A Study to Assess the Efficacy and Safety of BIIB059 (Litifilimab) in Participants With Active Subacute Cutaneous Lupus Erythematosus (SCLE) and/or Chronic Cutaneous Lupus Erythematosus (CCLE) With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy

Subacute Cutaneous Lupus Erythematosus Clinical Trial

— AMETHYST  

Official title:

A 2-Part Seamless Part A (Phase 2)/Part B (Phase 3) Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of BIIB059 in Participants With Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (AMETHYST)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05531565
• Other study ID #: 230LE301
• Secondary ID: 2020-000727-40
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: September 13, 2022
• Est. completion date: December 14, 2027

Study information

• Verified date: June 2024
• Source: Biogen
• Contact: US Biogen Clinical Trial Center
• Phone: 866-633-4636
• Email: clinicaltrials[@]biogen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objectives of the study are to evaluate the efficacy of BIIB059 (litifilimab) compared with placebo in reducing skin disease activity measured by the Cutaneous Lupus Activity of Physician's Global Assessment-Revised (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 BIIB059 in reducing SCLE and/or CCLE disease activity by CLA-IGA-R, CLASI-A; to evaluate additional efficacy parameters of BIIB059 in reducing SCLE and/or CCLE disease activity; safety; tolerability; and immunogenicity of BIIB059 [Parts A and B].

Description:

BIIB059 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 474
• Est. completion date: December 14, 2027
• Est. primary completion date: October 20, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key 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. Active severe lupus nephritis.

3. Active neuropsychiatric SLE.

4. Use of intralesional corticosteroids within 1 week prior to Screening and during the study.

5. 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

Related Conditions & MeSH terms

• Lupus Erythematosus, Cutaneous
• Lupus Erythematosus, Discoid
• Lupus Erythematosus, Systemic
• Subacute Cutaneous Lupus Erythematosus

Intervention

Drug:
• BIIB059 (litifilimab)
Administered as specified in the treatment arm.
• Placebo
Administered as specified in the treatment arm.

