Dose Ranging Study To Assess Efficacy, Safety and Tolerability Of PF-06700841 Topical Cream In Psoriasis

NCT ID: NCT03850483

Last Updated: 2022-06-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

344 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-08

Study Completion Date

2021-04-20

Brief Summary

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This is a Phase 2b, randomized, double blind, vehicle controlled, parallel group, multicenter study in participants with mild to moderate plaque psoriasis. The duration of study participation will be approximately 22 weeks, including up to a 6 week screening period, 12 week treatment period, and approximately 4 week follow up period. Approximately 280 participants are planned to be randomized into the study.

Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vehicle cream QD

Vehicle cream applied once daily (QD)

Group Type PLACEBO_COMPARATOR

Vehicle (Placebo)

Intervention Type DRUG

Vehicle topical cream

PF-06700841 0.1% cream QD

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

Group Type EXPERIMENTAL

PF-06700841

Intervention Type DRUG

PF-06700841 topical cream

PF-06700841 0.3% cream QD

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

Group Type EXPERIMENTAL

PF-06700841

Intervention Type DRUG

PF-06700841 topical cream

PF-06700841 1% cream QD

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

Group Type EXPERIMENTAL

PF-06700841

Intervention Type DRUG

PF-06700841 topical cream

PF-06700841 3% cream QD

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

Group Type EXPERIMENTAL

PF-06700841

Intervention Type DRUG

PF-06700841 topical cream

PF-06700841 0.3% cream BID

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

Group Type EXPERIMENTAL

PF-06700841

Intervention Type DRUG

PF-06700841 topical cream

PF-06700841 1% cream BID

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

Group Type EXPERIMENTAL

PF-06700841

Intervention Type DRUG

PF-06700841 topical cream

Vehicle cream BID

Vehicle cream applied twice daily (BID)

Group Type PLACEBO_COMPARATOR

Vehicle (Placebo)

Intervention Type DRUG

Vehicle topical cream

PF-06700841 3% cream BID

PF-06700841 3% cream applied twice daily (BID)

Group Type EXPERIMENTAL

PF-06700841

Intervention Type DRUG

PF-06700841 topical cream

Interventions

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PF-06700841

PF-06700841 topical cream

Intervention Type DRUG

Vehicle (Placebo)

Vehicle topical cream

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* plaque psoriasis for 6 months
* PGA score mild or moderate
* body surface area (BSA) 2-15%

Exclusion Criteria

* other skin conditions that would interfere with the evaluation of psoriasis
* history of herpes zoster or simplex
* Infected with Mycobacterium tuberculosis
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Center for Dermatology and Plastic Surgery/CCT

Scottsdale, Arizona, United States

Site Status

Center for Dermatology and Plastic Surgery

Scottsdale, Arizona, United States

Site Status

Burke Pharmaceutical Research

Hot Springs, Arkansas, United States

Site Status

Anaheim Clinical Trials, LLC

Anaheim, California, United States

Site Status

California Skin Institute

Anaheim, California, United States

Site Status

California Dermatology & Clinical Research Institute

Encinitas, California, United States

Site Status

First OC Dermatology

Fountain Valley, California, United States

Site Status

Clinical Science Institute

Santa Monica, California, United States

Site Status

New England Research Associates, LLC

Bridgeport, Connecticut, United States

Site Status

Dermatology Physicians of Connecticut

Shelton, Connecticut, United States

Site Status

Olympian Clinical Research

Clearwater, Florida, United States

Site Status

Accel Research Sites - DeLand Clinical Research Unit

DeLand, Florida, United States

Site Status

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Site Status

Renstar Medical Research

Ocala, Florida, United States

Site Status

MidState Skin Institute

Ocala, Florida, United States

Site Status

Renstar Medical Research

Ocala, Florida, United States

Site Status

Park Avenue Dermatology, PA

Orange Park, Florida, United States

Site Status

Center for Clinical Studies

Tampa, Florida, United States

Site Status

Dundee Dermatology

West Dundee, Illinois, United States

Site Status

Ds Research

Clarksville, Indiana, United States

Site Status

DS Research

Louisville, Kentucky, United States

Site Status

Meridian Clinical Research, LLC

Baton Rouge, Louisiana, United States

Site Status

MediSearch Clinical Trials

Saint Joseph, Missouri, United States

Site Status

Hassman Research Institute

Berlin, New Jersey, United States

Site Status

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, United States

Site Status

Bayside Dermatology Center

Bayside, New York, United States

Site Status

Dermatology Consulting Services, PLLC

High Point, North Carolina, United States

Site Status

M3 Wake Research, Inc.

Raleigh, North Carolina, United States

Site Status

Vital Prospects Clinical Research Institute, PC

Tulsa, Oklahoma, United States

Site Status

Health Concepts

Rapid City, South Dakota, United States

Site Status

Rivergate Dermatology Clinical Research

Goodlettsville, Tennessee, United States

Site Status

Austin Institute for Clinical Research, Inc.

