Study of Daxdilimab (HZN-7734) for the Treatment of Systemic Lupus Erythematosus in an Open-label Extension Study

NCT05430854 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: HZNP-DAX-204
• Study Type: interventional
• Target: 155
• Locations: 9 countries
• Sites: 52

Brief Summary

A Phase 2, Open-Label Extension study to evaluate the long-term safety and tolerability of daxdilimab in participants with Systemic Lupus Erythematosus completing the treatment period of the RECAST SLE clinical study.

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (3)

• Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)

  An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an IP, whether or not considered related to the IP. A TEAE is defined as any AE with an onset date on or after the first dose date in the OLE study.

  Up to approximately 56 weeks

• Number of Participants Who Experienced Serious Adverse Events (SAEs)

  An AE is considered "serious" if, in the view of either the Investigator or Sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * Persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions * A congenital abnormality/birth defect * Important medical events judged to jeopardize the participant(s).

  Up to approximately 56 weeks

• Number of Participants Who Experienced AEs of Special Interest (AESI)

  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. In this study, AESIs were: * Hypersensitivity reaction, including anaphylaxis * Severe (Grade 3 or higher) viral infections/reactivations * Opportunistic infections * Malignancy (except non-melanoma skin cancer).

  Up to approximately 56 weeks

Secondary Outcomes (3)

• Serum Concentration of Daxdilimab

  Week 0 (Week 0 = Day 1), Week 12, Week 24, Week 36, Week 48, Week 56

• Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Count

  Week 0 (Week 0 = Day 1), Week 12, Week 24, Week 36, Week 48, Week 56

• Number of Participants Expressing Anti-drug Antibodies (ADA)

  Up to approximately 56 weeks

Study Arms (1)

Daxdilimab

EXPERIMENTAL

Daxdilimab injections over a total of 48 weeks.

Biological: Daxdilimab

Interventions

Daxdilimab BIOLOGICAL

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

Also known as: HZN-7734

Daxdilimab

Eligibility Criteria

• Age: 18 Years - 72 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.
• Must have completed the treatment period in the RECAST SLE study.
• Women of childbearing potential must have a negative urine pregnancy test on Day 1.
• Nonsterilized male subjects who are sexually active with a woman partner of childbearing potential must agree to use a condom with spermicide from Day 1 and until 3 months (approximately 5 half-lives) after receipt of the last dose.

You may not qualify if:

• Any condition or change during the RECAST SLE study that in the opinion of the Investigator or the Sponsor would interfere with evaluation and interpretation of subject safety or alter the risk-benefit associated with IP administration.
• Participation in another clinical study with an IP during the RECAST SLE study period.
• Planned elective surgeries that in the opinion of the Investigator or the Sponsor would interfere with evaluation and interpretation of subject safety.
• Any herpes zoster, cytomegalovirus, or Epstein-Barr virus infection that was not completely resolved prior to Visit 1.
• Clinically significant active infection at Visit 1, in the opinion of the Investigator.
• Pregnant or lactating females.

Sponsors & Collaborators

• Amgen: lead

Study Sites (52)

Inland Rheumatology Clinical Trials Incorporated

Upland, California, 91786, United States

Location

Clinical Research of West Florida Inc - Clearwater

Clearwater, Florida, 33765-2616, United States

Location

Millennium Research

Ormond Beach, Florida, 32174, United States

Location

IRIS Research and Development LLC

Plantation, Florida, 33324, United States

Location

Clinical Research of West Florida Inc - Tampa

Tampa, Florida, 33606-1246, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Bluegrass Community Research Inc

