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

Primary Purpose

Acne Inversa

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PF-06650833
PF-06700841
PF-06826647
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Inversa

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • The University Of Alabama At Birmingham
  • The University of Alabama at Birmingham Hospital Outreach Lab
  • The University of Alabama at Birmingham Investigation Drug Services Pharmacy
  • The University of Alabama at Birmingham
  • Mayo Clinic
  • Center for Dermatology Clinical Research, Inc.
  • Pacific Clinical Trials
  • Keck School of Medicine of University of Southern California
  • UCSF Dermatology Clinic
  • University of California San Francisco
  • UCSF Psoriasis and Skin Treatment Center
  • Clinical Science Institute
  • New England Research Associates, LLC
  • Dermatology Physicians of Connecticut
  • Total Dermatology Care Center
  • Jacksonville Center for Clinical Research
  • Olympian Clinical Research Largo Office
  • University of Miami Hospital
  • Tory Sullivan MD PA
  • Renstar Medical Research
  • MidState Skin Institute
  • Renstar Medical Research
  • Park Avenue Dermatology
  • Leavitt Medical Associates of Florida d/b/a Ameriderm Research
  • Riverchase Dermatology and Cosmetic Surgery
  • ForCare Clinical Research
  • Alliance Clinical Research of Tampa
  • MedaPhase Inc.
  • Advanced Medical Research PC
  • Georgia Skin Cancer and Aesthetic Dermatology
  • NorthShore University HealthSystem Dermatology Clinic
  • Ds Research
  • Dawes Fretzin Clinical Research Group, LLC
  • DS Research
  • Boston Medical Center
  • Boston University General Clinical Research Unit
  • Beth Israel Deaconess Medical Center
  • Wayne State University / Integrative Biosciences Center
  • Revival Research Institute, LLC
  • Clinical Research Unit
  • Lillihei Clinical Research Unit
  • University of Minnesota Department of Dermatology
  • MediSearch Clinical Trials
  • Saint Louis University - Department of Dermatology
  • Skin Specialists PC
  • J Woodson Clinical Studies Group
  • Icahn School of Medicine at Mount Sinai
  • Vital Prospects Clinical Research Institute
  • Penn State Health Milton S. Hershey Medical Center
  • Penn State Health Radiology - University Physician Center
  • Paddington Testing Company, Inc
  • Thomas Jefferson University Hospital
  • Thomas Jefferson University
  • Dermatology and Skin Cancer Consultants
  • Clinical Research Solutions
  • Dermatology and Skin Cancer Consultants
  • Arlington Research Center
  • Austin Institute for Clinical Research, Inc.
  • University of Utah MidValley Dermatology
  • Virginia Commonwealth University Medical Center
  • Bellevue Dermatology Clinical Research Center
  • Bellevue Dermatology Clinic
  • Dermatology Associates of Seattle
  • Woden Dermatology
  • Premier Specialists Pty Ltd
  • Holdsworth House Medical Practice
  • Veracity Clinical Research
  • Skin Health Institute Inc.
  • Sinclair Dermatology
  • SimcoDerm Medical and Surgical Dermatology Center
  • Manna Research (London)
  • DermEffects
  • SKiN Centre for Dermatology
  • The Centre for Dermatology
  • Diex Recherche Sherbrooke Inc.
  • Centre de Recherche Saint-Louis
  • Alpha Recherche Clinique

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort placebo

Arm Description

PF-06650833

PF-6700841

PF-06826647

placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, 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.
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).
This estimand was intended to provide difference between treated and placebo in percentage of participants with a total AN count of 0 or 1, or 0, 1 or 2, respectively at week 16. Confidence interval (CI) was calculated using Blyth-Still-Casella method.
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)].
The analysis of covariance (ANCOVA) model was implemented for statistical testing, which included terms of treatment group, the stratification factors, and the baseline value as the independent variable.
