A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
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)
2 other identifiers
interventional
350
26 countries
164
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2019
Typical duration for phase_2
164 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2019
CompletedFirst Posted
Study publicly available on registry
February 19, 2019
CompletedStudy Start
First participant enrolled
April 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 5, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 5, 2023
CompletedResults Posted
Study results publicly available
September 5, 2024
CompletedSeptember 5, 2024
August 1, 2024
4.5 years
February 15, 2019
June 28, 2024
August 29, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving SLE Responder Index (SRI) Change of 4 (SRI-4) at Week 52
SRI-4 components included Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), British Isles Lupus Assessment Group (BILAG) 2004 and Physician's Global Assessment (PhGA). Participants were classified as SRI-4 responders, if they met all of the following criteria compared with baseline: 1) greater than or equal to (\>=) 4 point reduction in SLEDAI-2K score; 2) no new BILAG A organ domain score or 2 new BILAG B organ domain scores; 3) no worsening (less than \[\<\] 0.3 point increase) in PhGA score. SLEDAI-2K: assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG: assesses disease extent, severity in individual organ system (range: A \[severe\] to E \[no disease\]; higher score = less severity). PhGA: assesses worsening in participant's general health status (range: 0 \[none\] to 3 \[severe\]; higher score = higher severity).
Week 52
Secondary Outcomes (21)
Percentage of Participants Achieving British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) at Week 52
Week 52
Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 52
Week 52
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
Week 52 for achieving reduction in dose along with Week 40 to Week 52 for sustained dosing
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
12 Weeks prior at Week 52 (Week 40 to Week 52)
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
Week 52
- +16 more secondary outcomes
Study Arms (4)
Placebo
PLACEBO COMPARATORPlacebo
PF-06700841 15 mg
EXPERIMENTALPF-06700841 15 mg
PF-06700841 30 mg
EXPERIMENTALPF-06700841 30 mg
PF-06700841 45 mg
EXPERIMENTALPF-06700841 45 mg
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (164)
UAB Department of Medicine Clinical Research Enterprise
Birmingham, Alabama, 35205, United States
The Kirklin Clinic
Birmingham, Alabama, 35233, United States
UAB Hospital Department of Pharmacy
Birmingham, Alabama, 35249, United States
UAB Hospital-Clinical Research Unit (CRU)
Birmingham, Alabama, 35249, United States
The University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
UAB Department of Medicine Clinical Research Enterprise
Birmingham, Alabama, 35294, United States
St. Joseph Heritage Healthcare
Fullerton, California, 92835, United States
Advanced Medical Research, LLC
La Palma, California, 90623, United States
Arthritis and Osteoporosis Medical Center
La Palma, California, 90623, United States
Desert Medical Advances
Palm Desert, California, 92260-9368, United States
East Bay Rheumatology Medical Group, Inc.
San Leandro, California, 94578, United States
Millennium Clinical Trials
Thousand Oaks, California, 91360, United States
Inland Rheumatology and Osteoporosis Medical Group
Upland, California, 91786, United States
Inland Rheumatology Clinical Trials, Inc.
Upland, California, 91786, United States
New England Research Associates, LLC
Bridgeport, Connecticut, 06606, United States
New England Research Associates
Bridgeport, Connecticut, 06606, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905, United States
Clinical Research of West Florida
Clearwater, Florida, 33765, United States
Private Practice of Robert W. Levin
Clearwater, Florida, 33765, United States
SIMEDHealth, LLC Attn: Rheumatology
Gainesville, Florida, 32607, United States
SIMEDHealth, LLC
Gainesville, Florida, 32607, United States
Omega Research MetroWest, LLC
Orlando, Florida, 32808, United States
Akumin, Inc
Palm Harbor, Florida, 34685, United States
Akumin Inc
St. Petersburg, Florida, 33703, United States
West Broward Rheumatology Associates, Inc
Tamarac, Florida, 33321, United States
Akumin Inc.
