Clinical trial • Phase III • Dermatology

ANIFROLUMAB for Cutaneous lupus erythematosus

Phase III trial of ANIFROLUMAB for Cutaneous lupus erythematosus.

Overview

Trial Therapeutic Area
Dermatology
Trial Disease
Cutaneous lupus erythematosus
Trial Stage
Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
29-04-2024
First CTIS Authorization Date
27-08-2024

Trial design

Randomised, open-label, anifrolumab (investigational product) administered subcutaneously once weekly; matching placebo solution for injection in apfs (0.8 ml fill volume) administered subcutaneously once weekly during the double-blind period (day 1/week 0 to week 23); participants randomized 1:1. placebo recipients receive open-label anifrolumab from week 24 to week 51.-controlled Phase III trial in Austria, Bulgaria, Denmark and others.

Randomised
Yes
Open Label
Yes
Comparator
Anifrolumab (investigational product) administered subcutaneously once weekly; Matching placebo solution for injection in aPFS (0.8 mL fill volume) administered subcutaneously once weekly during the double-blind period (Day 1/Week 0 to Week 23); participants randomized 1:1. Placebo recipients receive open-label anifrolumab from Week 24 to Week 51.
Target Sample Size
260
Trial Duration For Participant
448

Eligibility

Recruits 260 Vulnerable population selected. Participants are adults (18–70 years) and informed consent is required via country-specific informed consent forms (multiple country ICFs provided). Multiple country-specific ICF documents and related patient information materials are listed (languages and country-specific ICFs available). No assent procedures for minors are described (minors excluded)..

Vulnerable Population
Vulnerable population selected. Participants are adults (18–70 years) and informed consent is required via country-specific informed consent forms (multiple country ICFs provided). Multiple country-specific ICF documents and related patient information materials are listed (languages and country-specific ICFs available). No assent procedures for minors are described (minors excluded).

Inclusion criteria

  • {"criterion_text":"- Male and/or female participant must be 18 to 70 years of age inclusive, at the time of signing the ICF.\n- Participants must have a confirmed diagnosis of CLE. Diagnosis must be clinically and histologically confirmed with the following: •\tCLASI-A total score ≥ 10 points at Screening and confirmed at randomization. •\tInadequate response or intolerant to antimalarial therapy. -\tAt least one antimalarial agent used for at least 12 weeks (not continuous is acceptable) prior to Screening. Participants must be on a stable dose of antimalarial agent for at least 2 weeks prior to ICF signature. OR -\tPreviously documented discontinuation of antimalarial agents due to poor tolerability and/or side effects. In case an antimalarial treatment had not been initiated due to medical reasons (in particular the presence of medical contraindications), then at least one of the following medications for CLE must have been tried any time before Screening: •\tTopical calcineurin inhibitors, administered for ≥ 3 months. •\tSystemic glucocorticoids taken for ≥ 6 weeks. •\tA conventional immunosuppressant, including, azathioprine, mycophenolate mofetil (or mycophenolic acid), dapsone, or methotrexate administered for ≥ 3 months.\n- Participants should have no medical history or signs or symptoms of active or prior tuberculosis infection (TB) and the same should reflect in chest radiograph or a chest CT scan result. •\tNo history of latent TB prior to initial Screening Visit. •\tThe participant must undergo an IFN-γ release assay IGRA (e.g., QFT-G test) test for TB.\n- Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n- Females who have been or are sexually active with an intact cervix must have documentation of a cervical cancer screening (Pap smear or HPV tests as per local guidelines) with a normal test result within 2 years prior to randomization."}

Exclusion criteria

  • {"criterion_text":"- History or evidence of suicidal ideation.\n- Any severe case of herpes zoster infection prior to randomization.\n- Any clinical cytomegalovirus (CMV) or Epstein-Barr virus infection that has not been completely resolved.\n- Clinically significant chronic infection within 8 weeks prior to signing the ICF or any infection requiring hospitalization or treatment with IV anti-infectives not completed at least 4 weeks prior to signing the ICF.\n- COVID-19 infection: •\tHistory of severe COVID-19 infection and/or clinically significant unresolved complications due to COVID-19 infection. •\tAny COVID 19 infection within 2 weeks prior to Day 1.\n- Participants who do not meet the study restrictions for prior receipt of anifrolumab, using all biologics, directly acting cytotoxic B cell-depleting therapies (eg, rituximab), and any investigational product.\n- A known history of allergy or reaction to any component of the study intervention formulation or history of anaphylaxis to any human gamma globulin therapy.\n- Any history of an anaphylactic reaction to human proteins, or monoclonal antibodies.\n- At screening, if participants do not meet the eligibility criteria assessed based on laboratory test results e.g. tests for total bilirubin, serum creatinine etc.\n- Severe or life-threatening SLE.\n- Active SLE or Sjögren’s Syndrome.\n- Any active skin conditions other than CLE that may interfere with the study.\n- History of, or current diagnosis of, catastrophic APS within 1 year prior to signing the ICF.\n- History of recurrent infection requiring hospitalization and IV antibiotics.\n- Known history of primary immunodeficiency, splenectomy, or any underlying condition that makes the participant prone to infection, or a positive result for HIV infection at Screening.\n- Confirmed positive test for hepatitis B serology.\n- Presence of active hepatitis C infection."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Number of participants with CLASI-70 response at Week 24.","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Total CLASI A score, change from baseline at Week 24.","definition_or_measurement_approach":""}
  • {"endpoint_text":"-\tNumber of participants with CLASI-70 response at Week 12. -\tParticipants with ≥ 7 point reduction from baseline in CLASI A total score (yes/no) at Week 12. -\tNumber of participants with CLASI 50 response at Week 12.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change from baseline at Week 24 in Skindex-29+3 domain scores.","definition_or_measurement_approach":""}
  • {"endpoint_text":"-\tTime from IP start date to CLASI 70 response; -\tTime from IP start date to CLASI 50 response.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number of participants with CLASI 50 response at Week 24.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number of participants who are primary endpoint responders (CLASI-70 response at Week 24) and sustain CLASI-70 response up to and including Week 52.","definition_or_measurement_approach":""}
  • {"endpoint_text":"-\tPharmacokinetic (PK) assessment (Ctrough) for subcutaneously administered anifrolumab in participants with CLE will be performed.","definition_or_measurement_approach":""}
  • {"endpoint_text":"-\tPharmacodynamic (PD) assessment for subcutaneously administered anifrolumab in participants with CLE will be performed.","definition_or_measurement_approach":""}
  • {"endpoint_text":"-\tThe immunogenicity of subcutaneously administered anifrolumab in participants with CLE will be evaluated.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number of participants with adverse events.","definition_or_measurement_approach":""}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
260
Recruitment Window Months
39
Consent Approach
Informed consent is obtained from adult participants (aged 18–70) via country-specific subject information sheets and informed consent forms (ICFs). Multiple country-language ICFs and related consent materials are provided (examples include English, French, German, Spanish, Italian, Dutch, Greek, Polish, Portuguese, Bulgarian, Slovak, Romanian, Danish). No assent for minors is described (minors excluded).

Methods

  • Country-specific printed recruitment materials: recruitment brochures, recruitment posters, and patient letters (examples: Slovakia, Denmark, France, Bulgaria, Greece, Spain, Italy, Portugal, Romania, Poland, Austria, Germany, Netherlands).
  • Country-specific recruitment procedure documents describing site-based recruitment workflows (e.g., 'Recruitment Procedure Description' and country procedure PDFs).
  • Patient-facing digital materials and websites (country-specific recruitment websites and pre-login landing pages described in recruitment documents).
  • Consent navigator and other online consent-support materials (country-specific Consent Navigator / Longboat Consent Navigator referenced in recruitment documents).
  • Patient-facing flyers and clinical trial leaflets and study information letters (multiple languages/countries) intended for adults with the target condition (CLE).

Geography

Total Number Of Sites
83
Total Number Of Participants
344

Austria

Earliest CTIS Part Ii Submission Date
30-07-2024
Latest Decision Or Authorization Date
13-03-2026
Processing Time Days
591
Number Of Sites
4
Number Of Participants
18

Sites

Site Name
Medizinische Universitaet Innsbruck
Department Name
#0402: Dermatologie und Venerologie
Contact Person Name
Barbara Boeckle
Contact Person Email
barbara.boeckle@i-med.ac.at
Site Name
Medical University Of Graz
Department Name
#0403: Universitätsklinik für Dermatologie und Venerologie
Contact Person Name
Wolfgang Salmhofer
Site Name
Ordensklinikum Linz GmbH
Department Name
#0401: Dermatologie
Contact Person Name
Konrad Lehner
Site Name
Klinik Hietzing
Department Name
#0405:Abteilung für Dermatologie
Contact Person Name
Christian Posch

Bulgaria

Earliest CTIS Part Ii Submission Date
08-08-2024
Latest Decision Or Authorization Date
22-12-2025
Processing Time Days
501
Number Of Sites
2
Number Of Participants
12

Sites

Site Name
Diagnostic Consultation Center XX-Sofia EOOD
Department Name
#0904
Contact Person Name
Tomov Toma
Contact Person Email
dr.toma.tomov@abv.bg
Site Name
Dkc Fokus-5 Lzip OOD
Department Name
#0903
Contact Person Name
Grisha Mateev
Contact Person Email
grisha_mateev@yahoo.com

Denmark

Earliest CTIS Part Ii Submission Date
09-08-2024
Latest Decision Or Authorization Date
15-12-2025
Processing Time Days
493
Number Of Sites
2
Number Of Participants
10

Sites

Site Name
Rigshospitalet
Department Name
2002: Center for Rheumatology and Spine Diseases
Contact Person Name
Søren Jacobsen
Contact Person Email
soeren.jacobsen.01@regionh.dk
Site Name
Aarhus Universitetshospital
Department Name
#2001:Department of Dermatology
Contact Person Name
Stine Andersen
Contact Person Email
STNADE@rm.dk

France

Earliest CTIS Part Ii Submission Date
26-07-2024
Latest Decision Or Authorization Date
15-12-2025
Processing Time Days
507
Number Of Sites
12
Number Of Participants
50

Sites

Site Name
Groupe Hospitalier Du Havre
Department Name
2313:Medecine Interne
Contact Person Name
Vincent Langlois
Contact Person Email
vincent.langlois@ch-havre.fr
Site Name
Centre Hospitalier Universitaire Rouen
Department Name
#2309:
Contact Person Name
Anne-Bénédicte Duval Modeste
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
#2302: Dermatology
Contact Person Name
Cristina Livideanu
Contact Person Email
livideanu.c@chu-toulouse.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
#2304:Dermatologie
Contact Person Name
Nicolas Dupin
Contact Person Email
nicolas.dupin@aphp.fr
Site Name
Hospital Edouard Herriot
Department Name
#2301: Dermatologie
Contact Person Name
Cécile LESORT
Contact Person Email
cecile.lesort@chu-lyon.fr
Site Name
Hopitaux Universitaires Pitie Salpetriere
Department Name
#2307: Médecine Interne
Contact Person Name
Zahir Amoura
Contact Person Email
zahir.amoura@aphp.fr
Site Name
Hospital Hotel Dieu
Department Name
#2312: Clinique dermatologique
Contact Person Name
Claire Bernier
Contact Person Email
claire.bernier@chu-nantes.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
#2308: Pôle Régional de Cancérologie
Contact Person Name
Damien Boutin
Contact Person Email
damien.boutin@chu-poitiers.fr
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
2315:Dermatologie
Contact Person Name
Géraldine Jeudy
Contact Person Email
geraldine.jeudy@chu-dijon.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
2314:Dermatologie
Contact Person Name
Julien Seneschal
Site Name
Hopital Saint Louis
Department Name
#2306: Dermatologie
Contact Person Name
Jean-David Bouaziz
Contact Person Email
jean-david.bouaziz@aphp.fr
Site Name
Hopitaux Universitaires Pitie Salpetriere (additional listing)
Department Name
#2305: Dermatologie
Contact Person Name
François Chasset
Contact Person Email
francois.chasset@aphp.fr

Germany

Earliest CTIS Part Ii Submission Date
26-07-2024
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
643
Number Of Sites
12
Number Of Participants
52

Sites

Site Name
Philipps-Universitaet Marburg
Department Name
#2613: Dermatologie & Allergologie
Contact Person Name
Julia Hinterseher
Contact Person Email
Julia.hinterseher@uk-gm.de
Site Name
St. Josef-Hospital
Department Name
#2606: Dermatology
Contact Person Name
Falk Bechara
Site Name
Technische Universitaet Dresden
Department Name
#2605: Klinik und Poliklinik für Dermatologie
Contact Person Name
Susanne Abraham
Contact Person Email
susanne.abraham@ukdd.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
#2602: Klinik für Dermatologie, Venerologie und Allergologie, Allergologie und Immunologie
Contact Person Name
Margitta Worm
Contact Person Email
margitta.worm@charite.de
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
#2611:Hautklinik
Contact Person Name
Michael Sticherling
Site Name
Medizinische Hochschule Hannover
Department Name
#2603: Klinik für Dermatologie, Allergologie und Venerologie
Contact Person Name
Matthias Schefzyk
Site Name
Helios Universitaetsklinikum Wuppertal
Department Name
#2607: Zentrum für Dermatologie, Allergologie und Dermatochirurgie
Contact Person Name
Silke Hofmann
Site Name
Universitaet Leipzig
Department Name
#2604: Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie
Contact Person Name
Jan-Christoph Simon
Site Name
Universitaetsklinikum Essen AöR
Department Name
#2610: Hautklinik
Contact Person Name
Frederik Krefting
Contact Person Email
frederik.krefting@uk-essen.de
Site Name
Medical Center - University Of Freiburg
Department Name
2614: Dermatology
Contact Person Name
Franziska Schauer
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
#2609: Klinik und Poliklinik für Dermatologie
Contact Person Name
Bernadett Kurz
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
#2601: Hautklinik/ Clinical Research Center
Contact Person Name
Miriam Wittmann

Greece

Earliest CTIS Part Ii Submission Date
23-07-2024
Latest Decision Or Authorization Date
17-12-2025
Processing Time Days
512
Number Of Sites
4
Number Of Participants
24

Sites

Site Name
Athens Medical Center S.A.
Department Name
#3005: Dermatology Department
Contact Person Name
Markos Papakonstantis
Contact Person Email
markospapakonstantis@gmail.com
Site Name
University General Hospital Attikon
Department Name
#3001:4th Department of Internal Medicine
Contact Person Name
Dimitrios Boumpas
Contact Person Email
boumpasd@med.uoc.gr
Site Name
Laiko General Hospital Of Athens
Department Name
#3002:1st Department of Propaedeutic Internal Medicine
Contact Person Name
Maria Tektonidou
Contact Person Email
mtektonidou@gmail.com
Site Name
Andreas Syngros Hospital Of Venereal And Dermatological Diseases
Department Name
#3003: Dermatology Department
Contact Person Name
Vassiliki Chasapi
Contact Person Email
chasapiresearch@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
22-07-2024
Latest Decision Or Authorization Date
16-12-2025
Processing Time Days
512
Number Of Sites
9
Number Of Participants
40

Sites

Site Name
Ospedale San Raffaele S.r.l.
Department Name
#4106:Unità Clinica di Immunologia, Reumatologia, Allergologia e Malattie Rare
Contact Person Name
Lorenzo Dagna
Contact Person Email
dagna.lorenzo@unisr.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
#4107:UOC Dermatologia
Contact Person Name
Clara De Simone
Contact Person Email
clara.desimone@unicatt.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
#4103:U.O. Dermatologia
Contact Person Name
Piergiacomo Calzavara Pinton
Site Name
Azienda USL IRCCS Di Reggio Emilia
Department Name
4109:Reumatologia
Contact Person Name
Carlo Salvarani
Contact Person Email
carlo.salvarani@ausl.re.it
Site Name
University Hospital Of Ferrara
Department Name
#4108:UOC Reumatologia
Contact Person Name
Marcello Govoni
Contact Person Email
gvl@unife.it
Site Name
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
#4105:UOC Reumatologia
Contact Person Name
Francesco Ciccia
Contact Person Email
francescociccia@tiscali.it
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
#4102:UOSD Porfirie e Malattie Rare
Contact Person Name
MIRIAM TEOLI
Contact Person Email
miriam.teoli@ifo.it
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
#4104:SOD Clinica di Dermatologia
Contact Person Name
Oriana Simonetti
Site Name
Azienda USL Toscana Centro
Department Name
#4101:SOS Dermatologia Speciale Medica
Contact Person Name
Emiliano Antiga
Contact Person Email
emiliano.antiga@unifi.it

Netherlands

Earliest CTIS Part Ii Submission Date
09-08-2024
Latest Decision Or Authorization Date
15-12-2025
Processing Time Days
493
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
Radboud universitair medisch centrum Stichting
Department Name
#5002:Dermatology
Contact Person Name
Elke De Jong
Contact Person Email
Elke.deJong@radboudumc.nl
Site Name
Amphia Hospital
Department Name
#5004:Dermatology
Contact Person Name
Sebastiaan Prens
Contact Person Email
BPrens@amphia.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
#5001:Dermatology
Contact Person Name
Hok Bing Thio
Contact Person Email
h.thio@erasmusmc.nl

Poland

Earliest CTIS Part Ii Submission Date
25-07-2024
Latest Decision Or Authorization Date
22-12-2025
Processing Time Days
515
Number Of Sites
9
Number Of Participants
32

Sites

Site Name
Prywatny Gabinet Dermatologiczny Dr Elzbieta Klujszo
Department Name
#5709:Dermatology
Contact Person Name
Elzbieta Klujszo
Contact Person Email
klujszoe@gmail.com
Site Name
Gyncentrum Sp. z o.o.
Department Name
#5703: Dermatology
Contact Person Name
Marcin Zakrzewski
Contact Person Email
m.zakrzewski@gyncentrum.pl
Site Name
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Department Name
#5702:Klinika Dermatologii
Contact Person Name
Irena Walecka-Herniczek
Contact Person Email
irena.walecka@cskmswia.gov.pl
Site Name
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
Department Name
#5707:Dermatology
Contact Person Name
Brygida Kwiatkowska
Contact Person Email
kwiatkowskabrygida@gmail.com
Site Name
Klinika Ambroziak Sp. z o.o.
Department Name
#5701:Dermatology
Contact Person Name
Bartłomiej Kwiek
Contact Person Email
principal@klinikaambroziak.pl
Site Name
Labderm Essence Sp. z o.o.
Department Name
#5706:Dermatology
Contact Person Name
Beata Bergler - Czop
Contact Person Email
bbergler-czop@sum.edu.pl
Site Name
Derm-Art
Department Name
#5708:Dermatology
Contact Person Name
Waldemar Placek
Contact Person Email
w.placek@wp.pl
Site Name
Miejski Szpital Zespolony W Olsztynie
Department Name
#5705:Klinika Dermatologii
Contact Person Name
Agnieszka Owczarczyk - Saczonek
Contact Person Email
aganek@wp.pl
Site Name
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
Department Name
5710:Klinika Dermatologii
Contact Person Name
Adam Reich
Contact Person Email
adamandrzejreich@gmail.com

Portugal

Earliest CTIS Part Ii Submission Date
20-03-2025
Latest Decision Or Authorization Date
17-12-2025
Processing Time Days
272
Number Of Sites
4
Number Of Participants
16

Sites

Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
5804: Dermatologia
Contact Person Name
Celeste Brito
Contact Person Email
celeste.brito@hb.min-saude.pt
Site Name
Unidade Local De Saude De Santo Antonio E.P.E.
Department Name
5802:Dermatologia
Contact Person Name
Tiago Torres
Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
5801: Dermatologia
Contact Person Name
Maria Margarida Martins Goncalo
Contact Person Email
7200@chuc.min-saude.pt
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
5803: Dermatologia
Contact Person Name
Joana Antunes

Romania

Earliest CTIS Part Ii Submission Date
02-04-2025
Latest Decision Or Authorization Date
19-12-2025
Processing Time Days
261
Number Of Sites
3
Number Of Participants
20

Sites

Site Name
Spitalul Clinic Judetean Mures
Department Name
6101: Dermatology
Contact Person Name
Silviu Morariu
Contact Person Email
silviu_morariu@yahoo.com
Site Name
Cabinet Medical Individual Lauderma
Department Name
6104: Dermatology
Contact Person Name
Laura Gheuca-Solovastru
Contact Person Email
drmagdadinu@yahoo.com
Site Name
Spitalul Clinic Colentina Bucuresti
Department Name
6105: Dermatology 2
Contact Person Name
Magdalena CONSTANTIN
Contact Person Email
drmagdadinu@yahoo.com

Slovakia

Earliest CTIS Part Ii Submission Date
17-04-2025
Latest Decision Or Authorization Date
15-12-2025
Processing Time Days
242
Number Of Sites
2
Number Of Participants
8

Sites

Site Name
Narodny Ustav Reumatickych Chorob
Department Name
6703: Ustav reumatickych chorob
Contact Person Name
Olga Lukacova
Contact Person Email
olga.lukacova@nurch.sk
Site Name
Univerzitna nemocnica L. Pasteura Kosice
Department Name
6704: Klinika dermatovenerologie
Contact Person Name
Janette Baloghova
Contact Person Email
janettebaloghova@gmail.com

Spain

Earliest CTIS Part Ii Submission Date
11-06-2024
Latest Decision Or Authorization Date
18-12-2025
Processing Time Days
556
Number Of Sites
17
Number Of Participants
54

Sites

Site Name
El Hospital Universitario De Gran Canaria Dr. Negrin
Department Name
#7013:Dermatología
Contact Person Name
Carolina Medina Gil
Contact Person Email
carolina.medina.gil@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
#7001:Reumatologia
Contact Person Name
Josefina Cortés Hernández
Contact Person Email
fina.cortes@vhir.org
Site Name
Complexo Hospitalario Universitario De Vigo
Department Name
#7008:Reumatología
Contact Person Name
José Pego Reigosa
Site Name
Hospital Universitario Dr Peset Aleixandre
Department Name
#7005:Dermatology
Contact Person Name
Andrea Estébanez Corrales
Contact Person Email
Andreaestebanez_7@hotmail.com
Site Name
Hospital General Universitario De Valencia
Department Name
#7009:Reumatología
Contact Person Name
Cristina Campos Fernandez
Contact Person Email
campos_crifer@gva.es
Site Name
Hospital Universitario Virgen De Las Nieves
Department Name
#7010:Dermatologia
Contact Person Name
Manuel Sanchez Diaz
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
#7014:Dermatología
Contact Person Name
Rita Cabeza Martinez
Contact Person Email
ritacabeza@gmail.com
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
#7007:Dermatologia
Contact Person Name
Esther Roé Crespo
Contact Person Email
eroe@santpau.cat
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
#7011:Demartología
Contact Person Name
Maria Elena de las Heras Alonso
Contact Person Email
Elena.heras@salud.madrid.org
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
#7016:Reumatologia e Immunologia
Contact Person Name
Mercedes Freire González
Site Name
Bellvitge University Hospital
Department Name
#7004:Dermatología
Contact Person Name
Ignasi Figueras Nart
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
#7017:Dermatología
Contact Person Name
María del Rosario Haro Ramos
Contact Person Email
rharo@fjd.es
Site Name
Hospital Universitario Virgen De Valme
Department Name
#7012:Reumatología
Contact Person Name
Rosalía Martínez Pérez
Site Name
Hospital Universitario De Salamanca
Department Name
#7006:Dermatologia
Contact Person Name
Susana Gómez Castro
Contact Person Email
sgomezc@saluscastillayleon.es
Site Name
Hospital Universitario De La Princesa
Department Name
#7002:Dermatología
Contact Person Name
María Luisa Martos
Contact Person Email
Luisa.martos@gironsalud.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
#7003:Dermatología
Contact Person Name
Jon Fulgencio Barbarin
Contact Person Email
jonfulgencio@hotmail.com
Site Name
Hospital General Universitario De Castellon
Department Name
#7015:Reumatología
Contact Person Name
Arantxa Conesa Mateos
Contact Person Email
arantxaconesa@hotmail.com

Sponsor

Primary sponsor

Full Name
AstraZeneca AB
Organisation Type
Pharmaceutical company
Country Of Registered Address
Sweden

Contract research organisations

Name
Parexel International (IRL) Limited
Responsibilities
Logistic expertise, Electronical Patient Reported Outcomes, Clinical Reported Outcomes, Skin Photography Equipment and Services, Recruitment services, eTMF management, Translation services
Name
Excelya Greece CRO Single Member S.A.

Third parties

  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"Logistic expertise, Electronical Patient Reported Outcomes, Clinical Reported Outcomes, Skin Photography Equipment and Services, Recruitment services, eTMF management, Translation services","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"Excelya Greece CRO Single Member S.A.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Anifrolumab
Active Substance
ANIFROLUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Authorisation Status
prodAuthStatus: 1
Frequency
Once weekly
Investigational Product Name
Matching placebo solution for injection in aPFS; 0.8 mL fill volume
Modality
Other
Frequency
Once weekly (during double-blind period)

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