Study Stopped
Study is completed; primary analysis completed.
A Phase II Study of M2951 in SLE
A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects With SLE
2 other identifiers
interventional
469
19 countries
157
Brief Summary
M2951 is an investigational drug under evaluation for treatment of autoimmune and inflammatory disorders. The purpose of the study was to assess the Safety and Efficacy of M2951 in participants with Systemic Lupus Erythematosus (SLE).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2017
Typical duration for phase_2
157 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
November 23, 2016
CompletedFirst Posted
Study publicly available on registry
November 29, 2016
CompletedStudy Start
First participant enrolled
January 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 27, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 23, 2020
CompletedResults Posted
Study results publicly available
December 17, 2020
CompletedApril 12, 2021
March 1, 2021
2.9 years
November 23, 2016
November 18, 2020
March 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (29)
DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52
SRI-4 response was defined as greater than or equal to (\>=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score, no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and no treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to Systemic Lupus Erythematosus (SLE) divided into 9 organ systems. For each organ system A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale =from 0(very well) to 100(very poor).
Week 52
DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52
SRI-6 response was defined as \>= 6-point reduction in SLEDAI-2K total score, no new BILAG A and no more than 1 new BILAG B domain score and no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0 (no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system :A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale =from 0(very well) to 100(very poor).
Week 52
DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)
Adverse event (AE) was defined as any untoward medical occurrence in a participant, which does not necessarily have causal relationship with treatment. A serious AE was defined as an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged in participant hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs: events between first dose of study drug that were absent before treatment/that worsened relative to pre-treatment state up to 56 weeks. TEAEs included both serious TEAEs and non-serious TEAEs. Number of participants with TEAEs and serious TEAEs were reported.
Baseline up to Week 56
DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)
Severity of TEAEs were graded using NCI-CTCAE v4.03 toxicity grades, as follows: Grade 1= Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening and Grade 5 = Death. Number of participants with TEAEs by severity were reported.
Baseline up to Week 56
DBPC Period: Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Vital signs included body temperature, systolic and diastolic blood pressure, pulse rate, respiratory rate, weight and height. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in vital signs were reported.
Baseline up to Week 56
DBPC Period: Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Findings
12-lead ECG recordings included rhythm, heart rate (as measured by RR interval), PR interval, QRS duration, and QT interval. The corrected QT interval (QTcF) was calculated using Fridericia's formula. 12-lead ECG recordings were obtained after the participants have rested for at least 10 minutes in semisupine position. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in 12-lead ECG findings were reported.
Baseline up to Week 56
DBPC Period: Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters
Laboratory investigation included hematology, biochemistry, urinalysis and coagulation. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in laboratory parameters were reported.
Baseline up to Week 56
DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2
Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 2.
Week 2
DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4
Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 4.
Week 4
DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12
Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 12.
Week 12
DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24
Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 24.
Week 24
DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36
Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 36.
Week 36
DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52
Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 52
Week 52
DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56
Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 56
Week 56
DBPC Period: Mean Absolute Total B Cell Count at Week 4
Mean total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence activated cell sorting was performed for the analysis of B cell counts.
Week 4
DBPC Period: Mean Absolute Total B Cell Count at Week 24
Mean absolute total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence activated cell sorting was performed for the analysis of B cell counts.
Week 24
DBPC Period: Mean Absolute Total B Cell Count at Week 52
Mean absolute total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence activated cell sorting was performed for the analysis of B cell counts.
Week 52
DBPC Period: Mean Absolute Total B Cell Count at Week 56
Mean absolute total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence activated cell sorting was performed for the analysis of B cell counts.
Week 56
DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2
Change from baseline in the serum levels of IgG, IgA, IgM were assessed.
Baseline and Week 2
DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4
Change from baseline in the serum levels of IgG, IgA, IgM were assessed.
Baseline and Week 4
DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12
Change from baseline in the serum levels of IgG, IgA, IgM were assessed.
Baseline and Week 12
DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24
Change from baseline in the serum levels of IgG, IgA, IgM were assessed.
