Clinical trial NCT03845517: A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-02-19
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

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.

Primary outcomes:
measure: Percentage of Participants Achieving SLE Responder Index (SRI) Change of 4 (SRI-4) at Week 52
timeFrame: Week 52
Secondary outcomes:
measure: Percentage of Participants Achieving British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) at Week 52
timeFrame: Week 52
measure: Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 52
timeFrame: Week 52
measure: 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
timeFrame: Week 52 for achieving reduction in dose along with Week 40 to Week 52 for sustained dosing
measure: 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
timeFrame: 12 Weeks prior at Week 52 (Week 40 to Week 52)
measure: 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
timeFrame: Week 52
measure: Change From Baseline in Total Scores of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Physical Health Domain Scores of Lupus Quality of Life (LupusQoL) at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Emotional Health Domain Scores of LupusQoL at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Body Image Domain Scores of LupusQoL at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Pain Domain Scores of LupusQoL at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Planning Domain Scores of LupusQoL at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Fatigue Domain Scores of LupusQoL at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Intimate Relationship Domain Scores of LupusQoL at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Burden to Others Domain Scores of LupusQoL at Week 52
timeFrame: Baseline, Week 52
measure: Incidence Rate of Severe Flare Event
timeFrame: Week 52
measure: Number of Participants With Treatment-Emergent Adverse Events (AE)
timeFrame: 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)
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: 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)
measure: Number of Participants With Adverse Events Leading to Discontinuation From Study
timeFrame: 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)
measure: Number of Participants With Clinically Significant Vital Signs Abnormalities
timeFrame: 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)
measure: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
timeFrame: 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)
measure: Number of Participants With Laboratory Test Abnormalities
timeFrame: 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)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Department of Medicine Clinical Research Enterprise
state: Alabama
city: Birmingham
country: United States
facility: The Kirklin Clinic
state: Alabama
city: Birmingham
country: United States
facility: UAB Hospital Department of Pharmacy
state: Alabama
city: Birmingham
country: United States
facility: UAB Hospital-Clinical Research Unit (CRU)
state: Alabama
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
city: Birmingham
country: United States
facility: UAB Department of Medicine Clinical Research Enterprise
state: Alabama
city: Fullerton
country: United States
facility: St. Joseph Heritage Healthcare
state: California
city: La Palma
country: United States
facility: Advanced Medical Research, LLC
state: California
city: La Palma
country: United States
facility: Arthritis and Osteoporosis Medical Center
state: California
city: Palm Desert
country: United States
facility: Desert Medical Advances
state: California
city: San Leandro
country: United States
facility: East Bay Rheumatology Medical Group, Inc.
state: California
city: Thousand Oaks
country: United States
facility: Millennium Clinical Trials
state: California
city: Upland
country: United States
facility: Inland Rheumatology and Osteoporosis Medical Group
state: California
city: Upland
country: United States
facility: Inland Rheumatology Clinical Trials, Inc.
state: California
city: Bridgeport
country: United States
facility: New England Research Associates, LLC
state: Connecticut
city: Bridgeport
country: United States
facility: New England Research Associates
state: Connecticut
city: Stamford
country: United States
facility: Stamford Therapeutics Consortium
state: Connecticut
city: Clearwater
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Clearwater
country: United States
facility: Private Practice of Robert W. Levin
state: Florida
city: Gainesville
country: United States
facility: SIMEDHealth, LLC Attn: Rheumatology
state: Florida
city: Gainesville
country: United States
facility: SIMEDHealth, LLC
state: Florida
city: Orlando
country: United States
facility: Omega Research MetroWest, LLC
state: Florida
city: Palm Harbor
country: United States
facility: Akumin, Inc
state: Florida
city: Saint Petersburg
country: United States
facility: Akumin Inc
state: Florida
city: Tamarac
country: United States
facility: West Broward Rheumatology Associates, Inc
state: Florida
city: Tampa
country: United States
facility: Akumin Inc.
state: Florida
city: Tampa
country: United States
facility: Rose Radiology dba Akumin Inc.
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Tampa
country: United States
facility: AdventHealth Tampa
state: Florida
city: Decatur
country: United States
facility: Jefrey D. Lieberman, M.D., P.C.
state: Georgia
city: Marietta
country: United States
facility: Atlanta Research Center for Rheumatology
state: Georgia
city: Idaho Falls
country: United States
facility: Institute of Arthritis Research
state: Idaho
city: Kansas City
country: United States
facility: Investigational Drug Services University of Kansas Hospital
state: Kansas
city: Kansas City
country: United States
facility: The University of Kansas Hospital
state: Kansas
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Baton Rouge
country: United States
facility: Ochsner Clinic Foundation, Baton Rouge
state: Louisiana
city: Brighton
country: United States
facility: University of Michigan Brighton Center for Specialty Care
state: Michigan
city: Las Vegas
country: United States
facility: Innovative health Research
state: Nevada
city: Brooklyn
country: United States
facility: NYU Langone Ambulatory Care Brooklyn Heights
state: New York
city: Canton
country: United States
facility: St. Lawrence Health System
state: New York
city: Manhasset
country: United States
facility: Feinstein Institute for Medical Research
state: New York
city: Manhasset
country: United States
facility: Northshore University Hospital
state: New York
city: New York
country: United States
facility: Columbia University Medical Center.