Locations

Country	Name	City	State
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	CINME - Centro De Investigaciones Metabolicas	Ciudad Autonoma de Buenos Aire	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	Centro de Investigaciones Medicas Mar del Plata	Mar del Plata	Buenos Aires
Argentina	Instituto de Reumatologia	Mendoza
Argentina	Instituto de Investigaciones Clinicas Quilmes	Quilmes	Buenos Aires
Argentina	Instituto CAICI	Rosario	Santa Fe
Argentina	CER San Juan Centro Polivalente de Asistencia e Inv. Clinica	San Juan
Argentina	Centro de Investigaciones Medicas Tucuman	San Miguel de Tucuman	Tucuman
Argentina	Clinica Mayo de Urgencias Medicas Cruz Blanca SRL	San Miguel de Tucuman	Tucuman
Argentina	Investigaciones Clinicas Tucuman	San Miguel de Tucuman	Tucuman
Brazil	Santa Casa de Misericordia de Belo Horizonte	Belo Horizonte	Minas Gerais
Brazil	L2IP - Instituto de Pesquisas Clínicas Ltda.	Brasilia	Distrito Federal
Brazil	HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará	Fortaleza	Ceará
Brazil	CMiP - Centro Mineiro de Pesquisa	Juiz de Fora	Minas Gerais
Brazil	Hospital Bruno Born	Lajeado	Rio Grande Do Sul
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul
Brazil	LMK Serviços Médicos S/S Ltda	Porto Alegre	Rio Grande Do Sul
Brazil	Nucleo de Pesquisa Clinica do Rio Grande do Sul	Porto Alegre	Rio Grande Do Sul
Brazil	IDERJ - Instituto de Dermatologia e Estética do Brasil Ltda	Rio de Janeiro	Rio Do Janeiro
Brazil	Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A	Rio de Janeiro	Rio Do Janeiro
Brazil	Clínica SER da Bahia	Salvador	Bahia
Brazil	IPC MT Instituto de Pesquisas Clinicas do Mato Grosso	Santo Ângelo	Mato Grosso
Brazil	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	CEDOES - Diagnóstico e Pesquisa	Vitória	Espírito Santo
Bulgaria	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	DCC Focus 5 - MEOH OOD	Sofia
Bulgaria	Military Medical Academy - MHAT - Sofia	Sofia
Canada	Laser Rejuvenation Clinics, Inc.	Calgary	Alberta
Canada	Laster Rejuvenation Clinics Edmonton D.T. Inc.	Edmonton	Alberta
Canada	Dermatology Ottawa Research Centre	Ottawa	Ontario
Canada	DIEX Recherche Sherbrooke Inc.	Sherbrooke	Quebec
Canada	Medicor Research Inc	Sudbury	Ontario
Chile	Centro Medico SkinMed	Las Condes
Chile	BioMedica Research Group	Santiago
Chile	CeCim Biocinetic	Santiago
Chile	CIEC - Centro Internacional de Estudios Clínicos	Santiago
Chile	Dermacross	Santiago
Chile	Clinical Research Chile SpA.	Valdivia
Chile	Oncocentro APYS	Viña del Mar
Colombia	Centro de Investigacion Medico Asistencial S.A.S	Barranquilla	Atlántico
Colombia	Servimed S.A.S.	Bucaramanga	Santander
Colombia	Healthy Medical Center	Zipaquirá	Cundinamarca
France	Hôpital Privé d'Antony	Antony	Hauts De Seine
France	CHU Besançon - Hôpital Jean Minjoz	Besançon Cedex	Doubs
France	CHU de Caen - Hopital de la Cote de Nacre	Caen	Calvados
France	Hôpital Saint-Louis	Cedex 10	Paris
France	Hopital Edouard Herriot - CHU Lyon	Lyon	Rhone
France	Hôpital de la Timone	Marseille cedex 5	Bouches-du-Rhône
France	Hopital Saint Eloi	Montpellier Cedex 5	Herault
France	CHU Nice - Hopital de l Archet	Nice cedex 3	Alpes Maritimes
France	Hopital Tenon	Paris
France	Hopital Larrey	Toulouse Cedex 9	Haute Garonne
Germany	Fachklinik Bad Bentheim Dermatologie	Bad Bentheim	Niedersachsen
Germany	Charité - Campus Charité Mitte	Berlin
Germany	Universitaetsklinikum Bonn AoeR	Bonn	Nordrhein Westfalen
Germany	Elbekliniken Buxtehude GmbH	Buxtehude	Niedersachsen
Germany	Universitaetsklinikum Carl Gustav Carus TU Dresden	Dresden	Sachsen
Germany	Universitaetsklinikum Erlangen	Erlangen	Bayern
Germany	Universitaetsklinikum Halle (Saale)	Halle	Sachsen Anhalt
Germany	Universitaetsklinikum Heidelberg	Heidelberg	Baden Wuerttemberg
Germany	Universitaetsklinikum Schleswig-Holstein - Campus Kiel	Kiel	Schleswig Holstein
Germany	Universitaetsklinikum Muenster	Muenster	Nordrhein Westfalen
Germany	Klinikum Oldenburg AoeR	Oldenburg	Niedersachsen
Hungary	Pecsi Tudomanyegyetem	Pecs
Italy	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
Japan	Aomori Prefectural Central Hospital	Aomori-shi	Aomori-Ken
Japan	Teikyo University Hospital	Itabashi-ku	Tokyo-To
