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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03845517




Registration number
NCT03845517
Ethics application status
Date submitted
15/02/2019
Date registered
19/02/2019
Date last updated
1/11/2023

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
Proportion of participants achieving the Systemic Lupus Erythematosus Responder Index (SRI) change of 4 (SRI-4) at Week 52.
Timepoint [1] 0 0
Week 52
Secondary outcome [1] 0 0
Proportion of participants achieving the British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) at Week 52.
Timepoint [1] 0 0
Baseline, Week 52
Secondary outcome [2] 0 0
Proportion of participants achieving the Lupus Low Disease Activity State (LLDAS) at Week 52.
Timepoint [2] 0 0
Baseline, Week 52
Secondary outcome [3] 0 0
Proportion of participants achieving a reduction in prednisone (or equivalent) at Week 52.
Timepoint [3] 0 0
Baseline, Week 52
Secondary outcome [4] 0 0
Proportion of participants achieving SRI-4 at Week 52 and have a sustained reduction of prednisone (or equivalent) at Week 52.
Timepoint [4] 0 0
Week 52
Secondary outcome [5] 0 0
Percentage of Participants with Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI-A) Total Activity Score =10 at Baseline with =50% Reduction in CLASI-A Total Activity Score
Timepoint [5] 0 0
Baseline, Week 52
Secondary outcome [6] 0 0
Change from baseline in the 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 the total scores of the Lupus Quality of Life (LupusQoL) at Week 52.
Timepoint [7] 0 0
Baseline, Week 52
Secondary outcome [8] 0 0
Time to first severe flare in PF 06700841 treated participants relative to placebo.
Timepoint [8] 0 0
Baseline, Week 52
Secondary outcome [9] 0 0
Number of treatment emergent adverse events (AE's)
Timepoint [9] 0 0
Baseline through Week 56
Secondary outcome [10] 0 0
Number of discontinuations due to AE's
Timepoint [10] 0 0
Baseline through Week 56
Secondary outcome [11] 0 0
Number of clinically significant abnormalities in vital signs
Timepoint [11] 0 0
Baseline through Week 56
Secondary outcome [12] 0 0
Number of clinically significant abnormalities in electrocardiograms
Timepoint [12] 0 0
Baseline through Week 56
Secondary outcome [13] 0 0
Number of clinically significant abnormalities in clinical laboratory values.
Timepoint [13] 0 0
Baseline through Week 56

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
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United States of America
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Alabama
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California
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Connecticut
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Florida
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Georgia
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Kansas
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Louisiana
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Michigan
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Nevada
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Tennessee
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Washington
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Argentina
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Tucuman
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Leuven
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Merksem
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Plovdiv
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Ruse
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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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Cundinamarca
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Colombia
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Santander
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Czechia
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France
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Paris
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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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Romania
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Bucuresti
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Beograd
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Niska Banja
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Badalona
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Barcelona
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Sevilla
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Taiwan
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Kaohsiung City
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Taipei
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Taoyuan City
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Ukraine
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Kyiv
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Lviv
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Odesa
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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
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Leeds
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United Kingdom
State/province [102] 0 0
London

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

Ethics approval
Ethics application status

Summary
Brief summary
Assessment of PF-06700841 in participants with moderate to severe active, generalized
Systemic Lupus Erythematosus (SLE) that have inadequate response to standard of care.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03845517
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/ct2/show/NCT03845517