Dose Ranging Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of PF-06700841 Topical Cream in Participants With Mild or Moderate Atopic Dermatitis
CompletedPhase 2Results postedLast 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.
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 ImputationPrimary· 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 (
Group
Value
95% 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 ImputationSecondary· 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
Group
Value
95% CI
Vehicle Cream Once Daily (QD)
10.8
4.8 – 22.2
PF-06700841 0.1% Cream QD
29.7
18.5 – 43.3
PF-06700841 0.3% Cream QD
33.3
21.3 – 47.0
PF-06700841 1.0% Cream QD
40.5
28.0 – 54.4
PF-06700841 3.0% Cream QD
44.4
30.2 – 59.1
Vehicle Cream Twice Daily (BID)
13.9
6.9 – 25.4
PF-06700841 0.3% Cream BID
33.3
21.3 – 47.0
PF-06700841 1.0% Cream BID
27.0
15.5 – 40.2
Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6: Multiple ImputationSecondary· 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 (
Group
Value
95% 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 ImputationSecondary· 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
Group
Value
95% CI
Vehicle Cream Once Daily (QD)
16.2
7.3 – 29.3
PF-06700841 0.1% Cream QD
16.7
7.5 – 30.2
PF-06700841 0.3% Cream QD
20.0
11.0 – 33.8
PF-06700841 1.0% Cream QD
29.7
18.5 – 43.3
PF-06700841 3.0% Cream QD
44.4
30.2 – 59.1
Vehicle Cream Twice Daily (BID)
13.9
6.9 – 25.4
PF-06700841 0.3% Cream BID
28.6
16.4 – 41.9
PF-06700841 1.0% Cream BID
25.7
15.4 – 39.2
At Week 2
Group
Value
95% CI
Vehicle Cream Once Daily (QD)
24.3
14.5 – 37.0
PF-06700841 0.1% Cream QD
30.6
18.9 – 44.0
PF-06700841 0.3% Cream QD
42.9
30.0 – 58.1
PF-06700841 1.0% Cream QD
48.6
34.3 – 63.0
PF-06700841 3.0% Cream QD
61.1
47.0 – 74.6
Vehicle Cream Twice Daily (BID)
25.0
14.9 – 38.0
PF-06700841 0.3% Cream BID
45.7
31.7 – 60.8
PF-06700841 1.0% Cream BID
37.1
23.6 – 52.2
At Week 3
Group
Value
95% CI
Vehicle Cream Once Daily (QD)
21.6
11.2 – 34.3
PF-06700841 0.1% Cream QD
38.9
25.4 – 53.0
PF-06700841 0.3% Cream QD
48.6
33.8 – 63.5
PF-06700841 1.0% Cream QD
59.5
45.6 – 72.0
PF-06700841 3.0% Cream QD
58.3
44.0 – 71.0
Vehicle Cream Twice Daily (BID)
33.3
21.3 – 47.0
PF-06700841 0.3% Cream BID
51.4
36.5 – 66.2
PF-06700841 1.0% Cream BID
57.1
41.9 – 70.0
At Week 4
Group
Value
95% CI
Vehicle Cream Once Daily (QD)
35.1
22.2 – 49.3
PF-06700841 0.1% Cream QD
38.9
25.4 – 53.0
PF-06700841 0.3% Cream QD
51.4
36.5 – 66.2
PF-06700841 1.0% Cream QD
62.2
48.0 – 75.2
PF-06700841 3.0% Cream QD
58.3
44.0 – 71.0
Vehicle Cream Twice Daily (BID)
30.6
18.9 – 44.0
PF-06700841 0.3% Cream BID
60.0
44.8 – 74.0
PF-06700841 1.0% Cream BID
60.0
44.8 – 74.0
At Week 6
Group
Value
95% CI
Vehicle Cream Once Daily (QD)
40.5
28.0 – 54.4
PF-06700841 0.1% Cream QD
41.7
29.0 – 56.0
PF-06700841 0.3% Cream QD
51.4
