – 1.5
PF-04965842 200 mg OL to PF-04965842 200 mg DB	0.2	-0.1 – 0.4

Pruritus VAS: Change at Week 28

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	2.4	1.9 – 2.9
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	1.1	0.8 – 1.4
PF-04965842 200 mg OL to PF-04965842 200 mg DB	0.5	0.3 – 0.8

Pruritus VAS: Change at Week 40

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	2.2	1.6 – 2.8
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	1.2	0.9 – 1.6
PF-04965842 200 mg OL to PF-04965842 200 mg DB	0.4	0.1 – 0.7

Pruritus VAS: Change at Week 52

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	1.8	1.2 – 2.4
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	1.3	0.9 – 1.6
PF-04965842 200 mg OL to PF-04965842 200 mg DB	0.5	0.2 – 0.8

Sleep Loss VAS: Change at Week 12

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	-5.0	-5.2 – -4.8
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	-5.0	-5.2 – -4.8
PF-04965842 200 mg OL to PF-04965842 200 mg DB	-5.1	-5.3 – -4.9

Sleep Loss VAS: Change at Week 16

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	2.3	2.0 – 2.6
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	0.5	0.3 – 0.8
PF-04965842 200 mg OL to PF-04965842 200 mg DB	0.0	-0.2 – 0.2

Sleep Loss VAS: Change at Week 28

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	1.3	0.9 – 1.7
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	0.6	0.4 – 0.9
PF-04965842 200 mg OL to PF-04965842 200 mg DB	0.2	0.0 – 0.4

Percentage of Participants With >=50% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period Secondary · Baseline, Weeks 12, 16, 28, 40 and 52

SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregive

Week 12

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	97.4	95.4 – 99.3
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	98.5	97.0 – 100.0
PF-04965842 200 mg OL to PF-04965842 200 mg DB	97.0	94.9 – 99.0

Week 16

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	25.6	20.3 – 30.8
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	72.0	66.6 – 77.4
PF-04965842 200 mg OL to PF-04965842 200 mg DB	89.1	85.4 – 92.8

Week 28

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	15.8	11.4 – 20.2
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	56.8	50.7 – 62.8
PF-04965842 200 mg OL to PF-04965842 200 mg DB	75.7	70.5 – 80.9

Week 40

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	14.4	10.2 – 18.6
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	51.2	45.1 – 57.2
PF-04965842 200 mg OL to PF-04965842 200 mg DB	69.0	63.3 – 74.6

Week 52

Group	Value	95% CI
PF-04965842 200 mg OL to Placebo DB	14.8	10.5 – 19.1
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	44.6	38.5 – 50.6
PF-04965842 200 mg OL to PF-04965842 200 mg DB	65.8	60.0 – 71.6

Adverse events — posted to ClinicalTrials.gov

Time frame: From screening up to 28 days after last dose of study treatment (maximum up to Week 56). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

PF-04965842 200 mg OL

Serious: 20/1233 (2%)

Deaths: 1/1233

PF-04965842 200 mg OL to Placebo DB

Serious: 3/267 (1%)

Deaths: 0/267

PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB

Serious: 9/265 (3%)

Deaths: 0/265

PF-04965842 200 mg OL to PF-04965842 200 mg DB

Serious: 14/266 (5%)

Deaths: 0/266

PF-04965842 200 mg Rescue Period

Serious: 4/351 (1%)

Deaths: 0/351

Serious adverse events (40 terms)

