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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

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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04092452