A Study to Evaluate the Safety and Efficacy of PF-06650833, PF-06700841, and PF 06826647 in Adults With Hidradenitis Suppurativa
A PHASE 2A, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 16-WEEK STUDY EVALUATING THE SAFETY AND EFFICACY OF PF-06650833, PF-06700841, AND PF-06826647 IN ADULTS WITH MODERATE TO SEVERE HIDRADENITIS SUPPURATIVA
1 other identifier
interventional
194
3 countries
77
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2019
77 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2019
CompletedFirst Posted
Study publicly available on registry
September 17, 2019
CompletedStudy Start
First participant enrolled
December 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 10, 2022
CompletedResults Posted
Study results publicly available
June 15, 2023
CompletedJune 15, 2023
May 1, 2023
2.1 years
September 15, 2019
December 24, 2022
May 19, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16- Minimum Risk (MR) [Full Analysis Set (FAS), Non-responder Imputation (NRI)].
HiSCR response was defined as at least a 50% reduction in total abscess and inflammatory nodule (AN) count relative to baseline, and no increase in abscess count, and no increase in draining fistula count. Confidence interval (CI) was calculated using Blyth-Still-Casella method.
At week 16
Secondary Outcomes (24)
Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, NRI).
At weeks 1, 2, 4, 6, 8, and 12
Percentage of Participants Achieving a Total Abscess and Inflammatory Nodule (AN) Count of 0 or 1; 0, 1 or 2 at Week 16 - MR (FAS, NRI).
At week 16
Least Squares (LS) Mean of Percent Change From Baseline in AN Count at Weeks 1, 2, 4, 6, 8, 12 and 16 - Analysis of Covariance (ANCOVA) [FAS, Multiply Imputed (MI)].
At weeks 1, 2, 4, 6, 8, 12 and 16
Least Squares Mean of Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI).
At weeks 1, 2, 4, 6, 8, 12 and 16
Least Squares Mean of Percent Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI).
At weeks 1, 2, 4, 6, 8, 12 and 16
- +19 more secondary outcomes
Study Arms (4)
Cohort 1
EXPERIMENTALPF-06650833
Cohort 2
EXPERIMENTALPF-6700841
Cohort 3
EXPERIMENTALPF-06826647
Cohort placebo
PLACEBO COMPARATORplacebo
Interventions
Eligibility Criteria
You may qualify if:
- male or female participants, between 18-75, with a diagnosis of moderate to severe Hidradenitis Suppurativa
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (77)
The University Of Alabama At Birmingham
Birmingham, Alabama, 35233, United States
The University of Alabama at Birmingham Hospital Outreach Lab
Birmingham, Alabama, 35249, United States
The University of Alabama at Birmingham Investigation Drug Services Pharmacy
Birmingham, Alabama, 35249, United States
The University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Mayo Clinic
Scottsdale, Arizona, 85259, United States
Center for Dermatology Clinical Research, Inc.
Fremont, California, 94538, United States
Pacific Clinical Trials
Long Beach, California, 90806, United States
Keck School of Medicine of University of Southern California
Los Angeles, California, 90033, United States
UCSF Dermatology Clinic
San Francisco, California, 94115, United States
University of California San Francisco
San Francisco, California, 94115, United States
UCSF Psoriasis and Skin Treatment Center
San Francisco, California, 94118, United States
Clinical Science Institute
Santa Monica, California, 90404, United States
New England Research Associates, LLC
Bridgeport, Connecticut, 06606, United States
Dermatology Physicians of Connecticut
Shelton, Connecticut, 06484, United States
Total Dermatology Care Center
Jacksonville, Florida, 32204, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Olympian Clinical Research Largo Office
Largo, Florida, 33770, United States
University of Miami Hospital
Miami, Florida, 33125, United States
Tory Sullivan MD PA
North Miami Beach, Florida, 33162, United States
Renstar Medical Research
Ocala, Florida, 34470, United States
MidState Skin Institute
Ocala, Florida, 34471, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
Park Avenue Dermatology
Orange Park, Florida, 32073, United States
Leavitt Medical Associates of Florida d/b/a Ameriderm Research
Ormond Beach, Florida, 32174, United States
Riverchase Dermatology and Cosmetic Surgery
Pembroke Pines, Florida, 33028, United States
ForCare Clinical Research
Tampa, Florida, 33613, United States
Alliance Clinical Research of Tampa
Tampa, Florida, 33615, United States
MedaPhase Inc.
Newnan, Georgia, 30263, United States
Advanced Medical Research PC
Sandy Springs, Georgia, 30328, United States
Georgia Skin Cancer and Aesthetic Dermatology
Watkinsville, Georgia, 30677, United States
NorthShore University HealthSystem Dermatology Clinic
Skokie, Illinois, 60077, United States
Ds Research
Clarksville, Indiana, 47129, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250, United States
DS Research
Louisville, Kentucky, 40241, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Boston University General Clinical Research Unit
Boston, Massachusetts, 02118, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Wayne State University / Integrative Biosciences Center
Detroit, Michigan, 48202, United States
Revival Research Institute, LLC
Troy, Michigan, 48084, United States
Clinical Research Unit
Minneapolis, Minnesota, 55455, United States
Lillihei Clinical Research Unit
Minneapolis, Minnesota, 55455, United States
University of Minnesota Department of Dermatology
Minneapolis, Minnesota, 55455, United States
MediSearch Clinical Trials
Saint Joseph, Missouri, 64506, United States
Saint Louis University - Department of Dermatology
St Louis, Missouri, 63110, United States
Skin Specialists PC
Omaha, Nebraska, 68144, United States
J Woodson Clinical Studies Group
Henderson, Nevada, 89052, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Vital Prospects Clinical Research Institute
Tulsa, Oklahoma, 74136, United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Penn State Health Radiology - University Physician Center
Hershey, Pennsylvania, 17033, United States
Paddington Testing Company, Inc
Philadelphia, Pennsylvania, 19103, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Dermatology and Skin Cancer Consultants
Humboldt, Tennessee, 38343, United States
Clinical Research Solutions
Jackson, Tennessee, 38305, United States
Dermatology and Skin Cancer Consultants
Jackson, Tennessee, 38305, United States
Arlington Research Center
Arlington, Texas, 76011, United States
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, 78660, United States
University of Utah MidValley Dermatology
Murray, Utah, 84107, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298, United States
Bellevue Dermatology Clinical Research Center
Bellevue, Washington, 98004, United States
Bellevue Dermatology Clinic
Bellevue, Washington, 98004, United States
Dermatology Associates of Seattle
Seattle, Washington, 98101, United States
Woden Dermatology
Phillip, Australian Capital Territory, 2606, Australia
Premier Specialists Pty Ltd
Kogarah, New South Wales, 2217, Australia
Holdsworth House Medical Practice
Sydney, New South Wales, 2010, Australia
Veracity Clinical Research
Woolloongabba, Queensland, 4102, Australia
Skin Health Institute Inc.
Carlton, Victoria, 3053, Australia
Sinclair Dermatology
East Melbourne, Victoria, 3002, Australia
SimcoDerm Medical and Surgical Dermatology Center
Barrie, Ontario, L4M 7G1, Canada
Manna Research (London)
London, Ontario, N6A 2C2, Canada
DermEffects
London, Ontario, N6H 5L5, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, K9J 5K2, Canada
The Centre for Dermatology
Richmond Hill, Ontario, L4B 1A5, Canada
Diex Recherche Sherbrooke Inc.
Sherbrooke, Quebec, J1L 0H8, Canada
Centre de Recherche Saint-Louis
Québec, G1W4R4, Canada
Alpha Recherche Clinique
Québec, G2J 0C4, Canada
Related Publications (1)
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.
PMID: 38335032DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2019
First Posted
September 17, 2019
Study Start
December 2, 2019
Primary Completion
January 10, 2022
Study Completion
January 10, 2022
Last Updated
June 15, 2023
Results First Posted
June 15, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will share
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.