Austin, Texas, United States

Site Status

studies in Dermatology, LLC

Cypress, Texas, United States

Site Status

Center for Clinical Studies, LTD. LLP

Houston, Texas, United States

Site Status

Texas Dermatology and Laser Specialists

San Antonio, Texas, United States

Site Status

Center for Clinical Studies

Webster, Texas, United States

Site Status

Summit Clinical Research, LLC

Franklin, Virginia, United States

Site Status

Virginia Dermatology and Skin Cancer Center

Norfolk, Virginia, United States

Site Status

Veracity Clinical Research Pty Ltd

Woolloongabba, Queensland, Australia

Site Status

Emeritus Research

Camberwell, Victoria, Australia

Site Status

Sinclair Dermatology

East Melbourne, Victoria, Australia

Site Status

Cabrini Hospital

Malvern, Victoria, Australia

Site Status

Center for Skin and Venereal Diseases EOOD - Sofia

Sofia, , Bulgaria

Site Status

DCC Alexandrovska

Sofia, , Bulgaria

Site Status

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

Sofia, , Bulgaria

Site Status

Dermatological Clinic Sofia

Sofia, , Bulgaria

Site Status

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, Canada

Site Status

SKiN Health

Cobourg, Ontario, Canada

Site Status

Innovaderm Research Inc.

Montreal, Quebec, Canada

Site Status

Diex Recherche Sherbrooke Inc.

Sherbrooke, Quebec, Canada

Site Status

Gentofte Hospital

Hellerup, , Denmark

Site Status

Fachklinik Bad Bentheim

Bad Bentheim, , Germany

Site Status

Emovis GmbH

Berlin, , Germany

Site Status

Rothhaar Studien GmbH

Berlin, , Germany

Site Status

ISA - Interdisciplinary Study Association GmbH

Berlin, , Germany

Site Status

Klinikum Bielefeld gem.GmbH

Bielefeld, , Germany

Site Status

Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

Dresden, , Germany

Site Status

MENSINGDERMA research GmbH

Hamburg, , Germany

Site Status

MVZ Alstermed GmbH

Hamburg, , Germany

Site Status

Dermatologische Gemeinschaftspraxis

Mahlow, , Germany

Site Status

Klinische Forschung Schwerin GmbH

Schwerin, , Germany

Site Status

Semmelweis Egyetem Altalanos Orvostudomanyi Kar

Budapest, , Hungary

Site Status

Debreceni Egyetem Klinikai Kozpont

Debrecen, , Hungary

Site Status

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

Kecskemét, , Hungary

Site Status

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, , Hungary

Site Status

Kitago Dermatology Clinic

Sapporo, Hokkaido, Japan

Site Status

Nakatsuhifuka Clinic

Kita-ku, Osaka-shi, Osaka, Japan

Site Status

Parkside Hiroo Ladies Clinic

Minato-ku, Tokyo, Japan

Site Status

Tanpopo Skin Clinic

Ōta-ku, Tokyo, Japan

Site Status

Samoncho Dermatological Clinic

Shinjuku-ku, Tokyo, Japan

Site Status

Medical Corporation Jitai-kai Tachikawa Dermatology Clinic

Tachikawa, Tokyo, Japan

Site Status

Riga 1st Hospital

Riga, , Latvia

Site Status

Aesthetic dermatology clinic of Prof. J. Kisis

Riga, , Latvia

Site Status

Health and Aesthetics Ltd

Riga, , Latvia

Site Status

Outpatient Clinic of Ventspils

Ventspils, , Latvia

Site Status

Zdrowie Osteo-Medic s.c. LiA Racewicz, AiJ Supronik

Bialystok, , Poland

Site Status

Nasz Lekarz Przychodnie Medyczne

Torun, , Poland

Site Status

MTZ Clinical Research Sp. z o.o

Warsaw, , Poland

Site Status

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

Wroclaw, , Poland

Site Status

Countries

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United States Australia Bulgaria Canada Denmark Germany Hungary Japan Latvia Poland

References

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Forman SB, Pariser DM, Poulin Y, Vincent MS, Gilbert SA, Kieras EM, Qiu R, Yu D, Papacharalambous J, Tehlirian C, Peeva E. TYK2/JAK1 Inhibitor PF-06700841 in Patients with Plaque Psoriasis: Phase IIa, Randomized, Double-Blind, Placebo-Controlled Trial. J Invest Dermatol. 2020 Dec;140(12):2359-2370.e5. doi: 10.1016/j.jid.2020.03.962. Epub 2020 Apr 18.

Reference Type BACKGROUND
PMID: 32311398 (View on PubMed)

Draelos ZD, Bushmakin AG, Ghosh P, Xenakis J, Cappelleri JC. Validation of the Peak Pruritus-Numerical Rating Scale in patients with chronic plaque psoriasis: results from a phase 2 study. Int J Dermatol. 2024 Dec;63(12):e375-e382. doi: 10.1111/ijd.17428. Epub 2024 Aug 19.

Reference Type DERIVED
PMID: 39160651 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=B7931023

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Other Identifiers

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2018-003051-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

B7931023

Identifier Type: -

Identifier Source: org_study_id

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