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

NCT05591222 | Terminated Phase 2 DMC FDA Drug

• 2 other identifiers: HZNP-DAX-2022023-509746-35-00
• Study Type: interventional
• Target: 72
• Locations: 11 countries
• Sites: 68

Brief 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.

Conditions

Discoid Lupus Erythematosus

Keywords

Discoid Lupus Erythematosus; Immune System Diseases; Lupus Erythematosus, Cutaneous; Skin Diseases; Connective Tissue Diseases

Outcome Measures

Primary Outcomes (1)

• Mean Change in Cutaneous Lupus Erythematosus Disease and Severity Index-Activity (CLASI-A) Score from Baseline to Week 24

  Baseline to Week 24

Secondary Outcomes (6)

• Percentage of Participants who Achieve 0 or 1 on the Cutaneous Lupus Activity-investigator's Global Assessment (CLA-IGA) scale at Week 24

  Week 24

• Percentage of Participants who Achieve a ≥ 50% Reduction in CLASI-A Score from Baseline at Week 24

  Baseline to Week 24

• Mean Change in the Score of Activity and Damage in Discoid Lupus Erythematosus (SADDLE) from Baseline to Week 24

  Baseline to Week 24

• Serum Concentration of Daxdilimab Over Time

  Day 1 to Week 24

• Percentage of Participants who Develop Anti-Drug Antibodies (ADA)

  Day 1 to Week 32

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Administration of placebo Q4W from Day 1 through Week 20.

Drug: Placebo

Daxdilimab; Low Dose

EXPERIMENTAL

Administration of daxdilimab low dose Q4W from Day 1 through Week 20.

Drug: Daxdilimab

Daxdilimab; High Dose

EXPERIMENTAL

Administration of daxdilimab high dose Q4W from Day 1 through Week 20.

Drug: Daxdilimab

Interventions

Placebo DRUG

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

Placebo

Daxdilimab DRUG

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

Also known as: HZN-7734

Daxdilimab; High Dose; Daxdilimab; Low Dose

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to understand and provide written informed consent.
• Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial.
• A diagnosis of DLE for ≥ 6 months prior to screening supported by a history of:
• A biopsy or
• a clinical feature score of ≥ 7 on the DLE Classification Criteria (DLECC) scale.
• Currently active discoid lupus with all the following:
• Digital photography adjudicated with central reading to confirm a currently active discoid disease lesion.
• CLASI-A score ≥ 8 related to discoid lesions at Baseline.
• Treatment refractory DLE defined as active disease despite current or historical treatment with a systemic treatment.
• Females are eligible to participate if they are not pregnant or breastfeeding, and meet the contraceptive/barrier requirement(s).
• Males are eligible to participate if they agree to the contraceptive/barrier requirement(s).
• Vaccination status should be up to date per local standards.

You may not qualify if:

• Participation in another clinical study with an investigational drug within 4 weeks prior to Randomization or within 5 published half-lives, whichever is longer.
• Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product (IP) or interpretation of participant safety or trial results.
• Weight \> 160 kg (352 pounds) at Screening.
• History of allergy, hypersensitivity reaction, or anaphylaxis to any component of the IP or to a previous monoclonal antibody (mAb) or human immunoglobin (Ig) therapy.
• Breastfeeding or pregnant women or women who intend to become pregnant anytime from signing the informed consent form (ICF) through 6 months after receiving the last dose of IP.
• Splenectomy.
• Spontaneous or induced abortion, still or live birth, or pregnancy ≤ 4 weeks prior to screening through randomization.
• History of clinically significant cardiac disease including unstable angina, myocardial infarction, congestive heart failure within 6 months prior to Randomization; arrhythmia requiring active therapy, except for clinically insignificant extra systoles, or minor conduction abnormalities.
• History of cancer within the past 5 years, except as follows:
• Cutaneous basal cell or squamous cell carcinoma treated with curative therapy.
• Any underlying condition that in the opinion of the Investigator significantly predisposes the participant to infection.
• Known history of a primary immunodeficiency or an underlying condition, such as known human immunodeficiency virus (HIV) infection, or a positive result for HIV infection per central laboratory.
• Participants with positive hepatitis B serologic test results.
• All participants will undergo testing for hepatitis C antibody (HCVAb) during Screening.
• Participants who are HCVAb positive will be reflex tested for hepatitis C virus (HCV) RNA and if HCV RNA is positive, the participant is not eligible for the study.

Sponsors & Collaborators

• Amgen: lead

Study Sites (68)

Arkansas Research Trials

North Little Rock, Arkansas, 72117, United States

Location

Wallace Medical Group

Beverly Hills, California, 90211, United States

Location

The Center for Dermatology Clinical Research

Fremont, California, 94538, United States

Location

Clinical Science Institute

Santa Monica, California, 90404, United States

Location

Miami Dermatology & Laser Research

Miami, Florida, 33173, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

Location

Detroit Clinical Research Center, PC

Farmington Hills, Michigan, 48334, United States

Location

Michigan Dermatology Institute

Waterford, Michigan, 48328, United States

Location

Minnesota Clinical Study Center

New Brighton, Minnesota, 55112, United States

Location

MediSearch Clinical Trials

Saint Joseph, Missouri, 64506, United States

Location

Forest Hills Dermatology

Forest Hills, New York, 11375, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Wright State Physicians

Fairborn, Ohio, 45324, United States

Location

Paddington Testing Company, Inc.

Philadelphia, Pennsylvania, 19103, United States

Location

Autoimmune Skin Diseases Unit, Dept. of Dermatology

Philadelphia, Pennsylvania, 19104, United States

Location

Center for Clinical Studies (Cypress)

Houston, Texas, 77065, United States

Location

Fundacion Scherbovsky

Mendoza, Mendoza Province, CP5500, Argentina

Location

CIPREC

Ciudad Autonoma Buenos Aires, C1061AAS, Argentina

Location

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

Fortaleza, Ceará, 60430-275, Brazil

Location

Hospital Universitário Evangélico Mackenzie

Água Verde, Paraná, 80240-220, Brazil

Location

Fundação Faculdade Regional de Medicina de São José do Rio Preto, CIP - Centro Integrado de Pesquisa

Sao Jose Rio, Preto Sao Paulo, 15090-000, Brazil

Location

Complexo Hospitalar de Niterói

Niterói, Rio Do Janeiro, 24020-076, Brazil

Location

Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A

Rio de Janeiro, Rio Do Janeiro, 20241-180, Brazil

Location

Fundação Universidade de Caxias do Sul - Instituto de Pesquisas em Saúde da Universidade de Caxias do Sul

Caxias do Sul, Rio Grande do Sul, 95070-560, Brazil

Location

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, 90035-001, Brazil

Location

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

Location

LMK Serviços Médicos S/S

Porto Alegre, Rio Grande do Sul, 90480-000, Brazil

Location

Universidade Estadual de Campinas

Campinas, São Paulo, 13083-888, Brazil

Location

Hospital Christovão da Gama - Centro de Estudos

Santo André, São Paulo, 09030-010, Brazil

Location

Centro Multidisciplinar de Estudos Clinicos

São Bernardo do Campo, São Paulo, 09715, Brazil

Location

IMC - Instituto de Moléstias Cardiovasculares Tatuí

Tatuí, São Paulo, 18270-170, Brazil

Location

IPITEC Instituto de Pesquisa Inovação Tecnológica

São Paulo, 01223-001, Brazil

Location

DCC 'Sveti Georgi' EOOD

Haskovo, 6300, Bulgaria

Location

Ambulatory for specialized medical care - individual practice for specialized medical care - skin and venereal diseases

Sofia, 1407, Bulgaria

Location

DCC "Alexandrovska" EOOD

Sofia, 1431, Bulgaria

Location

Medical Center Eurohealth EOOD

Sofia, 1606, Bulgaria

Location

Alberta DermaSurgery Centre

Edmonton, Alberta, T6G 1C3, Canada

Location

Brunswick Dermatology Center

Fredericton, New Brunswick, E3B 1G9, Canada

Location

DermEffects

London, Ontario, N6H 5L5, Canada

Location

North York Research, Inc

Toronto, Ontario, M2N 3A6, Canada

Location

K. Papp Clinical Research

Waterloo, Ontario, N2J 1C4, Canada

Location

Fakultni nemocnice u sv. Anny v Brne

Brno, 602 00, Czechia

Location

Sanatorium Profesora Arenbergera

Prague, 110 00, Czechia

Location

Bispebjerg Hospital, Dermato-Venerologisk Afdeling Og Videncenter for Sårheling, D/S.

Copenhagen NV, 2400, Denmark

Location

OUH

Odense C, 5000, Denmark

Location

Sjællands Universitetshospital

Roskilde, 4000, Denmark

Location

Service de dermatologie, hôpital Archet 2, CHU NICE

Nice Alpes, Maritimes, 6200, France

Location

Hopital Edouard Herriot - CHU Lyon

Lyon, 69003, France

Location

CHU Poitiers - Hôpital la Milétrie

Poitiers, 86021, France

Location

CHU de Rouen - Hôpital Charles Nicolle

Rouen, 76031, France

Location

Universitaetsklinikum Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

BAG Dr. Freitag und Knöll

Falkensee, Brandenburg, 14612, Germany

Location

Klinikum Oldenburg AöR

Oldenburg, Lower Saxony, 26133, Germany

Location

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Universitätsklinikum Carl Gustav Carus TU Dresden, Klinik und Poliklinik f. Dermatologie

Dresden, Saxony, 01307, Germany

Location

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

General Hospital of Athens "Evangelismos"

Athens, 10676, Greece

Location

401 General Military Hospital of Athens

Athens, 11525, Greece

Location

University General Hospital "Attikon"

Athens, 12462, Greece

Location

Andreas Syggros Hospital

Athens, 16121, Greece

Location

University General Hospital of Larissa

Larissa, 41110, Greece

Location

General Hospital Papageorgiou

Thessaloniki, 56429, Greece

Location

Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski, Pawel Brzewski Spolka Cywilna

Krakow, 30-002, Poland

Location

Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o.

Malbork, 82-200, Poland

Location

Kliniczny Szpital Wojewodzki nr 1 im.F.Chopina

Rzeszów, 35-055, Poland

Location

LASER CLINIC S.C. Dr Tomasz Kochanowski Dr Andrzej Krolicki

Szczecin, 70-332, Poland

Location

Clinical Research Group Sp. z o.o.

Warsaw, 01-142, Poland

Location

Centralny Szpital Kliniczny MSWiA

Warsaw, 02-807, Poland

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Lupus Erythematosus, Discoid; Immune System Diseases; Lupus Erythematosus, Cutaneous; Skin Diseases; Connective Tissue Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: October 24, 2022
• Study Start: December 29, 2022
• Primary Completion: May 8, 2025
• Study Completion: May 8, 2025
• Last Updated: October 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

CZ (2); CA (5); BR (14); FR (4); AR (2); US (16); BU (4); DE (6); GR (6); DK (3); PL (6)