Study Evaluating Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis (JADE Mono-2)

• ClinicalTrials.gov Identifier: NCT03575871
• Recruitment Status: Completed
• First Posted: July 3, 2018
• Results First Posted: April 21, 2020
• Last Update Posted: April 21, 2020
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

Brief Summary:

B7451013 is a Phase 3 study to evaluate PF-04965842 in patients aged 12 years and older with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. The efficacy and safety of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily, will be evaluated relative to placebo over 12 weeks of study participation. Eligible patients will have an option to enter a long-term extension study after completing 12 weeks of treatment.

Condition or disease	Intervention/treatment	Phase
Dermatitis, Atopic	Drug: PF-04965842 100 mg; Drug: PF-04965842 200 mg; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 391 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04965842 MONOTHERAPY IN SUBJECTS AGED 12 YEARS AND OLDER, WITH MODERATE TO SEVERE ATOPIC DERMATITIS
• Actual Study Start Date: June 29, 2018
• Actual Primary Completion Date: August 13, 2019
• Actual Study Completion Date: August 13, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: PF-04965842 100 mg	Drug: PF-04965842 100 mg; PF-04965842 100 mg, administered as two tablets to be taken orally once daily for 12 weeks
Experimental: PF-04965842 200 mg	Drug: PF-04965842 200 mg; PF-04965842 200 mg, administered as two tablets to be taken orally once daily for 12 weeks
Placebo Comparator: Placebo	Drug: Placebo; Placebo, administered as two tablets to be taken orally once daily for 12 weeks

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Baseline at Week 12 [ Time Frame: Baseline, Week 12 ]
   IGA assesses 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, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded soles, palms and scalp.
2. Percentage of Participants Achieving Eczema Area and Severity Index Response of >=75 Percent (%) Improvement (EASI-75) From Baseline at Week 12 [ Time Frame: Baseline, Week 12 ]
   EASI evaluates 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 <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+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.

Secondary Outcome Measures :

1. Percentage of Participants Who Achieved at Least 4-Points Improvement From Baseline in the Numerical Rating Scale (NRS) for Severity of Pruritus at Weeks 2, 4, 8 and 12 [ Time Frame: Baseline, Weeks 2, 4, 8 and 12 ]
   Participants were asked to assess their worst pruritus/itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst possible itching), where higher scores indicated greater severity.
2. Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 12 [ Time Frame: Baseline, Week 12 ]
   PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin [lighter or darker], bleeding from skin, seeping or oozing fluid from skin [other than blood], and skin swelling). Participant had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition.
3. Time to Achieve >=4 Points Improvement From Baseline in Numerical Rating Scale (NRS) for Severity of Pruritus [ Time Frame: Baseline up to Day 15 ]
   Participants were asked to assess their worst itching/pruritus due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst itch imaginable), where higher scores indicated greater severity.
4. Percentage of Participants Achieving Eczema Area and Severity Index Response of >=75% Improvement (EASI-75) From Baseline at Weeks 2, 4 and 8 [ Time Frame: Baseline, Weeks 2, 4, and 8 ]
   EASI evaluates 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 <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+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
5. Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Weeks 2, 4 and 8 [ Time Frame: Baseline, Weeks 2, 4, and 8 ]
   IGA assesses 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, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded sole, palms and scalp.
6. Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) at Week 2, 4, 8 and 12 [ Time Frame: Weeks 2, 4, 8 and 12 ]
   IGA assesses 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, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded soles, palms and scalp.
7. Percentage of Participants Achieving Eczema Area and Severity Index Response of >=50% Improvement (EASI-50) From Baseline at Weeks 2, 4, 8 and 12 [ Time Frame: Baseline, Weeks 2, 4, 8, and 12 ]
   EASI evaluates 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 <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+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
8. Percentage of Participants Achieving Eczema Area and Severity Index Response of >=90% Improvement (EASI-90) From Baseline at Weeks 2, 4, 8 and 12 [ Time Frame: Baseline, Weeks 2, 4, 8, and 12 ]
   EASI evaluates 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 <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+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
9. Percentage of Participants Achieving Eczema Area and Severity Index Response of 100% Improvement (EASI-100) From Baseline at Weeks 2, 4, 8 and 12 [ Time Frame: Baseline, Weeks 2, 4, 8, and 12 ]
   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]) 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+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
10. Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 2, 4, 8 and 12 [ Time Frame: Baseline, Weeks 2, 4, 8, and 12 ]
    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]) 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+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
11. Change From Baseline in the Percentage Body Surface Area (%BSA) Affected at Week 2, 4, 8, and 12 [ Time Frame: Baseline, Weeks 2, 4, 8, and 12 ]
    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 hand with fingers in a closed position) 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% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD.
12. Percentage of Participants With Percentage Body Surface Area (%BSA) (From EASI) < 5% at Weeks 2, 4, 8 and 12 [ Time Frame: Weeks 2, 4, 8, and 12 ]
    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 hand with fingers in a closed position) 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 limb, 3.33% for trunk and 2.5% for lower limb. % BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD.
13. Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8 and 12 [ Time Frame: Baseline, Weeks 2, 4, 8, and 12 ]
    SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where "0" = no itch/no sleeplessness and "10" = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.
14. Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response >=75% Improvement From Baseline at Week 2, 4, 8 and 12 [ Time Frame: Baseline, Weeks 2, 4, 8, and 12 ]
    SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.
15. Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch at Weeks 2, 4, 8 and 12 [ Time Frame: Baseline, Weeks 2, 4, 8, and 12 ]
    SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.
16. Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) Sleep Loss at Weeks 2, 4, 8 and 12 [ Time Frame: Baseline, Weeks 2, 4, 8, and 12 ]
    SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.
17. Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8 and 12 [ Time Frame: Baseline, Weeks 2, 4, 8, and 12 ]
    SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.

