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)

Assessment of PF-06700841 in participants with moderate to severe active, generalized Systemic Lupus Erythematosus (SLE) that have inadequate response to standard of care.

Study Overview

• Status: Completed
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Drug: Placebo; Drug: PF-06700841 15 mg; Drug: PF-06700841 30 mg; Drug: PF-06700841 45 mg

• Study Type: Interventional
• Enrollment (Actual): 350
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Tucuman
    • San Miguel de Tucuman, Tucuman, Argentina, T4000AXL
      • Centro de Investigaciones Medicas Tucuman
• Australia
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • Optimus Clinical Research
  • Victoria
    • Camberwell, Victoria, Australia, 3124
      • Emeritus Research
• Belgium
  • Leuven, Belgium, 3000
    • UZ Leuven
  • Merksem, Belgium, 2170
    • Ziekenhuisnetwerk Antwerpen Jan Palfijn (ZNA Jan Palfijn)
• Bulgaria
  • Plovdiv, Bulgaria, 4000
    • DCC Sveti Georgi EOOD
  • Plovdiv, Bulgaria, 4000
    • MHAT Plovdiv AD
  • Ruse, Bulgaria, 7002
    • UMHAT Kanev AD
  • Sofia, Bulgaria, 1431
    • UMHAT "Sv.Ivan Rilski" EAD
  • Sofia, Bulgaria, 1432
    • UMHAT "Sv. Ivan Rilski" EAD
• Canada
  • Quebec
    • Rimouski, Quebec, Canada, G5L 5T1
      • Centre Intégré de Santé et de Services Sociaux du Bas-Saint-Laurent
    • Trois-Rivieres, Quebec, Canada, G8Z 1Y2
      • Centre de Recherche Musculo-Squelettique
• China
  • Beijing, China, 100730
    • Peking Union Medical College Hospital
  • Shanghai, China, 200025
    • Ruijin Hospital- Shanghai Jiaotong University School of Medicine
  • Shanghai, China, 200040
    • Fudan University Hua Shan Hospital
  • Anhui
    • Hefei, Anhui, China, 230001
      • Anhui Provincial Hospital
  • Hunan
    • Changsha, Hunan, China, 410011
      • The second Xiangya hospital of central south university
  • Jiangsu
    • Suzhou, Jiangsu, China, 215006
      • The First Affiliated Hospital of Soochow University
  • Tianjin
    • Tianjin, Tianjin, China, 300052
      • Tianjin Medical University General Hospital
• Colombia
  • Antioquia
    • Medellin, Antioquia, Colombia, 050034
      • Hospital Pablo Tobon Uribe
  • Atlantico
    • Barranquilla, Atlantico, Colombia, 080002
      • Centro Integral de Reumatología del Caribe S.A.S - CIRCARIBE S.A.S
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia, 110221
      • Bluecare Salud S.A.S Sede Centro Médico Integral Chicó MedPlus CRI
    • Bogotá, Cundinamarca, Colombia, 110221
      • Centro de Investigación en Reumatología y Especialidades Médicas SAS - CIREEM SAS
  • Santander
    • Bucaramanga, Santander, Colombia, 680003
      • Medicity S.A.S.
• Czechia
  • Praha 2, Czechia, 128 08
    • Vseobecna fakultni nemocnice v Praze
  • Praha 2, Czechia, 12802
    • Nemocnicni lekarna VFN
  • Praha 2, Czechia, 12850
    • Revmatologicky ustav
• France
  • Paris, France, 75014
    • Hopital Cochin
  • Paris, France, 75013
    • Hôpital Pitié Salpêtrière, Centre des Maladies Auto-immunes
  • Pessac, France, 33604
    • CHU de Bordeaux, Groupe Hospitalier Sud, Hôpital Haut Lévèque
• Germany
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Lübeck, Germany, 23538
    • Universitätsklinikum Schleswig Holstein - Campus Lübeck
• Greece
  • Athens, Greece, 11527
    • Laiko General Hospital, University of Athens
  • Haidari, Greece, 12462
    • University Hospital Attikon
  • Crete
    • Heraklion, Crete, Greece, 71110
      • University General Hospital of Heraklion
• Hong Kong
  • Hong Kong, Hong Kong
    • Tuen Mun Hospital
• Hungary
  • Budapest, Hungary, 1036
    • Qualiclinic Kft.
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Gyula, Hungary, 5700
    • Békés Vármegyei Központi Kórház
• Italy
  • Pavia, Italy, 27100
    • Fondazione IRCCS Policlinico S.Matteo
• Japan
  • Chiba, Japan, 260-8712
    • National Hospital Organization Chiba-East Hospital
  • Fukuoka, Japan, 810-8563
    • National Hospital Organization Kyushu Medical Center
  • Hiroshima, Japan, 734-8551
    • Hiroshima University Hospital
  • Hokkaido
    • Asahikawa, Hokkaido, Japan, 070-8644
      • National Hospital Organization Asahikawa Medical Center
    • Sapporo, Hokkaido, Japan, 060-8648
      • Hokkaido University Hospital
  • Miyagi
    • Sendai, Miyagi, Japan, 980-8574
      • Tohoku University Hospital
  • Nagasaki
    • Sasebo, Nagasaki, Japan, 857-1195
      • Sasebo Chuo Hospital
  • Okinawa
    • Naha, Okinawa, Japan, 900-0015
      • Shinkenko Clinic
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-8560
      • St. Luke's International Hospital
• Korea, Republic of
  • Daegu, Korea, Republic of, 41944
