AzTrials
AzTrials

Discoid Lupus ErythematosusPhase 2NCT05591222

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

A Phase 2 study testing Daxdilimab in people with Discoid Lupus Erythematosus, run by Amgen at 68 sites in 11 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Discoid Lupus Erythematosus
What is being tested?
Daxdilimab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
68 sitesin 11 countries
Study dates
29 Dec 2022to 8 May 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 12Show fewer
  • 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.

Who cannot join

  • 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.
Show all 27Show fewer
  • 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.

Trial locations and contacts

68 sites in 11 countries.

68 sites in 11 countries

United States16 sites

  • Wallace Medical Group

    Beverly Hills, California, 90211

  • Ohio State University

    Columbus, Ohio, 43210

  • Wright State Physicians

    Fairborn, Ohio, 45324

  • Detroit Clinical Research Center, PC

    Farmington Hills, Michigan, 48334

  • Forest Hills Dermatology

    Forest Hills, New York, 11375

  • The Center for Dermatology Clinical Research

    Fremont, California, 94538

  • Center for Clinical Studies (Cypress)

    Houston, Texas, 77065

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46250

  • Miami Dermatology & Laser Research

    Miami, Florida, 33173

  • Minnesota Clinical Study Center

    New Brighton, Minnesota, 55112

  • Arkansas Research Trials

    North Little Rock, Arkansas, 72117

  • Paddington Testing Company, Inc.

    Philadelphia, Pennsylvania, 19103

  • Autoimmune Skin Diseases Unit, Dept. of Dermatology

    Philadelphia, Pennsylvania, 19104

  • MediSearch Clinical Trials

    Saint Joseph, Missouri, 64506

  • Clinical Science Institute

    Santa Monica, California, 90404

  • Michigan Dermatology Institute

    Waterford, Michigan, 48328

Other trials in United States

Brazil14 sites

  • Hospital Universitário Evangélico Mackenzie

    Água Verde, Paraná, 80240-220

  • Universidade Estadual de Campinas

    Campinas, São Paulo, 13083-888

  • 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

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

    Fortaleza, Ceará, 60430-275

  • Complexo Hospitalar de Niterói

    Niterói, Rio Do Janeiro, 24020-076

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90035-001

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90050-170

  • LMK Serviços Médicos S/S

    Porto Alegre, Rio Grande do Sul, 90480-000

  • Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A

    Rio de Janeiro, Rio Do Janeiro, 20241-180

  • Hospital Christovão da Gama - Centro de Estudos

    Santo André, São Paulo, 09030-010

  • Centro Multidisciplinar de Estudos Clinicos

    São Bernardo do Campo, São Paulo, 09715

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

    Sao Jose Rio, Preto Sao Paulo, 15090-000

  • IPITEC Instituto de Pesquisa Inovação Tecnológica

    São Paulo, 01223-001

  • IMC - Instituto de Moléstias Cardiovasculares Tatuí

    Tatuí, São Paulo, 18270-170

Other trials in Brazil

Germany6 sites

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117

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

    Dresden, Saxony, 01307

  • BAG Dr. Freitag und Knöll

    Falkensee, Brandenburg, 14612

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

    Mainz, Rhineland-Palatinate, 55131

  • Klinikum Oldenburg AöR

    Oldenburg, Lower Saxony, 26133

  • Universitaetsklinikum Tuebingen

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Greece6 sites

  • General Hospital of Athens "Evangelismos"

    Athens, 10676

  • 401 General Military Hospital of Athens

    Athens, 11525

  • University General Hospital "Attikon"

    Athens, 12462

  • Andreas Syggros Hospital

    Athens, 16121

  • University General Hospital of Larissa

    Larissa, 41110

  • General Hospital Papageorgiou

    Thessaloniki, 56429

Other trials in Greece

Poland6 sites

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

    Krakow, 30-002

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

    Malbork, 82-200

  • Kliniczny Szpital Wojewodzki nr 1 im.F.Chopina

    Rzeszów, 35-055

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

    Szczecin, 70-332

  • Clinical Research Group Sp. z o.o.