Eligibility Criteria

• Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 12 years of age or older with a minimum body weight of 40 kg
• Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate to severe disease (>= the following scores: BSA 10%, IGA 3, EASI 16, Pruritus NRS severity 4)
• Recent history of inadequate response or inability to tolerate topical AD treatments or require systemic treatments for AD control

Exclusion Criteria:

• Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
• Prior treatment with JAK inhibitors
• Other active nonAD inflammatory skin diseases or conditions affecting skin
• Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator
• Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception

Contacts and Locations

Locations

United States, California

Emmaus Research Center, Inc.

Anaheim, California, United States, 92804

Advanced Research Center, Inc. - Los Alamitos Site

Los Alamitos, California, United States, 90720

Peninsula Research Associates, Inc.

Rolling Hills Estates, California, United States, 90274

Clinical Science Institute

Santa Monica, California, United States, 90404

United States, Colorado

Asthma and Allergy Associates, PC

Colorado Springs, Colorado, United States, 80907

Colorado Springs Dermatology Clinic, PC

Colorado Springs, Colorado, United States, 80910

United States, Florida

Olympian Clinical Research

Clearwater, Florida, United States, 33756

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, United States, 32256

Precision Imaging

Jacksonville, Florida, United States, 32256

Solutions Through Advanced Research, Inc.