Japan	Shimane University Hospital	Izumo-shi	Shimane-Ken
Japan	Kakogawa Central City Hospital	Kakogawa-shi	Hyogo-Ken
Japan	Kanazawa University Hospital	Kanazawa-shi	Ishikawa-Ken
Japan	NHO Osaka Minami Medical Center	Kawachinagano-shi	Osaka-Fu
Japan	St. Marianna University Hospital	Kawasaki-shi	Kanagawa-Ken
Japan	Hospital of the University of Occupational and Environmental Health	Kitakyushu-shi	Fukuoka-Ken
Japan	Kumamoto University Hospital	Kumamoto-shi	Kumamoto-Ken
Japan	Nagasaki University Hospital	Nagasaki-Shi	Nagasaki-Ken
Japan	JCHO Chukyo Hospital	Nagoya-shi	Aichi-Ken
Japan	NHO Nagoya Medical Center	Nagoya-shi	Aichi-Ken
Japan	Niigata University Medical & Dental Hospital	Niigata-shi	Niigata-Ken
Japan	Japanese Red Cross Okayama Hospital	Okayama-shi	Okayama-Ken
Japan	Kita Harima Medical Center	Ono-shi	Hyogo-Ken
Japan	Daini Osaka Police Hospital	Osaka-shi	Osaka-Fu
Japan	Kindai University Hospital	Osakasayama-shi	Osaka-Fu
Japan	Shiga University of Medical Science Hospital	Otsu-shi	Shiga-Ken
Japan	Hokkaido University Hospital	Sapporo-shi	Hokkaido
Japan	Tohoku University Hospital	Sendai-shi	Miyagi-Ken
Japan	Showa University East Hospital	Shinagawa-ku	Tokyo-To
Japan	Osaka University Hospital	Suita-shi	Osaka-Fu
Japan	Takatsuki Red Cross Hospital	Takatsuki-shi	Osaka-Fu
Japan	Fujita Health University Hospital	Toyoake-shi	Aichi-Ken
Japan	Juntendo University Urayasu Hospital	Urayasu-shi	Chiba-Ken
Japan	Wakayama Medical University Hospital	Wakayama-shi	Wakayama-Ken
Japan	NHO Yokohama Medical Center	Yokohama-shi	Kanagawa-Ken
Japan	Yokohama City University Hospital	Yokohama-shi	Kanagawa-Ken
Japan	Yokohama City University Medical Center	Yokohama-shi	Kanagawa-Ken
Japan	University of Fukui Hospital	Yoshida-gun	Fukui-Ken
Korea, Republic of	Korea University Ansan Hospital	Ansan-si	Gyeonggi-do
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Hanyang University Seoul Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon	Gyeonggi-do
Mexico	Derma Norte del Bajio S.C.	Aguascalientes
Mexico	Investigacion y Biomedicina de Chihuahua, S.C.	Chihuahua
Mexico	Clinstile, S.A. de C.V.	Ciudad de México	Distrito Federal
Mexico	Consultorio Privado Dr. Miguel Cortes Hernandez	Cuernavaca	Morelos
Mexico	Centro de investigacion medica y reumatologia	Guadalajara	Jalisco
Mexico	Medical Care & Research SA de CV	Merida	Yucatán
Mexico	Centro de Investigacion Clínica GRAMEL S.C	Mexico	Distrito Federal
Philippines	Cebu Doctors University Hospital	Cebu City
Philippines	Mary Mediatrix Medical Center	Lipa City
Philippines	The Medical City Clark	Mabalacat	Pampanga
Philippines	Jose R. Reyes Memorial Medical Center	Manila
Philippines	Medical Center Manila	Manila
Philippines	Philippine General Hospital	Manila
Philippines	St. Luke's Medical Center	Quezon City
Philippines	Far Eastern University - Dr. Nicanor Reyes Medical Foundation	Quezon City, Metro Manila
Philippines	Ilocos Training and Regional Medical Center	San Fenando, La Union
Poland	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	Royalderm	Warszawa
Poland	Szpital Kliniczny Dzieciatka Jezus	Warszawa
Poland	Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spólka Partnerska	Wroclaw
Portugal	Centro Hospitalar e Universitário de Coimbra, E.P.E (HUC)	Coimbra
Portugal	Hospital CUF Descobertas	Lisboa
Portugal	Hospital de Egas Moniz	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
Puerto Rico	Dr. Samuel Sanchez PSC	Caguas
Puerto Rico	GCM Medical Group PSC - Hato Rey	San Juan
Saudi Arabia	King Faisal Specialist Hospital & Research Center	Riyadh
Saudi Arabia	King Saud University	Riyadh
Serbia	Institute of Rheumatology	Belgrade
Serbia	University Clinical Center of Serbia	Belgrade
Serbia	Clinical Center of Vojvodina	Novi Sad
Slovakia	Artromac n.o.	Kosice
Slovakia	Narodny ustav reumatickych chorob	Piestany
Spain	Hospital Universitario Fundacion Alcorcon	Alcorcón	Madrid
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitario Reina Sofia	Cordoba
Spain	Complejo Hospitalario Universitario A Coruña	La Coruña
Spain	Hospital Universitario Puerta de Hierro Majadahonda	Majadahonda	Madrid
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Spain	Hospital Universitario Rio Hortega	Valladolid	Cantabria