Tampa, Florida, 33603, United States
Rose Radiology dba Akumin Inc.
Tampa, Florida, 33603, United States
Clinical Research of West Florida
Tampa, Florida, 33606, United States
AdventHealth Tampa
Tampa, Florida, 33613, United States
Jefrey D. Lieberman, M.D., P.C.
Decatur, Georgia, 30033, United States
Atlanta Research Center for Rheumatology
Marietta, Georgia, 30060, United States
Institute of Arthritis Research
Idaho Falls, Idaho, 83404, United States
Investigational Drug Services University of Kansas Hospital
Kansas City, Kansas, 66103, United States
The University of Kansas Hospital
Kansas City, Kansas, 66160, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Ochsner Clinic Foundation, Baton Rouge
Baton Rouge, Louisiana, 70836, United States
University of Michigan Brighton Center for Specialty Care
Brighton, Michigan, 48116, United States
Innovative health Research
Las Vegas, Nevada, 89128, United States
NYU Langone Ambulatory Care Brooklyn Heights
Brooklyn, New York, 11201, United States
St. Lawrence Health System
Canton, New York, 13617, United States
Feinstein Institute for Medical Research
Manhasset, New York, 11030, United States
Northshore University Hospital
Manhasset, New York, 11030, United States
Columbia University Medical Center.
New York, New York, 10032, United States
Irving Institute for Clinical and Transitional Research
New York, New York, 10032, United States
St. Lawrence Health System
Potsdam, New York, 13676, United States
Joint and Muscle Research Institute
Charlotte, North Carolina, 28204, United States
Arthritis & Rheumatology Center of Oklahoma PLLC
Oklahoma City, Oklahoma, 73102, United States
West Tennessee Research Institute
Jackson, Tennessee, 38305, United States
Gupta, Ramesh C MD
Memphis, Tennessee, 38119-5214, United States
Tekton Research
Austin, Texas, 78745, United States
Accurate Clinical Management, LLC
Baytown, Texas, 77521, United States
Rheumatic Disease Clinical Research Center, LLC
Houston, Texas, 77004, United States
Accurate Clinical Research
Houston, Texas, 77089, United States
Arthritis Clinic of Central Texas
San Marcos, Texas, 78666, United States
Arthritis Northwest, PLLC
Spokane, Washington, 99204, United States
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina
Optimus Clinical Research
Kogarah, New South Wales, 2217, Australia
Emeritus Research
Camberwell, Victoria, 3124, Australia
UZ Leuven
Leuven, 3000, Belgium
Ziekenhuisnetwerk Antwerpen Jan Palfijn (ZNA Jan Palfijn)
Merksem, 2170, Belgium
DCC Sveti Georgi EOOD
Plovdiv, 4000, Bulgaria
MHAT Plovdiv AD
Plovdiv, 4000, Bulgaria
Umhat Kanev Ad
Rousse, 7002, Bulgaria
UMHAT "Sv.Ivan Rilski" EAD
Sofia, 1431, Bulgaria
UMHAT "Sv. Ivan Rilski" EAD
Sofia, 1432, Bulgaria
Centre intégré de santé et de services sociaux du Bas-Saint-Laurent
Rimouski, Quebec, G5L 5T1, Canada
Centre de Recherche Musculo-Squelettique
Trois-Rivières, Quebec, G8Z 1Y2, Canada
Anhui Provincial Hospital
Hefei, Anhui, 230001, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
Peking Union Medical College Hospital
Beijing, 100730, China
Ruijin Hospital- Shanghai Jiaotong University School of Medicine
Shanghai, 200025, China
Fudan University Hua Shan Hospital
Shanghai, 200040, China
Hospital Pablo Tobon Uribe
Medellín, Antioquia, 050034, Colombia
Centro Integral de Reumatología del Caribe S.A.S - CIRCARIBE S.A.S
Barranquilla, Atlántico, 080002, Colombia
Bluecare Salud S.A.S Sede Centro Médico Integral Chicó MedPlus CRI
Bogota, Cundinamarca, 110221, Colombia
Centro de Investigación en Reumatología y Especialidades Médicas SAS - CIREEM SAS
Bogotá, Cundinamarca, 110221, Colombia
Medicity S.A.S.
