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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04092452
Ethics application status
Date submitted
15/09/2019
Date registered
17/09/2019
Date last updated
17/11/2020

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 with Hidradenitis Suppurativa Clinical Response (HiSCR) response
Timepoint [1] 0 0
Week 16
Secondary outcome [1] 0 0
Percentage of participants with HiSCR response
Timepoint [1] 0 0
Weeks 1, 2, 4, 6, 8, and 12.
Secondary outcome [2] 0 0
Percentage of participants with a total abscess and inflammatory nodule (AN) count of 0 or 1; 0, 1, or 2
Timepoint [2] 0 0
Week 16
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Weeks 1, 2, 4, 6, 8, 12 and 16.
Secondary outcome [4] 0 0
Percent CFB in NRS, at worst and on average respectively, in participants who have baseline NRS =3
Timepoint [4] 0 0
Weeks 1, 2, 4, 6, 8, 12 and 16
Secondary outcome [5] 0 0
Change From Baseline (CFB) in Numeric Rating Scale (NRS), at worst and on average
Timepoint [5] 0 0
Weeks 1, 2, 4, 6, 8, 12 and 16.
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
Week 16
Secondary outcome [7] 0 0
Incidence of treatment emergent adverse events (adverse events and serious adverse events), significant changes in vital signs, clinical laboratory abnormalities, and electrocardiogram (ECG)
Timepoint [7] 0 0
baseline up to week 16
Secondary outcome [8] 0 0
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.
Timepoint [8] 0 0
Week 16
Secondary outcome [9] 0 0
Proportion of participants achieving a Dermatology Life Quality Index (DLQI)=0 or 1
Timepoint [9] 0 0
Week 16
Secondary outcome [10] 0 0
Summary of plasma concentration of PF 06700841, PF 06826647 and PF 06650833
Timepoint [10] 0 0
baseline up to week 16
Secondary outcome [11] 0 0
Percent change from baseline (CFB) in AN count
Timepoint [11] 0 0
Weeks 1, 2, 4, 6, 8, 12 and 16
Secondary outcome [12] 0 0
Absolute score and percent CFB in International Hidradenitis Suppurativa Severity Score System (IHS4).
Timepoint [12] 0 0
Weeks 1, 2, 4, 6, 8, 12 and 16
Secondary outcome [13] 0 0
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
Timepoint [13] 0 0
Weeks 4, 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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Westmead Hospital - Westmead
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
2145 - Westmead
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
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
Nebraska
Country [14] 0 0
United States of America
State/province [14] 0 0
Nevada
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
Oklahoma
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Utah
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
Canada
State/province [23] 0 0
Ontario
Country [24] 0 0
Canada
State/province [24] 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/show/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
Pfizer CT.gov Call Center
Address 0 0
Country 0 0
Phone 0 0
1-800-718-1021
Fax 0 0
Email 0 0
ClinicalTrials.gov_Inquiries@pfizer.com
Contact person for scientific queries

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