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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03845517




Registration number
NCT03845517
Ethics application status
Date submitted
15/02/2019
Date registered
19/02/2019

Titles & IDs
Public title
A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
Scientific title
A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
Secondary ID [1] 0 0
2018-004175-12
Secondary ID [2] 0 0
B7931028
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - PF-06700841 15 mg
Treatment: Drugs - PF-06700841 30 mg
Treatment: Drugs - PF-06700841 45 mg

Placebo comparator: Placebo - Placebo

Experimental: PF-06700841 15 mg - PF-06700841 15 mg

Experimental: PF-06700841 30 mg - PF-06700841 30 mg

Experimental: PF-06700841 45 mg - PF-06700841 45 mg


Treatment: Drugs: Placebo
Placebo

Treatment: Drugs: PF-06700841 15 mg
PF-06700841 15 mg

Treatment: Drugs: PF-06700841 30 mg
PF-06700841 30 mg

Treatment: Drugs: PF-06700841 45 mg
PF-06700841 45 mg
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving SLE Responder Index (SRI) Change of 4 (SRI-4) at Week 52
Timepoint [1] 0 0
Week 52
Secondary outcome [1] 0 0
Percentage of Participants Achieving British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) at Week 52
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 52
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
Percentage of Participants Achieving a Reduction in Prednisone (or Equivalent) Dose to <=7.5 mg/Day and Sustained for 12 Weeks Prior to Week 52 in Participants on Prednisone >7.5 mg/Day (or Equivalent) at Baseline
Timepoint [3] 0 0
Week 52 for achieving reduction in dose along with Week 40 to Week 52 for sustained dosing
Secondary outcome [4] 0 0
Percentage of Participants Achieving a SRI-4 Response With Prednisone Dose Reduced to <=7.5 mg/Day and Sustained for 12 Weeks at Week 52 in Participants on Prednisone >7.5 mg/Day (or Equivalent) at Baseline
Timepoint [4] 0 0
12 Weeks prior at Week 52 (Week 40 to Week 52)
Secondary outcome [5] 0 0
Percentage of Participants With >= 50% Reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 52 in Participants With Baseline CLASI-A Score >=10
Timepoint [5] 0 0
Week 52
Secondary outcome [6] 0 0
Change From Baseline in Total Scores of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Week 52
Timepoint [6] 0 0
Baseline, Week 52
Secondary outcome [7] 0 0
Change From Baseline in Physical Health Domain Scores of Lupus Quality of Life (LupusQoL) at Week 52
Timepoint [7] 0 0
Baseline, Week 52
Secondary outcome [8] 0 0
Change From Baseline in Emotional Health Domain Scores of LupusQoL at Week 52
Timepoint [8] 0 0
Baseline, Week 52
Secondary outcome [9] 0 0
Change From Baseline in Body Image Domain Scores of LupusQoL at Week 52
Timepoint [9] 0 0
Baseline, Week 52
Secondary outcome [10] 0 0
Change From Baseline in Pain Domain Scores of LupusQoL at Week 52
Timepoint [10] 0 0
Baseline, Week 52
Secondary outcome [11] 0 0
Change From Baseline in Planning Domain Scores of LupusQoL at Week 52
Timepoint [11] 0 0
Baseline, Week 52
Secondary outcome [12] 0 0
Change From Baseline in Fatigue Domain Scores of LupusQoL at Week 52
Timepoint [12] 0 0
Baseline, Week 52
Secondary outcome [13] 0 0
Change From Baseline in Intimate Relationship Domain Scores of LupusQoL at Week 52
Timepoint [13] 0 0
Baseline, Week 52
Secondary outcome [14] 0 0
Change From Baseline in Burden to Others Domain Scores of LupusQoL at Week 52
Timepoint [14] 0 0
Baseline, Week 52
Secondary outcome [15] 0 0
Incidence Rate of Severe Flare Event
Timepoint [15] 0 0
Week 52
Secondary outcome [16] 0 0
Number of Participants With Treatment-Emergent Adverse Events (AE)
Timepoint [16] 0 0
Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks)
Secondary outcome [17] 0 0
Number of Participants With Serious Adverse Events (SAEs)
Timepoint [17] 0 0
Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks)
Secondary outcome [18] 0 0
Number of Participants With Adverse Events Leading to Discontinuation From Study
Timepoint [18] 0 0
Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks)
Secondary outcome [19] 0 0
Number of Participants With Clinically Significant Vital Signs Abnormalities
Timepoint [19] 0 0
Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks)
Secondary outcome [20] 0 0
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Timepoint [20] 0 0
Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks)
Secondary outcome [21] 0 0
Number of Participants With Laboratory Test Abnormalities
Timepoint [21] 0 0
Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks)

