MedPath

A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus (AMETHYST)

Phase 2
Recruiting
Conditions
Subacute Cutaneous Lupus Erythematosus
Chronic Cutaneous Lupus Erythematosus
Interventions
Drug: Placebo
Registration Number
NCT05531565
Lead Sponsor
Biogen
Brief Summary

In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with cutaneous lupus erythematosus (CLE). The study will focus on participants who have either active subacute CLE or chronic CLE, or both. They may also have systemic lupus erythematosus (SLE). The participants did not respond to antimalarial therapy or had problems with the treatment that made it hard to continue.

The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the skin disease. Researchers will measure symptoms of CLE over time using a variety of scoring tools. These include the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), the Cutaneous Lupus Activity of Investigator's Global Assessment-Revised (CLA-IGA-R), and the SELENA-SLEDAI Flare Index (SFI).

The main questions researchers want to answer are:

* How many participants have a score of 0 or 1 on the CLA-IGA-R looking at skin redness after treatment?

* How many participants have their skin disease activity go down by at least 70%?

Researchers will also learn more about the safety of litifilimab. They will study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and CLE have on the quality of life of participants using a group of questionnaires.

The study will be split into 2 parts - Part A and Part B. Both parts will be done as follows:

* After screening, participants will be randomized to receive either litifilimab or placebo for the 1st treatment period. A placebo looks like the study drug but contains no real medicine.

* Participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks.

* The 1st treatment period will be double blinded which means neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo.

* This double blinded treatment period will last 24 weeks, after which the 2nd treatment period will begin.

* During the 2nd treatment period, all participants will receive litifilimab for 28 weeks.

* After completing treatment in this study, participants that qualify will be given the choice to join the Long-Term Extension study, 230LE305. If they do not, they will move into a follow-up safety period that will last up to 24 weeks.

* The total study duration for participants will be up to 80 weeks

Detailed Description

Litifilimab is a humanized immunoglobulin G1 (IgG1) monoclonal antibody targeting blood dendritic cell antigen 2 and is being investigated for the potential treatment of systemic lupus erythematosus and cutaneous lupus erythematosus. The primary objectives of the study are to evaluate the efficacy of litifilimab compared with placebo in reducing skin disease activity measured by the CLA-IGA-R score \[Parts A and B (US)\] and the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score \[Part B (ROW)\] in participants with active SCLE and/or CCLE with or without systemic manifestations and refractory and/or intolerant to antimalarials. The secondary objectives of the study are to evaluate the efficacy of litifilimab in reducing SCLE and/or CCLE disease activity by CLA-IGA-R, CLASI-A; to evaluate additional efficacy parameters of litifilimab in reducing SCLE and/or CCLE disease activity; safety; tolerability; and immunogenicity of litifilimab \[Parts A and B\].

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
474
Inclusion Criteria
  1. Histologically confirmed (in the past or during the Screening period) diagnosis of CLE with or without systemic manifestations.
  2. Must have active cutaneous manifestations that meet study criteria.
  3. Must have a CLASI-A score ≥10.
  4. Must have an active CLE lesion despite an adequate trial of antimalarial treatment.

Key

Exclusion Criteria
  1. Any active skin conditions other than CLE that may interfere with the study assessments of CLE.
  2. Diagnosis of mixed connective tissue disease [(within 1 year of signing the informed consent form (ICF)] or any history of overlap syndromes of SLE including concomitant presence with rheumatoid arthritis, dermatomyositis and/or polymyositis, systemic sclerosis, psoriatic arthritis, or any other autoimmune disease that may confound the evaluation of the disease activity or the effect of the investigational product. Exceptions for overlap syndrome of SLE include participants with overlap syndrome of SLE with myositis and secondary Sjögren's syndrome at screening is permitted provided the participant also meets the criteria for classification as SLE. A past history of mixed connective tissue disease that over time has developed into a diagnosis of SLE is permitted, provided diagnosis of SLE has been present for at least 1 year.
  3. Active severe lupus nephritis.
  4. Active neuropsychiatric SLE.
  5. Use of intralesional corticosteroids within 1 week prior to Screening and during the study.
  6. Use of immunosuppressive or disease-modifying treatments for SLE or CLE [via an oral, intravenous (IV), or SC route] that were initiated less than 12 weeks prior to randomization, have not been at a stable and allowable dose.

NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Part A (Phase 2): LitifilimabLitifilimabParticipants will receive litifilimab subcutaneously (SC) once every 4 weeks (Q4W) from Week 0 to Week 20, with an additional dose of litifilimab at Week 2 during the double-blind placebo-controlled (DBPC) treatment period. Following the DBPC treatment period, participants will receive litifilimab during the extended treatment period (ETP) from Week 24 to Week 48, with an additional dose of litifilimab-matching placebo at Week 26.
Part A (Phase 2): PlaceboPlaceboParticipants will receive litifilimab-matching placebo SC Q4W from Week 0 to Week 20, with an additional dose of litifilimab-matching placebo at Week 2 during the DBPC treatment period. Following the DBPC treatment period, participants will receive litifilimab during the ETP from Week 24 to Week 48, with an additional dose of litifilimab at Week 26.
Part B (Phase 3): LitifilimabLitifilimabParticipants will receive litifilimab SC Q4W from Week 0 to Week 20, with an additional dose of litifilimab at Week 2 during the DBPC treatment period. Following the DBPC treatment period, participants will receive litifilimab during the ETP from Week 24 to Week 48, with an additional dose of litifilimab-matching placebo at Week 26.
Part B (Phase 3): PlaceboPlaceboParticipants will receive litifilimab-matching placebo SC Q4W from Week 0 to Week 20, with an additional dose of litifilimab-matching placebo at Week 2 during the DBPC treatment period. Following the DBPC treatment period, participants will receive litifilimab during the ETP from Week 24 to Week 48, with an additional dose of litifilimab at Week 26.
Primary Outcome Measures
NameTimeMethod
Parts A (US+ROW) and B (US): Percentage of Participants who Achieve a Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) Erythema Score of 0 or 1Week 16
Part B (ROW): Percentage of Participants who Achieve Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity Score (CLASI-70) Response, Defined as ≥ 70% Decrease in CLASI-A Score From BaselineBaseline to Week 24
Secondary Outcome Measures
NameTimeMethod
Part A (US+ROW): Percentage of Participants who Achieve a CLASI-50 Response, Defined as a ≥ 50% Decrease in CLASI-A Score From BaselineWeeks 16 and 24
Part A (US+ROW): Absolute Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index Damage (CLASI-D) Score at Week 52Baseline to Week 52
Part A (US+ROW): Percent Change in CLASI-D ScoreBaseline to Week 52
Part B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R Erythema Score of 0 or 1, at Week 16 and Week 24, Respectively, for Participants in Full Analysis Set (FAS), who had CLA-IGA-R Erythema Score ≥3 and Other OMC Score ≥3 at BaselineWeeks 16 and 24
Part B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R OMC Score of 0 or 1, at Week 16 and Week 24, Respectively, for Participants in FAS, who had CLA-IGA-R Erythema Score ≥3 and OMC Score ≥3 at BaselineWeeks 16 and 24
Part B (US+ROW): Percentage of Participants who Achieve at Least 1 Level of Improvement From Baseline in the CLA-IGA-R Erythema ScoreUp to Week 24
Part B (US+ROW): Absolute Change in CLASI-D ScoreWeek 52
Part B (US+ROW): Percent Change in CLASI-D ScoreWeek 52
Part B (US+ROW): Change From Baseline in Cutaneous Lupus Erythematosus-Quality of Life (CLE-QoL) ScorePart B (US): Weeks 16 and 52; Part B (ROW): Weeks 24 and 52
Part B (US+ROW): Change From Baseline in Dermatology Life Quality Index (DLQI) ScorePart B (US): Weeks 16 and 52; Part B (ROW): Weeks 24 and 52
Part B (US+ROW): Change From Baseline in Numerical Rating Scale (NRS) for Pain in Skin RashPart B (US): Weeks 16 and 52; Part B (ROW): Weeks 24 and 52
Part B (US+ROW): Change From Baseline in NRS for Itch in Skin RashPart B (US): Weeks 16 and 52; Part B (ROW): Weeks 24 and 52
Parts A (US+ROW) and B (US): Percentage of Participants who Achieve a CLASI-70 Response, Defined as a ≥ 70% Decrease in CLASI-A Score From BaselinePart A (US+ROW): Weeks 16 and 24; Part B (US): Week 16
Parts A and B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R Erythema Score of 0 or 1Part A (US+ROW): Week 24; Part B (ROW): Week 24; Part B (US+ROW): Up to Week 24