    • Kyungpook National University Hospital (KNUH)
  • Gyeonggi-do
    • Suwon, Gyeonggi-do, Korea, Republic of, 16499
      • Ajou University Hospital
  • Seoul
    • Seocho-gu, Seoul, Korea, Republic of, 06591
      • The Catholic Univ. of Korea Seoul St. Mary's Hospital
• Mexico
  • Chihuahua, Mexico, 31000
    • Investigacion y Biomedicina de Chihuahua, Sociedad Civil
  • Guadalajara, Mexico, 45070
    • Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V
  • Mexico City, Mexico, 11850
    • CINTRE Centro de Investigación y Tratamiento Reumatológico S.C.
  • Cuauhtémoc
    • Mexico City, Cuauhtémoc, Mexico, 06700
      • CITER Centro de Investigacion y Tratamiento de las Enfermedades Reumáticas S.A. de C.V.
  • Guanajuato
    • León, Guanajuato, Mexico, 37000
      • Morales Vargas Centro de Investigación S.C.
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 45070
      • Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V
    • Zapopan, Jalisco, Mexico, 45070
      • Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V
    • Zapopan, Jalisco, Mexico, C.P. 45070
      • Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V
  • Tlalpan
    • Mexico City, Tlalpan, Mexico, 14080
      • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Yucatán
    • Mérida, Yucatán, Mexico, 97000
      • Centro Peninsular De Investigacion Clinica S.C.P.
• Poland
  • Bialystok, Poland, 15-297
    • Stanislaw Sierakowski Centrum Miriada
  • Bydgoszcz, Poland, 85-168
    • Szpital Biziela
  • Lublin, Poland, 20-582
    • Zespol Poradni Specjalistycznych Reumed, Onyksowa Filia nr 2
  • Nadarzyn, Poland, 05-830
    • NZOZ "Lecznica Mak-Med" s.c.
  • Sosnowiec, Poland, 41-200
    • Centrum Medyczne Medens S.C. Grupowa Praktyka Lekarska
  • Warszawa, Poland, 02-637
    • Narodowy Instytutu Geriatrii, Reumatologii i Rehabilitacji
  • Warszawa, Poland, 04-030
    • Mazowieckie Centrum Reumatologii i Osteoporozy M. Przygodzka Spolka jawna
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 02-637
      • Centrum Wsparcia Badań Klinicznych
• Portugal
  • Almada, Portugal, 2805-267
    • Hospital Garcia de Orta, E.P.E
  • Amadora, Portugal, 2720-276
    • Hospital Professor Doutor Fernando da Fonseca, E.P.E
  • Ponte de Lima, Portugal, 4990-078
    • Unidade Local de Saúde do Alto Minho, E.P.E.
  • Porto, Portugal, 4099-001
    • Centro Hospitalar Universitario do Porto, E.P.E
• Romania
  • Bucuresti, Romania, 011172
    • Spitalul Clinic Sf. Maria
  • JUD. Brasov
    • Brasov, JUD. Brasov, Romania, 500283
      • SC Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL
  • Jud. Cluj
    • Cluj-Napoca, Jud. Cluj, Romania, 400006
      • Spitalul Clinic Judetean de Urgenta Cluj-Napoca
  • Sector 1
    • Bucuresti, Sector 1, Romania, 014461
      • S.C. Euroclinic Hospital S.A
• Serbia
  • Beograd, Serbia, 11000
    • Institut za Reumatologiju
  • Beograd, Serbia, 11000
    • Klinicki Centar Srbije, Klinika za alergologiju i imunologiju
  • Beograd, Serbia, 11000
    • Vojnomedicinska akademija, Klinika za reumatologiju
  • Niska Banja, Serbia, 18205
    • Institut Niska Banja, Klinika za Reumatologiju
• Spain
  • Badalona, Spain, 08916
    • Hospital Germans Trias i Pujol
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron
  • Barcelona, Spain, 08022
    • Clinica Sagrada Familia
  • La Coruna, Spain, 15006
    • Complexo Hospitalario Universitario A Coruña
  • Sevilla, Spain, 41010
    • Hospital Quiron Infanta Luisa
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36200
      • Hospital Do Meixoeiro
• Taiwan
  • Kaohsiung City, Taiwan, 81362
    • Kaohsiung Veterans General Hospital
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Taichung, Taiwan, 40201
    • Chung Shan Medical University Hospital
  • Taichung City, Taiwan, 40447
    • China Medical University Hospital
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taoyuan City, Taiwan, 333
    • Chang Gung Memorial Hospital Linkou Branch
  • Taiwan (r.o.c)
    • Taichung City, Taiwan (r.o.c), Taiwan, 40447
      • China Medical University Hospital
• Ukraine
  • Kyiv, Ukraine, 03680
    • State Institution National Scientific Center "M.D. Strazhesko Institute of Cardiology"
  • Kyiv, Ukraine, 03680
    • State Institution National Scientific Center "M.D. Strazhesko Institute of Cardiology" of National
  • Lviv, Ukraine, 79011
    • Communal non-profitable enterprise "Lviv City Clinical Hospital #4"
  • Odesa, Ukraine, 65000
    • Multifield Medical Center of Odessa National Medical University
  • Odesa, Ukraine, 65025
    • CNPE "Odesa Regional Clinical Hospital" of Odesa Regional Council
  • Odesa, Ukraine, 65000
    • Multifield Medical Center of Odesa National Medical University
