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

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

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.

Study Overview

• Status: Terminated
• Conditions: Discoid Lupus Erythematosus
• Intervention / Treatment: Drug: Daxdilimab; Drug: Placebo

Detailed Description

Approximately 72 participants will be enrolled to receive daxdilimab or placebo administered subcutaneously once every four weeks (Q4W) from Day 1 to Week 20. The maximum trial duration per participant is approximately 36 weeks including screening, the 24 weeks for the treatment period where participants will receive daxdilimab or placebo, and approximately 8 weeks for the follow-up period. Safety evaluations will be performed regularly throughout the course of the study.

Acquired from Horizon in 2024.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Autonoma Buenos Aires, Argentina, C1061AAS
    • CIPREC
  • Mendoza Province
    • Mendoza, Mendoza Province, Argentina, CP5500
      • Fundacion Scherbovsky
• Brazil
  • São Paulo, Brazil, 01223-001
    • IPITEC Instituto de Pesquisa Inovação Tecnológica
  • Ceará
    • Fortaleza, Ceará, Brazil, 60430-275
      • HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
  • Paraná
    • Água Verde, Paraná, Brazil, 80240-220
      • Hospital Universitario Evangelico Mackenzie
  • Preto Sao Paulo
    • Sao Jose Rio, Preto Sao Paulo, Brazil, 15090-000
      • Fundação Faculdade Regional de Medicina de São José do Rio Preto, CIP - Centro Integrado de Pesquisa
  • Rio Do Janeiro
    • Niterói, Rio Do Janeiro, Brazil, 24020-076
      • Complexo Hospitalar de Niteroi
    • Rio de Janeiro, Rio Do Janeiro, Brazil, 20241-180
      • Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A
  • Rio Grande do Sul
    • Caxias do Sul, Rio Grande do Sul, Brazil, 95070-560
      • Fundação Universidade de Caxias do Sul - Instituto de Pesquisas em Saúde da Universidade de Caxias do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-001
      • Hospital Moinhos de Vento
    • Porto Alegre, Rio Grande do Sul, Brazil, 90050-170
      • Irmandade da Santa Casa de Misericórdia de Porto Alegre
    • Porto Alegre, Rio Grande do Sul, Brazil, 90480-000
      • LMK Serviços Médicos S/S
  • São Paulo
    • Campinas, São Paulo, Brazil, 13083-888
      • Universidade Estadual de Campinas
    • Santo André, São Paulo, Brazil, 09030-010
      • Hospital Christovão da Gama - Centro de Estudos
    • São Bernardo do Campo, São Paulo, Brazil, 09715
      • Centro Multidisciplinar de Estudos Clinicos
    • Tatuí, São Paulo, Brazil, 18270-170
      • IMC - Instituto de Moléstias Cardiovasculares Tatuí
• Bulgaria
  • Haskovo, Bulgaria, 6300
    • DCC 'Sveti Georgi' EOOD
  • Sofia, Bulgaria, 1407
    • Ambulatory for specialized medical care - individual practice for specialized medical care - skin and venereal diseases
  • Sofia, Bulgaria, 1431
    • DCC "Alexandrovska" EOOD
  • Sofia, Bulgaria, 1606
    • Medical Center Eurohealth EOOD
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1C3
      • Alberta Dermasurgery Centre
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B 1G9
      • Brunswick Dermatology Center
  • Ontario
    • London, Ontario, Canada, N6H 5L5
      • Dermeffects
    • Toronto, Ontario, Canada, M2N 3A6
      • North York Research, Inc
    • Waterloo, Ontario, Canada, N2J 1C4
      • K. Papp Clinical Research
• Czechia
  • Brno, Czechia, 602 00
    • Fakultni Nemocnice u sv. Anny v Brne
  • Prague, Czechia, 110 00
    • Sanatorium Profesora Arenbergera
• Denmark
  • Copenhagen NV, Denmark, 2400
    • Bispebjerg Hospital, Dermato-Venerologisk Afdeling Og Videncenter for Sårheling, D/S.
  • Odense C, Denmark, 5000
    • OUH
  • Roskilde, Denmark, 4000
    • Sjællands Universitetshospital
• France