Eligibility
Key inclusion criteria
* Male and/or female subjects between =18 and =75 years of age inclusive.
* Diagnosis of moderate to severe active Lupus.
* Receiving a stable dose of methotrexate, azathioprine, leflunomide, mizoribine, mycophenolate/mycophenolic acid, anti-malarials or corticosteroids.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Active renal lupus
* Severe active central nervous system (CNS) lupus
* Have cancer or a history of cancer within 5 years of screening.
* Have a history of thrombosis (venous or arterial) or other vascular complications within the last 6 months, or any history of either recurrent thrombosis or a pulmonary embolus.
* Active bacterial, viral, fungal, mycobacterial or other infections
* Psychiatric condition including recent or active suicidal ideation or behavior
* Have active fibromyalgia/myofascial/chronic pain.
* Pregnant female subjects; breastfeeding female subjects; females subjects planning to become pregnant during the study; fertile male subjects and WOCBP who are unwilling or unable to use a highly effective method of contraception.

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
18/04/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/10/2023
Sample size
Target
Accrual to date
Final
350
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Optimus Clinical Research - Kogarah
Recruitment hospital [2] 0 0
Emeritus Research - Camberwell
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
3124 - Camberwell
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
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
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Nevada
Country [11] 0 0
United States of America
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New York
Country [12] 0 0
United States of America
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North Carolina
Country [13] 0 0
United States of America
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Oklahoma
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Washington
Country [17] 0 0
Argentina
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Tucuman
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Belgium
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Leuven
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Belgium
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Merksem
Country [20] 0 0
Bulgaria
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Plovdiv
Country [21] 0 0
Bulgaria
State/province [21] 0 0
Ruse
Country [22] 0 0
Bulgaria
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Sofia
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Canada
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Quebec
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China
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Anhui
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China
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Hunan
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China
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Jiangsu
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China
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Tianjin
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China
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Beijing
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China
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Shanghai
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Colombia
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Antioquia
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Colombia
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Atlantico
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Colombia
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Cundinamarca
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Colombia
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Santander
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Czechia
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Praha 2
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France
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Paris
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France
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Pessac
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Germany
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Hannover
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Germany
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Lübeck
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Greece
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Crete
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Greece
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Athens
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Haidari
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Budapest
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Hungary
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Debrecen
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Hungary
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Gyula
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Italy
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Pavia
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Hokkaido
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Miyagi
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Nagasaki
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Okinawa
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Tokyo
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Chiba
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Fukuoka
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Hiroshima
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Korea, Republic of
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Gyeonggi-do
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Seoul
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Mazowieckie
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Bialystok
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Lublin
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Nadarzyn
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Sosnowiec
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Warszawa
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Almada
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Amadora
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Porto
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Romania
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JUD. Brasov
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Jud. Cluj
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Romania
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Sector 1
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Bucuresti
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Serbia
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Beograd
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Serbia
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Niska Banja
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Spain
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Pontevedra
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Badalona
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Barcelona
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Spain
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La Coruna
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Sevilla
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Taiwan
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Taiwan (r.o.c)
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Taiwan
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Kaohsiung City
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Taiwan
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Taichung City
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Taiwan
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Taichung
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Taiwan
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Taipei
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Taiwan
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Taoyuan City
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Ukraine
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Kyiv
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Ukraine
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Lviv
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Ukraine
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Odesa
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Ukraine
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Ternopil
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Ukraine
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Uzhgorod
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Ukraine
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Vinnytsia
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United Kingdom
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Hampshire
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United Kingdom
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Doncaster
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United Kingdom
State/province [102] 0 0
Leeds
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United Kingdom
State/province [103] 0 0
London

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/NCT03845517