Parts A and B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R Other Morphologic Characteristics (OMC) Score of 0 or 1 and at Least 1 Level of Improvement From BaselinePart A (US+ROW): Weeks 16 and 24; Part B (US): Week 16; Part B (ROW): Week 24; Part B (US+ROW): Up to Week 24
Parts A and B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R OMC Score of 0Part A (US+ROW): Weeks 16 and 24; Part B (US+ROW): Up to Week 24
Parts A and B (US+ROW): Percentage of Participants With at Least 1 Level of Improvement From Baseline in CLA-IGA-R OMC ScorePart A (US+ROW): Weeks 16 and 24; Part B (US+ROW): Up to Week 24
Parts A and B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R Follicular Activity Score of 0Parts A and B (US+ROW): Weeks 16 and 24; Part B (US+ROW): Up to Week 24
Parts A and B (US+ROW): Percentage of Participants who Achieve a CLASI-A Score of 0 or 1Up to Week 24
Parts A and B (US+ROW): Percentage of Participants who Achieve a CLASI-A Score of 0 to 3Up to Week 24
Parts A and B (US+ROW): Percentage of Participants who Achieve a CLASI 70 ResponseUp to Week 24
Parts A and B (US+ROW): Percentage of Participants who Achieve a CLASI 50 ResponseUp to Week 24
Parts A and B (US+ROW): Percentage of Participants who Achieve a 7-Point Reduction From Baseline in CLASI-A ScoreUp to Week 24
Parts A and B (US+ROW): Percentage of Participants With a CLASI-70 Response at Week 52 Among CLASI-70 Responders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Litifilimab During the DBPC Treatment Period (TP)Week 52
Parts A and B (US+ROW): Percentage of Participants With CLA-IGA-R Erythema Score of 0 or 1 at Week 52 Among CLA-IGA-R Erythema Responders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Litifilimab During the DBPC TPWeek 52
Parts A and B(US+ROW): Percentage of Participants With CLA-IGA-R OMC Score of 0/1 & at Least 1 Level of Improvement From Baseline at Week 52 Among CLA-IGA-R OMC Responders at Weeks 16 &24, Respectively, who Were Assigned to Receive Litifilimab in DBPC TPWeek 52
Parts A and B (US+ROW): Percentage of Participants With CLA-IGA-R OMC Score of 0 at Week 52 Among CLA-IGA-R OMC Responders With CLA-IGA-R OMC Score of 0 at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Litifilimab During DBPC TPWeek 52
Parts A and B(US+ROW):Percentage of Participants With CLA-IGA-R Follicular Activity Score of 0 at Week 52 Among CLA-IGA-R Follicular Activity Responders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Litifilimab in DBPC TPWeek 52
Parts A and B (US+ROW): Percentage of Participants With a CLASI-70 Response at Week 52 Among CLASI-70 Nonresponders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Placebo During the DBPC TPWeek 52
Parts A and B (US+ROW): Percentage of Participants With a CLA-IGA-R Erythema Score of 0 or 1 at Week 52 Among CLA-IGA-R Erythema Nonresponders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Placebo During the DBPC TPWeek 52
Parts A, B(US+ROW):Percentage of Participants With CLA-IGA-R OMC Score of 0/1 and at Least 1 Level of Improvement From Baseline at Week 52 Among CLA-IGA-R OMC Nonresponders at Weeks 16 and 24, Respectively, who Were Assigned to Receive Placebo in DBPC TPWeek 52
Parts A and B (US+ROW): Number of Participants With Anti-Litifilimab Antibodies in Serum During the StudyUp to Week 76
Parts A and B (US+ROW): Percentage of Participants With a CLA-IGA-R OMC Score of 0 at Week 52 Among CLA-IGA-R OMC Nonresponders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Placebo During the DBPC TPWeek 52
Parts A and B(US+ROW): Percentage of Participants who Achieve CLA-IGA-R Follicular Activity Score of 0 at Week 52 Among CLA-IGA-R Follicular Activity Nonresponders at Weeks 16 and 24, Respectively, who Were Randomly Assigned to Receive Placebo in DBPC TPWeek 52
Parts A and B (US+ROW): Annualized Mild and Moderate Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index Flare Index (SFI) Rate and Annualized Severe SFI Rate Through Week 24Up to Week 24
Parts A and B (US+ROW): Annualized Mild and Moderate SFI Rate and Annualized Severe SFI Rate Through Week 16Up to Week 16
Parts A and B (US+ROW): Annualized Mild and Moderate SFI Rate and Annualized Severe SFI Rate Through Week 52Up to Week 52
Parts A and B (US+ROW): Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)Up to Week 76