Bucaramanga, Santander Department, 680003, Colombia
Vseobecna fakultni nemocnice v Praze
Prague, 128 08, Czechia
Nemocnicni lekarna VFN
Prague, 12802, Czechia
Revmatologicky ustav
Prague, 12850, Czechia
Hôpital Pitié Salpêtrière, Centre des Maladies Auto-immunes
Paris, 75013, France
Hôpital Cochin
Paris, 75014, France
CHU de Bordeaux, Groupe Hospitalier Sud, Hôpital Haut Lévèque
Pessac, 33604, France
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Universitätsklinikum Schleswig Holstein - Campus Lübeck
Lübeck, 23538, Germany
University General Hospital of Heraklion
Heraklion, Crete, 71110, Greece
Laiko General Hospital, University of Athens
Athens, 11527, Greece
University Hospital ATTIKON
Haidari, 12462, Greece
Tuen Mun Hospital
Hong Kong, Hong Kong
Qualiclinic Kft.
Budapest, 1036, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Békés Vármegyei Központi Kórház
Gyula, 5700, Hungary
Fondazione IRCCS Policlinico S.Matteo
Pavia, 27100, Italy
National Hospital Organization Asahikawa Medical Center
Asahikawa, Hokkaido, 070-8644, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648, Japan
Tohoku University Hospital
Sendai, Miyagi, 980-8574, Japan
Sasebo Chuo Hospital
Sasebo, Nagasaki, 857-1195, Japan
Shinkenko clinic
Naha, Okinawa, 900-0015, Japan
St. Luke's International Hospital
Chuo-ku, Tokyo, 104-8560, Japan
National Hospital Organization Chiba-East Hospital
Chiba, 260-8712, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, 810-8563, Japan
Hiroshima University Hospital
Hiroshima, 734-8551, Japan
CITER Centro de Investigación y Tratamiento de las Enfermedades Reumáticas S.A. de C.V.
Mexico City, Cuauhtémoc, 06700, Mexico
Morales Vargas Centro de Investigación S.C.
León, Guanajuato, 37000, Mexico
Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V
Guadalajara, Jalisco, 45070, Mexico
Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V
Zapopan, Jalisco, 45070, Mexico
Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V
Zapopan, Jalisco, C.P. 45070, Mexico
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, Tlalpan, 14080, Mexico
Centro Peninsular de Investigación Clínica S.C.P.
Mérida, Yucatán, 97000, Mexico
Investigación y Biomedicina de Chihuahua, Sociedad Civil
Chihuahua City, 31000, Mexico
Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V
Guadalajara, 45070, Mexico
CINTRE Centro de Investigación y Tratamiento Reumatológico S.C.
Mexico City, 11850, Mexico
Centrum Wsparcia Badan Klinicznych
Warsaw, Masovian Voivodeship, 02-637, Poland
Stanislaw Sierakowski Centrum Miriada
Bialystok, 15-297, Poland
Szpital Biziela
Bydgoszcz, 85-168, Poland
Zespol Poradni Specjalistycznych Reumed, Onyksowa Filia nr 2
Lublin, 20-582, Poland
NZOZ "Lecznica Mak-Med" s.c.
Nadarzyn, 05-830, Poland
Centrum Medyczne MEDENS S.C. Grupowa Praktyka Lekarska
Sosnowiec, 41-200, Poland
Narodowy Instytutu Geriatrii, Reumatologii i Rehabilitacji
Warsaw, 02-637, Poland
Mazowieckie Centrum Reumatologii i Osteoporozy M. Przygodzka Spolka jawna
Warsaw, 04-030, Poland
Hospital Garcia de Orta, E.P.E
Almada, 2805-267, Portugal
Hospital Professor Doutor Fernando da Fonseca, E.P.E
Amadora, 2720-276, Portugal
Unidade Local de Saude do Alto Minho, E.P.E.
