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

Phase 2

Active, not recruiting

• Conditions: Discoid Lupus Erythematosus
• Interventions: Drug: Placebo; Drug: Daxdilimab

• Registration Number: NCT05591222
• Lead Sponsor: Amgen

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.

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 Timeline

• Study First Submitted: 2022-10-19
• Study First Submitted QC: 2022-10-19
• Study First Posted: 2022-10-24
• Study Start: 2022-12-29
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12
• Primary Completion: 2025-08-04
• Study Completion: 2025-08-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 99

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Administration of placebo Q4W from Day 1 through Week 20.
Daxdilimab; Low Dose	Daxdilimab	Administration of daxdilimab low dose Q4W from Day 1 through Week 20.
Daxdilimab; High Dose	Daxdilimab	Administration of daxdilimab high dose Q4W from Day 1 through Week 20.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	CLA-IGA will be assessed by 5-point Likert Scale (0-4).
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)	Day 1 to SFU2 (Week 32)	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: 1. Results in death; 2. 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.

Trial Locations

Locations (68)

Wallace Medical Group; 🇺🇸 Beverly Hills, California, United States

Arkansas Research Trials; 🇺🇸 North Little Rock, Arkansas, 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

Michigan Dermatology Institute; 🇺🇸 Waterford, Michigan, United States

Detroit Clinical Research Center, PC; 🇺🇸 Farmington Hills, 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; 🇦🇷 Ciudad de Mendoza, Mendoza, 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; 🇧🇷 Niteroi, 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, Sao Paulo, Brazil

Hospital Christovão da Gama - Centro de Estudos; 🇧🇷 Santo André, Sao Paulo, Brazil

Centro Multidisciplinar de Estudos Clinicos; 🇧🇷 São Bernardo Do Campo, Sao Paulo, Brazil

IMC - Instituto de Moléstias Cardiovasculares Tatuí; 🇧🇷 Tatuí, Sao 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; 🇨🇿 Praha 1, Czechia

Bispebjerg Hospital, Dermato-Venerologisk Afdeling Og Videncenter for Sårheling, D/S.; 🇩🇰 Copenhagen NV, Denmark

OUH; 🇩🇰 Odense C, Denmark

CHU Poitiers - Hôpital la Milétrie; 🇫🇷 Poitiers Cedex, France

Sjællands Universitetshospital; 🇩🇰 Roskilde, Denmark

Service de dermatologie, hôpital Archet 2, CHU NICE; 🇫🇷 Nice Alpes, Maritimes, France

Hopital Edouard Herriot - CHU Lyon; 🇫🇷 Lyon, France

CHU de Rouen - Hôpital Charles Nicolle; 🇫🇷 Rouen, France

Universitaetsklinikum Tuebingen; 🇩🇪 Tuebingen, Baden Wuerttemberg, Germany

BAG Dr. Freitag und Knöll; 🇩🇪 Falkensee, Brandenburg, Germany

Klinikum Oldenburg AöR; 🇩🇪 Oldenburg, Niedersachsen, Germany

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz; 🇩🇪 Mainz, Rheinland Pfalz, Germany

Universitätsklinikum Carl Gustav Carus TU Dresden, Klinik und Poliklinik f. Dermatologie; 🇩🇪 Dresden, Sachsen, 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

General Hospital Papageorgiou; 🇬🇷 Thessaloniki, Greece

Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski, Pawel Brzewski Spolka Cywilna; 🇵🇱 Krakow, Poland

Andreas Syggros Hospital; 🇬🇷 Athens, Greece

University General Hospital of Larissa; 🇬🇷 Larissa, Greece

Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o.; 🇵🇱 Malbork, Poland

LASER CLINIC S.C. Dr Tomasz Kochanowski Dr Andrzej Krolicki; 🇵🇱 Szczecin, Poland

Clinical Research Group Sp. z o.o.; 🇵🇱 Warszawa, Poland

Kliniczny Szpital Wojewodzki nr 1 im.F.Chopina; 🇵🇱 Rzeszów, Poland

Centralny Szpital Kliniczny MSWiA; 🇵🇱 Warszawa, Poland