Sweden	Karolinska Universitetssjukhuset - Solna	Stockholm
Switzerland	Centre Hospitalier Universitaire Vaudois (CHUV)	Lausanne
Switzerland	Kantonsspital St. Gallen	St. Gallen
Taiwan	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
United Kingdom	Queen Elizabeth Hospital	Birmingham	West Midlands
United Kingdom	Chapel Allerton Hospital	Leeds	West Yorkshire
United Kingdom	Whipps Cross University Hospital	London	Greater London
United Kingdom	Manchester Royal Infirmary	Manchester	Greater Manchester
United States	Albuquerque Center For Rheumatology	Albuquerque	New Mexico
United States	University of New Mexico School of Medicine	Albuquerque	New Mexico
United States	David Fivenson, MD, Dermatology, PLLC	Ann Arbor	Michigan
United States	Pinnacle Research Group, LLC	Anniston	Alabama
United States	Oakland Hills Dermatology	Auburn Hills	Michigan
United States	Austin Regional Clinic, P.A.	Austin	Texas
United States	UAB Center for Women's Reproductive Health	Birmingham	Alabama
United States	Brigham And Women's Hospital	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	NYU Langone Brooklyn	Brooklyn	New York
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	University of Cincinnati Department of Dermatology	Cincinnati	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Precision Comprehensive Clinical Research Solutions	Colleyville	Texas
United States	Ohio State University	Columbus	Ohio
United States	Metroplex Clinical Research Center, LLC	Dallas	Texas
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Omega Research Debary, LLC	DeBary	Florida
United States	Denver Arthritis Clinic	Denver	Colorado
United States	Duke Dermatology South Durham	Durham	North Carolina
United States	Universal Dermatology, PLLC	Fairport	New York
United States	AA MRC LLC Ahmed Arif Medical Research Center	Flint	Michigan
United States	Centre for Rheumatology, Immunology and Arthritis	Fort Lauderdale	Florida
United States	North Texas Center for Clinical Research	Frisco	Texas
United States	University of Florida	Gainesville	Florida
United States	UTMB Department of Dermatology	Galveston	Texas
United States	Northwell Health, Inc. PRIME	Great Neck	New York
United States	Medication Management, LLC	Greensboro	North Carolina
United States	Penn State University Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana
United States	The Regents of the University of California	La Jolla	California
United States	Dermatology Research Associates	Los Angeles	California
United States	Medical Research Center of Miami	Miami	Florida
United States	University of Miami Miller School of Medicine	Miami	Florida
United States	Charisma Medical and Research Center	Miami Lakes	Florida
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Essential Dermatology	Natick	Massachusetts
United States	Columbia University Medical center	New York	New York
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Arizona Arthritis & Rheumatology Research, PLLC	Phoenix	Arizona
United States	Beacon Clinical Research, LLC	Quincy	Massachusetts
United States	West End Dermatology Associates	Richmond	Virginia
United States	OrthoIllinois	Rockford	Illinois
United States	Saint Louis University	Saint Louis	Missouri
United States	University of Utah Health Sciences Center	Salt Lake City	Utah
United States	Clinical Science Institute	Santa Monica	California
United States	Revival Research Institute, LLC	Troy	Michigan
United States	Inland Rheumatology Clinical Trials, Inc.	Upland	California
United States	Arthritis & Osteoporosis Clinic	Waco	Texas
United States	University of Massachusetts, Worcester	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Bulgaria,  Canada,  Chile,  Colombia,  France,  Germany,  Hungary,  Italy,  Japan,  Korea, Republic of,  Mexico,  Philippines,  Poland,  Portugal,  Puerto Rico,  Saudi Arabia,  Serbia,  Slovakia,  Spain,  Sweden,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 1		Week 16
Primary	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 Baseline		Baseline to Week 24
Secondary	Part A (US+ROW): Percentage of Participants who Achieve a CLASI-50 Response, Defined as a = 50% Decrease in CLASI-A Score From Baseline		Weeks 16 and 24
