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

NCT03903822 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: B79310222018-003050-24
• Study Type: interventional
• Target: 292
• Locations: 10 countries
• Sites: 76

Brief Summary

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.

Conditions

Atopic Dermatitis

Keywords

Mild-to-Moderate Atopic Dermatitis; topical

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6: Multiple Imputation

  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 (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.

  Baseline, Week 6

Secondary Outcomes (26)

• Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score Clear (0) or Almost Clear (1) and a Reduction From Baseline of Greater Than or Equal to ( >=2) Points at Week 6: Non-responder Imputation

  Baseline, Week 6

• Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6: Multiple Imputation

  Baseline, Week 6

• Percentage of Participants Achieving >=2 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4 and 6: Non-responder Imputation

  Baseline, Weeks 1, 2, 3, 4 and 6

• Percentage of Participants Achieving >=4 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4, 6 and Follow-up Visit: Non-responder Imputation

  Baseline, Weeks 1, 2, 3, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)

• Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 3, 4, 6 and Follow-up Visit

  Baseline, Weeks 1, 2, 3, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)

Study Arms (8)

PF-06700841 0.1% cream QD

EXPERIMENTAL

PF-06700841 0.1% cream applied once daily (QD)

Drug: PF-06700841

PF-06700841 0.3% cream QD

EXPERIMENTAL

PF-06700841 0.3% cream applied once daily (QD)

Drug: PF-06700841

PF-06700841 1% cream QD

EXPERIMENTAL

PF-06700841 1% cream applied once daily (QD)

Drug: PF-06700841

PF-06700841 3% cream QD

EXPERIMENTAL

PF-06700841 3% cream applied once daily (QD)

Drug: PF-06700841

PF-06700841 0.3% cream BID

EXPERIMENTAL

PF-06700841 0.3% cream applied twice daily (BID)

Drug: PF-06700841

PF-06700841 1% cream BID

EXPERIMENTAL

PF-06700841 1% cream applied twice daily (BID)

Drug: PF-06700841

Vehicle cream QD

PLACEBO COMPARATOR

Vehicle cream applied once daily (QD)

Drug: Vehicle (Placebo)

Vehicle cream BID

PLACEBO COMPARATOR

Vehicle cream applied twice daily (BID)

Drug: Vehicle (Placebo)

Interventions

PF-06700841 DRUG

PF-06700841 topical cream

PF-06700841 0.1% cream QD; PF-06700841 0.3% cream BID; PF-06700841 0.3% cream QD; PF-06700841 1% cream BID; PF-06700841 1% cream QD; PF-06700841 3% cream QD

Vehicle (Placebo) DRUG

Vehicle topical cream

Vehicle cream BID; Vehicle cream QD

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of Atopic Dermatitis for at least 3 months
• Investigator's Global Assessment (IGA) Score of 2 or 3
• Eczema Area Severity Index (EASI) score of 3-21
• Body Surface Area (BSA) of 2-20%
• Peak pruritus-Numerical Rating Scale (PPNRS) of Grade 2 or more

You may not qualify if:

• Other forms of dermatological diseases (other than atopic dermatitis)
• Fitzpatrick skin type score greater than 5
• Clinically significant abnormal ECG, vital signs, and laboratory values
• Infection with HBV, HCV, herpes zoster or tuberculosis

Sponsors & Collaborators

• Pfizer: lead

Study Sites (76)

Clinical Research Center of Alabama, LLC

Birmingham, Alabama, 35244, United States

Location

Center for Dermatology and Plastic Surgery/CCT

Scottsdale, Arizona, 85260, United States

Location

Center for Dermatology and Plastic Surgery

Scottsdale, Arizona, 85260, United States

Location

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

Location

First OC Dermatology

Fountain Valley, California, 92708, United States

Location

Beach Allergy and Asthma Specialty Group, A Medical Corporation

Long Beach, California, 90808, United States

Location

Clinical Science Institute

Santa Monica, California, 90404, United States

Location

New England Associates, LLC

Bridgeport, Connecticut, 06606, United States

Location

Dermatology Physicians of Connecticut

Shelton, Connecticut, 06484, United States

Location

Yolanda C. Holmes, MD

Washington D.C., District of Columbia, 20036, United States

Location

Olympian Clinical Research

Clearwater, Florida, 33756, United States

Location

Accel Research Sites - DeLand Clinical Research Unit

DeLand, Florida, 32720, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, 32256, United States

Location

Precision Imaging

Jacksonville, Florida, 32256, United States

Location

Solutions Through Advanced Research, Inc

Jacksonville, Florida, 32256, United States

Location

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, 32801, United States

Location

Leavitt Medical Associates of Florida d/b/a Ameriderm Research

Ormond Beach, Florida, 32174, United States

Location

Advanced Medical Research PC

Sandy Springs, Georgia, 30328, United States

Location

Sneeze, Wheeze & Itch Associates, LLC

Normal, Illinois, 61761, United States

Location

DS Research

New Albany, Indiana, 47150, United States

Location

DS Research

Louisville, Kentucky, 40241, United States

Location

Meridian Clinical Research, LLC

Baton Rouge, Louisiana, 70808, United States

Location

MediSearch Clinical Trials

Saint Joseph, Missouri, 64506, United States

Location

Dermatology Consulting Services, PLLC

High Point, North Carolina, 27262, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Vital Prospects Clinical Research Institute, PC