state: New York
city: New York
country: United States
facility: Irving Institute for Clinical and Transitional Research
state: New York
city: Potsdam
country: United States
facility: St. Lawrence Health System
state: New York
city: Charlotte
country: United States
facility: Joint and Muscle Research Institute
state: North Carolina
city: Oklahoma City
country: United States
facility: Arthritis & Rheumatology Center of Oklahoma PLLC
state: Oklahoma
city: Jackson
country: United States
facility: West Tennessee Research Institute
state: Tennessee
city: Memphis
country: United States
facility: Gupta, Ramesh C MD
state: Tennessee
city: Austin
country: United States
facility: Tekton Research
state: Texas
city: Baytown
country: United States
facility: Accurate Clinical Management, LLC
state: Texas
city: Houston
country: United States
facility: Rheumatic Disease Clinical Research Center, LLC
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Research
state: Texas
city: San Marcos
country: United States
facility: Arthritis Clinic of Central Texas
state: Texas
city: Spokane
country: United States
facility: Arthritis Northwest, PLLC
state: Washington
city: San Miguel de Tucuman
country: Argentina
facility: Centro de Investigaciones Medicas Tucuman
state: Tucuman
city: Kogarah
country: Australia
facility: Optimus Clinical Research
state: New South Wales
city: Camberwell
country: Australia
facility: Emeritus Research
state: Victoria
city: Leuven
country: Belgium
facility: UZ Leuven
city: Merksem
country: Belgium
facility: Ziekenhuisnetwerk Antwerpen Jan Palfijn (ZNA Jan Palfijn)
city: Plovdiv
country: Bulgaria
facility: DCC Sveti Georgi EOOD
city: Plovdiv
country: Bulgaria
facility: MHAT Plovdiv AD
city: Ruse
country: Bulgaria
facility: Umhat Kanev Ad
city: Sofia
country: Bulgaria
facility: UMHAT "Sv.Ivan Rilski" EAD
city: Sofia
country: Bulgaria
facility: UMHAT "Sv. Ivan Rilski" EAD
city: Rimouski
country: Canada
facility: Centre intégré de santé et de services sociaux du Bas-Saint-Laurent
state: Quebec
city: Trois-Rivieres
country: Canada
facility: Centre de Recherche Musculo-Squelettique
state: Quebec
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Shanghai
country: China
facility: Ruijin Hospital- Shanghai Jiaotong University School of Medicine
city: Shanghai
country: China
facility: Fudan University Hua Shan Hospital
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe
state: Antioquia
city: Barranquilla
country: Colombia
facility: Centro Integral de Reumatología del Caribe S.A.S - CIRCARIBE S.A.S
state: Atlantico
city: Bogota
country: Colombia
facility: Bluecare Salud S.A.S Sede Centro Médico Integral Chicó MedPlus CRI
state: Cundinamarca
city: Bogotá
country: Colombia
facility: Centro de Investigación en Reumatología y Especialidades Médicas SAS - CIREEM SAS
state: Cundinamarca
city: Bucaramanga
country: Colombia
facility: Medicity S.A.S.
state: Santander
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Praha 2
country: Czechia
facility: Nemocnicni lekarna VFN
city: Praha 2
country: Czechia
facility: Revmatologicky ustav
city: Paris
country: France
facility: Hôpital Pitié Salpêtrière, Centre des Maladies Auto-immunes
city: Paris
country: France
facility: Hôpital Cochin
city: Pessac
country: France
facility: CHU de Bordeaux, Groupe Hospitalier Sud, Hôpital Haut Lévèque
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig Holstein - Campus Lübeck
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion
state: Crete
city: Athens
country: Greece
facility: Laiko General Hospital, University of Athens
city: Haidari
country: Greece
facility: University Hospital ATTIKON
city: Hong Kong
country: Hong Kong
facility: Tuen Mun Hospital
city: Budapest
country: Hungary
facility: Qualiclinic Kft.
