Study of Daxdilimab (HZN-7734) for the Treatment of Systemic Lupus Erythematosus in an Open-label Extension Study
- Registration Number
- NCT05430854
- Lead Sponsor
- Amgen
- 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.
- Detailed Description
Approximately 156 participants will be enrolled to receive daxdilimab administered subcutaneously over 48 weeks. The maximum trial duration per participant is approximately 56 weeks, including the 48 weeks for the open-label treatment period where participants will receive daxdilimab 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 155
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Daxdilimab Daxdilimab Daxdilimab injections over a total of 48 weeks.
- Primary Outcome Measures
Name Time Method Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) Up to approximately 56 weeks 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.
Number of Participants Who Experienced Serious Adverse Events (SAEs) Up to approximately 56 weeks 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).Number of Participants Who Experienced AEs of Special Interest (AESI) Up to approximately 56 weeks 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).
- Secondary Outcome Measures
Name Time Method Serum Concentration of Daxdilimab Week 0 (Week 0 = Day 1), Week 12, Week 24, Week 36, Week 48, Week 56 Serum concentration of daxdilimab refers to the amount of daxdilimab present in the blood serum at a given time. Blood samples were collected via venipuncture at the specified time frames. Week 0 corresponds to the last day of the treatment period in the parent study and Day 1 of the treatment period in the OLE study.
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 PDCs count refers to the number of pDCs present in a blood sample. Blood samples were collected via venipuncture at the specified time frames. Week 0 corresponds to the last day of the treatment period in the parent study and Day 1 of the treatment period in the OLE study.
Number of Participants Expressing Anti-drug Antibodies (ADA) Up to approximately 56 weeks ADA incidence is the number of the participants with ADA positive post-Baseline only or boosted their preexisting ADA during the trial. Persistent positive was defined as ADA positive at ≥ 2 post-Baseline assessments (with ≥ 16 weeks between first and last positive) or positive at last post-Baseline assessment. Transient positive was defined as ADA post-Baseline positive but did not fulfill the criteria of persistent positive.
Trial Locations
- Locations (52)
Kianous Stavros
🇬🇷Thessaloníki, Greece
Athens General Hospital 'G Gennimatas
🇬🇷Athens, Greece
University General Hospital of Larissa
🇬🇷Larisa, Greece
Centro Peninsular de Investigacion S.C.P
🇲🇽Merida, Yucatán, Mexico
Hospital Universitario A Coruña
🇪🇸A Coruña, Spain
Consultorio de Reumatologia
🇲🇽Ciudad de Mexico, Mexico
Klinika Reumatologii i Rehabilitacji Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im W. Degi
🇵🇱Poznań, Wielkopolskie, Poland
Inland Rheumatology Clinical Trials Incorporated
🇺🇸Upland, California, United States
Clinical Research of West Florida Inc - Clearwater
🇺🇸Clearwater, Florida, United States
Millennium Research
🇺🇸Ormond Beach, Florida, United States
IRIS Research and Development LLC
🇺🇸Plantation, Florida, United States
Bluegrass Community Research Inc
🇺🇸Lexington, Kentucky, United States
NYU Langone Ambulatory Care Brooklyn Heights
🇺🇸Brooklyn, New York, United States
Paramount Medical Research and Consulting LLC
🇺🇸Middleburg Heights, Ohio, United States
DJL Clinical Research
🇺🇸Charlotte, North Carolina, United States
Southwest Rheumatology Research, LLC
🇺🇸Mesquite, Texas, United States
Precision Comprehensive Clinical Research Solutions
🇺🇸Colleyville, Texas, United States
Metroplex Clinical Research Center
🇺🇸Dallas, Texas, United States
Clínica Adventista Belgrano
🇦🇷Estomba, Buenos Aires, Argentina
Morales Vargas Centro de Investigacion SC
🇲🇽León, Guanajuato, Mexico
Clinical Research of West Florida Inc - Tampa
🇺🇸Tampa, Florida, United States
Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
Framingham Centro Médico
🇦🇷La Plata, Buenos Aires, Argentina
Instituto CER S.A
🇦🇷Quilmes, Buenos Aires, Argentina
Laiko General Hospital of Athens
🇬🇷Athens, Greece
Centrum Medyczne Plejady
🇵🇱Kraków, Malopolskie, Poland
Medycyna Kliniczna Marzena Waszczak-Jeka
🇵🇱Warszawa, Mazowieckie, Poland
Institute of Rheumatology Belgrade
🇷🇸Belgrade, Serbia
Spectrum Medical, Inc
🇺🇸Danville, Virginia, United States
Centro de Investigación en Artritis y Osteoporosis
🇲🇽Mexicali, Baja California, Mexico
Consultorios Médicos Dr. Doreski
🇦🇷Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Quilmes SRL
🇦🇷Quilmes, Buenos Aires, Argentina
Krishna Institute of Medical Sciences
🇮🇳Secunderabad, Andhra Pradesh, India
Centro de Investigación y Tratamiento Reumatológico S.C
🇲🇽San Miguel, Distrito Federal, Mexico
Clinica de Investigacion en Reumatologia y Obesidad
🇲🇽Guadalajara, Mexico
Centrum Medyczne AMED
🇵🇱Warszawa, Mazowieckie, Poland
National Taiwan University Hospital
🇨🇳Taipei, Province Of China, Taiwan
Pratia MCM
🇵🇱Krakow, Malopolskie, Poland
Nasz Lekarz Osrodek Badan Klinicznych
🇵🇱Bydgoszcz, Poland
Centrym Medyczne AMED oddzial w Lodzi
🇵🇱Łódź, Lodzkie, Poland
University Clinical Center Kragujevac
🇷🇸Kragujevac, Serbia
Centro Medico Privado de Reumatologia
🇦🇷San Miguel De Tucumán, Tucumán, Argentina
AES - AS - Sushruta Multispeciality Hospital & Research Center Pvt Ltd - Hubli
🇮🇳Hubli, Karnataka, India
Centro de Estudios de Investigacion Basica Y Clinica SC
🇲🇽Jalisco, Mexico
Twoja Przychodnia - Centrum Medyczne Nowa Sol
🇵🇱Nowa Sól, Lubuskie, Poland
Military Medical Academy
🇷🇸Belgrade, Serbia
Consultorio de Investigaciones Reumatologicas
🇦🇷San Miguel De Tucumán, Tucumán, Argentina
Bioclinica - Centro Integral En Reumatologia Sociedad Anónima de Capital Variable
🇲🇽Guadalajara, Jalisco, Mexico
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
🇲🇽Zapopan, Jalisco, Mexico
Jasleen Hospital
🇮🇳Nagpur, Maharashtra, India
AES - AS - Panchshil Hospital - Ahmedabad
🇮🇳Ahmedabad, Gujarat, India
AES - AS - Unity Trauma Center and ICU - Unity Hospital - Surat
🇮🇳Sūrat, Gujarat, India