36.5 – 66.2
PF-06700841 1.0% Cream QD
56.8
43.2 – 70.7
PF-06700841 3.0% Cream QD
61.1
47.0 – 74.6
Vehicle Cream Twice Daily (BID)
30.6
18.9 – 44.0
PF-06700841 0.3% Cream BID
60.0
44.8 – 74.0
PF-06700841 1.0% Cream BID
60.0
44.8 – 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 ImputationSecondary· 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
Group
Value
95% CI
Vehicle Cream Once Daily (QD)
0.0
0.0 – 8.2
PF-06700841 0.1% Cream QD
3.3
0.4 – 14.0
PF-06700841 0.3% Cream QD
3.1
0.3 – 13.1
PF-06700841 1.0% Cream QD
16.1
8.1 – 29.7
PF-06700841 3.0% Cream QD
10.7
4.0 – 23.8
Vehicle Cream Twice Daily (BID)
3.3
0.4 – 14.0
PF-06700841 0.3% Cream BID
3.3
0.4 – 14.0
PF-06700841 1.0% Cream BID
11.1
4.2 – 24.8
At Week 2
Group
Value
95% CI
Vehicle Cream Once Daily (QD)
9.1
3.4 – 20.2
PF-06700841 0.1% Cream QD
10.0
3.7 – 22.1
PF-06700841 0.3% Cream QD
9.4
3.5 – 20.7
PF-06700841 1.0% Cream QD
19.4
8.8 – 32.7
PF-06700841 3.0% Cream QD
25.0
13.9 – 40.0
Vehicle Cream Twice Daily (BID)
10.0
3.7 – 22.1
PF-06700841 0.3% Cream BID
13.3
5.9 – 27.9
PF-06700841 1.0% Cream BID
33.3
20.4 – 50.0
At Week 3
Group
Value
95% CI
Vehicle Cream Once Daily (QD)
12.1
5.4 – 25.1
PF-06700841 0.1% Cream QD
23.3
12.9 – 37.6
PF-06700841 0.3% Cream QD
15.6
7.8 – 28.7
PF-06700841 1.0% Cream QD
32.3
18.7 – 48.2
PF-06700841 3.0% Cream QD
32.1
19.7 – 47.3
Vehicle Cream Twice Daily (BID)
10.0
3.7 – 22.1
PF-06700841 0.3% Cream BID
20.0
9.1 – 33.9
PF-06700841 1.0% Cream BID
37.0
22.1 – 54.7
At Week 4
Group
Value
95% CI
Vehicle Cream Once Daily (QD)
18.2
8.2 – 31.3
PF-06700841 0.1% Cream QD
26.7
14.0 – 41.6
PF-06700841 0.3% Cream QD
28.1
17.0 – 43.3
PF-06700841 1.0% Cream QD
35.5
21.3 – 51.8
PF-06700841 3.0% Cream QD
50.0
33.3 – 66.7
Vehicle Cream Twice Daily (BID)
10.0
3.7 – 22.1
PF-06700841 0.3% Cream BID
30.0
18.2 – 45.5
PF-06700841 1.0% Cream BID
37.0
22.1 – 54.7
At Week 6
Group
Value
95% CI
Vehicle Cream Once Daily (QD)
18.2
8.2 – 31.3
PF-06700841 0.1% Cream QD
30.0
18.2 – 45.5
PF-06700841 0.3% Cream QD
34.4
20.7 – 50.0
PF-06700841 1.0% Cream QD
45.2
29.7 – 60.1
PF-06700841 3.0% Cream QD
50.0
33.3 – 66.7
Vehicle Cream Twice Daily (BID)
16.7
8.3 – 30.8
PF-06700841 0.3% Cream BID
33.3
19.3 – 49.2
PF-06700841 1.0% Cream BID
40.7
24.8 – 58.3
At Follow-up visit
Group
Value
95% CI
Vehicle Cream Once Daily (QD)
9.1
3.4 – 20.2
PF-06700841 0.1% Cream QD
30.0
18.2 – 45.5
PF-06700841 0.3% Cream QD
21.9
12.1 – 36.2
PF-06700841 1.0% Cream QD
19.4
8.8 – 32.7
PF-06700841 3.0% Cream QD
21.4
9.8 – 36.6
Vehicle Cream Twice Daily (BID)
20.0
9.1 – 33.9
PF-06700841 0.3% Cream BID
20.0
9.1 – 33.9
PF-06700841 1.0% Cream BID
7.4
2.0 – 20.4
Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 3, 4, 6 and Follow-up VisitSecondary· 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
Group
Value
95% 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