  • Ternopil, Ukraine, 46002
    • CNPE "Ternopil University Hospital" of Ternopil regional council, Department of Rheumatology
  • Uzhgorod, Ukraine, 88000
    • Zakarpattia Regional Clinical Hospital n.a. A. Novak
  • Vinnytsia, Ukraine, 21028
    • CNPE "Vinnytsya regional Clinical Hospital named after N.I.Pirogov Vinnytsia Regional Council"
• United Kingdom
  • Doncaster, United Kingdom, DN2 5LT
    • Doncaster Royal Infirmary, Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
  • Leeds, United Kingdom, LS7 4SA
    • The Leeds Teaching Hospitals NHS Trust, Chapel Allerton Hospital
  • London, United Kingdom, SE1 9RT
    • Guy's and St Thomas' NHS Foundation Trust Guy's Hospital
  • Hampshire
    • Southampton, Hampshire, United Kingdom, SO16 6YD
      • Southampton General Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • The University of Alabama at Birmingham
    • Birmingham, Alabama, United States, 35249
      • UAB Hospital Department of Pharmacy
    • Birmingham, Alabama, United States, 35249
      • UAB Hospital-Clinical Research Unit (CRU)
    • Birmingham, Alabama, United States, 35294
      • UAB Department of Medicine Clinical Research Enterprise
    • Birmingham, Alabama, United States, 35233
      • The Kirklin Clinic
    • Birmingham, Alabama, United States, 35205
      • UAB Department of Medicine Clinical Research Enterprise
  • California
    • Fullerton, California, United States, 92835
      • St. Joseph Heritage Healthcare
    • La Palma, California, United States, 90623
      • Advanced Medical Research, LLC
    • La Palma, California, United States, 90623
      • Arthritis and Osteoporosis Medical Center
    • Palm Desert, California, United States, 92260-9368
      • Desert Medical Advances
    • San Leandro, California, United States, 94578
      • East Bay Rheumatology Medical Group, Inc.
    • Thousand Oaks, California, United States, 91360
      • Millennium Clinical Trials
    • Upland, California, United States, 91786
      • Inland Rheumatology Clinical Trials, Inc.
    • Upland, California, United States, 91786
      • Inland Rheumatology and Osteoporosis Medical Group
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606
      • New England Research Associates, LLC
    • Bridgeport, Connecticut, United States, 06606
      • New England Research Associates
    • Stamford, Connecticut, United States, 06905
      • Stamford Therapeutics Consortium
  • Florida
    • Clearwater, Florida, United States, 33765
      • Clinical Research of West Florida
    • Clearwater, Florida, United States, 33765
      • Private Practice of Robert W. Levin
    • Gainesville, Florida, United States, 32607
      • SIMEDHealth, LLC Attn: Rheumatology
    • Gainesville, Florida, United States, 32607
      • SIMEDHealth, LLC
    • Orlando, Florida, United States, 32808
      • Omega Research MetroWest, LLC
    • Palm Harbor, Florida, United States, 34685
      • Akumin, Inc
    • Saint Petersburg, Florida, United States, 33703
      • Akumin Inc
    • Tamarac, Florida, United States, 33321
      • West Broward Rheumatology Associates, Inc
    • Tampa, Florida, United States, 33606
      • Clinical Research of West Florida
    • Tampa, Florida, United States, 33613
      • AdventHealth Tampa
    • Tampa, Florida, United States, 33603
      • Akumin Inc.
    • Tampa, Florida, United States, 33603
      • Rose Radiology dba Akumin Inc.
  • Georgia
    • Decatur, Georgia, United States, 30033
      • Jefrey D. Lieberman, M.D., P.C.
    • Marietta, Georgia, United States, 30060
      • Atlanta Research Center for Rheumatology
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Institute of Arthritis Research
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
    • Kansas City, Kansas, United States, 66103
      • Investigational Drug Services University of Kansas Hospital
    • Kansas City, Kansas, United States, 66160
      • The University of Kansas Hospital
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70836
      • Ochsner Clinic Foundation, Baton Rouge
  • Michigan
    • Brighton, Michigan, United States, 48116
      • University of Michigan Brighton Center for Specialty Care
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Innovative Health Research
  • New York
    • Brooklyn, New York, United States, 11201
      • NYU Langone Ambulatory Care Brooklyn Heights
    • Canton, New York, United States, 13617
      • St. Lawrence Health System
    • Manhasset, New York, United States, 11030
      • Feinstein Institute for Medical Research
    • Manhasset, New York, United States, 11030
      • Northshore University Hospital
    • New York, New York, United States, 10032
