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

• ClinicalTrials.gov Identifier: NCT04092452
• Recruitment Status: Completed
• First Posted: September 17, 2019
• Last Update Posted: July 12, 2022
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: September 15, 2019
• First Posted Date: September 17, 2019
• Last Update Posted Date: July 12, 2022
• Actual Study Start Date: December 2, 2019
• Actual Primary Completion Date: January 10, 2022 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 15, 2019): Percentage of participants with Hidradenitis Suppurativa Clinical Response (HiSCR) response [ Time Frame: Week 16 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 5, 2020)

• Percentage of participants with HiSCR response [ Time Frame: Weeks 1, 2, 4, 6, 8, and 12. ]
• Percentage of participants with a total abscess and inflammatory nodule (AN) count of 0 or 1; 0, 1, or 2 [ Time Frame: Week 16 ]
• Percentage of participants with ≥30% reduction and ≥1 unit reduction from baseline in Patient's Global Assessment (PGA) Skin Pain numeric rating scale (NRS30) - at worst and on average, respectively, amongst participants with baseline NRS >3 [ Time Frame: Weeks 1, 2, 4, 6, 8, 12 and 16. ]
• Percent CFB in NRS, at worst and on average respectively, in participants who have baseline NRS ≥3 [ Time Frame: Weeks 1, 2, 4, 6, 8, 12 and 16 ]
• Change From Baseline (CFB) in Numeric Rating Scale (NRS), at worst and on average [ Time Frame: Weeks 1, 2, 4, 6, 8, 12 and 16. ]
• Proportion of participants achieving erythema score of 1 or 0 in all affected anatomic regions among participants who have an erythema score of 2 or more in at least 1 anatomic region at baseline [ Time Frame: Week 16 ]
• Incidence of treatment emergent adverse events (adverse events and serious adverse events), significant changes in vital signs, clinical laboratory abnormalities, and electrocardiogram (ECG) [ Time Frame: baseline up to week 16 ]
• Absolute score and change from baseline (CFB) at time points specified in the SoA in HS Symptom Items and Dermatology Life Quality Index (DLQI) total score. [ Time Frame: Week 16 ]
• Proportion of participants achieving a Dermatology Life Quality Index (DLQI)=0 or 1 [ Time Frame: Week 16 ]
• Summary of plasma concentration of PF 06700841, PF 06826647 and PF 06650833 [ Time Frame: baseline up to week 16 ]
• Percent change from baseline (CFB) in AN count [ Time Frame: Weeks 1, 2, 4, 6, 8, 12 and 16 ]
• Absolute score and percent CFB in International Hidradenitis Suppurativa Severity Score System (IHS4). [ Time Frame: Weeks 1, 2, 4, 6, 8, 12 and 16 ]
• Proportion of participants who experience an HS flare, defined as at least a 25% increase in AN count with a minimum increase of 2 relative to Baseline [ Time Frame: Weeks 4, 8, 12 and 16 ]

Original Secondary Outcome Measures (submitted: September 15, 2019)

• Percentage of participants with HiSCR response [ Time Frame: Weeks 1, 2, 4, 6, 8, and 12. ]
• Percentage of participants with a total abscess and inflammatory nodule (AN) count of 0 or 1; 0, 1, or 2 [ Time Frame: Week 16 ]
• Percentage of participants with ≥30% reduction and ≥1 unit reduction from baseline in Patient's Global Assessment (PGA) Skin Pain numeric rating scale (NRS30) - at worst and on average, respectively, amongst participants with baseline NRS >3 [ Time Frame: Weeks 1, 2, 4, 6, 8, 12 and 16. ]
• Percent CFB in NRS, at worst and on average respectively, in participants who have baseline NRS ≥3 [ Time Frame: Weeks 1, 2, 4, 6, 8, 12 and 16 ]
• Change From Baseline (CFB) in Numeric Rating Scale (NRS), at worst and on average [ Time Frame: Weeks 1, 2, 4, 6, 8, 12 and 16. ]
• Proportion of participants achieving erythema score of 1 or 0 in all affected anatomic regions among participants who have an erythema score of 2 or more in at least 1 anatomic region at baseline [ Time Frame: Week 16 ]
• Incidence of treatment emergent adverse events (adverse events and serious adverse events), significant changes in vital signs, clinical laboratory abnormalities, and electrocardiogram (ECG) [ Time Frame: baseline up to week 16 ]
• Absolute score and change from baseline (CFB) at time points specified in the SoA in HS Symptom Items and Dermatology Life Quality Index (DLQI) total score. [ Time Frame: Week 16 ]
• Proportion of participants achieving a Dermatology Life Quality Index (DLQI)=0 or 1 [ Time Frame: Week 16 ]
• Summary of plasma concentration of PF 06700841, PF 06826647 and PF 06650833 [ Time Frame: baseline up to week 16 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The treatment period is a parallel design

Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

• Condition: Acne Inversa

Intervention

• Drug: PF-06650833
  400 mg QD
• Drug: PF-06700841
  45 mg QD
• Drug: PF-06826647
  400 mg QD
• Drug: Placebo
  placebo

Study Arms

• Experimental: Cohort 1
  PF-06650833
  Intervention: Drug: PF-06650833
• Experimental: Cohort 2
  PF-6700841
  Intervention: Drug: PF-06700841
• Experimental: Cohort 3
  PF-06826647
  Intervention: Drug: PF-06826647
• Placebo Comparator: Cohort placebo
  placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 17, 2022): 194
• Original Estimated Enrollment (submitted: September 15, 2019): 192
• Actual Study Completion Date: January 10, 2022
• Actual Primary Completion Date: January 10, 2022 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Canada, United States

Administrative Information

• NCT Number: NCT04092452
• Other Study ID Numbers: C2501007
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: Yes
• 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.
• URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

• Current Responsible Party: Pfizer
• Original Responsible Party: Same as current
• Current Study Sponsor: Pfizer
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: July 2022