Not provided
Not provided
Not provided
Not provided
Sponsor Decision
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daxdilimab | Experimental | Daxdilimab injections over a total of 48 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daxdilimab | Biological | Daxdilimab will be administered subcutaneously as two injections for each dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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:
| Up to approximately 56 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentration of Daxdilimab | 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. | Week 0 (Week 0 = Day 1), Week 12, Week 24, Week 36, Week 48, Week 56 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inland Rheumatology Clinical Trials Incorporated | Upland | California | 91786 | United States | ||
| Clinical Research of West Florida Inc - Clearwater |
Not provided
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This was an open-label extension (OLE) of study VIB7734.P2.S1 (NCT04925934). Eligible participants were enrolled after the completion of the VIB7734.P2.S1 study. 155 participants were enrolled at 54 centers in the United States, Argentina, Greece, India, Mexico, Poland, Serbia, Spain and Taiwan from 01 June 2022 to 31 October 2023.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo/Daxdilimab 200 mg Every 12 Weeks (Q12W) | Participants who received placebo in the parent study received daxdilimab 200 mg subcutaneous (SC) injection Q12W in this OLE Study. |
| FG001 | Daxdilimab 200 mg Every 4 Weeks (Q4W)/Daxdilimab 200 mg Q12W |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 17, 2022 | Aug 14, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Count | 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. | Week 0 (Week 0 = Day 1), Week 12, Week 24, Week 36, Week 48, Week 56 |
| Number of Participants Expressing Anti-drug Antibodies (ADA) | 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. | Up to approximately 56 weeks |
| Clearwater |
| Florida |
| 33765-2616 |
| United States |
| Millennium Research | Ormond Beach | Florida | 32174 | United States |
| IRIS Research and Development LLC | Plantation | Florida | 33324 | United States |
| Clinical Research of West Florida Inc - Tampa | Tampa | Florida | 33606-1246 | United States |
| Emory University School of Medicine | Atlanta | Georgia | 30322 | United States |
| Bluegrass Community Research Inc | Lexington | Kentucky | 40504-2931 | United States |
| NYU Langone Ambulatory Care Brooklyn Heights | Brooklyn | New York | 11201 | United States |
| DJL Clinical Research | Charlotte | North Carolina | 28210-8509 | United States |
| Paramount Medical Research and Consulting LLC | Middleburg Heights | Ohio | 44130-3483 | United States |
| Precision Comprehensive Clinical Research Solutions | Colleyville | Texas | 76034-5913 | United States |
| Metroplex Clinical Research Center | Dallas | Texas | 75231 | United States |
| Southwest Rheumatology Research, LLC | Mesquite | Texas | 75150 | United States |
| Spectrum Medical, Inc | Danville | Virginia | 24541-1222 | United States |
| Consultorios Médicos Dr. Doreski | Ciudad Autónoma de Buenos Aires | Buenos Aires | C1426ABP | Argentina |
| Clínica Adventista Belgrano | Estomba | Buenos Aires | C1430EGF | Argentina |
| Framingham Centro Médico | La Plata | Buenos Aires | B1902COS | Argentina |
| Instituto CER S.A | Quilmes | Buenos Aires | B1878DVB | Argentina |
| Instituto de Investigaciones Clinicas Quilmes SRL | Quilmes | Buenos Aires | B1878GEG | Argentina |
| Centro Medico Privado de Reumatologia | San Miguel de Tucumán | Tucumán Province | T4000AXL | Argentina |
| Consultorio de Investigaciones Reumatologicas | San Miguel de Tucumán | Tucumán Province | T4000AXL | Argentina |
| Athens General Hospital 'G Gennimatas | Athens | 115 27 | Greece |
| Laiko General Hospital of Athens | Athens | 115 27 | Greece |
| University General Hospital of Larissa | Larissa | 411 10 | Greece |
| Kianous Stavros | Thessaloniki | 546 36 | Greece |
| Krishna Institute of Medical Sciences | Secunderabad | Andhra Pradesh | 500003 | India |
| AES - AS - Panchshil Hospital - Ahmedabad | Ahmedabad | Gujarat | 380005 | India |
| AES - AS - Unity Trauma Center and ICU - Unity Hospital - Surat | Surat | Gujarat | 395010 | India |
| AES - AS - Sushruta Multispeciality Hospital & Research Center Pvt Ltd - Hubli | Hubli | Karnataka | 580021 | India |
| Jasleen Hospital | Nagpur | Maharashtra | 440012 | India |
| Centro de Investigación en Artritis y Osteoporosis | Mexicali | Estado de Baja California | Mexico |
| Morales Vargas Centro de Investigacion SC | León | Guanajuato | 37000 | Mexico |
| Bioclinica - Centro Integral En Reumatologia Sociedad Anónima de Capital Variable | Guadalajara | Jalisco | 44160 | Mexico |
| Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. | Zapopan | Jalisco | 45030 | Mexico |
| Centro de Investigación y Tratamiento Reumatológico S.C | San Miguel | Mexico City | 11850 | Mexico |
| Centro Peninsular de Investigacion S.C.P | Mérida | Yucatán | 97000 | Mexico |
| Clinica de Investigacion en Reumatologia y Obesidad | Guadalajara | 44600 | Mexico |
| Centro de Estudios de Investigacion Basica Y Clinica SC | Jalisco | 44690 | Mexico |
| Consultorio de Reumatologia | Mexico City | 07760 | Mexico |
| Klinika Reumatologii i Rehabilitacji Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im W. Degi | Poznan | Greater Poland Voivodeship | 61-545 | Poland |
| Centrum Medyczne Plejady | Krakow | Lesser Poland Voivodeship | 30-363 | Poland |
| Pratia MCM | