Clinical trial NCT04092452: A Study to Evaluate the Safety and Efficacy of PF-06650833, PF-06700841, and PF 06826647 in Adults With Hidradenitis Suppurativa
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Inversa
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-09-17
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The treatment period is a parallel design
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16- Minimum Risk (MR) [Full Analysis Set (FAS), Non-responder Imputation (NRI)].
timeFrame: At week 16
Secondary outcomes:
measure: Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, NRI).
timeFrame: At weeks 1, 2, 4, 6, 8, and 12
measure: 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).
timeFrame: At week 16
measure: 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)].
timeFrame: At weeks 1, 2, 4, 6, 8, 12 and 16
measure: 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).
timeFrame: At weeks 1, 2, 4, 6, 8, 12 and 16
measure: 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).
timeFrame: At weeks 1, 2, 4, 6, 8, 12 and 16
measure: Percentage of Participants Who Experienced a Hidradenitis Suppurativa (HS) Flare at Weeks 4, 8, 12 and 16 - MR [FAS, Only Observed Data (OBS)].
timeFrame: At weeks 4, 8, 12 and 16
measure: Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI)
timeFrame: At weeks 1, 2, 4, 6, 8, 12 and 16
measure: Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI)
timeFrame: At weeks 1, 2, 4, 6, 8, 12 and 16
measure: Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI)
timeFrame: At weeks 1, 2, 4, 6, 8, 12 and 16
measure: Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI)
timeFrame: At weeks 1, 2, 4, 6, 8, 12 and 16
measure: Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI)
timeFrame: At weeks 1, 2, 4, 6, 8, 12 and 16
measure: Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI)
timeFrame: At weeks 1, 2, 4, 6, 8, 12 and 16
measure: Percentage of Participants Achieving Erythema Response Among Participants With Baseline Erythema Score ≥2 in at Least 1 Region at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS, NRI)
timeFrame: At weeks 1, 2, 4, 6, 8, 12 and 16
measure: Number of Participants With Treatment-Emergent Adverse Events (All Causalities)
timeFrame: Up to 20 weeks
measure: Number of Participants With Treatment-Emergent Adverse Events (Treatment Related)
timeFrame: Up to 20 weeks
measure: Number of Participants With Incidence of Post-baseline Vital Signs of Clinical Concern - Increase From Baseline (Safety Analysis Set)
timeFrame: Up to 20 weeks
measure: Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set)
timeFrame: Up to 20 weeks
measure: Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set)
timeFrame: Up to 20 weeks
measure: Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS)
timeFrame: At weeks 1, 2, 4, 6, 8, 12 and 16
measure: Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS)
timeFrame: At weeks 1, 2, 4, 6, 8, 12 and 16
measure: Least Squares Mean of Absolute Score in Dermatology Life Quality Index (DLQI) Total Score up to Week 16 - MMRM (FAS, OBS)
timeFrame: At weeks 4, 8, 12 and 16
measure: Least Squares Mean of Change From Baseline in DLQI Total Score up to Week 16 - MMRM (FAS, OBS)
timeFrame: At weeks 4, 8, 12 and 16
measure: Percentage of Participants Achieving DLQI Total Score of 0 or 1 up to Week 16 - MR (FAS With Baseline >1, NRI)
timeFrame: At weeks 4, 8, 12 and 16
measure: Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set)
timeFrame: At weeks 1, 2, 4, 6, 8, 12 and 16
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University Of Alabama At Birmingham
state: Alabama
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham Hospital Outreach Lab
state: Alabama
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham Investigation Drug Services Pharmacy
state: Alabama
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research, Inc.
