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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03963401




Registration number
NCT03963401
Ethics application status
Date submitted
15/05/2019
Date registered
24/05/2019
Date last updated
4/08/2021

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of PF-06700841 in Subjects With Active Psoriatic Arthritis
Scientific title
A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF PF-06700841 TO EVALUATE THE EFFICACY AT 16 WEEKS AND TO EVALUATE THE SAFETY AND EFFICACY UP TO 1 YEAR IN SUBJECTS WITH ACTIVE PSORIATIC ARTHRITIS
Secondary ID [1] 0 0
2018-004241-16
Secondary ID [2] 0 0
B7931030
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriatic Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

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

Experimental: PF-06700841 60 mg once daily - PF-06700841 60 mg once daily for 52 weeks

Experimental: PF-06700841 30 mg once daily - PF-06700841 30 mg once daily for 52 weeks

Experimental: PF-06700841 10 mg once daily followed by 60 mg once daily - PF-06700841 10 mg once daily for 16 weeks, followed by 60 mg once daily until Week 52

Experimental: PF-06700841 10 mg once daily followed by 30 mg once daily - PF-06700841 10 mg once daily for 16 weeks, followed by 30 mg once daily until Week 52

Placebo comparator: Placebo once daily followed by 60 mg once daily - Placebo once daily for 16 weeks, followed by PF-06700841 60 mg once daily until Week 52

Placebo comparator: Placebo once daily followed by 30 mg once daily - Placebo once daily for 16 weeks, followed by PF-06700841 30 mg once daily until Week 52


Treatment: Drugs: PF-06700841
Starting after the Week 16 visit, subjects receiving PF-06700841 10 mg once daily will start to randomly receive either the 60 mg QD dose or 30 mg QD dose until Week 52, as predetermined at randomization. All subjects will receive blinded dosing throughout the 52 weeks study treatment period in order to maintain the study blind.

Other interventions: Placebo
Starting after the Week 16 visit, subjects receiving placebo will start to randomly receive either the 60 mg QD dose or 30 mg QD dose until Week 52, as predetermined at randomization. All subjects will receive blinded dosing throughout the 52 weeks study treatment period in order to maintain the study blind.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving an American College of Rheumatology 20 (ACR20) Response at Week 16
Timepoint [1] 0 0
Week 16
Secondary outcome [1] 0 0
Percentage of Participants Achieving an ACR20 Response at Week 16 in the Subgroup of Participants Who Were Tumor Necrosis Factor (TNF) a Inhibitor naïve
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
Percentage of Participants Achieving an ACR20 Response at Weeks 2, 4, 8, 12, 20, 28, 36, 44 and 52
Timepoint [2] 0 0
Weeks 2, 4, 8, 12, 20, 28, 36, 44 and 52
Secondary outcome [3] 0 0
Percentage of Participants Achieving an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Timepoint [3] 0 0
Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Secondary outcome [4] 0 0
Percentage of Participants Achieving an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Timepoint [4] 0 0
Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Secondary outcome [5] 0 0
Change From Baseline in Tender/Painful Joint Count at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Timepoint [5] 0 0
Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Secondary outcome [6] 0 0
Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Timepoint [6] 0 0
Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Secondary outcome [7] 0 0
Change From Baseline in Patient's Assessment of Arthritis Pain at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Timepoint [7] 0 0
Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Secondary outcome [8] 0 0
Change From Baseline in Patient's Global Assessment of Arthritis at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Timepoint [8] 0 0
Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Secondary outcome [9] 0 0
Change From Baseline in Physician's Global Assessment of Arthritis at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Timepoint [9] 0 0
Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Secondary outcome [10] 0 0
Change From Baseline in Health Assessment Questionnaire (HAQ) Disability Index (DI) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Timepoint [10] 0 0
Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Secondary outcome [11] 0 0
Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Timepoint [11] 0 0
Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Secondary outcome [12] 0 0
Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Timepoint [12] 0 0
Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Secondary outcome [13] 0 0
Percentage of Participants Achieving a PASI 90 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Timepoint [13] 0 0
Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Secondary outcome [14] 0 0
Percentage of Participants Achieving a PASI 100 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Timepoint [14] 0 0
Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Secondary outcome [15] 0 0
Change From Baseline in the Enthesitis Score (Using the Spondyloarthritis Research Consortium of Canada [SPARCC] Enthesitis Index) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Timepoint [15] 0 0
Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Secondary outcome [16] 0 0
Change From Baseline in the Enthesitis Score (Using the Leeds Enthesitis Index) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Timepoint [16] 0 0
Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Secondary outcome [17] 0 0
Change From Baseline in the Dactylitis Severity Score (DSS) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Timepoint [17] 0 0
Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Secondary outcome [18] 0 0
Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Score at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Timepoint [18] 0 0
Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Secondary outcome [19] 0 0
Change From Baseline in the Patient's Global Joint and Skin Assessment-Visual Analog Scale (PGJS-VAS) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Timepoint [19] 0 0
Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Secondary outcome [20] 0 0
Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Timepoint [20] 0 0
Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52
Secondary outcome [21] 0 0
Change From Baseline in the Short-Form-36 Health Survey (SF-36) Version 2, Acute at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Timepoint [21] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Secondary outcome [22] 0 0
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Timepoint [22] 0 0
Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Secondary outcome [23] 0 0
Percentage of Participants Achieving Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Timepoint [23] 0 0
Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Secondary outcome [24] 0 0
Change From Baseline in the Disease Activity Index for Reactive Arthritis/PsA (DAREA/DAPSA) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Timepoint [24] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Secondary outcome [25] 0 0
Percentage of Participants Achieving the Psoriatic Arthritis Response Criteria (PsARC) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Timepoint [25] 0 0
Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Secondary outcome [26] 0 0
Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Timepoint [26] 0 0
Baseline, Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52
Secondary outcome [27] 0 0
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) From Baseline (Day 1) Through Week 56 (All Causalities)
Timepoint [27] 0 0
Baseline (Day 1) through Week 56
Secondary outcome [28] 0 0
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) From Baseline (Day 1) Through Week 56 (Treatment-related)
Timepoint [28] 0 0
Baseline (Day 1) through Week 56
Secondary outcome [29] 0 0
Number of Participants Who Discontinued From Study Due to Treatment-emergent AEs From Baseline (Day 1) Through Week 56
Timepoint [29] 0 0
Baseline (Day 1) through Week 56

