The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03845517
Ethics application status
Date submitted
15/02/2019
Date registered
19/02/2019
Date last updated
25/06/2020

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
Time to first severe flare in PF 06700841 treated participants relative to placebo.
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
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 [4] 0 0
Baseline, Week 52
Secondary outcome [5] 0 0
Change from baseline in the total scores of Functional Assessment of Chronic Illness Therapy Fatigue (FACIT F) at Week 52.
Timepoint [5] 0 0
Baseline, Week 52
Secondary outcome [6] 0 0
Change from baseline in the total scores of the Lupus Quality of Life (LupusQoL) at Week 52.
Timepoint [6] 0 0
Baseline, Week 52
Secondary outcome [7] 0 0
Number of treatment emergent adverse events (AE's)
Timepoint [7] 0 0
Baseline through Week 56
Secondary outcome [8] 0 0
Number of discontinuations due to AE's
Timepoint [8] 0 0
Baseline through Week 56
Secondary outcome [9] 0 0
Number of clinically significant abnormalities in vital signs
Timepoint [9] 0 0
Baseline through Week 56
Secondary outcome [10] 0 0
Number of clinically significant abnormalities in electrocardiograms
Timepoint [10] 0 0
Baseline through Week 56
Secondary outcome [11] 0 0
Number of clinically significant abnormalities in clinical laboratory values.
Timepoint [11] 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
Gender
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 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)
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
Colorado
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
Idaho
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
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
Nevada
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Oklahoma
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
Belgium
State/province [19] 0 0
Leuven
Country [20] 0 0
Bulgaria
State/province [20] 0 0
Plovdiv
Country [21] 0 0
Bulgaria
State/province [21] 0 0
Ruse
Country [22] 0 0
Bulgaria
State/province [22] 0 0
Sofia
Country [23] 0 0
Canada
State/province [23] 0 0
Quebec
Country [24] 0 0
Colombia
State/province [24] 0 0
Antioquia
Country [25] 0 0
Colombia
State/province [25] 0 0
Atlantico
Country [26] 0 0
Colombia
State/province [26] 0 0
Cundinamarca
Country [27] 0 0
Colombia
State/province [27] 0 0
Santander
Country [28] 0 0
Czechia
State/province [28] 0 0
Praha 2
Country [29] 0 0
France
State/province [29] 0 0
Paris
Country [30] 0 0
France
State/province [30] 0 0
Pessac
Country [31] 0 0
France
State/province [31] 0 0
Strasbourg
Country [32] 0 0
Germany
State/province [32] 0 0
Berlin
Country [33] 0 0
Germany
State/province [33] 0 0
Hannover
Country [34] 0 0
Germany
State/province [34] 0 0
Lübeck
Country [35] 0 0
Germany
State/province [35] 0 0
Mainz
Country [36] 0 0
Greece
State/province [36] 0 0
Crete
Country [37] 0 0
Greece
State/province [37] 0 0
Athens
Country [38] 0 0
Greece
State/province [38] 0 0
Haidari
Country [39] 0 0
Hungary
State/province [39] 0 0
Budapest
Country [40] 0 0
Hungary
State/province [40] 0 0
Debrecen
Country [41] 0 0
Hungary
State/province [41] 0 0
Gyula
Country [42] 0 0
Japan
State/province [42] 0 0
Fukuoka
Country [43] 0 0
Japan
State/province [43] 0 0
Hokkaido
Country [44] 0 0
Japan
State/province [44] 0 0
Miyagi
Country [45] 0 0
Japan
State/province [45] 0 0
Nagasaki
Country [46] 0 0
Japan
State/province [46] 0 0
Tokyo
Country [47] 0 0
Japan
State/province [47] 0 0
Chiba
Country [48] 0 0
Japan
State/province [48] 0 0
Hiroshima
Country [49] 0 0
Korea, Republic of
State/province [49] 0 0
Seoul
Country [50] 0 0
Korea, Republic of
State/province [50] 0 0
Yeongtong-go
Country [51] 0 0
Korea, Republic of
State/province [51] 0 0
Daegu
Country [52] 0 0
Korea, Republic of
State/province [52] 0 0
Incheon
Country [53] 0 0
Mexico
State/province [53] 0 0
Cuauhtémoc
Country [54] 0 0
Mexico
State/province [54] 0 0
Guanajuato
Country [55] 0 0
Mexico
State/province [55] 0 0
Jalisco
Country [56] 0 0
Mexico
State/province [56] 0 0
Yucatán
Country [57] 0 0
Mexico
State/province [57] 0 0
Chihuahua
Country [58] 0 0
Mexico
State/province [58] 0 0
Mexico City
Country [59] 0 0
Poland
State/province [59] 0 0
Bialystok
Country [60] 0 0
Poland
State/province [60] 0 0
Bydgoszcz
Country [61] 0 0
Poland
State/province [61] 0 0
Lublin
Country [62] 0 0
Poland
State/province [62] 0 0
Sosnowiec
Country [63] 0 0
Poland
State/province [63] 0 0
Warszawa
Country [64] 0 0
Portugal
State/province [64] 0 0
Almada
Country [65] 0 0
Portugal
State/province [65] 0 0
Amadora
Country [66] 0 0
Portugal
State/province [66] 0 0
Coimbra
Country [67] 0 0
Portugal
State/province [67] 0 0
Ponte de Lima
Country [68] 0 0
Portugal
State/province [68] 0 0
Porto
Country [69] 0 0
Romania
State/province [69] 0 0
JUD. Brasov
Country [70] 0 0
Romania
State/province [70] 0 0
Jud. Cluj
Country [71] 0 0
Romania
State/province [71] 0 0
Jud. Iasi
Country [72] 0 0
Romania
State/province [72] 0 0
Sector 1
Country [73] 0 0
Romania
State/province [73] 0 0
Bucuresti
Country [74] 0 0
Spain
State/province [74] 0 0
Badalona
Country [75] 0 0
Spain
State/province [75] 0 0
Barcelona
Country [76] 0 0
Spain
State/province [76] 0 0
La Coruna
Country [77] 0 0
Spain
State/province [77] 0 0
Sevilla
Country [78] 0 0
Taiwan
State/province [78] 0 0
Taiwan (r.o.c)
Country [79] 0 0
Taiwan
State/province [79] 0 0
Kaohsiung City
Country [80] 0 0
Taiwan
State/province [80] 0 0
Taichung
Country [81] 0 0
Taiwan
State/province [81] 0 0
Taipei
Country [82] 0 0
Ukraine
State/province [82] 0 0
Kyiv
Country [83] 0 0
Ukraine
State/province [83] 0 0
Lviv
Country [84] 0 0
Ukraine
State/province [84] 0 0
Odesa
Country [85] 0 0
Ukraine
State/province [85] 0 0
Ternopil
Country [86] 0 0
Ukraine
State/province [86] 0 0
Uzhgorod
Country [87] 0 0
Ukraine
State/province [87] 0 0
Vinnytsia

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/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
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/NCT03845517