Ponte de Lima, 4990-078, Portugal
Centro Hospitalar Universitario do Porto, E.P.E
Porto, 4099-001, Portugal
SC Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL
Brasov, JUD. Brasov, 500283, Romania
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
Cluj-Napoca, JUD. CLUJ, 400006, Romania
S.C. Euroclinic Hospital S.A
Bucharest, Sector 1, 014461, Romania
Spitalul Clinic Sf. Maria
Bucharest, 011172, Romania
Institut za Reumatologiju
Belgrade, 11000, Serbia
Klinicki Centar Srbije, Klinika za alergologiju i imunologiju
Belgrade, 11000, Serbia
Vojnomedicinska akademija, Klinika za reumatologiju
Belgrade, 11000, Serbia
Institut Niska Banja, Klinika za Reumatologiju
Niška Banja, 18205, Serbia
Ajou University Hospital
Suwon, Gyeonggi-do, 16499, South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seocho-gu, Seoul, 06591, South Korea
Kyungpook National University Hospital (KNUH)
Daegu, 41944, South Korea
Hospital do Meixoeiro
Vigo, Pontevedra, 36200, Spain
Complexo Hospitalario Universitario A Coruna
A Coruña, 15006, Spain
Hospital Germans Trias i Pujol
Badalona, 08916, Spain
Clinica Sagrada Familia
Barcelona, 08022, Spain
Hospital Universitario Vall d'Hebron
Barcelona, 08035, Spain
Hospital Quiron Infanta Luisa
Seville, 41010, Spain
China Medical University Hospital
Taichung, Taiwan (r.o.c), 40447, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, 81362, Taiwan
Chung Shan Medical University Hospital
Taichung, 40201, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Chang Gung Memorial Hospital Linkou Branch
Taoyuan, 333, Taiwan
State Institution National Scientific Center "M.D. Strazhesko Institute of Cardiology" of National
Kyiv, 03680, Ukraine
State Institution National Scientific Center "M.D. Strazhesko Institute of Cardiology"
Kyiv, 03680, Ukraine
Communal non-profitable enterprise "Lviv City Clinical Hospital #4"
Lviv, 79011, Ukraine
Multifield Medical Center of Odesa National Medical University
Odesa, 65000, Ukraine
Multifield Medical Center of Odessa National Medical University
Odesa, 65000, Ukraine
CNPE "Odesa Regional Clinical Hospital" of Odesa Regional Council
Odesa, 65025, Ukraine
CNPE "Ternopil University Hospital" of Ternopil regional council, Department of Rheumatology
Ternopil, 46002, Ukraine
Zakarpattia Regional Clinical Hospital n.a. A. Novak
Uzhhorod, 88000, Ukraine
CNPE "Vinnytsya regional Clinical Hospital named after N.I.Pirogov Vinnytsia Regional Council"
Vinnytsia, 21028, Ukraine
Southampton General Hospital
Southampton, Hampshire, SO16 6YD, United Kingdom
Doncaster Royal Infirmary, Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
Doncaster, DN2 5LT, United Kingdom
The Leeds Teaching Hospitals NHS Trust, Chapel Allerton Hospital
Leeds, LS7 4SA, United Kingdom
Guy's and St Thomas' NHS Foundation Trust Guy's Hospital
London, SE1 9RT, United Kingdom
Related Publications (1)
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.
PMID: 33687069DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
For the PF-06700841 30 mg, there was a total of 1 death which was reported in both on-treatment and follow-up phases in participant flow section.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2019
First Posted
February 19, 2019
Study Start
April 18, 2019
Primary Completion
October 5, 2023
Study Completion
October 5, 2023
Last Updated
September 5, 2024
Results First Posted
September 5, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will share
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.