Baseline and Week 24
DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36
Change from baseline in the serum levels of IgG, IgA, IgM were assessed.
Baseline and Week 36
DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52
Change from baseline in the serum levels of IgG, IgA, IgM were assessed.
Baseline and Week 52
DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56
Change from baseline in the serum levels of IgG, IgA, IgM were assessed.
Baseline and Week 56
DBPC Period: Change From Baseline in Total B Cell Count at Week 4
Change from baseline in Total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence-activated cell sorting was performed for the analysis of B cell counts.
Baseline and Week 4
DBPC Period: Change From Baseline in Total B Cell Count at Week 24
Change from baseline in Total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence-activated cell sorting was performed for the analysis of B cell counts.
Baseline and Week 24
DBPC Period: Change From Baseline in Total B Cell Count at Week 52
Change from baseline in Total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence-activated cell sorting was performed for the analysis of B cell counts.
Baseline and Week 52
DBPC Period: Change From Baseline in Total B Cell Count at Week 56
Change from baseline in Total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence-activated cell sorting was performed for the analysis of B cell counts.
Baseline and Week 56
Secondary Outcomes (27)
DBPC Period: Time to First Severe British Isles Lupus Assessment Group (BILAG) A Flare
Baseline up to Week 56
DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52 in Serologically Active (SA) Subgroup
Week 52
DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52 in Serologically Active Subgroup
Week 52
DBPC Period: Time to First British Isles Lupus Assessment Group (BILAG) A or 2B Moderate to Severe Flare
Baseline up to Week 56
DBPC Period: Number of Participants With British Isles Lupus Assessment Group (BILAG) 2004 Flare-Free Status During the 52-Week Treatment Period
up to Week 52
- +22 more secondary outcomes
Study Arms (8)
Double-Blind Placebo-Controlled (DBPC) Period: Placebo
PLACEBO COMPARATORDBPC Period: M2951 25 mg QD
EXPERIMENTALDBPC Period: M2951 75 mg QD
EXPERIMENTALDBPC Period: M2951 50 mg BID
EXPERIMENTALLong-Term Extension (LTE) Period: Placebo/ M2951 50 mg BID
EXPERIMENTALLTE Period: M2951 25 mg QD/ M2951 50 mg BID
EXPERIMENTALLTE Period: M2951 75 mg QD/ M2951 50 mg BID
EXPERIMENTALLTE Period: M2951 50 mg BID/ M2951 50 mg BID
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Eligible male and female participants, aged 18 to 75 years
- Must have diagnosis of SLE with either the Systemic Lupus International Collaborating Clinics (SLICC) criteria for SLE, or at least four of the 11 American College of Rheumatology (ACR) classification criteria for SLE, of at least six months duration prior to Screening
- SLEDAI-2K total score greater than or equal to (\>=) 6 (including clinical SLEDAI greater than or equal to (\>=) 4) at Screening Visit
- And be positive for anti-double-stranded Deoxyribonucleic Acid (DNA) and/or anti-nuclear antibody (ANA greater than or equal to (\>=) 1:80) and/or anti-Smith (anti-Sm) antibody at the time of Screening
You may not qualify if:
- Participants are not eligible for this study if they have active, clinically significant interstitial lung disease or pulmonary arterial hypertension
- Proteinuria (urine protein to creatinine ratio \[UPCR\] \> 4 mg/mg)
- Acutely worsened renal function
- Central nervous system SLE
- Or within two weeks prior to Screening or during Screening: use of oral corticosteroids greater than (\>) 30 mg daily prednisone equivalent
- Use of injectable corticosteroids, or change in dose of corticosteroids.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (157)
Pinnacle Research Group LLC
Anniston, Alabama, 36207, United States
Arizona Arthritis & Rheumatology Associates, P.C.
Mesa, Arizona, 85210, United States
Arizona Arthritis & Rheumatology Associates, P.C.
Phoenix, Arizona, 85032, United States
Advanced Research Center, Inc.