Jacksonville, Florida, United States, 32256

Clinical Neuroscience Solutions, Inc

Orlando, Florida, United States, 32801

ForCare Clinical Research

Tampa, Florida, United States, 33613

United States, Idaho

Imaging Center of Idaho

Caldwell, Idaho, United States, 83605

ASR, LLC

Nampa, Idaho, United States, 83687

United States, Louisiana

Meridian Clinical Research

Baton Rouge, Louisiana, United States, 70808

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

United States, Missouri

MediSearch Clinical Trials

Saint Joseph, Missouri, United States, 64506

United States, New York

Sadick Research Group

New York, New York, United States, 10075

United States, North Carolina

PMG Research of Wilmington, LLC

Wilmington, North Carolina, United States, 28411

United States, Ohio

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States, 43210

The Ohio State University Dermatology East

Gahanna, Ohio, United States, 43230

United States, Tennessee

Tanenbaum Dermatology Center

Memphis, Tennessee, United States, 38117

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, United States, 38119

United States, Texas

Austin Institute for Clinical Research, Inc. - Central

Austin, Texas, United States, 78705

Center for Clinical Studies, LTD. LLP

Houston, Texas, United States, 77004

West Houston Dermatology, PA

Houston, Texas, United States, 77082

United States, Virginia

Summit Clinical Research, LLC

Franklin, Virginia, United States, 23851

Virginia Dermatology and Skin Cancer Center

Norfolk, Virginia, United States, 23502

Australia, New South Wales

Australian Clinical Research Network

Maroubra, New South Wales, Australia, 2035

Australia, Queensland

The Skin Centre

Benowa, Queensland, Australia, 4217

Veracity Clinical Research Pty Ltd

Woolloongabba, Queensland, Australia, 4102

Australia, Victoria

Skin and Cancer Foundation Inc

Carlton, Victoria, Australia

Sinclair Dermatology

East Melbourne, Victoria, Australia, 3002

Royal Melbourne Hospital

Parkville, Victoria, Australia, 3050

The Royal Children's Hospital (RCH)

Parkville, Victoria, Australia, 3052

Bulgaria

Medical Centre Asklepii OOD

Dupnitsa, Bulgaria, 2600

MHAT Dr. Tota Venkova AD

Gabrovo, Bulgaria, 5300

"Acibadem City Clinic MHAT Tokuda" EAD

Sofia, Bulgaria, 1407

"DCC Aleksandrovska" EOOD

Sofia, Bulgaria, 1431

Diagnostic Consultative Center Fokus-5

Sofia, Bulgaria, 1463

Medical Centre Synexus Sofia EOOD

Sofia, Bulgaria, 1784

Canada, British Columbia

University of British Columbia Department of Dermatology and Skin Science

Vancouver, British Columbia, Canada, V5Z 4E8

Canada, Manitoba

Winnipeg Clinic

Winnipeg, Manitoba, Canada, R3C 0N2

Canada, Ontario

North York Research Inc.

North York, Ontario, Canada, M2M 4J5

Oshawa Clinic Dermatology Trials

Oshawa, Ontario, Canada, L1H 1B9

York Dermatology Clinic and Research Centre

Richmond Hill, Ontario, Canada, L4C 9M7

Research Toronto

Toronto, Ontario, Canada, M4W 2N2

Canada, Quebec

Diex Recherche Sherbrooke Inc.

Sherbrooke, Quebec, Canada, J1L 0H8

China, Beijing

Peking University First Hospital

Beijing, Beijing, China, 100034

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing, China, 100050

China, Chongqing

The Second Affiliated Hospital of Army Medical University, PLA

Chongqing, Chongqing, China, 400037

China, Guangdong

The University of Hong Kong - Shenzhen Hospital

Shenzhen, Guangdong, China, 518053

China

Tianjin Medical University General Hospital, Dermatological Department

Tianjin, China, 300052

Czechia

Dermamedica S.R.O.

Nachod, Czechia, 547 01

Oblastni nemocnice Nachod a.s., Radiodiagnosticke oddeleni

Nachod, Czechia, 547 01

Lekarna u Stribrneho orla

Nachod, Czechia, 54701

Sanatorium profesora Arenbergera

Praha 1, Czechia, 11000

Lekarna U sv. Ignace

Praha 2, Czechia, 120 00

Dermatologicka Ambulance

Svitavy, Czechia, 568 02

Lekarna na Hranicni

Svitavy, Czechia, 56802

Germany

Fachklinik Bad Bentheim

Bad Bentheim, Germany, 48455

ISA GmbH

Berlin, Germany, 10789

Fachärztliche Gemeinschaftspraxis für Dermatologie und Venerologie, Allergologie,

Blankenfelde-Mahlow, Germany, 15831

IKF Pneumologie GmbH & Co KG

Frankfurt, Germany, 60596

Klinische Forschung Hamburg GmbH

Hamburg, Germany, 20253

Universitaet Muenster

Münster, Germany, 48149

Klinische Forschung Schwerin GmbH

Schwerin, Germany, 19055

Hungary

SE AOK Bor, Nemikortani es Boronkologiai Klinika

Budapest, Hungary, 1085

Budapest Főváros XIX. Kerületi Önkormányzat Kispesti Egészsegügyi Intézete

Budapest, Hungary, 1195

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary, 4032

ALLERGO-DERM BAKOS Kft.

