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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04092452




Registration number
NCT04092452
Ethics application status
Date submitted
15/09/2019
Date registered
17/09/2019
Date last updated
15/06/2023

Titles & IDs
Public title
A Study to Evaluate the Safety and Efficacy of PF-06650833, PF-06700841, and PF 06826647 in Adults With Hidradenitis Suppurativa
Scientific 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
Secondary ID [1] 0 0
C2501007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acne Inversa 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PF-06650833
Treatment: Drugs - PF-06700841
Treatment: Drugs - PF-06826647
Treatment: Drugs - Placebo

Experimental: Cohort 1 - PF-06650833

Experimental: Cohort 2 - PF-6700841

Experimental: Cohort 3 - PF-06826647

Placebo comparator: Cohort placebo - placebo


Treatment: Drugs: PF-06650833
400 mg QD

Treatment: Drugs: PF-06700841
45 mg QD

Treatment: Drugs: PF-06826647
400 mg QD

Treatment: Drugs: Placebo
placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16- Minimum Risk (MR) [Full Analysis Set (FAS), Non-responder Imputation (NRI)].
Timepoint [1] 0 0
At week 16
Secondary outcome [1] 0 0
Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, NRI).
Timepoint [1] 0 0
At weeks 1, 2, 4, 6, 8, and 12
Secondary outcome [2] 0 0
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).
Timepoint [2] 0 0
At week 16
Secondary outcome [3] 0 0
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)].
Timepoint [3] 0 0
At weeks 1, 2, 4, 6, 8, 12 and 16
Secondary outcome [4] 0 0
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).
Timepoint [4] 0 0
At weeks 1, 2, 4, 6, 8, 12 and 16
Secondary outcome [5] 0 0
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).
Timepoint [5] 0 0
At weeks 1, 2, 4, 6, 8, 12 and 16
Secondary outcome [6] 0 0
Percentage of Participants Who Experienced a Hidradenitis Suppurativa (HS) Flare at Weeks 4, 8, 12 and 16 - MR [FAS, Only Observed Data (OBS)].
Timepoint [6] 0 0
At weeks 4, 8, 12 and 16
Secondary outcome [7] 0 0
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)
Timepoint [7] 0 0
At weeks 1, 2, 4, 6, 8, 12 and 16
Secondary outcome [8] 0 0
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)
Timepoint [8] 0 0
At weeks 1, 2, 4, 6, 8, 12 and 16
Secondary outcome [9] 0 0
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)
Timepoint [9] 0 0
At weeks 1, 2, 4, 6, 8, 12 and 16
Secondary outcome [10] 0 0
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)
Timepoint [10] 0 0
At weeks 1, 2, 4, 6, 8, 12 and 16
Secondary outcome [11] 0 0
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)
Timepoint [11] 0 0
At weeks 1, 2, 4, 6, 8, 12 and 16
Secondary outcome [12] 0 0
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)
Timepoint [12] 0 0
At weeks 1, 2, 4, 6, 8, 12 and 16
Secondary outcome [13] 0 0
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)
Timepoint [13] 0 0
At weeks 1, 2, 4, 6, 8, 12 and 16
Secondary outcome [14] 0 0
Number of Participants With Treatment-Emergent Adverse Events (All Causalities)
Timepoint [14] 0 0
Up to 20 weeks
Secondary outcome [15] 0 0
Number of Participants With Treatment-Emergent Adverse Events (Treatment Related)
Timepoint [15] 0 0
Up to 20 weeks
Secondary outcome [16] 0 0
Number of Participants With Incidence of Post-baseline Vital Signs of Clinical Concern - Increase From Baseline (Safety Analysis Set)
Timepoint [16] 0 0
Up to 20 weeks
Secondary outcome [17] 0 0
Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set)
Timepoint [17] 0 0
Up to 20 weeks
Secondary outcome [18] 0 0
Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set)
Timepoint [18] 0 0
Up to 20 weeks
Secondary outcome [19] 0 0
Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS)
Timepoint [19] 0 0
At weeks 1, 2, 4, 6, 8, 12 and 16
Secondary outcome [20] 0 0
Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS)
Timepoint [20] 0 0
At weeks 1, 2, 4, 6, 8, 12 and 16
Secondary outcome [21] 0 0
Least Squares Mean of Absolute Score in Dermatology Life Quality Index (DLQI) Total Score up to Week 16 - MMRM (FAS, OBS)
Timepoint [21] 0 0
At weeks 4, 8, 12 and 16
Secondary outcome [22] 0 0
Least Squares Mean of Change From Baseline in DLQI Total Score up to Week 16 - MMRM (FAS, OBS)
Timepoint [22] 0 0
At weeks 4, 8, 12 and 16
Secondary outcome [23] 0 0
Percentage of Participants Achieving DLQI Total Score of 0 or 1 up to Week 16 - MR (FAS With Baseline >1, NRI)
Timepoint [23] 0 0
At weeks 4, 8, 12 and 16
Secondary outcome [24] 0 0
Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set)
Timepoint [24] 0 0
At weeks 1, 2, 4, 6, 8, 12 and 16

Eligibility
Key inclusion criteria
* male or female participants, between 18-75, with a diagnosis of moderate to severe Hidradenitis Suppurativa
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/12/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/01/2022
Sample size
Target
Accrual to date
Final
194
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
Recruitment hospital [1] 0 0
Woden Dermatology - Phillip
Recruitment hospital [2] 0 0
Premier Specialists Pty Ltd - Kogarah
Recruitment hospital [3] 0 0
Holdsworth House Medical Practice - Sydney
Recruitment hospital [4] 0 0
Veracity Clinical Research - Woolloongabba
Recruitment hospital [5] 0 0
Skin Health Institute Inc. - Carlton
Recruitment hospital [6] 0 0
Sinclair Dermatology - East Melbourne
Recruitment postcode(s) [1] 0 0
2606 - Phillip
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2010 - Sydney
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
3053 - Carlton
Recruitment postcode(s) [6] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
Nebraska
Country [15] 0 0
United States of America
State/province [15] 0 0
Nevada
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
Oklahoma
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Utah
Country [22] 0 0
United States of America
State/province [22] 0 0
Virginia
Country [23] 0 0
United States of America
State/province [23] 0 0
Washington
Country [24] 0 0
Canada
State/province [24] 0 0
Ontario
Country [25] 0 0
Canada
State/province [25] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04092452
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04092452