      • Columbia University Medical Center.
    • New York, New York, United States, 10032
      • Irving Institute for Clinical and Transitional Research
    • Potsdam, New York, United States, 13676
      • St. Lawrence Health System
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Joint and Muscle Research Institute
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73102
      • Arthritis & Rheumatology Center of Oklahoma PLLC
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • West Tennessee Research Institute
    • Memphis, Tennessee, United States, 38119-5214
      • Gupta, Ramesh C MD
  • Texas
    • Austin, Texas, United States, 78745
      • Tekton Research
    • Baytown, Texas, United States, 77521
      • Accurate Clinical Management, LLC
    • Houston, Texas, United States, 77089
      • Accurate Clinical Research
    • Houston, Texas, United States, 77004
      • Rheumatic Disease Clinical Research Center, LLC
    • San Marcos, Texas, United States, 78666
      • Arthritis Clinic of Central Texas
  • Washington
    • Spokane, Washington, United States, 99204
      • Arthritis Northwest, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo
Experimental: PF-06700841 15 mg	Drug: PF-06700841 15 mg; PF-06700841 15 mg
Experimental: PF-06700841 30 mg	Drug: PF-06700841 30 mg; PF-06700841 30 mg
Experimental: PF-06700841 45 mg	Drug: PF-06700841 45 mg; PF-06700841 45 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) at Week 52	BICLA included: BILAG-2004, SLEDAI-2K and PhGA. Participants were classified as responders, if they met all the following criteria: BILAG-2004 improvement (all A scores at baseline improved to B/C/D and all B scores improved to C or D); no worsening in disease activity (no new BILAG-2004 A scores or =<1 new B score); no worsening of total SLEDAI-2K score; no significant deterioration (<10 percent [%] worsening) in analogue PhGA. 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
Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 52	LLDAS was defined as SLE disease activity index (SLEDAI-2k <=4, with no activity in major organ systems [renal, central nervous system, cardiopulmonary, vasculitis, fever]) and no haemolytic anaemia or gastrointestinal activity; no new lupus disease activity compared with the previous assessment; a Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-SLEDAI PhGA (scale 0-3; higher scores = higher severity) <=1; a current prednisolone (or equivalent) dose <=7.5 milligram per day (mg/daily); and well tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents.	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	In this outcome measure data is reported for participants who achieved a reduction in prednisone (or equivalent) dose to <=7.5 mg/day and sustained for 12 Weeks prior at Week 52 and they also sustained this dose reduction for 12 weeks prior to Week 52 (Week 40 to Week 52).	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	In this outcome measure data is reported for participants who achieved a reduction in SRI-4 response with prednisone dose reduced to <=7.5 mg/day and sustained for 12 weeks at Week 52.	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	CLASI is an validated measurement instrument for lupus erythematosus developed for use in clinical studies that consists of separate scores for the activity of the disease (CLASI-A). The CLASI activity score is calculated on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. The CLASI activity score ranges from 0-70, with higher scores indicating more severe skin disease. Severity categories based on the CLASI activity score are as follows: mild (0-9), moderate (10-20), and severe (21-70).	Week 52
Change From Baseline in Total Scores of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Week 52	The FACIT-F Scale is a participant completed questionnaire consisting of 13 items that assess fatigue. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0 = not at all; 1 = a little bit; 2 =somewhat; 3 = quite a bit; 4 = very much). Instrument scoring yielded a range from 0 to 52 (negatively worded items were reversed during analysis), with higher scores representing better participant status (less fatigue).	Baseline, Week 52
Change From Baseline in Physical Health Domain Scores of Lupus Quality of Life (LupusQoL) at Week 52	The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others; measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Physical health domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life.	Baseline, Week 52
Change From Baseline in Emotional Health Domain Scores of LupusQoL at Week 52	The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Emotional health domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life.	Baseline, Week 52