Group
Value
95% 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
Group
Value
95% 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
Group
Value
95% 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
Group
Value
95% 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
Group
Value
95% 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 ImputationSecondary· 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
Group
Value
95% CI
Vehicle Cream Once Daily (QD)
5.4
1.4 – 15.5
PF-06700841 0.1% Cream QD
0.0
0.0 – 7.3
PF-06700841 0.3% Cream QD
19.4
10.7 – 32.8
PF-06700841 1.0% Cream QD
5.4
1.4 – 15.5
PF-06700841 3.0% Cream QD
16.7
7.5 – 30.2
Vehicle Cream Twice Daily (BID)
0.0
0.0 – 7.5
PF-06700841 0.3% Cream BID
13.9
6.9 – 25.4
PF-06700841 1.0% Cream BID
21.6
11.2 – 34.3
At Week 2
Group
Value
95% CI
Vehicle Cream Once Daily (QD)
8.1
3.0 – 18.5
PF-06700841 0.1% Cream QD
10.8
4.8 – 22.2
PF-06700841 0.3% Cream QD
27.8
15.9 – 40.9
PF-06700841 1.0% Cream QD
24.3
14.5 – 37.0
PF-06700841 3.0% Cream QD
38.9
25.4 – 53.0
Vehicle Cream Twice Daily (BID)
13.9
6.9 – 25.4
PF-06700841 0.3% Cream BID
25.0
14.9 – 38.0
PF-06700841 1.0% Cream BID
32.4
20.6 – 46.4
At Week 3
Group
Value
95% CI
Vehicle Cream Once Daily (QD)
5.4
1.4 – 15.5
PF-06700841 0.1% Cream QD
16.2
7.3 – 29.3
PF-06700841 0.3% Cream QD
36.1
22.9 – 50.0
PF-06700841 1.0% Cream QD
43.2
29.3 – 56.8
PF-06700841 3.0% Cream QD
41.7
29.0 – 56.0
Vehicle Cream Twice Daily (BID)
19.4
10.7 – 32.8
PF-06700841 0.3% Cream BID
19.4
10.7 – 32.8
PF-06700841 1.0% Cream BID
43.2
29.3 – 56.8
At Week 4
Group
Value
95% CI
Vehicle Cream Once Daily (QD)
24.3
14.5 – 37.0
PF-06700841 0.1% Cream QD
21.6
11.2 – 34.3
PF-06700841 0.3% Cream QD
38.9
25.4 – 53.0
PF-06700841 1.0% Cream QD
43.2
29.3 – 56.8
PF-06700841 3.0% Cream QD
50.0
35.3 – 64.7
Vehicle Cream Twice Daily (BID)
22.2
11.6 – 35.3
PF-06700841 0.3% Cream BID
36.1
22.9 – 50.0
PF-06700841 1.0% Cream BID
48.6
34.3 – 63.0
At Week 6
Group
Value
95% CI
Vehicle Cream Once Daily (QD)
35.1
22.2 – 49.3
PF-06700841 0.1% Cream QD
32.4
20.6 – 46.4
PF-06700841 0.3% Cream QD
52.8
38.0 – 67.2
PF-06700841 1.0% Cream QD
54.1
40.2 – 68.2
PF-06700841 3.0% Cream QD
50.0
35.3 – 64.7
Vehicle Cream Twice Daily (BID)
16.7
7.5 – 30.2
PF-06700841 0.3% Cream BID
36.1
22.9 – 50.0
PF-06700841 1.0% Cream BID
51.4
37.0 – 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
Group
Value
95% CI
Vehicle Cream Once Daily (QD)
18
PF-06700841 0.1% Cream QD
17
PF-06700841 0.3% Cream QD
11
PF-06700841 1.0% Cream QD
12
PF-06700841 3.0% Cream QD
10
Vehicle Cream Twice Daily (BID)
17
PF-06700841 0.3% Cream BID
9
PF-06700841 1.0% Cream BID
14
SAEs
Group
Value
95% CI
Vehicle Cream Once Daily (QD)
0
PF-06700841 0.1% Cream QD
0
PF-06700841 0.3% Cream QD
0
PF-06700841 1.0% Cream QD
0
PF-06700841 3.0% Cream QD
0
Vehicle Cream Twice Daily (BID)
0
PF-06700841 0.3% Cream BID