Szolnok, Hungary, 5000

Japan

Queen's square Medical Facilities Queen's square Dermatology and Allergology

Yokohama, Kanagawa, Japan, 220-6208

Noguchi Dermatology Clinic

Kamimashiki-gun, Kumamoto, Japan, 861-3101

Yoshioka Dermatology Clinic

Neyagawa, Osaka, Japan, 572-0838

Kume Clinic

Sakai, Osaka, Japan, 593-8324

Sumire Dermatology Clinic

Edogawa-ku, Tokyo, Japan, 133-0057

Matsuyama Dermatology Clinic

Nakano-ku, Tokyo, Japan, 165-0026

Hoshikuma Dermatology・Allergy Clinic

Fukuoka, Japan, 814-0171

Sanrui Hifuka

Saitama, Japan, 330-0854

Korea, Republic of

Soon Chun Hyang University Bucheon Hospital

Bucheon-si, Gyeonggi-do, Korea, Republic of, 14584

The Catholic University of Korea, Incheon St.Mary's Hospital

Bupyeong-gu, Incheon, Korea, Republic of, 21431

Inha University Hospital

Jung-gu, Incheon, Korea, Republic of, 22332

Kyungpook National University Hospital

Daegu, Korea, Republic of, 41944

Chonnam National University Hospital

Gwangju, Korea, Republic of, 61469

Korea University Anam Hospital

Seoul, Korea, Republic of, 02841

Severance Hospital, Yonsei Univ. Health System

Seoul, Korea, Republic of, 03722

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, Korea, Republic of, 06591

Chung-Ang University Hospital

Seoul, Korea, Republic of, 06973

Hallym university Kangnam Sacred Heart Hospital

Seoul, Korea, Republic of, 07441

Latvia

Selga Freiberga private practice in dermatovenerology and cosmetology

Jelgava, Latvia, LV-3001

Riga 1st Hospital, Clinic for Dermatology and STD

Riga, Latvia, LV-1001

Aesthetic dermatology clinic of Prof. J. Kisis

Riga, Latvia, LV-1003

Health Centre 4 Ltd. Diagnostics Centre

Riga, Latvia, LV-1003

Health Centre 4 Ltd

Riga, Latvia, LV-1013

Poland

NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL s.c.

Bialystok, Poland, 15-453

KLIMED Marek Klimkiewicz

Białystok, Poland, 15-704

Centrum Nowoczesnych Terapii "DOBRY LEKARZ" sp. z o. o.

Krakow, Poland, 31-011

Centrum Badań Klinicznych JCI

Kraków, Poland, 30-348

Krakowskie Centrum Medyczne Sp. z o.o.

Kraków, Poland, 31-501

Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna

Lodz, Poland, 90-242

KO-MED Centra Kliniczne Lublin II

Lublin, Poland, 20-362

Clinical Research Center Sp. z o.o. MEDIC-R Sp. k.

Poznan, Poland, 60-848

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, Poland, 71-434

Synexus Polska Sp. z o. o. Oddzial w Warszawie

Warszawa, Poland, 01-192

Centrum Medyczne AMED

Warszawa, Poland, 01-518

MTZ Clinical Research Sp. z o.o.

Warszawa, Poland, 02-106

Klinika Ambroziak Sp. z o.o.

Warszawa, Poland, 02-758

Synexus Polska Sp. z o.o. Oddzial we Wroclawiu

Wroclaw, Poland, 50-381

Lukasz Matusiak "4HEALTH"

Wrocław, Poland, 50-566

United Kingdom

Plymouth Hospitals NHS Trust, Derriford Hospital

Plymouth, Devon, United Kingdom, PL6 8DH

MAC Clinical Research

Blackpool, Lancashire, United Kingdom, FY2 0JH

MAC Clinical Research Ltd

Cannock, South Staffordshire, United Kingdom, WS11 0BN

Barnsley Hospital NHS Foundation Trust

Barnsley, South Yorkshire, United Kingdom, S75 2EP

University Hospital Bristol NHS Foundation Trust

Bristol, United Kingdom, BS2 8HW

MAC Clinical Research Ltd

Manchester, United Kingdom, M13 9NQ

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

  Study Documents (Full-Text)

Documents provided by Pfizer:

Study Protocol  [PDF] December 6, 2018

Statistical Analysis Plan  [PDF] August 26, 2019

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Blauvelt A, Boguniewicz M, Brunner PM, Luna PC, Biswas P, DiBonaventura M, Farooqui SA, Rojo R, Cameron MC. Abrocitinib monotherapy in Investigator's Global Assessment nonresponders: improvement in signs and symptoms of atopic dermatitis and quality of life. J Dermatolog Treat. 2022 Aug;33(5):2605-2613. doi: 10.1080/09546634.2022.2059053. Epub 2022 Jul 6.