Tulsa, Oklahoma, 74136, United States

Location

Health Concepts

Rapid City, South Dakota, 57702, United States

Location

Tanenbaum Dermatology Center

Memphis, Tennessee, 38117, United States

Location

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, 38119, United States

Location

studies in Dermatology, LLC

Cypress, Texas, 77433, United States

Location

Center for Clinical Studies, LTD.LLP

Houston, Texas, 77004, United States

Location

Ventavia Research Group LLC

Hurst, Texas, 76054, United States

Location

Center for Clinical Studies, LTD. LLP

Webster, Texas, 77598, United States

Location

Summit Clinical Research, LLC

Franklin, Virginia, 23851, United States

Location

Virginia Dermatology and Skin Cancer Center

Norfolk, Virginia, 23502, United States

Location

Australian Clinical Research Network

Maroubra, New South Wales, 2035, Australia

Location

Emeritus Research

Camberwell, Victoria, 3124, Australia

Location

Sinclair Dermatology

East Melbourne, Victoria, 3002, Australia

Location

Cabrini Hospital

Malvern, Victoria, 3144, Australia

Location

Center for Skin and Venereal Diseases EOOD - Sofia

Sofia, 1404, Bulgaria

Location

DCC Alexandrovska

Sofia, 1431, Bulgaria

Location

Diagnostic Consultative Center - Fokus-5 - Medical Establishment for Outpatient Care OOD

Sofia, 1463, Bulgaria

Location

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

SKiN Health

Cobourg, Ontario, K9A 4J9, Canada

Location

Innovaderm Research Inc.

Montreal, Quebec, H2X 2V1, Canada

Location

Diex Recherche Sherbrooke Inc.

Sherbrooke, Quebec, J1L 0H8, Canada

Location

Gentofte Hospital

Hellerup, 2900, Denmark

Location

Emovis GmbH

Berlin, 10629, Germany

Location

Rothhaar Studien GmbH

Berlin, 10783, Germany

Location

ISA - Interdisciplinary Study Association GmbH

Berlin, 10789, Germany

Location

Klinikum Bielefeld gem.GmbH

Bielefeld, 33647, Germany

Location

Universitätsklinikum Bonn AöR

Bonn, 53127, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt, 60590, Germany

Location

MENSINGDERMA research GmbH

Hamburg, 22391, Germany

Location

MVZ Alstermed GmbH

Hamburg, 22391, Germany

Location

Dermatologische Gemeinschaftspraxis

Mahlow, 15831, Germany

Location

Klinische Forschung Schwerin GmbH

Schwerin, 19055, Germany

Location

Semmelweis Egyetem Altalanos Orvostudomanyi Kar

Budapest, 1085, Hungary

Location

Debreceni Egyetem Klinikai Kozpont

Debrecen, 4032, Hungary

Location

Bacs-Kiskun Megyei Korhaz Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktato Korhaza

Kecskemét, 6000, Hungary

Location

CRU Hungary Kft.

Miskolc, 3529, Hungary

Location

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, 6720, Hungary

Location

Kitago Dermatology Clinic

Sapporo, Hokkaido, 003-0833, Japan

Location

Nakatsuhifuka Clinic

Kita-ku, Osaka-shi, Osaka, 531-0072, Japan

Location

Parkside Hiroo Ladies Clinic

Minato-ku, Tokyo, 106-0047, Japan

Location

Tanpopo Skin Clinic

Ōta-ku, Tokyo, 143-0023, Japan

Location

Shinjuku Minamiguchi Dermatology Skin Clinic

Shinjuku-ku, Tokyo, 160-0023, Japan

Location

Medical Corporation Jitai-kai Tachikawa Dermatology Clinic

Tachikawa, Tokyo, 190-0023, Japan

Location

Aesthetic dermatology clinic of Prof. J. Kisis

Riga, LV-1003, Latvia

Location

Health and Aesthetics Ltd

Riga, LV-1009, Latvia

Location

Outpatient Clinic of Ventspils

Ventspils, LV3601, Latvia

Location

NZOZ Specjalistyczny Ośrodek Dermatologiczny DERMAL s.c.

Bialystok, 15-453, Poland

Location

NASZ LEKARZ Przychodnie Medyczne

Torun, 87-100, Poland

Location

MTZ Clinical Research Sp. z o.o

Warsaw, 02-106, Poland

Location

WroMedica I. Bielicka, A. Strzalkowska s.c.

Wroclaw, 51-685, Poland

Location

Related Links

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

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

PF-06700841

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2019
• First Posted: April 4, 2019
• Study Start: May 13, 2019
• Primary Completion: May 7, 2020
• Study Completion: May 7, 2020
• Last Updated: March 29, 2021
• Results First Posted: March 29, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share

Locations

CA (4); BU (3); AU (4); HU (5); PL (4); DE (10); LA (3); US (36); DK (1); JP (6)