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Gyula
country: Hungary
facility: Békés Vármegyei Központi Kórház
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico S.Matteo
city: Asahikawa
country: Japan
facility: National Hospital Organization Asahikawa Medical Center
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Sendai
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Sasebo
country: Japan
facility: Sasebo Chuo Hospital
state: Nagasaki
city: Naha
country: Japan
facility: Shinkenko clinic
state: Okinawa
city: Chuo-ku
country: Japan
facility: St. Luke's International Hospital
state: Tokyo
city: Chiba
country: Japan
facility: National Hospital Organization Chiba-East Hospital
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
city: Seocho-gu
country: Korea, Republic of
facility: The Catholic Univ. of Korea Seoul St. Mary's Hospital
state: Seoul
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital (KNUH)
city: Mexico City
country: Mexico
facility: CITER Centro de Investigación y Tratamiento de las Enfermedades Reumáticas S.A. de C.V.
state: Cuauhtémoc
city: León
country: Mexico
facility: Morales Vargas Centro de Investigación S.C.
state: Guanajuato
city: Guadalajara
country: Mexico
facility: Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V
state: Jalisco
city: Zapopan
country: Mexico
facility: Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V
state: Jalisco
city: Zapopan
country: Mexico
facility: Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V
state: Jalisco
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
state: Tlalpan
city: Mérida
country: Mexico
facility: Centro Peninsular de Investigación Clínica S.C.P.
state: Yucatán
city: Chihuahua
country: Mexico
facility: Investigación y Biomedicina de Chihuahua, Sociedad Civil
city: Guadalajara
country: Mexico
facility: Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V
city: Mexico City
country: Mexico
facility: CINTRE Centro de Investigación y Tratamiento Reumatológico S.C.
city: Warszawa
country: Poland
facility: Centrum Wsparcia Badan Klinicznych
state: Mazowieckie
city: Bialystok
country: Poland
facility: Stanislaw Sierakowski Centrum Miriada
city: Bydgoszcz
country: Poland
facility: Szpital Biziela
city: Lublin
country: Poland
facility: Zespol Poradni Specjalistycznych Reumed, Onyksowa Filia nr 2
city: Nadarzyn
country: Poland
facility: NZOZ "Lecznica Mak-Med" s.c.
city: Sosnowiec
country: Poland
facility: Centrum Medyczne MEDENS S.C. Grupowa Praktyka Lekarska
city: Warszawa
country: Poland
facility: Narodowy Instytutu Geriatrii, Reumatologii i Rehabilitacji
city: Warszawa
country: Poland
facility: Mazowieckie Centrum Reumatologii i Osteoporozy M. Przygodzka Spolka jawna
city: Almada
country: Portugal
facility: Hospital Garcia de Orta, E.P.E
city: Amadora
country: Portugal
facility: Hospital Professor Doutor Fernando da Fonseca, E.P.E
city: Ponte de Lima
country: Portugal
facility: Unidade Local de Saude do Alto Minho, E.P.E.
city: Porto
country: Portugal
facility: Centro Hospitalar Universitario do Porto, E.P.E
city: Brasov
country: Romania
facility: SC Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL
state: JUD. Brasov
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Cluj-Napoca
state: Jud. Cluj
city: Bucuresti
country: Romania
facility: S.C. Euroclinic Hospital S.A
state: Sector 1
city: Bucuresti
country: Romania
facility: Spitalul Clinic Sf. Maria
city: Beograd
country: Serbia
facility: Institut za Reumatologiju
city: Beograd
country: Serbia
facility: Klinicki Centar Srbije, Klinika za alergologiju i imunologiju
city: Beograd
country: Serbia
facility: Vojnomedicinska akademija, Klinika za reumatologiju
city: Niska Banja
country: Serbia
facility: Institut Niska Banja, Klinika za Reumatologiju
city: Vigo
country: Spain
facility: Hospital do Meixoeiro
state: Pontevedra
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Clinica Sagrada Familia
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: La Coruna
country: Spain
facility: Complexo Hospitalario Universitario A Coruna
city: Sevilla
country: Spain
facility: Hospital Quiron Infanta Luisa
city: Taichung City
country: Taiwan
facility: China Medical University Hospital
state: Taiwan (r.o.c)
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Taichung City
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital Linkou Branch
city: Kyiv
country: Ukraine
facility: State Institution National Scientific Center "M.D. Strazhesko Institute of Cardiology" of National
city: Kyiv
country: Ukraine
facility: State Institution National Scientific Center "M.D. Strazhesko Institute of Cardiology"
city: Lviv
country: Ukraine
facility: Communal non-profitable enterprise "Lviv City Clinical Hospital #4"
city: Odesa
country: Ukraine
facility: Multifield Medical Center of Odesa National Medical University
city: Odesa
country: Ukraine
facility: Multifield Medical Center of Odessa National Medical University
city: Odesa
country: Ukraine
facility: CNPE "Odesa Regional Clinical Hospital" of Odesa Regional Council
city: Ternopil
country: Ukraine
facility: CNPE "Ternopil University Hospital" of Ternopil regional council, Department of Rheumatology
city: Uzhgorod
country: Ukraine
facility: Zakarpattia Regional Clinical Hospital n.a. A. Novak
city: Vinnytsia
country: Ukraine
facility: CNPE "Vinnytsya regional Clinical Hospital named after N.I.Pirogov Vinnytsia Regional Council"
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: Hampshire
city: Doncaster
country: United Kingdom
facility: Doncaster Royal Infirmary, Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
city: Leeds
country: United Kingdom
facility: The Leeds Teaching Hospitals NHS Trust, Chapel Allerton Hospital
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust Guy's Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.