Anaheim, California, 92805, United States
Wallace Rheumatic Study Center
Beverly Hills, California, 90211, United States
Medvin Clinical Research
Covina, California, 91722, United States
Southern California Permanent Medical Group
Fontana, California, 92335, United States
Global Research Management
Glendale, California, 91204, United States
University of Southern California
Los Angeles, California, 90033, United States
East Bay Rheumatology Medical Group, Inc.
San Leandro, California, 94578, United States
Inland Rheumatology Clinical Trials, Inc.
Upland, California, 91786, United States
Nazanin Firooz, MD Inc.
West Hills, California, 91307, United States
University of Colorado Denver Anschutz Medical Campus
Aurora, Colorado, 80045, United States
Yale School Of Medicine
New Haven, Connecticut, 06519, United States
Clinical Research of West Florida - Corporate
Clearwater, Florida, 33765, United States
Omega Research Consultants
DeBary, Florida, 32713, United States
Center for Rheumatology, Immunology & Arthritis
Fort Lauderdale, Florida, 33309, United States
Hope Clinical Trials
Miami, Florida, 33165, United States
IRIS Research and Development
Plantation, Florida, 33324, United States
McIlwain Medical Group, PA
Tampa, Florida, 33614, United States
Meridien Research, Inc.
Tampa, Florida, 33634, United States
Marietta Rheumatology Associates, PC
Marietta, Georgia, 30060, United States
The University of Chicago Medicine
Chicago, Illinois, 60637, United States
LSU Health Sciences Center Gastroenterology
Shreveport, Louisiana, 71103, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
AA MRC LLC Ahmed Arif Medical Research Center
Flint, Michigan, 48439, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Washington University in St. Louis
St Louis, Missouri, 63110, United States
Hospital for Special Surgery
New York, New York, 10021, United States
SUNY Upstate Medical Center
Syracuse, New York, 13210, United States
Montefiore Medical Center PRIME
The Bronx, New York, 10461, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Medication Management, LLC
Greensboro, North Carolina, 27408, United States
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, 15224, United States
Innovative Clinical Research, LLC
Greenville, South Carolina, 29601, United States
Metroplex Clinical Research Center, LLC
Dallas, Texas, 75231, United States
Accurate Clinical Research, Inc.
Houston, Texas, 77034, United States
Accurate Clinical Management - Brionez
Houston, Texas, 77084, United States
Medical Center Research, LLC Webster Office
Pearland, Texas, 77584, United States
DM Clinical Research
Tomball, Texas, 77375, United States
FSAEI HE " First Moscow State Medical University n.a. I.M. Sechenov" of the MoH of the RF
Seattle, Washington, United States
Instituto de Investigaciones Clinicas
Mar del Plata, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Quilmes
Quilmes, Buenos Aires, Argentina
Centro Integral de Reumatologia
San Miguel de Tucumán, Tucumán Province, Argentina
Centro Medico Privado de Reumatologia
San Miguel de Tucumán, Tucumán Province, Argentina
Investigaciones Clinicas Tucuman
San Miguel de Tucumán, Tucumán Province, Argentina
APRILLUS
Ciudad Autonoma Buenos Aires, Argentina
Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada
Ciudad Autonoma Buenos Aires, Argentina
Clinica Adventista Belgrano
Ciudad Autonoma Buenos Aires, Argentina
Hospital Britanico de Buenos Aires
Ciudad Autonoma Buenos Aires, Argentina
Hospital General de Agudos Dr. J. M. Ramos Mejia
Ciudad Autonoma Buenos Aires, Argentina
Sanatorio Allende
Córdoba, Argentina
Instituto de Reumatologia
Mendoza, Argentina
Cordis S.A.