Trial Locations

Locations (255)

Pinnacle Research Group, LLC

🇺🇸

Anniston, Alabama, United States

UAB Center for Women's Reproductive Health

🇺🇸

Birmingham, Alabama, United States

Arizona Arthritis & Rheumatology Research, PLLC

🇺🇸

Phoenix, Arizona, United States

The Regents of the University of California

🇺🇸

La Jolla, California, United States

Dermatology Research Associates

🇺🇸

Los Angeles, California, United States

Clinical Science Institute

🇺🇸

Santa Monica, California, United States

Inland Rheumatology Clinical Trials, Inc.

🇺🇸

Upland, California, United States

Denver Arthritis Clinic

🇺🇸

Denver, Colorado, United States

Omega Research Debary, LLC

🇺🇸

DeBary, Florida, United States

Centre for Rheumatology, Immunology and Arthritis

🇺🇸

Fort Lauderdale, Florida, United States

University of Florida

🇺🇸

Gainesville, Florida, United States

Charisma Medical and Research Center

🇺🇸

Miami Lakes, Florida, United States

University of Miami Miller School of Medicine

🇺🇸

Miami, Florida, United States

Medical Research Center of Miami

🇺🇸

Miami, Florida, United States

Rush University Medical Center

🇺🇸

Chicago, Illinois, United States

OrthoIllinois

🇺🇸

Rockford, Illinois, United States

Dawes Fretzin Clinical Research Group, LLC

🇺🇸

Indianapolis, Indiana, United States

LSU Health Sciences Center Shreveport

🇺🇸

New Orleans, Louisiana, United States

Tufts Medical Center

🇺🇸

Boston, Massachusetts, United States

Brigham And Women's Hospital

🇺🇸

Boston, Massachusetts, United States

Essential Dermatology

🇺🇸

Natick, Massachusetts, United States

Beacon Clinical Research, LLC

🇺🇸

Quincy, Massachusetts, United States

University of Massachusetts, Worcester

🇺🇸

Worcester, Massachusetts, United States

David Fivenson, MD, Dermatology, PLLC

🇺🇸

Ann Arbor, Michigan, United States

Oakland Hills Dermatology

🇺🇸

Auburn Hills, Michigan, United States

AA MRC LLC Ahmed Arif Medical Research Center

🇺🇸

Flint, Michigan, United States

Aomori Prefectural Central Hospital

🇯🇵

Aomori-shi, Aomori-Ken, Japan

Revival Research Institute, LLC

🇺🇸

Troy, Michigan, United States

Saint Louis University

🇺🇸

Saint Louis, Missouri, United States

University of Nebraska Medical Center

🇺🇸

Omaha, Nebraska, United States

Albuquerque Center For Rheumatology

🇺🇸

Albuquerque, New Mexico, United States

University of New Mexico School of Medicine

🇺🇸

Albuquerque, New Mexico, United States

NYU Langone Brooklyn

🇺🇸

Brooklyn, New York, United States

Universal Dermatology, PLLC

🇺🇸

Fairport, New York, United States

Northwell Health, Inc. PRIME

🇺🇸

Great Neck, New York, United States

Columbia University Medical center

🇺🇸

New York, New York, United States

University of North Carolina at Chapel Hill

🇺🇸

Chapel Hill, North Carolina, United States

Duke Dermatology South Durham

🇺🇸

Durham, North Carolina, United States

Medication Management, LLC

🇺🇸

Greensboro, North Carolina, United States

University of Cincinnati Department of Dermatology

🇺🇸

Cincinnati, Ohio, United States

University Hospitals Cleveland Medical Center

🇺🇸

Cleveland, Ohio, United States

Ohio State University

🇺🇸

Columbus, Ohio, United States

Penn State University Milton S. Hershey Medical Center

🇺🇸

Hershey, Pennsylvania, United States

University of Pennsylvania

🇺🇸

Philadelphia, Pennsylvania, United States

Vanderbilt University Medical Center

🇺🇸

Nashville, Tennessee, United States

Austin Regional Clinic, P.A.