Lexington, Kentucky, 40504-2931, United States

Location

NYU Langone Ambulatory Care Brooklyn Heights

Brooklyn, New York, 11201, United States

Location

DJL Clinical Research

Charlotte, North Carolina, 28210-8509, United States

Location

Paramount Medical Research and Consulting LLC

Middleburg Heights, Ohio, 44130-3483, United States

Location

Precision Comprehensive Clinical Research Solutions

Colleyville, Texas, 76034-5913, United States

Location

Metroplex Clinical Research Center

Dallas, Texas, 75231, United States

Location

Southwest Rheumatology Research, LLC

Mesquite, Texas, 75150, United States

Location

Spectrum Medical, Inc

Danville, Virginia, 24541-1222, United States

Location

Consultorios Médicos Dr. Doreski

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ABP, Argentina

Location

Clínica Adventista Belgrano

Estomba, Buenos Aires, C1430EGF, Argentina

Location

Framingham Centro Médico

La Plata, Buenos Aires, B1902COS, Argentina

Location

Instituto CER S.A

Quilmes, Buenos Aires, B1878DVB, Argentina

Location

Instituto de Investigaciones Clinicas Quilmes SRL

Quilmes, Buenos Aires, B1878GEG, Argentina

Location

Centro Medico Privado de Reumatologia

San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

Location

Consultorio de Investigaciones Reumatologicas

San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

Location

Athens General Hospital 'G Gennimatas

Athens, 115 27, Greece

Location

Laiko General Hospital of Athens

Athens, 115 27, Greece

Location

University General Hospital of Larissa

Larissa, 411 10, Greece

Location

Kianous Stavros

Thessaloniki, 546 36, Greece

Location

Krishna Institute of Medical Sciences

Secunderabad, Andhra Pradesh, 500003, India

Location

AES - AS - Panchshil Hospital - Ahmedabad

Ahmedabad, Gujarat, 380005, India

Location

AES - AS - Unity Trauma Center and ICU - Unity Hospital - Surat

Surat, Gujarat, 395010, India

Location

AES - AS - Sushruta Multispeciality Hospital & Research Center Pvt Ltd - Hubli

Hubli, Karnataka, 580021, India

Location

Jasleen Hospital

Nagpur, Maharashtra, 440012, India

Location

Centro de Investigación en Artritis y Osteoporosis

Mexicali, Estado de Baja California, Mexico

Location

Morales Vargas Centro de Investigacion SC

León, Guanajuato, 37000, Mexico

Location

Bioclinica - Centro Integral En Reumatologia Sociedad Anónima de Capital Variable

Guadalajara, Jalisco, 44160, Mexico

Location

Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.

Zapopan, Jalisco, 45030, Mexico

Location

Centro de Investigación y Tratamiento Reumatológico S.C

San Miguel, Mexico City, 11850, Mexico

Location

Centro Peninsular de Investigacion S.C.P

Mérida, Yucatán, 97000, Mexico

Location

Clinica de Investigacion en Reumatologia y Obesidad

Guadalajara, 44600, Mexico

Location

Centro de Estudios de Investigacion Basica Y Clinica SC

Jalisco, 44690, Mexico

Location

Consultorio de Reumatologia

Mexico City, 07760, Mexico

Location

Klinika Reumatologii i Rehabilitacji Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im W. Degi

Poznan, Greater Poland Voivodeship, 61-545, Poland

Location

Centrum Medyczne Plejady

Krakow, Lesser Poland Voivodeship, 30-363, Poland

Location

Pratia MCM

Krakow, Lesser Poland Voivodeship, 30-510, Poland

Location

Twoja Przychodnia - Centrum Medyczne Nowa Sol

Nowa Sól, Lubusz Voivodeship, 67-100, Poland

Location

Medycyna Kliniczna Marzena Waszczak-Jeka

Warsaw, Masovian Voivodeship, 00-874, Poland

Location

Centrum Medyczne AMED

Warsaw, Masovian Voivodeship, 03-291, Poland

Location

Nasz Lekarz Osrodek Badan Klinicznych

Bydgoszcz, 85-065, Poland

Location

Centrym Medyczne AMED oddzial w Lodzi

Lodz, Łódź Voivodeship, 91-365, Poland

Location

Institute of Rheumatology Belgrade

Belgrade, 11000, Serbia

Location

Military Medical Academy

Belgrade, 11000, Serbia

Location

University Clinical Center Kragujevac

Kragujevac, 34000, Serbia

Location

Hospital Universitario A Coruña

A Coruña, 15006, Spain

Location

National Taiwan University Hospital

Taipei, Province of China, 100, Taiwan

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: June 24, 2022
• Study Start: June 1, 2022
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

AR (7); ES (1); SE (3); IN (5); PL (8); ME (9); TW (1); GR (4); US (14)