  • Lyon, France, 69003
    • Hopital Edouard Herriot - CHU Lyon
  • Poitiers, France, 86021
    • CHU Poitiers - Hôpital la Milétrie
  • Rouen, France, 76031
    • CHU de Rouen - Hôpital Charles Nicolle
  • Maritimes
    • Nice Alpes, Maritimes, France, 6200
      • Service de dermatologie, hôpital Archet 2, CHU NICE
• Germany
  • Berlin, Germany, 10117
    • Charité - Universitätsmedizin Berlin
  • Baden-Wurttemberg
    • Tübingen, Baden-Wurttemberg, Germany, 72076
      • Universitaetsklinikum Tuebingen
  • Brandenburg
    • Falkensee, Brandenburg, Germany, 14612
      • BAG Dr. Freitag und Knöll
  • Lower Saxony
    • Oldenburg, Lower Saxony, Germany, 26133
      • Klinikum Oldenburg AöR
  • Rhineland-Palatinate
    • Mainz, Rhineland-Palatinate, Germany, 55131
      • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Universitätsklinikum Carl Gustav Carus TU Dresden, Klinik und Poliklinik f. Dermatologie
• Greece
  • Athens, Greece, 12462
    • University General Hospital "Attikon"
  • Athens, Greece, 16121
    • Andreas Syggros Hospital
  • Athens, Greece, 10676
    • General Hospital of Athens "Evangelismos"
  • Athens, Greece, 11525
    • 401 General Military Hospital of Athens
  • Larissa, Greece, 41110
    • University General Hospital of Larissa
  • Thessaloniki, Greece, 56429
    • General Hospital Papageorgiou
• Poland
  • Krakow, Poland, 30-002
    • Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski, Pawel Brzewski Spolka Cywilna
  • Malbork, Poland, 82-200
    • Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o.
  • Rzeszów, Poland, 35-055
    • Kliniczny Szpital Wojewodzki nr 1 im.F.Chopina
  • Szczecin, Poland, 70-332
    • LASER CLINIC S.C. Dr Tomasz Kochanowski Dr Andrzej Krolicki
  • Warsaw, Poland, 01-142
    • Clinical Research Group Sp. z o.o.
  • Warsaw, Poland, 02-807
    • Centralny Szpital Kliniczny Mswia
• United States
  • Arkansas
    • North Little Rock, Arkansas, United States, 72117
      • Arkansas Research Trials
  • California
    • Beverly Hills, California, United States, 90211
      • Wallace Medical Group
    • Fremont, California, United States, 94538
      • The Center for Dermatology Clinical Research
    • Santa Monica, California, United States, 90404
      • Clinical Science Institute
  • Florida
    • Miami, Florida, United States, 33173
      • Miami Dermatology & Laser Research
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Dawes Fretzin Clinical Research Group, LLC
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Detroit Clinical Research Center, PC
    • Waterford, Michigan, United States, 48328
      • Michigan Dermatology Institute
  • Minnesota
    • New Brighton, Minnesota, United States, 55112
      • Minnesota Clinical Study Center
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • MediSearch Clinical Trials
  • New York
    • Forest Hills, New York, United States, 11375
      • Forest Hills Dermatology
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University
    • Fairborn, Ohio, United States, 45324
      • Wright State Physicians
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Paddington Testing Company, Inc.
    • Philadelphia, Pennsylvania, United States, 19104
      • Autoimmune Skin Diseases Unit, Dept. of Dermatology
  • Texas
    • Houston, Texas, United States, 77065
      • Center for Clinical Studies (Cypress)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• 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:

  1. A biopsy or
  2. a clinical feature score of ≥ 7 on the DLE Classification Criteria (DLECC) scale.

• Currently active discoid lupus with all the following:

  1. Digital photography adjudicated with central reading to confirm a currently active discoid disease lesion.
  2. 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.