🇺🇸

Austin, Texas, United States

Precision Comprehensive Clinical Research Solutions

🇺🇸

Colleyville, Texas, United States

Metroplex Clinical Research Center, LLC

🇺🇸

Dallas, Texas, United States

UT Southwestern Medical Center

🇺🇸

Dallas, Texas, United States

North Texas Center for Clinical Research

🇺🇸

Frisco, Texas, United States

UTMB Department of Dermatology

🇺🇸

Galveston, Texas, United States

University of Texas Health Science Center at Houston

🇺🇸

Houston, Texas, United States

Arthritis & Osteoporosis Clinic

🇺🇸

Waco, Texas, United States

University of Utah Health Sciences Center

🇺🇸

Salt Lake City, Utah, United States

West End Dermatology Associates

🇺🇸

Richmond, Virginia, United States

CINME - Centro De Investigaciones Metabolicas

🇦🇷

Caba, Buenos Aires, Argentina

Centro de Investigaciones Medicas Mar del Plata

🇦🇷

Mar del Plata, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas Quilmes

🇦🇷

Quilmes, Buenos Aires, Argentina

APRILLUS Asistencia e Investigacion

🇦🇷

Ciudad Autonoma de Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina

Fundacion Respirar

🇦🇷

Ciudad Autonoma de Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina

Instituto CAICI

🇦🇷

Rosario, Santa Fe, Argentina

Clinica Mayo de Urgencias Medicas Cruz Blanca SRL

🇦🇷

San Miguel de Tucuman, Tucuman, Argentina

Centro de Investigaciones Medicas Tucuman

🇦🇷

San Miguel de Tucuman, Tucuman, Argentina

Investigaciones Clinicas Tucuman

🇦🇷

San Miguel de Tucuman, Tucuman, Argentina

Hospital Italiano de La Plata

🇦🇷

Buenos Aires, Argentina

Centro Privado de Medicina Familiar - Mind Out Research

🇦🇷

Ciudad Autonoma Buenos Aires, Argentina

Clinica Adventista Belgrano

🇦🇷

Ciudad Autonoma Buenos Aires, Argentina

Instituto de Reumatologia

🇦🇷

Mendoza, Argentina

CER San Juan Centro Polivalente de Asistencia e Inv. Clinica

🇦🇷

San Juan, Argentina

Clínica SER da Bahia

🇧🇷

Salvador, Bahia, Brazil

HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará

🇧🇷

Fortaleza, Ceará, Brazil

L2IP - Instituto de Pesquisas Clínicas Ltda.

🇧🇷

Brasilia, Distrito Federal, Brazil

CEDOES - Diagnóstico e Pesquisa

🇧🇷

Vitória, Espírito Santo, Brazil

IPC MT Instituto de Pesquisas Clinicas do Mato Grosso

🇧🇷

Santo Ângelo, Mato Grosso, Brazil

Santa Casa de Misericordia de Belo Horizonte

🇧🇷

Belo Horizonte, Minas Gerais, Brazil

CMiP - Centro Mineiro de Pesquisa

🇧🇷

Juiz de Fora, Minas Gerais, Brazil

Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A

🇧🇷

Rio de Janeiro, Rio Do Janeiro, Brazil

IDERJ - Instituto de Dermatologia e Estética do Brasil Ltda

🇧🇷

Rio de Janeiro, Rio Do Janeiro, Brazil

Hospital Bruno Born

🇧🇷

Lajeado, Rio Grande Do Sul, Brazil

Hospital de Clínicas de Porto Alegre

🇧🇷

Porto Alegre, Rio Grande Do Sul, Brazil

Nucleo de Pesquisa Clinica do Rio Grande do Sul

🇧🇷

Porto Alegre, Rio Grande Do Sul, Brazil

LMK Serviços Médicos S/S Ltda

🇧🇷

Porto Alegre, Rio Grande Do Sul, Brazil

Charité - Campus Charité Mitte

🇩🇪

Berlin, Germany

CEMEC - Centro Multidisciplinar de Estudos Clínicos

🇧🇷

Sao Bernardo Do Campo, Sao Paulo, Brazil

CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos

🇧🇷

São Paulo, Sao Paulo, Brazil

Medical center Medconsult Pleven OOD

🇧🇬

Pleven, Bulgaria

UMHAT 'Dr. Georgi Stranski', EAD

🇧🇬

Pleven, Bulgaria

DCC 1 - Ruse, EOOD

🇧🇬

Ruse, Bulgaria

DCC 'Alexandrovska', EOOD

🇧🇬

Sofia, Bulgaria

DCC Focus 5 - MEOH OOD

🇧🇬

Sofia, Bulgaria

Military Medical Academy - MHAT - Sofia

🇧🇬

Sofia, Bulgaria

Laser Rejuvenation Clinics, Inc.

🇨🇦

Calgary, Alberta, Canada

Laster Rejuvenation Clinics Edmonton D.T. Inc.

🇨🇦

Edmonton, Alberta, Canada

Dermatology Ottawa Research Centre

🇨🇦

Ottawa, Ontario, Canada

Medicor Research Inc

🇨🇦

Sudbury, Ontario, Canada

DIEX Recherche Sherbrooke Inc.

🇨🇦

Sherbrooke, Quebec, Canada

Centro Medico SkinMed

🇨🇱

Las Condes, Chile

Dermacross

🇨🇱

Santiago, Chile

BioMedica Research Group

🇨🇱

Santiago, Chile

CeCim Biocinetic

🇨🇱

Santiago, Chile

CIEC - Centro Internacional de Estudios Clínicos

🇨🇱

Santiago, Chile

Clinical Research Chile SpA.