0
PF-06700841 1.0% Cream BID
0
Number of Participants With Pre-defined Criteria For Vital SignsSecondary· 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
Group
Value
95% CI
Vehicle Cream Once Daily (QD)
0
PF-06700841 0.1% Cream QD
0
PF-06700841 0.3% Cream QD
1
PF-06700841 1.0% Cream QD
2
PF-06700841 3.0% Cream QD
0
Vehicle Cream Twice Daily (BID)
0
PF-06700841 0.3% Cream BID
0
PF-06700841 1.0% Cream BID
0
Sitting DBP: Change >= 20mmHg decrease
Group
Value
95% CI
Vehicle Cream Once Daily (QD)
1
PF-06700841 0.1% Cream QD
0
PF-06700841 0.3% Cream QD
0
PF-06700841 1.0% Cream QD
1
PF-06700841 3.0% Cream QD
0
Vehicle Cream Twice Daily (BID)
1
PF-06700841 0.3% Cream BID
0
PF-06700841 1.0% Cream BID
0
Supine DBP: Value <50 mmHg
Group
Value
95% CI
Vehicle Cream Once Daily (QD)
0
PF-06700841 0.1% Cream QD
0
PF-06700841 0.3% Cream QD
0
PF-06700841 1.0% Cream QD
0
PF-06700841 3.0% Cream QD
0
Vehicle Cream Twice Daily (BID)
1
PF-06700841 0.3% Cream BID
0
PF-06700841 1.0% Cream BID
0
Supine DBP: Change >= 20mmHg increase
Group
Value
95% CI
Vehicle Cream Once Daily (QD)
0
PF-06700841 0.1% Cream QD
1
PF-06700841 0.3% Cream QD
1
PF-06700841 1.0% Cream QD
2
PF-06700841 3.0% Cream QD
1
Vehicle Cream Twice Daily (BID)
0
PF-06700841 0.3% Cream BID
1
PF-06700841 1.0% Cream BID
0
Supine DBP: Change >= 20mmHg decrease
Group
Value
95% CI
Vehicle Cream Once Daily (QD)
0
PF-06700841 0.1% Cream QD
0
PF-06700841 0.3% Cream QD
0
PF-06700841 1.0% Cream QD
0
PF-06700841 3.0% Cream QD
0
Vehicle Cream Twice Daily (BID)
0
PF-06700841 0.3% Cream BID
1
PF-06700841 1.0% Cream BID
0
Sitting SBP: <90mmHg
Group
Value
95% CI
Vehicle Cream Once Daily (QD)
0
PF-06700841 0.1% Cream QD
0
PF-06700841 0.3% Cream QD
0
PF-06700841 1.0% Cream QD
1
PF-06700841 3.0% Cream QD
0
Vehicle Cream Twice Daily (BID)
0
PF-06700841 0.3% Cream BID
0
PF-06700841 1.0% Cream BID
0
Sitting SBP: change >= 30mmHg increase
Group
Value
95% CI
Vehicle Cream Once Daily (QD)
0
PF-06700841 0.1% Cream QD
0
PF-06700841 0.3% Cream QD
0
PF-06700841 1.0% Cream QD
1
PF-06700841 3.0% Cream QD
0
Vehicle Cream Twice Daily (BID)
0
PF-06700841 0.3% Cream BID
0
PF-06700841 1.0% Cream BID
1
Sitting SBP: change >= 30mmHg decrease
Group
Value
95% CI
Vehicle Cream Once Daily (QD)
0
PF-06700841 0.1% Cream QD
0
PF-06700841 0.3% Cream QD
0
PF-06700841 1.0% Cream QD
0
PF-06700841 3.0% Cream QD
1
Vehicle Cream Twice Daily (BID)
0
PF-06700841 0.3% Cream BID
0
PF-06700841 1.0% Cream BID
0
Number of Participants With Laboratory AbnormalitiesSecondary· Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) FindingsSecondary· 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
Group
Value
95% CI
Vehicle Cream Once Daily (QD)
0
PF-06700841 0.1% Cream QD
0
PF-06700841 0.3% Cream QD
0
PF-06700841 1.0% Cream QD
0
PF-06700841 3.0% Cream QD
1
Vehicle Cream Twice Daily (BID)
0
PF-06700841 0.3% Cream BID