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).
The IHS4 score was calculated by the number of nodules, the number of abscesses, and the number of draining tunnels. IHS4 score = (number of nodules × 1) + (number of abscesses × 2) + {number of draining tunnels (fistulae/sinuses) × 4}. Confidence interval (CI) was calculated using Blyth-Still-Casella method. Lower IHS4 absolute scores mean a better outcome.
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).
The IHS4 score was calculated by the number of nodules, the number of abscesses, and the number of draining tunnels. IHS4 score = (number of nodules × 1) + (number of abscesses × 2) + {number of draining tunnels (fistulae/sinuses) × 4}. Confidence interval (CI) was calculated using Blyth-Still-Casella method. Lower IHS4 absolute scores mean a better outcome.
Percentage of Participants Who Experienced a Hidradenitis Suppurativa (HS) Flare at Weeks 4, 8, 12 and 16 - MR [FAS, Only Observed Data (OBS)].
HS flare was defined as at least a 25% increase in AN count with a minimum increase of 2 relative to Baseline. Confidence interval (CI) was calculated using Blyth-Still-Casella method.
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)
The rate comparing treatment and placebo groups at each visit was analyzed using CMH test with MR weighting strategy between each of active treatment group and placebo. Confidence interval (CI) was calculated using Blyth-Still-Casella method. NRS30 was defined as ≥30% reduction and ≥1 unit reduction from baseline in Patient's Global Assessment (PGA) Skin Pain NRS. The range of skin pain was from 0 to 10. Lower IHS4 absolute scores mean a better outcome. Baseline was defined as the average of all values recorded between Day -6 and Day 1. Weekly data were average values of daily observations over 7 days. NRI (non-responder imputation) for missing values which were related to withdrawal and all other events except for COVID-19.
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)
The rate comparing treatment and placebo groups at each visit was analyzed using CMH test with MR weighting strategy between each of active treatment group and placebo. Confidence interval (CI) was calculated using Blyth-Still-Casella method. NRS30 was defined as ≥30% reduction and ≥1 unit reduction from baseline in Patient's Global Assessment (PGA) Skin Pain NRS. The range of skin pain was from 0 to 10. Lower IHS4 absolute scores mean a better outcome. Baseline was defined as the average of all values recorded between Day -6 and Day 1. Weekly data were average values of daily observations over 7 days. NRI (non-responder imputation) for missing values which were related to withdrawal and all other events except for COVID-19.
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)
Patient Global Assessment Skin Pain Numeric Rating Scale was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). These two concepts were measured within the same instrument, but were scored separately. There was no composite score for this endpoint. The higher the score, the worse the outcomes, ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). Subscales were not combined. The ANCOVA model was fitted. Confidence interval (CI) was calculated using Blyth-Still-Casella method.
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)
Patient Global Assessment Skin Pain Numeric Rating Scale was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). These two concepts were measured within the same instrument, but were scored separately. There was no composite score for this endpoint. The higher the score, the worse the outcomes, ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). Subscales were not combined. The ANCOVA model was fitted. Confidence interval (CI) was calculated using Blyth-Still-Casella method.
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)
Patient Global Assessment Skin Pain Numeric Rating Scale was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). These two concepts were measured within the same instrument, but were scored separately. There was no composite score for this endpoint. The higher the score, the worse the outcomes, ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). Subscales were not combined. The ANCOVA model was fitted. Confidence interval (CI) was calculated using Blyth-Still-Casella method.
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)
Patient Global Assessment Skin Pain Numeric Rating Scale was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). These two concepts were measured within the same instrument, but were scored separately. There was no composite score for this endpoint. The higher the score, the worse the outcomes, ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). Subscales were not combined. The ANCOVA model was fitted. Confidence interval (CI) was calculated using Blyth-Still-Casella method.
