A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)

Systemic Lupus Erythematosus Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03845517
• Other study ID #: B7931028
• Secondary ID: 2018-004175-12
• Status: Completed
• Phase: Phase 2
• Start date: April 18, 2019
• Est. completion date: October 5, 2023

Study information

• Verified date: October 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: October 5, 2023
• Est. primary completion date: October 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• Placebo
Placebo
• PF-06700841 15 mg
PF-06700841 15 mg
• PF-06700841 30 mg
PF-06700841 30 mg
• PF-06700841 45 mg
PF-06700841 45 mg

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Bulgaria,  Canada,  China,  Colombia,  Czechia,  France,  Germany,  Greece,  Hong Kong,  Hungary,  Italy,  Japan,  Korea, Republic of,  Mexico,  Poland,  Portugal,  Romania,  Serbia,  Spain,  Taiwan,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants achieving the Systemic Lupus Erythematosus Responder Index (SRI) change of 4 (SRI-4) at Week 52.		Week 52
Secondary	Proportion of participants achieving the British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) at Week 52.		Baseline, Week 52
Secondary	Proportion of participants achieving the Lupus Low Disease Activity State (LLDAS) at Week 52.		Baseline, Week 52
Secondary	Proportion of participants achieving a reduction in prednisone (or equivalent) at Week 52.		Baseline, Week 52
Secondary	Proportion of participants achieving SRI-4 at Week 52 and have a sustained reduction of prednisone (or equivalent) at Week 52.		Week 52
Secondary	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		Baseline, Week 52
Secondary	Change from baseline in the total scores of Functional Assessment of Chronic Illness Therapy Fatigue (FACIT F) at Week 52.		Baseline, Week 52
Secondary	Change from baseline in the total scores of the Lupus Quality of Life (LupusQoL) at Week 52.		Baseline, Week 52
Secondary	Time to first severe flare in PF 06700841 treated participants relative to placebo.		Baseline, Week 52
Secondary	Number of treatment emergent adverse events (AE's)		Baseline through Week 56
Secondary	Number of discontinuations due to AE's		Baseline through Week 56
Secondary	Number of clinically significant abnormalities in vital signs		Baseline through Week 56
Secondary	Number of clinically significant abnormalities in electrocardiograms		Baseline through Week 56
Secondary	Number of clinically significant abnormalities in clinical laboratory values.		Baseline through Week 56

External Links

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