🇨🇱

Valdivia, Chile

Oncocentro APYS

🇨🇱

Viña del Mar, Chile

Beijing Tongren Hospital, Capital Medical University

🇨🇳

Beijing, Beijing, China

Peking Union Medical College Hospital

🇨🇳

Beijing, Beijing, China

The First Affiliated Hospital of Chongqing Medical University

🇨🇳

Chongqing, Chongqing, China

The First Affiliated Hospital of Fujian Medical University

🇨🇳

Fuzhou, Fujian, China

Pecsi Tudomanyegyetem

🇭🇺

Pecs, Hungary

Dongguan People's Hospital

🇨🇳

Dongguan, Guangdong, China

Nanfang Hospital of Southern Medical University

🇨🇳

Guangzhou, Guangdong, China

Shenzhen Second People's Hospital

🇨🇳

Shenzhen, Guangdong, China

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

🇨🇳

Guangzhou, Guangzhou, China

Nanyang First People's Hospital

🇨🇳

Nanyang, Henan, China

Henan Provincial People's Hospital

🇨🇳

Zhengzhou, Henan, China

The second Xiangya Hospital of Central South University

🇨🇳

Changsha, Hunan, China

The First Affiliated Hospital of Baotou Medical College

🇨🇳

Baotou, Inner Mongolia, China

Hospital for Skin Diseases, Chinese Academy of Medical Sciences

🇨🇳

Nanjing, Jiangsu, China

Affiliated Hospital of Jiangsu University

🇨🇳

Zhenjiang, Jiangsu, China

The First Hospital of Jilin University

🇨🇳

Changchun City, Jilin, China

Qilu Hospital of Shandong University

🇨🇳

Jinan, Shandong, China

Ruijin Hospital of Shanghai Jiaotong University School of Medicine

🇨🇳

Shanghai, Shanghai, China

Zhongshan Hospital Fudan University

🇨🇳

Shanghai, Shanghai, China

Shanghai Skin Disease Hospital

🇨🇳

Shanghai, Shanghai, China

The Second Affiliated Hospital of Kunming Medical University

🇨🇳

Kunming, Yunnan, China

The First Affiliated Hospital of Zhejiang University school of medicine

🇨🇳

Hangzhou, Zhejiang, China

Hangzhou First People's Hospital

🇨🇳

Hangzhou, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

🇨🇳

Wenzhou, Zhejiang, China

Centro de Investigacion Medico Asistencial S.A.S

🇨🇴

Barranquilla, Atlántico, Colombia

Healthy Medical Center

🇨🇴

Zipaquirá, Cundinamarca, Colombia

Servimed S.A.S.

🇨🇴

Bucaramanga, Santander, Colombia

Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEM

🇨🇴

Bogotá, Colombia

CHU Nice - Hopital de l Archet

🇫🇷

Nice cedex 3, Alpes Maritimes, France

Hôpital de la Timone

🇫🇷

Marseille cedex 5, Bouches-du-Rhône, France

CHU de Caen - Hopital de la Cote de Nacre

🇫🇷

Caen, Calvados, France

CHU Besançon - Hôpital Jean Minjoz

🇫🇷

Besançon Cedex, Doubs, France

Hopital Larrey

🇫🇷

Toulouse Cedex 9, Haute Garonne, France

Hôpital Privé d'Antony

🇫🇷

Antony, Hauts De Seine, France

Hopital Saint Eloi

🇫🇷

Montpellier Cedex 5, Herault, France

Hôpital Saint-Louis

🇫🇷

Cedex 10, Paris, France

Hopital Edouard Herriot - CHU Lyon

🇫🇷

Lyon, Rhone, France

Hopital Tenon

🇫🇷

Paris, France

Universitaetsklinikum Heidelberg

🇩🇪

Heidelberg, Baden Wuerttemberg, Germany

Universitaetsklinikum Erlangen

🇩🇪

Erlangen, Bayern, Germany

Medical Center Manila

🇵🇭

Manila, Philippines

Fachklinik Bad Bentheim Dermatologie

🇩🇪

Bad Bentheim, Niedersachsen, Germany

Elbekliniken Buxtehude GmbH

🇩🇪

Buxtehude, Niedersachsen, Germany

Klinikum Oldenburg AoeR

🇩🇪

Oldenburg, Niedersachsen, Germany

Universitaetsklinikum Aachen AoeR

🇩🇪

Aachen, Nordrhein Westfalen, Germany

Universitaetsklinikum Bonn AoeR

🇩🇪

Bonn, Nordrhein Westfalen, Germany

Universitaetsklinikum Duesseldorf AoeR

🇩🇪

Duesseldorf, Nordrhein Westfalen, Germany

Universitaetsklinikum Muenster

🇩🇪

Muenster, Nordrhein Westfalen, Germany

Universitaetsklinikum Halle (Saale)

🇩🇪

Halle, Sachsen Anhalt, Germany

Universitaetsklinikum Carl Gustav Carus TU Dresden

🇩🇪

Dresden, Sachsen, Germany

Universitaetsklinikum Schleswig-Holstein - Campus Kiel

🇩🇪

Kiel, Schleswig Holstein, Germany

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS

🇮🇹

Bologna, Italy

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

🇮🇹

Brescia, Italy

Università degli studi di Firenze

🇮🇹

Firenze, Italy

IRCCS Ospedale Policlinico San Martino

🇮🇹

Genova, Italy

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

🇮🇹

Milano, Italy

Ospedale San Raffaele

🇮🇹

Milano, Italy

Azienda Ospedaliera Universitaria Policlinico 'Federico II'