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)
Erythema response was defined as achieving erythema score of 1 or 0 in all affected anatomic regions among participants who had an erythema score of 2 or more in at least 1 anatomic region at baseline. NRI for missing values which were related to withdrawal and all other events except for COVID-19. A four-point ordinal scale ranging was used: 0 (no redness), 1 (faint but discernible pink coloration), 2 (moderate red coloration), and 3 (very red or bright red coloration).
Number of Participants With Treatment-Emergent Adverse Events (All Causalities)
The treatment-emergent AEs (TEAEs) were considered as an adverse event that started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the last dose plus the lag time was flagged as TEAEs.
Number of Participants With Treatment-Emergent Adverse Events (Treatment Related)
The treatment-emergent AEs (TEAEs) were considered as an adverse event that started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the last dose plus the lag time was flagged as TEAEs.
Number of Participants With Incidence of Post-baseline Vital Signs of Clinical Concern - Increase From Baseline (Safety Analysis Set)
The vital signs were measured included temperature (Oral, Tympanic, Axillary or Temporal), pulse rate (beats/min) and blood pressure (mmHg).
Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set)
Laboratory test abnormalities included hematology, chemistry, urinalysis and biomarker.
Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set)
ECG parameters included QT interval, QTc interval, PR interval, and QRS complex.
Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS)
The Hidradenitis Suppurativa Symptom Items were 5 single items that assessed patient self-reported symptoms related to HS. The participants were asked to rate each symptom on a 0 to 10 numerical rating scale, with 0 indicating no symptom experience and 10 indicating the worst possible symptom. The symptoms assessed include: pain, tenderness, swelling, tiredness, and bother of lesion appearance. The higher the score, the worse the outcomes, ranging from 0 indicating no symptom experience and 10 indicating the worst possible symptom. These concepts were scored separately, and were not combined into a composite score. When using mixed effect model repeated measurement (MMRM) analysis, only observed data were used and missing data were not imputed.
Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS)
The Hidradenitis Suppurativa Symptom Items were 5 single items that assessed patient self-reported symptoms related to HS. The participants were asked to rate each symptom on a 0 to 10 numerical rating scale, with 0 indicating no symptom experience and 10 indicating the worst possible symptom. The symptoms assessed include: pain, tenderness, swelling, tiredness, and bother of lesion appearance. The higher the score, the worse the outcomes, ranging from 0 indicating no symptom experience and 10 indicating the worst possible symptom. These concepts were scored separately, and were not combined into a composite score. When using mixed effect model repeated measurement (MMRM) analysis, only observed data were used and missing data were not imputed.
Least Squares Mean of Absolute Score in Dermatology Life Quality Index (DLQI) Total Score up to Week 16 - MMRM (FAS, OBS)
The Dermatology Life Quality Index (DLQI) is a general dermatology questionnaire that consists of 10 items that assess patient health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment) over the last week. Scoring for each item is on a qualitative 0 to 3 scale, with options of "Not at all", "A little", "A lot", "Very much". The scores are added up to a total composite score with the range from the minimum score of 0 to the maximum score of 30. The higher the score, the worse the outcomes.
Least Squares Mean of Change From Baseline in DLQI Total Score up to Week 16 - MMRM (FAS, OBS)
The Dermatology Life Quality Index (DLQI) is a general dermatology questionnaire that consists of 10 items that assess patient health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment) over the last week. Scoring for each item is on a qualitative 0 to 3 scale, with options of "Not at all", "A little", "A lot", "Very much". The scores are added up to a total composite score with the range from the minimum score of 0 to the maximum score of 30. The higher the score, the worse the outcomes. The assessments examined a change from baseline in total score, where negative value means improvement in DLQI.
