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TERMINATED
NCT05591222
PHASE2

Study of Daxdilimab (HZN-7734) in Participants With Moderate-to-Severe Primary Discoid Lupus Erythematosus

Sponsor: Amgen

View on ClinicalTrials.gov

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

Interventions

DRUG

Placebo

Placebo will be administered subcutaneously as two injections for each dose.

DRUG

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