Salta, Argentina
Centro Polivalente de Asistencia e Inv. Clinica CER
San Juan, Argentina
UMHAT "Pulmed" OOD
Plovdiv, Bulgaria
MHAT - Ruse, AD
Rousse, Bulgaria
Medizinski Zentar-1-Sevlievo EOOD
Sevlievo, Bulgaria
Medical Center "Excelsior", OOD
Sofia, Bulgaria
Medical Center Comac Medical EOOD
Sofia, Bulgaria
UMHAT "SofiaMed", OOD
Sofia, Bulgaria
UMHAT "Sv. Ivan Rilski", EAD
Sofia, Bulgaria
Corporacion de Beneficencia Osorno
Osorno, Chile
Centro de Estudios Reumatologicos
Santiago, Chile
Centro Medico Prosalud
Santiago, Chile
Interin
Santiago, Chile
Psicomedica Clinical and Research Group
Santiago, Chile
Quantum Research Santiago
Santiago, Chile
Centro de Reumatologia y Ortopedia SAS
Barranquilla, Colombia
Clínica de la Costa Ltda.
Barranquilla, Colombia
Fundacion Instituto de Reumatologia Fernando Chalem
Bogotá, Colombia
Simedics Ips Sas
Bogotá, Colombia
Servimed S.A.S.
Bucaramanga, Colombia
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
Berlin, Germany
Humanitas Research Hospital
Rozzano, Milano, Italy
Ospedale San Raffaele
Milan, Italy
Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"
Napoli, Italy
Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia
Reggio Emilia, Italy
Policlinico Universitario Agostino Gemelli
Roma, Italy
Ehime University Hospital
Toon-shi, Ehime, Japan
Tobata General Hospital
Kitakyushu-shi, Fukuoka, Japan
University of Occupational and Environmental Health Hospital
Kitakyushu-shi, Fukuoka, Japan
NHO Asahikawa Medical Center
Asahikawa-shi, Hokkaido, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
Kagawa University Hospital
Kita-gun, Kagawa-ken, Japan
Eiraku Clinic
Kagoshima, Kagoshima-ken, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Seirei Hamamatsu General Hospital
Hamamatsu, Shizuoka, Japan
Dokkyo Medical University Hospital
Shimotsuga-gun, Tochigi, Japan
St. Luke's International Hospital
Chūōku, Tokyo-To, Japan
Tokyo Metropolitan Tama Medical Center
Fuchu-shi, Tokyo-To, Japan
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo-To, Japan
Keio University Hospital
Shinjuku-ku, Tokyo-To, Japan
Tottori University Hospital
Yonago-shi, Tottori, Japan
Hospital Pakar Sultanah Fatimah
Muar town, Johor, Malaysia
Hospital Umum Sarawak
Kuching, Sarawak, Malaysia
Hospital Selayang
Batu Caves, Selangor, Malaysia
International Medical University (IMU) Healthcare
Bukit Jalil, Selangor, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, Malaysia
CAP Research
Solferino-Phoenix, Mauritius
Morales Vargas Centro de Investigacion, S.C.
León, Guanajuato, Mexico
Clinica de Investigacion en Reumatologia y Obesidad S.C.
Guadalajara, Jalisco, Mexico
Unidad de Investigacion en Enfermedades Cronico Degenerativas SC
Guadalajara, Jalisco, Mexico
Unidad de Investigacion de las Enfermedades Reumaticas
Cuauhtémoc, Mexico City, Mexico
Clinstile, S.A. de C.V.
Mexico City, Mexico City, Mexico
Accelerium S. de R.L. de C.V.
Monterrey, Nuevo León, Mexico
Hospital Central Dr Ignacio Morones Prieto
San Luis Potosí City, San Luis Potos, Mexico
Clinical Research Institute S.C.
Tlalnepantla, State of Mexico, Mexico
Investigacion y Biomedicina de Chihuahua, S.C.