0
PF-06700841 1.0% Cream BID
0
PR interval : %change>=25/50%
Group
Value
95% CI
Vehicle Cream Once Daily (QD)
0
PF-06700841 0.1% Cream QD
1
PF-06700841 0.3% Cream QD
1
PF-06700841 1.0% Cream QD
0
PF-06700841 3.0% Cream QD
1
Vehicle Cream Twice Daily (BID)
0
PF-06700841 0.3% Cream BID
2
PF-06700841 1.0% Cream BID
0
QRS interval: value >120 msec
Group
Value
95% CI
Vehicle Cream Once Daily (QD)
0
PF-06700841 0.1% Cream QD
0
PF-06700841 0.3% Cream QD
0
PF-06700841 1.0% Cream QD
0
PF-06700841 3.0% Cream QD
0
Vehicle Cream Twice Daily (BID)
0
PF-06700841 0.3% Cream BID
1
PF-06700841 1.0% Cream BID
1
QRS interval: %Change>=50%
Group
Value
95% CI
Vehicle Cream Once Daily (QD)
0
PF-06700841 0.1% Cream QD
0
PF-06700841 0.3% Cream QD
0
PF-06700841 1.0% Cream QD
0
PF-06700841 3.0% Cream QD
0
Vehicle Cream Twice Daily (BID)
1
PF-06700841 0.3% Cream BID
0
PF-06700841 1.0% Cream BID
0
QTCF: 450 msec
Group
Value
95% CI
Vehicle Cream Once Daily (QD)
0
PF-06700841 0.1% Cream QD
0
PF-06700841 0.3% Cream QD
1
PF-06700841 1.0% Cream QD
1
PF-06700841 3.0% Cream QD
0
Vehicle Cream Twice Daily (BID)
1
PF-06700841 0.3% Cream BID
0
PF-06700841 1.0% Cream BID
0
QTCF: 30<=Change<60
Group
Value
95% CI
Vehicle Cream Once Daily (QD)
0
PF-06700841 0.1% Cream QD
1
PF-06700841 0.3% Cream QD
1
PF-06700841 1.0% Cream QD
1
PF-06700841 3.0% Cream QD
1
Vehicle Cream Twice Daily (BID)
2
PF-06700841 0.3% Cream BID
1
PF-06700841 1.0% Cream BID
0
Change From Baseline in Clinical Chemistry-Lactate Dehydrogenase Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up VisitSecondary· 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
Group
Value
95% 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
Group
Value
95% 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
Group
Value
95% 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
Group
Value
95% 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
Group
Value
95% 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 QD
4.0
± 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 BID
0.2
± 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.
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):
NCT04267250 — Effect Of Multiple Dose PF-06700841 On The Pharmacokinetics Of Single Dose Oral Contraceptive Steroids
· Phase 1
· completed
NCT04260464 — Renal Impairment Study of PF-06700841
· Phase 1
· completed
NCT04092452 — A Study to Evaluate the Safety and Efficacy of PF-06650833, PF-06700841, and PF 06826647 in Adults With Hidradenitis Sup
· Phase 2
· completed
NCT04090047 — A Study to Investigate the Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of PF-06700841 in Healthy Pa
· Phase 1
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 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: 29 March 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/NCT03903822.