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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

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT04092452
Collaborator
(none)
194
Enrollment
77
Locations
4
Arms
25.3
Actual Duration (Months)
2.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
194 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The treatment period is a parallel designThe 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 :
Dec 2, 2019
Actual Primary Completion Date :
Jan 10, 2022
Actual Study Completion Date :
Jan 10, 2022

Arms and Interventions

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

Primary Outcome Measures

  1. Percentage of participants with Hidradenitis Suppurativa Clinical Response (HiSCR) response [Week 16]

Secondary Outcome Measures

  1. Percentage of participants with HiSCR response [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 [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 [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 [Weeks 1, 2, 4, 6, 8, 12 and 16]

  5. Change From Baseline (CFB) in Numeric Rating Scale (NRS), at worst and on average [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 [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) [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. [Week 16]

  9. Proportion of participants achieving a Dermatology Life Quality Index (DLQI)=0 or 1 [Week 16]

  10. Summary of plasma concentration of PF 06700841, PF 06826647 and PF 06650833 [baseline up to week 16]

  11. Percent change from baseline (CFB) in AN count [Weeks 1, 2, 4, 6, 8, 12 and 16]

  12. Absolute score and percent CFB in International Hidradenitis Suppurativa Severity Score System (IHS4). [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 [Weeks 4, 8, 12 and 16]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 The University Of Alabama At Birmingham Birmingham Alabama United States 35233
2 The University of Alabama at Birmingham Hospital Outreach Lab Birmingham Alabama United States 35249
3 The University of Alabama at Birmingham Investigation Drug Services Pharmacy Birmingham Alabama United States 35249
4 The University of Alabama at Birmingham Birmingham Alabama United States 35294
5 Mayo Clinic Scottsdale Arizona United States 85259
6 Center for Dermatology Clinical Research, Inc. Fremont California United States 94538
7 Pacific Clinical Trials Long Beach California United States 90806
8 Keck School of Medicine of University of Southern California Los Angeles California United States 90033
9 UCSF Dermatology Clinic San Francisco California United States 94115
10 University of California San Francisco San Francisco California United States 94115
11 UCSF Psoriasis and Skin Treatment Center San Francisco California United States 94118
12 Clinical Science Institute Santa Monica California United States 90404
13 New England Research Associates, LLC Bridgeport Connecticut United States 06606
14 Dermatology Physicians of Connecticut Shelton Connecticut United States 06484
15 Total Dermatology Care Center Jacksonville Florida United States 32204
16 Jacksonville Center for Clinical Research Jacksonville Florida United States 32216
17 Olympian Clinical Research Largo Office Largo Florida United States 33770
18 University of Miami Hospital Miami Florida United States 33125
19 Tory Sullivan MD PA North Miami Beach Florida United States 33162
20 Renstar Medical Research Ocala Florida United States 34470
21 MidState Skin Institute Ocala Florida United States 34471
22 Renstar Medical Research Ocala Florida United States 34471
23 Park Avenue Dermatology Orange Park Florida United States 32073
24 Leavitt Medical Associates of Florida d/b/a Ameriderm Research Ormond Beach Florida United States 32174
25 Riverchase Dermatology and Cosmetic Surgery Pembroke Pines Florida United States 33028
26 ForCare Clinical Research Tampa Florida United States 33613
27 Alliance Clinical Research of Tampa Tampa Florida United States 33615
28 MedaPhase Inc. Newnan Georgia United States 30263
29 Advanced Medical Research PC Sandy Springs Georgia United States 30328
30 Georgia Skin Cancer and Aesthetic Dermatology Watkinsville Georgia United States 30677
31 NorthShore University HealthSystem Dermatology Clinic Skokie Illinois United States 60077
32 Ds Research Clarksville Indiana United States 47129
33 Dawes Fretzin Clinical Research Group, LLC Indianapolis Indiana United States 46250
34 DS Research Louisville Kentucky United States 40241
35 Boston Medical Center Boston Massachusetts United States 02118
36 Boston University General Clinical Research Unit Boston Massachusetts United States 02118
37 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
38 Wayne State University / Integrative Biosciences Center Detroit Michigan United States 48202
39 Revival Research Institute, LLC Troy Michigan United States 48084
40 Clinical Research Unit Minneapolis Minnesota United States 55455
41 Lillihei Clinical Research Unit Minneapolis Minnesota United States 55455
42 University of Minnesota Department of Dermatology Minneapolis Minnesota United States 55455
43 MediSearch Clinical Trials Saint Joseph Missouri United States 64506
44 Saint Louis University - Department of Dermatology Saint Louis Missouri United States 63110
45 Skin Specialists PC Omaha Nebraska United States 68144
46 J Woodson Clinical Studies Group Henderson Nevada United States 89052
47 Icahn School of Medicine at Mount Sinai New York New York United States 10029
48 Vital Prospects Clinical Research Institute Tulsa Oklahoma United States 74136
49 Penn State Health Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033
50 Penn State Health Radiology - University Physician Center Hershey Pennsylvania United States 17033
51 Paddington Testing Company, Inc Philadelphia Pennsylvania United States 19103
52 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107
53 Thomas Jefferson University Philadelphia Pennsylvania United States 19107
54 Dermatology and Skin Cancer Consultants Humboldt Tennessee United States 38343
55 Clinical Research Solutions Jackson Tennessee United States 38305
56 Dermatology and Skin Cancer Consultants Jackson Tennessee United States 38305
57 Arlington Research Center Arlington Texas United States 76011
58 Austin Institute for Clinical Research, Inc. Pflugerville Texas United States 78660
59 University of Utah MidValley Dermatology Murray Utah United States 84107
60 Virginia Commonwealth University Medical Center Richmond Virginia United States 23298
61 Bellevue Dermatology Clinical Research Center Bellevue Washington United States 98004
62 Bellevue Dermatology Clinic Bellevue Washington United States 98004
63 Dermatology Associates of Seattle Seattle Washington United States 98101
64 Woden Dermatology Phillip Australian Capital Territory Australia 2606
65 Premier Specialists Pty Ltd Kogarah New South Wales Australia 2217
66 Holdsworth House Medical Practice Sydney New South Wales Australia 2010
67 Veracity Clinical Research Woolloongabba Queensland Australia 4102
68 Skin Health Institute Inc. Carlton Victoria Australia 3053
69 Sinclair Dermatology East Melbourne Victoria Australia 3002
70 SimcoDerm Medical and Surgical Dermatology Center Barrie Ontario Canada L4M 7G1
71 Manna Research (London) London Ontario Canada N6A 2C2
72 DermEffects London Ontario Canada N6H 5L5
73 SKiN Centre for Dermatology Peterborough Ontario Canada K9J 5K2
74 The Centre for Dermatology Richmond Hill Ontario Canada L4B 1A5
75 Diex Recherche Sherbrooke Inc. Sherbrooke Quebec Canada J1L 0H8
76 Centre de Recherche Saint-Louis Quebec Canada G1W4R4
77 Alpha Recherche Clinique Quebec Canada G2J 0C4

Sponsors and Collaborators

  • Pfizer

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT04092452
Other Study ID Numbers:
  • C2501007
First Posted:
Sep 17, 2019
Last Update Posted:
Jul 12, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hidradenitis Suppurativa
Hidradenitis
PF-06700841

Study Results

No Results Posted as of Jul 12, 2022