A Study to Evaluate the Safety and Efficacy of PF-06650833, PF-06700841, and PF 06826647 in Adults With Hidradenitis Suppurativa

NCT ID: NCT04092452

Last Updated: 2023-06-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-02

Study Completion Date

2022-01-10

Brief Summary

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This is a study with 3 kinase inhibitors (PF 06650833, PF 06700841 and PF 06826647) in participants with moderate to severe HS. The study will have a maximum duration of approximately 26 weeks. This includes an up to 6-week Screening Period, a 16 week Dosing Period and a 4 week Follow up Period.

Detailed Description

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Conditions

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Acne Inversa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The treatment period is a parallel design
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Cohort 1

PF-06650833

Group Type EXPERIMENTAL

PF-06650833

Intervention Type DRUG

400 mg QD

Cohort 2

PF-6700841

Group Type EXPERIMENTAL

PF-06700841

Intervention Type DRUG

45 mg QD

Cohort 3

PF-06826647

Group Type EXPERIMENTAL

PF-06826647

Intervention Type DRUG

400 mg QD

Cohort placebo

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo

Interventions

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PF-06650833

400 mg QD

Intervention Type DRUG

PF-06700841

45 mg QD

Intervention Type DRUG

PF-06826647

400 mg QD

Intervention Type DRUG

Placebo

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* male or female participants, between 18-75, with a diagnosis of moderate to severe Hidradenitis Suppurativa

Exclusion Criteria

* History of human immunodeficiency virus (HIV) or positive HIV serology at screening,
* Infected with hepatitis B or hepatitis C viruses.
* Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
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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The University Of Alabama At Birmingham

Birmingham, Alabama, United States

Site Status

The University of Alabama at Birmingham Hospital Outreach Lab

Birmingham, Alabama, United States

Site Status

The University of Alabama at Birmingham Investigation Drug Services Pharmacy

Birmingham, Alabama, United States

Site Status

The University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Mayo Clinic

Scottsdale, Arizona, United States

Site Status

Center for Dermatology Clinical Research, Inc.

Fremont, California, United States

Site Status

Pacific Clinical Trials

Long Beach, California, United States

Site Status

Keck School of Medicine of University of Southern California

Los Angeles, California, United States

Site Status

UCSF Dermatology Clinic

San Francisco, California, United States

Site Status

University of California San Francisco

San Francisco, California, United States

Site Status

UCSF Psoriasis and Skin Treatment Center

San Francisco, 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

Total Dermatology Care Center

Jacksonville, Florida, United States

Site Status

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Site Status

Olympian Clinical Research Largo Office

Largo, Florida, United States

Site Status

University of Miami Hospital

Miami, Florida, United States

Site Status

Tory Sullivan MD PA

North Miami Beach, 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

Orange Park, Florida, United States

Site Status

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

Ormond Beach, Florida, United States

Site Status

Riverchase Dermatology and Cosmetic Surgery

Pembroke Pines, Florida, United States

Site Status

ForCare Clinical Research

Tampa, Florida, United States

Site Status

Alliance Clinical Research of Tampa

Tampa, Florida, United States

Site Status

MedaPhase Inc.

Newnan, Georgia, United States

Site Status

Advanced Medical Research PC

Sandy Springs, Georgia, United States

Site Status

Georgia Skin Cancer and Aesthetic Dermatology

Watkinsville, Georgia, United States

Site Status

NorthShore University HealthSystem Dermatology Clinic

Skokie, Illinois, United States

Site Status

Ds Research

Clarksville, Indiana, United States

Site Status

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States

Site Status

DS Research

Louisville, Kentucky, United States

Site Status

Boston Medical Center

Boston, Massachusetts, United States

Site Status

Boston University General Clinical Research Unit

Boston, Massachusetts, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Wayne State University / Integrative Biosciences Center

Detroit, Michigan, United States

Site Status

Revival Research Institute, LLC

Troy, Michigan, United States

Site Status

Clinical Research Unit

Minneapolis, Minnesota, United States

Site Status

Lillihei Clinical Research Unit

Minneapolis, Minnesota, United States

Site Status

University of Minnesota Department of Dermatology

Minneapolis, Minnesota, United States

Site Status

MediSearch Clinical Trials

Saint Joseph, Missouri, United States

Site Status

Saint Louis University - Department of Dermatology

St Louis, Missouri, United States

Site Status

Skin Specialists PC

Omaha, Nebraska, United States

Site Status

J Woodson Clinical Studies Group

Henderson, Nevada, United States

Site Status

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

Vital Prospects Clinical Research Institute

Tulsa, Oklahoma, United States

Site Status

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Penn State Health Radiology - University Physician Center

Hershey, Pennsylvania, United States

Site Status

Paddington Testing Company, Inc

Philadelphia, Pennsylvania, United States

Site Status

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

Dermatology and Skin Cancer Consultants

Humboldt, Tennessee, United States

Site Status

Clinical Research Solutions

Jackson, Tennessee, United States

Site Status

Dermatology and Skin Cancer Consultants

Jackson, Tennessee, United States

Site Status

Arlington Research Center

Arlington, Texas, United States

Site Status

Austin Institute for Clinical Research, Inc.

Pflugerville, Texas, United States

Site Status

University of Utah MidValley Dermatology

Murray, Utah, United States

Site Status

Virginia Commonwealth University Medical Center

Richmond, Virginia, United States

Site Status

Bellevue Dermatology Clinical Research Center

Bellevue, Washington, United States

Site Status

Bellevue Dermatology Clinic

Bellevue, Washington, United States

Site Status

Dermatology Associates of Seattle

Seattle, Washington, United States

Site Status

Woden Dermatology

Phillip, Australian Capital Territory, Australia

Site Status

Premier Specialists Pty Ltd

Kogarah, New South Wales, Australia

Site Status

Holdsworth House Medical Practice

Sydney, New South Wales, Australia

Site Status

Veracity Clinical Research

Woolloongabba, Queensland, Australia

Site Status

Skin Health Institute Inc.

Carlton, Victoria, Australia

Site Status

Sinclair Dermatology

East Melbourne, Victoria, Australia

Site Status

SimcoDerm Medical and Surgical Dermatology Center

Barrie, Ontario, Canada

Site Status

Manna Research (London)

London, Ontario, Canada

Site Status

DermEffects

London, Ontario, Canada

Site Status

SKiN Centre for Dermatology

Peterborough, Ontario, Canada

Site Status

The Centre for Dermatology

Richmond Hill, Ontario, Canada

Site Status

Diex Recherche Sherbrooke Inc.

Sherbrooke, Quebec, Canada

Site Status

Centre de Recherche Saint-Louis

Québec, , Canada

Site Status

Alpha Recherche Clinique

Québec, , Canada

Site Status

Countries

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United States Australia Canada

References

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Kimball AB, Peeva E, Forman S, Moiin A, Khattri S, Porter ML, Mangold AR, Ghosh P, Banfield C, Oemar B. Brepocitinib, Zimlovisertib, and Ropsacitinib in Hidradenitis Suppurativa. NEJM Evid. 2024 Mar;3(3):EVIDoa2300155. doi: 10.1056/EVIDoa2300155. Epub 2024 Feb 9.

Reference Type DERIVED
PMID: 38335032 (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=C2501007

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

Other Identifiers

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C2501007

Identifier Type: -

Identifier Source: org_study_id

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