Reaction	System	PF-04965842 200 mg OL	PF-04965842 200 mg OL to P…	PF-04965842 200 mg OL to P…	PF-04965842 200 mg OL to P…	PF-04965842 200 mg Rescue …
Dermatitis atopic	Skin and subcutaneous tissue disorders	—	—	—	—	—
Cellulitis	Infections and infestations	—	—	—	—	—
Vitello-intestinal duct remnant	Congenital, familial and genetic disorders	—	—	—	—	—
Microcytic anaemia	Blood and lymphatic system disorders	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—
Seizure	Nervous system disorders	—	—	—	—	—
Cataract	Eye disorders	—	—	—	—	—
Retinal detachment	Eye disorders	—	—	—	—	—
Retinal vein thrombosis	Eye disorders	—	—	—	—	—
Ulcerative keratitis	Eye disorders	—	—	—	—	—
Gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—	—	—
Inguinal hernia	Gastrointestinal disorders	—	—	—	—	—
Ureterolithiasis	Renal and urinary disorders	—	—	—	—	—
Haemarthrosis	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Myositis	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Osteonecrosis	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—
Abscess neck	Infections and infestations	—	—	—	—	—
Appendicitis	Infections and infestations	—	—	—	—	—
Diverticulitis	Infections and infestations	—	—	—	—	—
Eczema herpeticum	Infections and infestations	—	—	—	—	—
Gastrointestinal viral infection	Infections and infestations	—	—	—	—	—
Hepatitis E	Infections and infestations	—	—	—	—	—
Periodontitis	Infections and infestations	—	—	—	—	—
Peritonsillar abscess	Infections and infestations	—	—	—	—	—

Other adverse events (8 terms — click to expand)

Reaction	System	PF-04965842 200 mg OL	PF-04965842 200 mg OL to P…	PF-04965842 200 mg OL to P…	PF-04965842 200 mg OL to P…	PF-04965842 200 mg Rescue …
Nausea	Gastrointestinal disorders	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—
Dermatitis atopic	Skin and subcutaneous tissue disorders	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—
Acne	Skin and subcutaneous tissue disorders	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—
Blood creatine phosphokinase increased	Investigations	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—

Most-reported serious reactions: Dermatitis atopic, Cellulitis, Vitello-intestinal duct remnant, Microcytic anaemia, Thrombocytopenia, Seizure, Cataract, Retinal detachment.

Data from ClinicalTrials.gov NCT03627767 adverse events section.

Sponsor's own description

B7451014 is a Phase 3 study to investigate PF-04965842 in patients aged 12 years and over with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. Subjects responding well to an initial open-label 12 week treatment of PF-04965842 (200 mg) taken orally once daily (QD) will be identified and randomized in a double-blind manner to receive 200 mg QD PF-04965842, 100 mg QD PF-04965842, or QD placebo. Efficacy and safety of 2 doses of PF-04965842 will be evaluated relative to placebo over 40 weeks. Subjects experiencing significant worsening of their symptoms, i.e., protocol-defined flare, enter 12 weeks rescue treatment and receive 200 mg PF-04965842 together with a marketed topical medicine. Eligible patients will have the option to enter a long-term extension study after completing the initial 12 week treatment, the 12 week rescue treatment, and the 40 week blinded treatment.

Publications & conference data

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

Atopic dermatitis: an expanding therapeutic pipeline for a complex disease.
Bieber T. · · 2022 · cited 421× · PMID 34417579 · DOI 10.1038/s41573-021-00266-6
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
A Comprehensive Overview of Globally Approved JAK Inhibitors.
Shawky AM, Almalki FA, Abdalla AN, Abdelazeem AH, et al · · 2022 · cited 222× · PMID 35631587 · DOI 10.3390/pharmaceutics14051001
Emerging Topical and Systemic JAK Inhibitors in Dermatology.
Solimani F, Meier K, Ghoreschi K. · · 2019 · cited 199× · PMID 31849996 · DOI 10.3389/fimmu.2019.02847
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
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
Selective JAKinibs: Prospects in Inflammatory and Autoimmune Diseases.
T Virtanen A, Haikarainen T, Raivola J, Silvennoinen O. · · 2019 · cited 164× · PMID 30701418 · DOI 10.1007/s40259-019-00333-w
The translational revolution in atopic dermatitis: the paradigm shift from pathogenesis to treatment.
Facheris P, Jeffery J, Del Duca E, Guttman-Yassky E. · · 2023 · cited 150× · PMID 36928371 · DOI 10.1038/s41423-023-00992-4

Verify or expand the search:

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Trials testing the same drug.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03627767 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 20 September 2021

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/NCT03627767.

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

NCT03627767

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (40 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of PF-04965842 100 mg

Other recruiting trials for Dermatitis

Other Pfizer trials

Verify against primary sources