Percentage of Participants Achieving DLQI Total Score of 0 or 1 up to Week 16 - MR (FAS With Baseline >1, NRI)
The Dermatology Life Quality Index (DLQI) is a general dermatology questionnaire that consists of 10 items that assess patient health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment) over the last week. Scoring for each item is on a qualitative 0 to 3 scale, with options of "Not at all", "A little", "A lot", "Very much". The scores are added up to a total composite score with the range from the minimum score of 0 to the maximum score of 30. The higher the score, the worse the outcomes. The assessments examined the percentage of patients with complete resolution of dermatology specific quality of life impact, as assessed by a total score of ≤ 1 (range: 0 - 30), where higher percentage indicates better improvement in DLQI.
Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set)
In summary statistics for pharmacokinetic, concentration values below the lower limit of quantification (LLOQ) was set to zero.

Full Information

First Posted
September 15, 2019
Last Updated
May 19, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT04092452
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 2, 2019 (Actual)
Primary Completion Date
January 10, 2022 (Actual)
Study Completion Date
January 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Inversa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
The treatment period is a parallel design
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
194 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
PF-06650833
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
PF-6700841
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
PF-06826647
Arm Title
Cohort placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
PF-06650833
Intervention Description
400 mg QD
Intervention Type
Drug
Intervention Name(s)
PF-06700841
Intervention Description
45 mg QD
Intervention Type
Drug
Intervention Name(s)
PF-06826647
Intervention Description
400 mg QD
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16- Minimum Risk (MR) [Full Analysis Set (FAS), Non-responder Imputation (NRI)].
Description
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.
Time Frame
At week 16
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, NRI).
Description
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.
Time Frame
At weeks 1, 2, 4, 6, 8, and 12
Title
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).
Description
This estimand was intended to provide difference between treated and placebo in percentage of participants with a total AN count of 0 or 1, or 0, 1 or 2, respectively at week 16. Confidence interval (CI) was calculated using Blyth-Still-Casella method.
Time Frame
At week 16
Title
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)].
Description
The analysis of covariance (ANCOVA) model was implemented for statistical testing, which included terms of treatment group, the stratification factors, and the baseline value as the independent variable.
Time Frame
At weeks 1, 2, 4, 6, 8, 12 and 16
Title
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).
Description
The IHS4 score was calculated by the number of nodules, the number of abscesses, and the number of draining tunnels. IHS4 score = (number of nodules × 1) + (number of abscesses × 2) + {number of draining tunnels (fistulae/sinuses) × 4}. Confidence interval (CI) was calculated using Blyth-Still-Casella method. Lower IHS4 absolute scores mean a better outcome.
Time Frame
At weeks 1, 2, 4, 6, 8, 12 and 16
Title
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).
Description
The IHS4 score was calculated by the number of nodules, the number of abscesses, and the number of draining tunnels. IHS4 score = (number of nodules × 1) + (number of abscesses × 2) + {number of draining tunnels (fistulae/sinuses) × 4}. Confidence interval (CI) was calculated using Blyth-Still-Casella method. Lower IHS4 absolute scores mean a better outcome.
Time Frame
At weeks 1, 2, 4, 6, 8, 12 and 16
Title
Percentage of Participants Who Experienced a Hidradenitis Suppurativa (HS) Flare at Weeks 4, 8, 12 and 16 - MR [FAS, Only Observed Data (OBS)].
Description
HS flare was defined as at least a 25% increase in AN count with a minimum increase of 2 relative to Baseline. Confidence interval (CI) was calculated using Blyth-Still-Casella method.
Time Frame
At weeks 4, 8, 12 and 16
Title
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)
Description
The rate comparing treatment and placebo groups at each visit was analyzed using CMH test with MR weighting strategy between each of active treatment group and placebo. Confidence interval (CI) was calculated using Blyth-Still-Casella method. NRS30 was defined as ≥30% reduction and ≥1 unit reduction from baseline in Patient's Global Assessment (PGA) Skin Pain NRS. The range of skin pain was from 0 to 10. Lower IHS4 absolute scores mean a better outcome. Baseline was defined as the average of all values recorded between Day -6 and Day 1. Weekly data were average values of daily observations over 7 days. NRI (non-responder imputation) for missing values which were related to withdrawal and all other events except for COVID-19.