Secondary	Part A (US+ROW): Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Damage (CLASI-D) Score		Baseline to Week 52
Secondary	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 OMC Score =3 at Baseline		Weeks 16 and 24
Secondary	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 Baseline		Weeks 16 and 24
Secondary	Part B (US+ROW): Percentage of Participants who Achieve at Least 1 Level of Improvement From Baseline in the CLA-IGA-R Erythema Score		Up to Week 24
Secondary	Part B (US+ROW): Absolute Change in CLASI-D Score		Week 52
Secondary	Part B (US+ROW): Percent Change in CLASI-D Score		Week 52
Secondary	Part B (US+ROW): Change From Baseline in Cutaneous Lupus Erythematosus-Quality of Life (CLE-QoL) Score		Part B (US): Weeks 16 and 52; Part B (ROW): Weeks 24 and 52
Secondary	Part B (US+ROW): Change From Baseline in Dermatology Life Quality Index (DLQI) Score		Part B (US): Weeks 16 and 52; Part B (ROW): Weeks 24 and 52
Secondary	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 Baseline		Part A (US+ROW): Weeks 16 and 24; Part B (US): Week 16
Secondary	Parts A and B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R Erythema Score of 0 or 1		Part A (US+ROW): Week 24; Part B (ROW): Week 24; Part B (US+ROW): Up to Week 24
Secondary	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 Baseline		Part 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
Secondary	Parts A and B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R OMC Score of 0		Part A (US+ROW): Weeks 16 and 24; Part B (US+ROW): Up to Week 24
Secondary	Parts A and B (US+ROW): Percentage of Participants With at Least 1 Level of Improvement From Baseline in CLA-IGA-R OMC Score		Part A (US+ROW): Weeks 16 and 24; Part B (US+ROW): Up to Week 24
Secondary	Parts A and B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R Follicular Activity Score of 0		Parts A and B (US+ROW): Weeks 16 and 24; Part B (US+ROW): Up to Week 24
Secondary	Parts A and B (US+ROW): Percentage of Participants who Achieve a CLASI-A Score of 0 or 1		Up to Week 24
Secondary	Parts A and B (US+ROW): Percentage of Participants who Achieve a CLASI-A Score of 0 to 3		Up to Week 24
Secondary	Parts A and B (US+ROW): Percentage of Participants who Achieve a 70% Reduction in CLASI-A		Up to Week 24
Secondary	Parts A and B (US+ROW): Percentage of Participants who Achieve a 50% Reduction in CLASI-A		Up to Week 24
Secondary	Parts A and B (US+ROW): Percentage of Participants who Achieve a 7-Point Reduction From Baseline in CLASI-A Score		Up to Week 24
Secondary	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 BIIB059 During the DBPC Treatment Period (TP)		Week 52
Secondary	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 BIIB059 During the DBPC TP		Week 52
Secondary	Parts A and 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 Responders at Weeks 16 and 24, Respectively, who Were Assigned to Receive BIIB059 in DBPC TP		Week 52
Secondary	Parts A and B (US+ROW): Percentage of Participants With CLA-IGA-R OMC Score of 0 at Week 52 Among Responders With CLA-IGA-R OMC Score of 0 at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive BIIB059 During the DBPC TP		Week 52
Secondary	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 BIIB059 in DBPC TP		Week 52
Secondary	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 TP		Week 52
Secondary	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 TP		Week 52
Secondary	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 TP		Week 52
Secondary	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 TP		Week 52
Secondary	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 TP		Week 52
Secondary	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 24		Up to Week 24
Secondary	Parts A and B (US+ROW): Annualized Mild and Moderate SFI Rate and Annualized Severe SFI Rate Through Week 16		Up to Week 16
Secondary	Parts A and B (US+ROW): Annualized Mild and Moderate SFI Rate and Annualized Severe SFI Rate Through Week 52		Up to Week 52
Secondary	Parts A and B (US+ROW): Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)		Up to Week 76
Secondary	Parts A and B (US+ROW): Number of Participants With Anti-BIIB059 Antibodies in Serum During the Study		Up to Week 76