Eligibility
Key inclusion criteria
* Active arthritis at screening/baseline as indicated by >/= 3 tender/painful and 3 swollen joints.
* Active plaque psoriasis at screening and baseline.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Non-plaque forms of psoriasis (with exception of nail psoriasis).
* History of autoimmune rheumatic disease other than PsA; also prior history of or current, rheumatic inflammatory disease other than PsA.

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 administering 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
13/06/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/01/2021
Sample size
Target
Accrual to date
Final
219
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Rheumatology Research Unit - Maroochydore
Recruitment hospital [2] 0 0
Emeritus Research - Melbourne
Recruitment postcode(s) [1] 0 0
4558 - Maroochydore
Recruitment postcode(s) [2] 0 0
3124 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Bulgaria
State/province [1] 0 0
Plovdiv
Country [2] 0 0
Bulgaria
State/province [2] 0 0
Sofia
Country [3] 0 0
Czechia
State/province [3] 0 0
Hlucin
Country [4] 0 0
Czechia
State/province [4] 0 0
Pardubice
Country [5] 0 0
Czechia
State/province [5] 0 0
Praha 2
Country [6] 0 0
Czechia
State/province [6] 0 0
Praha 3
Country [7] 0 0
Czechia
State/province [7] 0 0
Uherske Hradiste
Country [8] 0 0
Estonia
State/province [8] 0 0
Tallinn
Country [9] 0 0
Hungary
State/province [9] 0 0
Budapest
Country [10] 0 0
Hungary
State/province [10] 0 0
Veszprem
Country [11] 0 0
Lithuania
State/province [11] 0 0
Kaunas
Country [12] 0 0
Lithuania
State/province [12] 0 0
Vilnius
Country [13] 0 0
Poland
State/province [13] 0 0
Bialystok
Country [14] 0 0
Poland
State/province [14] 0 0
Lublin
Country [15] 0 0
Poland
State/province [15] 0 0
Nadarzyn
Country [16] 0 0
Poland
State/province [16] 0 0
Nowa Sol
Country [17] 0 0
Poland
State/province [17] 0 0
Poznan
Country [18] 0 0
Poland
State/province [18] 0 0
Sochaczew
Country [19] 0 0
Poland
State/province [19] 0 0
Torun
Country [20] 0 0
Poland
State/province [20] 0 0
Warszawa
Country [21] 0 0
Russian Federation
State/province [21] 0 0
Moscow Region
Country [22] 0 0
Russian Federation
State/province [22] 0 0
Orenburg
Country [23] 0 0
Russian Federation
State/province [23] 0 0
Petrozavodsk
Country [24] 0 0
Russian Federation
State/province [24] 0 0
Ryazan
Country [25] 0 0
Russian Federation
State/province [25] 0 0
Saint Petersburg
Country [26] 0 0
Russian Federation
State/province [26] 0 0
Saratov
Country [27] 0 0
Russian Federation
State/province [27] 0 0
Vladimir
Country [28] 0 0
Russian Federation
State/province [28] 0 0
Yaroslavl
Country [29] 0 0
Serbia
State/province [29] 0 0
Belgrade
Country [30] 0 0
Serbia
State/province [30] 0 0
Niska Banja
Country [31] 0 0
Slovakia
State/province [31] 0 0
Piestany
Country [32] 0 0
Slovakia
State/province [32] 0 0
Poprad
Country [33] 0 0
Slovakia
State/province [33] 0 0
Rimavska Sobota
Country [34] 0 0
Spain
State/province [34] 0 0
A Coruna
Country [35] 0 0
Spain
State/province [35] 0 0
Sevilla

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a 52 week Phase 2b study designed to evaluate the efficacy at 16 weeks and to evaluate the safety and efficacy up to 1 year in subjects with active psoriatic arthritis.
Trial website
https://clinicaltrials.gov/study/NCT03963401
Trial related presentations / publications
Banfield C, Scaramozza M, Zhang W, Kieras E, Page KM, Fensome A, Vincent M, Dowty ME, Goteti K, Winkle PJ, Peeva E. The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a TYK2/JAK1 Inhibitor (PF-06700841) in Healthy Subjects and Patients With Plaque Psoriasis. J Clin Pharmacol. 2018 Apr;58(4):434-447. doi: 10.1002/jcph.1046. Epub 2017 Dec 21.
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/NCT03963401