Time Frame
At weeks 1, 2, 4, 6, 8, 12 and 16
Title
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)
Description
The rate comparing treatment and placebo groups at each visit was analyzed using CMH test with MR weighting strategy between each of active treatment group and placebo. Confidence interval (CI) was calculated using Blyth-Still-Casella method. NRS30 was defined as ≥30% reduction and ≥1 unit reduction from baseline in Patient's Global Assessment (PGA) Skin Pain NRS. The range of skin pain was from 0 to 10. Lower IHS4 absolute scores mean a better outcome. Baseline was defined as the average of all values recorded between Day -6 and Day 1. Weekly data were average values of daily observations over 7 days. NRI (non-responder imputation) for missing values which were related to withdrawal and all other events except for COVID-19.
Time Frame
At weeks 1, 2, 4, 6, 8, 12 and 16
Title
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)
Description
Patient Global Assessment Skin Pain Numeric Rating Scale was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). These two concepts were measured within the same instrument, but were scored separately. There was no composite score for this endpoint. The higher the score, the worse the outcomes, ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). Subscales were not combined. The ANCOVA model was fitted. Confidence interval (CI) was calculated using Blyth-Still-Casella method.
Time Frame
At weeks 1, 2, 4, 6, 8, 12 and 16
Title
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)
Description
Patient Global Assessment Skin Pain Numeric Rating Scale was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). These two concepts were measured within the same instrument, but were scored separately. There was no composite score for this endpoint. The higher the score, the worse the outcomes, ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). Subscales were not combined. The ANCOVA model was fitted. Confidence interval (CI) was calculated using Blyth-Still-Casella method.
Time Frame
At weeks 1, 2, 4, 6, 8, 12 and 16
Title
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)
Description
Patient Global Assessment Skin Pain Numeric Rating Scale was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). These two concepts were measured within the same instrument, but were scored separately. There was no composite score for this endpoint. The higher the score, the worse the outcomes, ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). Subscales were not combined. The ANCOVA model was fitted. Confidence interval (CI) was calculated using Blyth-Still-Casella method.
Time Frame
At weeks 1, 2, 4, 6, 8, 12 and 16
Title
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)
Description
Patient Global Assessment Skin Pain Numeric Rating Scale was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). These two concepts were measured within the same instrument, but were scored separately. There was no composite score for this endpoint. The higher the score, the worse the outcomes, ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). Subscales were not combined. The ANCOVA model was fitted. Confidence interval (CI) was calculated using Blyth-Still-Casella method.
Time Frame
At weeks 1, 2, 4, 6, 8, 12 and 16
Title
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)
Description
Erythema response was defined as achieving erythema score of 1 or 0 in all affected anatomic regions among participants who had an erythema score of 2 or more in at least 1 anatomic region at baseline. NRI for missing values which were related to withdrawal and all other events except for COVID-19. A four-point ordinal scale ranging was used: 0 (no redness), 1 (faint but discernible pink coloration), 2 (moderate red coloration), and 3 (very red or bright red coloration).
Time Frame
At weeks 1, 2, 4, 6, 8, 12 and 16
Title
Number of Participants With Treatment-Emergent Adverse Events (All Causalities)
Description
The treatment-emergent AEs (TEAEs) were considered as an adverse event that started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the last dose plus the lag time was flagged as TEAEs.
Time Frame
Up to 20 weeks
Title
Number of Participants With Treatment-Emergent Adverse Events (Treatment Related)
Description
The treatment-emergent AEs (TEAEs) were considered as an adverse event that started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the last dose plus the lag time was flagged as TEAEs.
Time Frame
Up to 20 weeks
Title
Number of Participants With Incidence of Post-baseline Vital Signs of Clinical Concern - Increase From Baseline (Safety Analysis Set)
Description
The vital signs were measured included temperature (Oral, Tympanic, Axillary or Temporal), pulse rate (beats/min) and blood pressure (mmHg).