Stander S, Bhatia N, Gooderham MJ, Silverberg JI, Thyssen JP, Biswas P, DiBonaventura M, Romero W, Farooqui SA. High threshold efficacy responses in moderate-to-severe atopic dermatitis are associated with additional quality of life benefits: pooled analyses of abrocitinib monotherapy studies in adults and adolescents. J Eur Acad Dermatol Venereol. 2022 Aug;36(8):1308-1317. doi: 10.1111/jdv.18170. Epub 2022 May 6.

Wojciechowski J, Malhotra BK, Wang X, Fostvedt L, Valdez H, Nicholas T. Population pharmacokinetic-pharmacodynamic modelling of platelet time-courses following administration of abrocitinib. Br J Clin Pharmacol. 2022 Aug;88(8):3856-3871. doi: 10.1111/bcp.15334. Epub 2022 Apr 11.

Wojciechowski J, Malhotra BK, Wang X, Fostvedt L, Valdez H, Nicholas T. Population Pharmacokinetics of Abrocitinib in Healthy Individuals and Patients with Psoriasis or Atopic Dermatitis. Clin Pharmacokinet. 2022 May;61(5):709-723. doi: 10.1007/s40262-021-01104-z. Epub 2022 Jan 21. Erratum In: Clin Pharmacokinet. 2022 Apr;61(4):591.

Cork MJ, McMichael A, Teng J, Valdez H, Rojo R, Chan G, Zhang F, Myers DE, DiBonaventura M. Impact of oral abrocitinib on signs, symptoms and quality of life among adolescents with moderate-to-severe atopic dermatitis: an analysis of patient-reported outcomes. J Eur Acad Dermatol Venereol. 2022 Mar;36(3):422-433. doi: 10.1111/jdv.17792. Epub 2021 Dec 4.

Simpson EL, Silverberg JI, Nosbaum A, Winthrop KL, Guttman-Yassky E, Hoffmeister KM, Egeberg A, Valdez H, Zhang M, Farooqui SA, Romero W, Thorpe AJ, Rojo R, Johnson S. Integrated Safety Analysis of Abrocitinib for the Treatment of Moderate-to-Severe Atopic Dermatitis From the Phase II and Phase III Clinical Trial Program. Am J Clin Dermatol. 2021 Sep;22(5):693-707. doi: 10.1007/s40257-021-00618-3. Epub 2021 Aug 18. Erratum In: Am J Clin Dermatol. 2021 Nov;22(6):905.

Silverberg JI, Thyssen JP, Simpson EL, Yosipovitch G, Stander S, Valdez H, Rojo R, Biswas P, Myers DE, Feeney C, DiBonaventura M. Impact of Oral Abrocitinib Monotherapy on Patient-Reported Symptoms and Quality of Life in Adolescents and Adults with Moderate-to-Severe Atopic Dermatitis: A Pooled Analysis of Patient-Reported Outcomes. Am J Clin Dermatol. 2021 Jul;22(4):541-554. doi: 10.1007/s40257-021-00604-9. Epub 2021 May 5. Erratum In: Am J Clin Dermatol. 2021 Sep;22(5):739.

Silverberg JI, Simpson EL, Thyssen JP, Gooderham M, Chan G, Feeney C, Biswas P, Valdez H, DiBonaventura M, Nduaka C, Rojo R. Efficacy and Safety of Abrocitinib in Patients With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial. JAMA Dermatol. 2020 Aug 1;156(8):863-873. doi: 10.1001/jamadermatol.2020.1406.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT03575871
• Other Study ID Numbers: B7451013; MONO-2 ( Other Identifier: Alias Study Number ); 2018-001136-21 ( EudraCT Number )
• First Posted: July 3, 2018
• Results First Posted: April 21, 2020
• Last Update Posted: April 21, 2020
• Last Verified: April 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
• URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:

atopic dermatitis; atopic eczema; eczema; JAK; janus kinase

Additional relevant MeSH terms:

Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Abrocitinib; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action