Chihuahua City, Mexico
Hogar Clínica San Juan de Dios - Arequipa
Arequipa, Peru
Clinica El Golf
Lima, Peru
Clinica Medica Cayetano Heredia
Lima, Peru
Clinica San Juan Bautista
Lima, Peru
Clinica Vesalio
Lima, Peru
GINOBS SA. Instituto de Ginecologia y Reproduccion
Lima, Peru
Hospital Nacional Cayetano Heredia
Lima, Peru
University of Washington Medical Center
Lima, Peru
ICCV Research Instituto del Cerebro y la Columna Vertebral
Miraflores, Peru
Angeles University Foundation Medical Center
Angeles City, Pampanga, Philippines
Mary Mediatrix Medical Center
Batangas, Philippines
De La Salle University Medical Center
Dasmariñas City, Cavite, Philippines
Davao Doctors Hospital
Davao City, Philippines
Southern Philippines Medical Center
Davao City, Philippines
Iloilo Doctors Hospital
Iloilo City, Philippines
St. Luke's Medical Center
Quezon City, Philippines
CERMED
Bialystok, Poland
Szpital Uniwersytecki nr 2 im.dr J. Biziela
Bydgoszcz, Poland
Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska lek. Barbara Bazela
Elblag, Poland
Centrum Medyczne Plejady
Krakow, Poland
Nzoz Atopia
Krakow, Poland
Rheuma Medicus Zaklad
Warsaw, Poland
Spitalul Clinic "Dr.I. Cantacuzino"
Bucharest, Romania
Spitalul Clinic "Sf. Maria"
Bucharest, Romania
S.C Mediab S.R.L
Târgu Mureş, Romania
LLC "Alliance Biomedical - Ural Group"
Izhevsk, Russia
TSBIH "Krasnoyarsk Interdistrict Clinical Hospital of Emergency Medical Care n.a. N.S. Karpovich
Krasnoyarsk, Russia
HMA - Hospital Maria Auxiliadora
Moscow, Russia
Ultramed
Omsk, Russia
LLC Medical Sanitary Unit#157
Saint Petersburg, Russia
Research Institute of Emergency Medical Care
Saint Petersburg, Russia
SPb SBIH "Clinical Rheumatological Hospital # 25"
Saint Petersburg, Russia
SIH "Saratov City Clinical Hospital # 12"
Saratov, Russia
Nebbiolo LLC
Tomsk, Russia
Wits Clinical Research
Johannesburg, Gauteng, South Africa
Winelands Medical Research Centre
Stellenbosch, Western Cape, South Africa
Naidoo, A - Netcare Umhlanga Hospital
Durban, 4319, South Africa
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
Dong-A University Hospital
Busan, South Korea
Kyungpook National University Hospital
Daegu, South Korea
Konkuk University Medical Center
Seoul, South Korea
Severance Hospital, Yonsei University
Seoul, South Korea
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, South Korea
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
Related Publications (3)
Montalban X, Wallace D, Genovese MC, Tomic D, Parsons-Rich D, Bolay CL, Kao AH, Guehring H. A plain language summary of what clinical studies can tell us about the safety of evobrutinib - a potential treatment for multiple sclerosis. Neurodegener Dis Manag. 2023 Aug;13(4):207-213. doi: 10.2217/nmt-2023-0003. Epub 2023 Jun 22.
PMID: 37345645DERIVEDMontalban X, Wallace D, Genovese MC, Tomic D, Parsons-Rich D, Le Bolay C, Kao AH, Guehring H. Characterisation of the safety profile of evobrutinib in over 1000 patients from phase II clinical trials in multiple sclerosis, rheumatoid arthritis and systemic lupus erythematosus: an integrated safety analysis. J Neurol Neurosurg Psychiatry. 2023 Jan;94(1):1-9. doi: 10.1136/jnnp-2022-328799. Epub 2022 Nov 23.
PMID: 36418156DERIVEDHannon 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
Primary and Secondary endpoints were planned to be analyze only for Double-Blind Placebo-controlled period.
Results Point of Contact
- Title
- Communication Center
- Organization
- Merck KGaA, Darmstadt, Germany
Study Officials
- STUDY DIRECTOR
Medical Responsible
EMD Serono Research & Development Institute, Inc., a business of Merck KGaA, Darmstadt, Germany
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2016
First Posted
November 29, 2016
Study Start
January 4, 2017
Primary Completion
November 27, 2019
Study Completion
March 23, 2020
Last Updated
April 12, 2021
Results First Posted
December 17, 2020
Record last verified: 2021-03