Time Frame
Up to 20 weeks
Title
Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set)
Description
Laboratory test abnormalities included hematology, chemistry, urinalysis and biomarker.
Time Frame
Up to 20 weeks
Title
Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set)
Description
ECG parameters included QT interval, QTc interval, PR interval, and QRS complex.
Time Frame
Up to 20 weeks
Title
Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS)
Description
The Hidradenitis Suppurativa Symptom Items were 5 single items that assessed patient self-reported symptoms related to HS. The participants were asked to rate each symptom on a 0 to 10 numerical rating scale, with 0 indicating no symptom experience and 10 indicating the worst possible symptom. The symptoms assessed include: pain, tenderness, swelling, tiredness, and bother of lesion appearance. The higher the score, the worse the outcomes, ranging from 0 indicating no symptom experience and 10 indicating the worst possible symptom. These concepts were scored separately, and were not combined into a composite score. When using mixed effect model repeated measurement (MMRM) analysis, only observed data were used and missing data were not imputed.
Time Frame
At weeks 1, 2, 4, 6, 8, 12 and 16
Title
Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS)
Description
The Hidradenitis Suppurativa Symptom Items were 5 single items that assessed patient self-reported symptoms related to HS. The participants were asked to rate each symptom on a 0 to 10 numerical rating scale, with 0 indicating no symptom experience and 10 indicating the worst possible symptom. The symptoms assessed include: pain, tenderness, swelling, tiredness, and bother of lesion appearance. The higher the score, the worse the outcomes, ranging from 0 indicating no symptom experience and 10 indicating the worst possible symptom. These concepts were scored separately, and were not combined into a composite score. When using mixed effect model repeated measurement (MMRM) analysis, only observed data were used and missing data were not imputed.
Time Frame
At weeks 1, 2, 4, 6, 8, 12 and 16
Title
Least Squares Mean of Absolute Score in Dermatology Life Quality Index (DLQI) Total Score up to Week 16 - MMRM (FAS, OBS)
Description
The Dermatology Life Quality Index (DLQI) is a general dermatology questionnaire that consists of 10 items that assess patient health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment) over the last week. Scoring for each item is on a qualitative 0 to 3 scale, with options of "Not at all", "A little", "A lot", "Very much". The scores are added up to a total composite score with the range from the minimum score of 0 to the maximum score of 30. The higher the score, the worse the outcomes.
Time Frame
At weeks 4, 8, 12 and 16
Title
Least Squares Mean of Change From Baseline in DLQI Total Score up to Week 16 - MMRM (FAS, OBS)
Description
The Dermatology Life Quality Index (DLQI) is a general dermatology questionnaire that consists of 10 items that assess patient health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment) over the last week. Scoring for each item is on a qualitative 0 to 3 scale, with options of "Not at all", "A little", "A lot", "Very much". The scores are added up to a total composite score with the range from the minimum score of 0 to the maximum score of 30. The higher the score, the worse the outcomes. The assessments examined a change from baseline in total score, where negative value means improvement in DLQI.
Time Frame
At weeks 4, 8, 12 and 16
Title
Percentage of Participants Achieving DLQI Total Score of 0 or 1 up to Week 16 - MR (FAS With Baseline >1, NRI)
Description
The Dermatology Life Quality Index (DLQI) is a general dermatology questionnaire that consists of 10 items that assess patient health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment) over the last week. Scoring for each item is on a qualitative 0 to 3 scale, with options of "Not at all", "A little", "A lot", "Very much". The scores are added up to a total composite score with the range from the minimum score of 0 to the maximum score of 30. The higher the score, the worse the outcomes. The assessments examined the percentage of patients with complete resolution of dermatology specific quality of life impact, as assessed by a total score of ≤ 1 (range: 0 - 30), where higher percentage indicates better improvement in DLQI.