state: California
city: Long Beach
country: United States
facility: Pacific Clinical Trials
state: California
city: Los Angeles
country: United States
facility: Keck School of Medicine of University of Southern California
state: California
city: San Francisco
country: United States
facility: UCSF Dermatology Clinic
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: San Francisco
country: United States
facility: UCSF Psoriasis and Skin Treatment Center
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Bridgeport
country: United States
facility: New England Research Associates, LLC
state: Connecticut
city: Shelton
country: United States
facility: Dermatology Physicians of Connecticut
state: Connecticut
city: Jacksonville
country: United States
facility: Total Dermatology Care Center
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Largo
country: United States
facility: Olympian Clinical Research Largo Office
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
city: North Miami Beach
country: United States
facility: Tory Sullivan MD PA
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Ocala
country: United States
facility: MidState Skin Institute
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orange Park
country: United States
facility: Park Avenue Dermatology
state: Florida
city: Ormond Beach
country: United States
facility: Leavitt Medical Associates of Florida d/b/a Ameriderm Research
state: Florida
city: Pembroke Pines
country: United States
facility: Riverchase Dermatology and Cosmetic Surgery
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Tampa
country: United States
facility: Alliance Clinical Research of Tampa
state: Florida
city: Newnan
country: United States
facility: MedaPhase Inc.
state: Georgia
city: Sandy Springs
country: United States
facility: Advanced Medical Research PC
state: Georgia
city: Watkinsville
country: United States
facility: Georgia Skin Cancer and Aesthetic Dermatology
state: Georgia
city: Skokie
country: United States
facility: NorthShore University HealthSystem Dermatology Clinic
state: Illinois
city: Clarksville
country: United States
facility: Ds Research
state: Indiana
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Louisville
country: United States
facility: DS Research
state: Kentucky
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Boston University General Clinical Research Unit
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University / Integrative Biosciences Center
state: Michigan
city: Troy
country: United States
facility: Revival Research Institute, LLC
state: Michigan
city: Minneapolis
country: United States
facility: Clinical Research Unit
state: Minnesota
city: Minneapolis
country: United States
facility: Lillihei Clinical Research Unit
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota Department of Dermatology
state: Minnesota
city: Saint Joseph
country: United States
facility: MediSearch Clinical Trials
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University - Department of Dermatology
state: Missouri
city: Omaha
country: United States
facility: Skin Specialists PC
state: Nebraska
city: Henderson
country: United States
facility: J Woodson Clinical Studies Group
state: Nevada
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute
state: Oklahoma
city: Hershey
country: United States
facility: Penn State Health Milton S. Hershey Medical Center
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Health Radiology - University Physician Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Paddington Testing Company, Inc
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Humboldt
country: United States
facility: Dermatology and Skin Cancer Consultants
state: Tennessee
city: Jackson
country: United States
facility: Clinical Research Solutions
state: Tennessee
city: Jackson
country: United States
facility: Dermatology and Skin Cancer Consultants
state: Tennessee
city: Arlington
country: United States
facility: Arlington Research Center
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research, Inc.
state: Texas
city: Murray
country: United States
facility: University of Utah MidValley Dermatology
state: Utah
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
city: Bellevue
country: United States
facility: Bellevue Dermatology Clinical Research Center
state: Washington
city: Bellevue
country: United States
facility: Bellevue Dermatology Clinic
state: Washington
city: Seattle
country: United States
facility: Dermatology Associates of Seattle
state: Washington
city: Phillip
country: Australia
facility: Woden Dermatology
state: Australian Capital Territory
city: Kogarah
country: Australia
facility: Premier Specialists Pty Ltd
state: New South Wales
city: Sydney
country: Australia
facility: Holdsworth House Medical Practice
state: New South Wales
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research
state: Queensland
city: Carlton
country: Australia
facility: Skin Health Institute Inc.
state: Victoria
city: East Melbourne
country: Australia
facility: Sinclair Dermatology
state: Victoria
city: Barrie
country: Canada
facility: SimcoDerm Medical and Surgical Dermatology Center
state: Ontario
city: London
country: Canada
facility: Manna Research (London)
state: Ontario
city: London
country: Canada
facility: DermEffects
state: Ontario
city: Peterborough
country: Canada
facility: SKiN Centre for Dermatology
state: Ontario
city: Richmond Hill
country: Canada
facility: The Centre for Dermatology
state: Ontario
city: Sherbrooke
country: Canada
facility: Diex Recherche Sherbrooke Inc.
state: Quebec
city: Quebec
country: Canada
facility: Centre de Recherche Saint-Louis
city: Quebec
country: Canada
facility: Alpha Recherche Clinique
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: