Clinical Research Directory
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Study of Daxdilimab (HZN-7734) in Participants With Moderate-to-Severe Primary Discoid Lupus Erythematosus
Sponsor: Amgen
Summary
A Phase 2, double-blind, randomized, placebo-controlled parallel-group study to evaluate the efficacy and safety of daxdilimab in participants with moderate-to-severe active primary Discoid Lupus Erythematosus (DLE) refractory to standard of care.
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Investigate the Efficacy and Safety of Daxdilimab Subcutaneous Injection in Reducing Disease Activity in Adult Participants With Moderate-to-Severe Primary Discoid Lupus Erythematosus
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
72
Start Date
2022-12-29
Completion Date
2025-05-08
Last Updated
2026-05-14
Healthy Volunteers
No
Conditions
Interventions
Placebo
Placebo will be administered subcutaneously as two injections for each dose.
Daxdilimab
Daxdilimab will be administered subcutaneously as two injections for each dose.
Locations (68)
Arkansas Research Trials
North Little Rock, Arkansas, United States
Wallace Medical Group
Beverly Hills, California, United States
The Center for Dermatology Clinical Research
Fremont, California, United States
Clinical Science Institute
Santa Monica, California, United States
Miami Dermatology & Laser Research
Miami, Florida, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
Detroit Clinical Research Center, PC
Farmington Hills, Michigan, United States
Michigan Dermatology Institute
Waterford, Michigan, United States
Minnesota Clinical Study Center
New Brighton, Minnesota, United States
MediSearch Clinical Trials
Saint Joseph, Missouri, United States
Forest Hills Dermatology
Forest Hills, New York, United States
Ohio State University
Columbus, Ohio, United States
Wright State Physicians
Fairborn, Ohio, United States
Paddington Testing Company, Inc.
Philadelphia, Pennsylvania, United States
Autoimmune Skin Diseases Unit, Dept. of Dermatology
Philadelphia, Pennsylvania, United States
Center for Clinical Studies (Cypress)
Houston, Texas, United States
Fundacion Scherbovsky
Mendoza, Mendoza Province, Argentina
CIPREC
Ciudad Autonoma Buenos Aires, Argentina
HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
Fortaleza, Ceará, Brazil
Hospital Universitário Evangélico Mackenzie
Água Verde, Paraná, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto, CIP - Centro Integrado de Pesquisa
Sao Jose Rio, Preto Sao Paulo, Brazil
Complexo Hospitalar de Niterói
Niterói, Rio Do Janeiro, Brazil
Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A
Rio de Janeiro, Rio Do Janeiro, Brazil
Fundação Universidade de Caxias do Sul - Instituto de Pesquisas em Saúde da Universidade de Caxias do Sul
Caxias do Sul, Rio Grande do Sul, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
LMK Serviços Médicos S/S
Porto Alegre, Rio Grande do Sul, Brazil
Universidade Estadual de Campinas
Campinas, São Paulo, Brazil
Hospital Christovão da Gama - Centro de Estudos
Santo André, São Paulo, Brazil
Centro Multidisciplinar de Estudos Clinicos
São Bernardo do Campo, São Paulo, Brazil
IMC - Instituto de Moléstias Cardiovasculares Tatuí
Tatuí, São Paulo, Brazil
IPITEC Instituto de Pesquisa Inovação Tecnológica
São Paulo, Brazil
DCC 'Sveti Georgi' EOOD
Haskovo, Bulgaria
Ambulatory for specialized medical care - individual practice for specialized medical care - skin and venereal diseases
Sofia, Bulgaria
DCC "Alexandrovska" EOOD
Sofia, Bulgaria
Medical Center Eurohealth EOOD
Sofia, Bulgaria
Alberta DermaSurgery Centre
Edmonton, Alberta, Canada
Brunswick Dermatology Center
Fredericton, New Brunswick, Canada
DermEffects
London, Ontario, Canada
North York Research, Inc
Toronto, Ontario, Canada
K. Papp Clinical Research
Waterloo, Ontario, Canada
Fakultni nemocnice u sv. Anny v Brne
Brno, Czechia
Sanatorium Profesora Arenbergera
Prague, Czechia
Bispebjerg Hospital, Dermato-Venerologisk Afdeling Og Videncenter for Sårheling, D/S.
Copenhagen NV, Denmark
OUH
Odense C, Denmark
Sjællands Universitetshospital
Roskilde, Denmark
Service de dermatologie, hôpital Archet 2, CHU NICE
Nice Alpes, Maritimes, France
Hopital Edouard Herriot - CHU Lyon
Lyon, France
CHU Poitiers - Hôpital la Milétrie
Poitiers, France
CHU de Rouen - Hôpital Charles Nicolle
Rouen, France
Universitaetsklinikum Tuebingen
Tübingen, Baden-Wurttemberg, Germany
BAG Dr. Freitag und Knöll
Falkensee, Brandenburg, Germany
Klinikum Oldenburg AöR
Oldenburg, Lower Saxony, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, Rhineland-Palatinate, Germany
Universitätsklinikum Carl Gustav Carus TU Dresden, Klinik und Poliklinik f. Dermatologie
Dresden, Saxony, Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany
General Hospital of Athens "Evangelismos"
Athens, Greece
401 General Military Hospital of Athens
Athens, Greece
University General Hospital "Attikon"
Athens, Greece
Andreas Syggros Hospital
Athens, Greece
University General Hospital of Larissa
Larissa, Greece
General Hospital Papageorgiou
Thessaloniki, Greece
Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski, Pawel Brzewski Spolka Cywilna
Krakow, Poland
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o.
Malbork, Poland
Kliniczny Szpital Wojewodzki nr 1 im.F.Chopina
Rzeszów, Poland
LASER CLINIC S.C. Dr Tomasz Kochanowski Dr Andrzej Krolicki
Szczecin, Poland
Clinical Research Group Sp. z o.o.
Warsaw, Poland
Centralny Szpital Kliniczny MSWiA
Warsaw, Poland