Change From Baseline in Body Image Domain Scores of LupusQoL at Week 52	The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Body image domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life.	Baseline, Week 52
Change From Baseline in Pain Domain Scores of LupusQoL at Week 52	The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Pain domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life.	Baseline, Week 52
Change From Baseline in Planning Domain Scores of LupusQoL at Week 52	The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Planning domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life.	Baseline, Week 52
Change From Baseline in Fatigue Domain Scores of LupusQoL at Week 52	The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Fatigue domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life.	Baseline, Week 52
Change From Baseline in Intimate Relationship Domain Scores of LupusQoL at Week 52	The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Intimate relationship domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life.	Baseline, Week 52
Change From Baseline in Burden to Others Domain Scores of LupusQoL at Week 52	The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Burden to others domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life.	Baseline, Week 52
Incidence Rate of Severe Flare Event	Incidence rate was defined as the number of new events per 100 person-years.	Week 52
Number of Participants With Treatment-Emergent Adverse Events (AE)	An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. TEAEs are events from first dose of study intervention to 4 weeks after last dose of study intervention that were absent before treatment or that worsened relative to pre-treatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and all non-SAEs.	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)
Number of Participants With Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.	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)
Number of Participants With Adverse Events Leading to Discontinuation From Study	An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. In this outcome measure, participants with adverse events leading to discontinuation from study were reported.	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)
Number of Participants With Clinically Significant Vital Signs Abnormalities	Vital signs included blood pressure, pulse rate, respiratory rate, and temperature. Clinical significance in vital signs abnormalities was judged by investigator.	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)
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities	Clinical significance in ECG abnormalities was judged by investigator.	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)
Number of Participants With Laboratory Test Abnormalities	Hematology (Hemoglobin[hgb], hematocrit, erythrocytes[ery]:<0.8*lower limit of normal[LLN];reticulocytes, reticulocytes/ery:<0.5*LLN,>1.5*upper LN[ULN];ery mean corpuscular volume[EMC], EMC hgb:<0.9*LLN,>1.5*ULN;EMC hgb concentration:<0.9* LLN;platelet:<0.5*LLN;leukocytes[leu]:<0.6*LLN,>1.5*ULN;lymphocytes, lymphocytes/leu, neutrophils, neutrophils/leu:<0.8* LLN,>1.2*ULN;basophils, basophils/leu, eosinophils, eosinophils/leu, monocytes, monocytes/leu:>1.2*ULN;activated partial thromboplastin time[PTT], PTT, prothrombin time:>1.1*ULN);Clinical chemistry (Total/direct/indirect bilirubin, glucose-fasting:>1.5*ULN; aspartate aminotransferase[AT], alanine AT:>3.0*ULN; protein, albumin, HDL cholesterol:<0.8*LLN;urea nitrogen, creatinine, triglyceride, cholesterol:>1.3*ULN;urate, LDL cholesterol:>1.2*ULN;potassium:<0.9*LLN,>1.1*ULN;calcium, bicarbonate:<0.9*LLN;creatine kinase:>2.0*ULN);Urinalysis (pH<4.5;glucose, protein, hgb, ketones, nitrite, leu esterase, granular/hyaline/WBCs casts:>1).	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)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

General Publications

• 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2019
• Primary Completion (Actual): October 5, 2023
• Study Completion (Actual): October 5, 2023

Study Registration Dates

• First Submitted: February 15, 2019
• First Submitted That Met QC Criteria: February 15, 2019
• First Posted (Actual): February 19, 2019

Study Record Updates

• Last Update Posted (Estimated): September 5, 2024
• Last Update Submitted That Met QC Criteria: August 29, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; PF-06700841
• Other Study ID Numbers: B7931028; 2018-004175-12 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No