Key Exclusion Criteria:

• 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.
• Active tuberculosis (TB), or a positive interferon-gamma release assay (IGRA) test at screening, unless documented history of appropriate treatment for active or latent TB.

Participants with an indeterminate IGRA test result can repeat the test, but if the repeat test is also indeterminate, they will be excluded.

• Any severe herpes virus family infection (including Epstein-Barr virus, cytomegalovirus (CMV)) at any time prior to Randomization, including, but not limited to, disseminated herpes, herpes encephalitis, recent recurrent herpes zoster (defined as 2 episodes within the last 2 years), or ophthalmic herpes.
• Any herpes zoster, CMV, or Epstein-Barr virus infection that was not completely resolved 12 weeks prior to Randomization.
• Opportunistic infection requiring hospitalization or parenteral antimicrobial treatment within 2 years prior to Randomization.
• Any acute illness or evidence of clinically significant active infection on Day 1.
• Participants who have COVID-19 or other significant infection, or in the judgment of the Investigator, may be at a high risk of COVID-19 or its complications should not be randomized.
• Systemic lupus erythematosus defined by fulfilling 2020 American College of Rheumatology/European Alliance of Associations for Rheumatology criteria for systemic lupus erythematosus (SLE).
• Current diagnosis of a systemic connective tissue disease.
• Current inflammatory skin disease other than DLE, that, in the opinion of the Investigator, could interfere with the inflammatory skin assessments and confound the disease activity assessments.
• Exposure to an experimental drug either 30 days, 5 half-lives of the agent, or twice the duration of the biological effect of the agent, whichever is longer, prior to Randomization and through the final trial visit.
• Receipt of a live-attenuated vaccine within 4 weeks prior to Randomization.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Administration of placebo Q4W from Day 1 through Week 20.	Drug: Placebo; Placebo will be administered subcutaneously as two injections for each dose.
Experimental: Daxdilimab; Low Dose; Administration of daxdilimab low dose Q4W from Day 1 through Week 20.	Drug: Daxdilimab; Daxdilimab will be administered subcutaneously as two injections for each dose.; Other Names: HZN-7734
Experimental: Daxdilimab; High Dose; Administration of daxdilimab high dose Q4W from Day 1 through Week 20.	Drug: Daxdilimab; Daxdilimab will be administered subcutaneously as two injections for each dose.; Other Names: HZN-7734

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants who Achieve 0 or 1 on the Cutaneous Lupus Activity-investigator's Global Assessment (CLA-IGA) scale at Week 24	CLA-IGA will be assessed by 5-point Likert Scale (0-4).	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
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)	AEs, Serious AEs (SAEs) and AEs of Special Interest (AESIs) will be monitored. An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of trial intervention, whether or not considered related to the trial intervention. An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: Results in death; Is life-threatening. An AESI is an AE of scientific and medical interest specific to understanding of the IP and may require close monitoring and collection of additional information by the Investigator. An AESI may be serious or nonserious.	Day 1 to SFU2 (Week 32)

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2022
• Primary Completion (Actual): May 8, 2025
• Study Completion (Actual): May 8, 2025

Study Registration Dates

• First Submitted: October 19, 2022
• First Submitted That Met QC Criteria: October 19, 2022
• First Posted (Actual): October 24, 2022

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Immune System Diseases; Connective Tissue Diseases; Skin Diseases; Lupus Erythematosus, Cutaneous; Discoid Lupus Erythematosus
• Additional Relevant MeSH Terms: Skin and Connective Tissue Diseases; Skin Diseases; Immune System Diseases; Connective Tissue Diseases; Lupus Erythematosus, Cutaneous; Lupus Erythematosus, Discoid
• Other Study ID Numbers: HZNP-DAX-202; 2023-509746-35-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No