    Warsaw, 01-142

  • Centralny Szpital Kliniczny MSWiA

    Warsaw, 02-807

Other trials in Poland

Canada5 sites

  • Alberta DermaSurgery Centre

    Edmonton, Alberta, T6G 1C3

  • Brunswick Dermatology Center

    Fredericton, New Brunswick, E3B 1G9

  • DermEffects

    London, Ontario, N6H 5L5

  • North York Research, Inc

    Toronto, Ontario, M2N 3A6

  • K. Papp Clinical Research

    Waterloo, Ontario, N2J 1C4

Other trials in Canada

Bulgaria4 sites

  • DCC 'Sveti Georgi' EOOD

    Haskovo, 6300

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

    Sofia, 1407

  • DCC "Alexandrovska" EOOD

    Sofia, 1431

  • Medical Center Eurohealth EOOD

    Sofia, 1606

Other trials in Bulgaria

France4 sites

  • Hopital Edouard Herriot - CHU Lyon

    Lyon, 69003

  • Service de dermatologie, hôpital Archet 2, CHU NICE

    Nice Alpes, Maritimes, 6200

  • CHU Poitiers - Hôpital la Milétrie

    Poitiers, 86021

  • CHU de Rouen - Hôpital Charles Nicolle

    Rouen, 76031

Other trials in France

Denmark3 sites

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

    Copenhagen NV, 2400

  • OUH

    Odense C, 5000

  • Sjællands Universitetshospital

    Roskilde, 4000

Other trials in Denmark

Argentina2 sites

  • CIPREC

    Ciudad Autonoma Buenos Aires, C1061AAS

  • Fundacion Scherbovsky

    Mendoza, Mendoza Province, CP5500

Other trials in Argentina

Czechia2 sites

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, 602 00

  • Sanatorium Profesora Arenbergera

    Prague, 110 00

Other trials in Czechia

About this study

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

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.

Read the 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.

Being tested
Placebo, Daxdilimab
Keywords
Discoid Lupus Erythematosus, Immune System Diseases, Lupus Erythematosus, Cutaneous, Skin Diseases, Connective Tissue Diseases
Medical subject headings
Lupus Erythematosus, Discoid, Immune System Diseases, Lupus Erythematosus, Cutaneous, Skin Diseases, Connective Tissue Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

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

  • DaxdilimabDrug

    Also called HZN-7734

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

Study groups in NCT05591222
Study groupRoleWhat they receive
PlaceboPlacebo comparatorAdministration of placebo Q4W from Day 1 through Week 20.
Receives: Drug: Placebo
Daxdilimab; Low DoseExperimentalAdministration of daxdilimab low dose Q4W from Day 1 through Week 20.
Receives: Drug: Daxdilimab
Daxdilimab; High DoseExperimentalAdministration of daxdilimab high dose Q4W from Day 1 through Week 20.
Receives: Drug: Daxdilimab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline to Week 24

Secondary outcomes (6)

  1. 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).

    Measured: Week 24

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

    Measured: Baseline to Week 24

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

    Measured: Baseline to Week 24

  4. Serum Concentration of Daxdilimab Over Time

    Measured: Day 1 to Week 24

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

    Measured: Day 1 to Week 32

  6. 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:

    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.

    Measured: Day 1 to SFU2 (Week 32)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2022
  2. Study start29 Dec 2022
  3. Primary completion8 May 2025
  4. Study completion8 May 2025

Why it stopped: Sponsor business decision, not related to safety concerns.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05591222
Sponsor's protocol ID
HZNP-DAX-202
Other IDs
2023-509746-35-00, 2023
Status last verified
May 2026
First submitted
19 Oct 2022
Last updated
14 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Daxdilimab in people with Discoid Lupus Erythematosus, run by Amgen at 68 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in United States, Brazil, Germany, Greece, Poland and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor business decision, not related to safety concerns.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in Cutaneous Lupus Erythematosus Disease and Severity Index-Activity (CLASI-A) Score from Baseline to Week 24 (time frame: Baseline to Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05591222.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in