🇮🇹

Napoli, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

🇮🇹

Roma, Italy

JCHO Chukyo Hospital

🇯🇵

Nagoya-shi, Aichi-Ken, Japan

NHO Nagoya Medical Center

🇯🇵

Nagoya-shi, Aichi-Ken, Japan

Fujita Health University Hospital

🇯🇵

Toyoake-shi, Aichi-Ken, Japan

Juntendo University Urayasu Hospital

🇯🇵

Urayasu-shi, Chiba-Ken, Japan

University of Fukui Hospital

🇯🇵

Yoshida-gun, Fukui-Ken, Japan

Hospital of the University of Occupational and Environmental Health

🇯🇵

Kitakyushu-shi, Fukuoka-Ken, Japan

Hokkaido University Hospital

🇯🇵

Sapporo-shi, Hokkaido, Japan

Kakogawa Central City Hospital

🇯🇵

Kakogawa-shi, Hyogo-Ken, Japan

Kita Harima Medical Center

🇯🇵

Ono-shi, Hyogo-Ken, Japan

Kanazawa University Hospital

🇯🇵

Kanazawa-shi, Ishikawa-Ken, Japan

St. Marianna University Hospital

🇯🇵

Kawasaki-shi, Kanagawa-Ken, Japan

Yokohama City University Medical Center

🇯🇵

Yokohama-shi, Kanagawa-Ken, Japan

Yokohama City University Hospital

🇯🇵

Yokohama-shi, Kanagawa-Ken, Japan

NHO Yokohama Medical Center

🇯🇵

Yokohama-shi, Kanagawa-Ken, Japan

Kumamoto University Hospital

🇯🇵

Kumamoto-shi, Kumamoto-Ken, Japan

Tohoku University Hospital

🇯🇵

Sendai-shi, Miyagi-Ken, Japan

Nagasaki University Hospital

🇯🇵

Nagasaki-Shi, Nagasaki-Ken, Japan

Niigata University Medical & Dental Hospital

🇯🇵

Niigata-shi, Niigata-Ken, Japan

Japanese Red Cross Okayama Hospital

🇯🇵

Okayama-shi, Okayama-Ken, Japan

NHO Osaka Minami Medical Center

🇯🇵

Kawachinagano-shi, Osaka-Fu, Japan

Daini Osaka Police Hospital

🇯🇵

Osaka-shi, Osaka-Fu, Japan

Kindai University Hospital

🇯🇵

Osakasayama-shi, Osaka-Fu, Japan

Osaka University Hospital

🇯🇵

Suita-shi, Osaka-Fu, Japan

Takatsuki Red Cross Hospital

🇯🇵

Takatsuki-shi, Osaka-Fu, Japan

Shiga University of Medical Science Hospital

🇯🇵

Otsu-shi, Shiga-Ken, Japan

Shimane University Hospital

🇯🇵

Izumo-shi, Shimane-Ken, Japan

Teikyo University Hospital

🇯🇵

Itabashi-ku, Tokyo-To, Japan

Showa University East Hospital

🇯🇵

Shinagawa-ku, Tokyo-To, Japan

Wakayama Medical University Hospital

🇯🇵

Wakayama-shi, Wakayama-Ken, Japan

Korea University Ansan Hospital

🇰🇷

Ansan-si, Gyeonggi-do, Korea, Republic of

Ajou University Hospital

🇰🇷

Suwon, Gyeonggi-do, Korea, Republic of

Chonnam National University Hospital

🇰🇷

Gwangju, Korea, Republic of

Severance Hospital, Yonsei University Health System

🇰🇷

Seoul, Korea, Republic of

Hanyang University Seoul Hospital

🇰🇷

Seoul, Korea, Republic of

The Catholic University of Korea, Seoul St. Mary's Hospital

🇰🇷

Seoul, Korea, Republic of

Clinstile, S.A. de C.V.

🇲🇽

Ciudad de México, Distrito Federal, Mexico

Centro de Investigacion Clínica GRAMEL S.C

🇲🇽

Mexico, Distrito Federal, Mexico

Centro de investigacion medica y reumatologia

🇲🇽

Guadalajara, Jalisco, Mexico

Consultorio Privado Dr. Miguel Cortes Hernandez

🇲🇽

Cuernavaca, Morelos, Mexico

Medical Care & Research SA de CV

🇲🇽

Merida, Yucatán, Mexico

Derma Norte del Bajio S.C.

🇲🇽

Aguascalientes, Mexico

Investigacion y Biomedicina de Chihuahua, S.C.