Time Frame
At weeks 4, 8, 12 and 16
Title
Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set)
Description
In summary statistics for pharmacokinetic, concentration values below the lower limit of quantification (LLOQ) was set to zero.
Time Frame
At weeks 1, 2, 4, 6, 8, 12 and 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
The University Of Alabama At Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
The University of Alabama at Birmingham Hospital Outreach Lab
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
The University of Alabama at Birmingham Investigation Drug Services Pharmacy
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
The University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Center for Dermatology Clinical Research, Inc.
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Pacific Clinical Trials
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Keck School of Medicine of University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCSF Dermatology Clinic
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
UCSF Psoriasis and Skin Treatment Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
Clinical Science Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
New England Research Associates, LLC
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
Dermatology Physicians of Connecticut
City
Shelton
State/Province
Connecticut
ZIP/Postal Code
06484
Country
United States
Facility Name
Total Dermatology Care Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Olympian Clinical Research Largo Office
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
University of Miami Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Tory Sullivan MD PA
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
MidState Skin Institute
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Park Avenue Dermatology
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
Leavitt Medical Associates of Florida d/b/a Ameriderm Research
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Riverchase Dermatology and Cosmetic Surgery
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
ForCare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Alliance Clinical Research of Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Facility Name
MedaPhase Inc.
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
Advanced Medical Research PC
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Georgia Skin Cancer and Aesthetic Dermatology
City
Watkinsville
State/Province
Georgia
ZIP/Postal Code
30677
Country
United States
Facility Name
NorthShore University HealthSystem Dermatology Clinic
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Ds Research
City
Clarksville
State/Province
Indiana
ZIP/Postal Code
47129
Country
United States
Facility Name
Dawes Fretzin Clinical Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
DS Research
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Boston University General Clinical Research Unit
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Wayne State University / Integrative Biosciences Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Revival Research Institute, LLC
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
Clinical Research Unit
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Lillihei Clinical Research Unit
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
University of Minnesota Department of Dermatology
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
MediSearch Clinical Trials
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Saint Louis University - Department of Dermatology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Skin Specialists PC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
J Woodson Clinical Studies Group
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Vital Prospects Clinical Research Institute
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Penn State Health Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Penn State Health Radiology - University Physician Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Paddington Testing Company, Inc
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Dermatology and Skin Cancer Consultants
City
Humboldt
State/Province
Tennessee
ZIP/Postal Code
38343
Country
United States
Facility Name
Clinical Research Solutions
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Dermatology and Skin Cancer Consultants
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Arlington Research Center
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
Austin Institute for Clinical Research, Inc.
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
University of Utah MidValley Dermatology
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Virginia Commonwealth University Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Bellevue Dermatology Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Bellevue Dermatology Clinic
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Dermatology Associates of Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Woden Dermatology
City
Phillip
State/Province
Australian Capital Territory
ZIP/Postal Code
2606
Country
Australia
Facility Name
Premier Specialists Pty Ltd
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Holdsworth House Medical Practice
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Veracity Clinical Research
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Skin Health Institute Inc.
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Facility Name
Sinclair Dermatology
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
SimcoDerm Medical and Surgical Dermatology Center
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Facility Name
Manna Research (London)
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 2C2
Country
Canada
Facility Name
DermEffects
City
London
State/Province
Ontario
ZIP/Postal Code
N6H 5L5
Country
Canada
Facility Name
SKiN Centre for Dermatology
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Facility Name
The Centre for Dermatology
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4B 1A5
Country
Canada
Facility Name
Diex Recherche Sherbrooke Inc.
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1L 0H8
Country
Canada
Facility Name
Centre de Recherche Saint-Louis
City
Quebec
ZIP/Postal Code
G1W4R4
Country
Canada
Facility Name
Alpha Recherche Clinique
City
Quebec
ZIP/Postal Code
G2J 0C4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C2501007
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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