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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04092452
Recruitment Status : Completed
First Posted : September 17, 2019
Last Update Posted : July 12, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acne Inversa Drug: PF-06650833 Drug: PF-06700841 Drug: PF-06826647 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 194 participants
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
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
Actual Study Start Date : December 2, 2019
Actual Primary Completion Date : January 10, 2022
Actual Study Completion Date : January 10, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1
PF-06650833
 Drug: PF-06650833
400 mg QD
Experimental: Cohort 2
PF-6700841
 Drug: PF-06700841
45 mg QD
Experimental: Cohort 3
PF-06826647
 Drug: PF-06826647
400 mg QD
Placebo Comparator: Cohort placebo
placebo
 Drug: Placebo
placebo


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of participants with Hidradenitis Suppurativa Clinical Response (HiSCR) response [ Time Frame: Week 16 ]

Secondary Outcome Measures :
  1. Percentage of participants with HiSCR response [ Time Frame: Weeks 1, 2, 4, 6, 8, and 12. ]
  2. Percentage of participants with a total abscess and inflammatory nodule (AN) count of 0 or 1; 0, 1, or 2 [ Time Frame: Week 16 ]
  3. 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. ]
  4. 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 ]
  5. 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. ]
  6. 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 ]
  7. 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 ]
  8. 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 ]
  9. Proportion of participants achieving a Dermatology Life Quality Index (DLQI)=0 or 1 [ Time Frame: Week 16 ]
  10. Summary of plasma concentration of PF 06700841, PF 06826647 and PF 06650833 [ Time Frame: baseline up to week 16 ]
  11. Percent change from baseline (CFB) in AN count [ Time Frame: Weeks 1, 2, 4, 6, 8, 12 and 16 ]
  12. Absolute score and percent CFB in International Hidradenitis Suppurativa Severity Score System (IHS4). [ Time Frame: Weeks 1, 2, 4, 6, 8, 12 and 16 ]
  13. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04092452


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04092452    
Other Study ID Numbers: C2501007
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: July 12, 2022
Last Verified: July 2022
Individual Participant Data (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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Bacterial Infections and Mycoses
 Infections
Skin Diseases, Infectious
Suppuration
PF-06700841
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action