🇲🇽

Chihuahua, Mexico

Invest Clinicas Sac Inst de Ginecologia y Reproduccion

🇵🇪

Lima, Peru

The Medical City Clark

🇵🇭

Mabalacat, Pampanga, Philippines

Cebu Doctors University Hospital

🇵🇭

Cebu City, Philippines

Mary Mediatrix Medical Center

🇵🇭

Lipa City, Philippines

Philippine General Hospital

🇵🇭

Manila, Philippines

Jose R. Reyes Memorial Medical Center

🇵🇭

Manila, Philippines

Far Eastern University - Dr. Nicanor Reyes Medical Foundation

🇵🇭

Quezon City, Metro Manila, Philippines

St. Luke's Medical Center

🇵🇭

Quezon City, Philippines

Ilocos Training and Regional Medical Center

🇵🇭

San Fenando, La Union, Philippines

Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski

🇵🇱

Krakow, Poland

SPZOZ Szpital Uniwersytecki w Krakowie

🇵🇱

Kraków, Poland

Dermoklinika Centrum Medyczne SC M Kierstan J Narbutt A Lesiak

🇵🇱

Lodz, Poland

Kliniczny Szpital Wojewodzki nr 1 im.F.Chopina

🇵🇱

Rzeszow, Poland

Szpital Kliniczny Dzieciatka Jezus

🇵🇱

Warszawa, Poland

Royalderm

🇵🇱

Warszawa, Poland

Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska

🇵🇱

Wroclaw, Poland

Centro Hospitalar e Universitário de Coimbra, E.P.E (HUC)

🇵🇹

Coimbra, Portugal

Hospital de Egas Moniz

🇵🇹

Lisboa, Portugal

Hospital CUF Descobertas

🇵🇹

Lisboa, Portugal

Centro Hospitalar Universitártio do Porto, E.P.E.

🇵🇹

Porto, Portugal

Unidade Local de Saúde do Alto Minho, E.P.E.

🇵🇹

Viana do Castelo, Portugal

Dr. Samuel Sanchez PSC

🇵🇷

Caguas, Puerto Rico

GCM Medical Group PSC - Hato Rey

🇵🇷

San Juan, Puerto Rico

King Faisal Specialist Hospital & Research Center

🇸🇦

Riyadh, Saudi Arabia

King Saud University

🇸🇦

Riyadh, Saudi Arabia

Institute of Rheumatology

🇷🇸

Belgrade, Serbia

University Clinical Center of Serbia

🇷🇸

Belgrade, Serbia

Clinical Center of Vojvodina

🇷🇸

Novi Sad, Serbia

Artromac n.o.

🇸🇰

Kosice, Slovakia

Narodny ustav reumatickych chorob

🇸🇰

Piestany, Slovakia

Hospital Universitari Germans Trias i Pujol

🇪🇸

Badalona, Barcelona, Spain

Hospital Universitario Rio Hortega

🇪🇸

Valladolid, Cantabria, Spain

Hospital Universitario Fundacion Alcorcon

🇪🇸

Alcorcón, Madrid, Spain

Hospital Universitario Puerta de Hierro Majadahonda

🇪🇸

Majadahonda, Madrid, Spain

Hospital del Mar

🇪🇸

Barcelona, Spain

Hospital de la Santa Creu i Sant Pau

🇪🇸

Barcelona, Spain

Hospital Universitario Reina Sofia

🇪🇸

Cordoba, Spain

Complejo Hospitalario Universitario A Coruña

🇪🇸

La Coruña, Spain

Hospital Universitario Virgen del Rocio

🇪🇸

Sevilla, Spain

Karolinska Universitetssjukhuset - Solna

🇸🇪

Stockholm, Sweden

Universitaetsspital Zuerich

🇨🇭

Zurich-Flughafen, Zurich, Switzerland

Centre Hospitalier Universitaire Vaudois (CHUV)

🇨🇭

Lausanne, Switzerland

Kantonsspital St. Gallen

🇨🇭

St. Gallen, Switzerland

Changhua Christian Medical Foundation Changhua Christian Hospital

🇨🇳

Changhua, Taiwan

Kaohsiung Chang Gung Memorial Hospital

🇨🇳

Kaohsiung, Taiwan

Taichung Veterans General Hospital

🇨🇳

Taichung, Taiwan

Taipei Veterans General Hospital

🇨🇳

Taipei, Taiwan

Whipps Cross University Hospital

🇬🇧

London, Greater London, United Kingdom

Manchester Royal Infirmary

🇬🇧

Manchester, Greater Manchester, United Kingdom

Queen Elizabeth Hospital

🇬🇧

Birmingham, West Midlands, United Kingdom

Chapel Allerton Hospital

🇬🇧

Leeds, West Yorkshire, United Kingdom

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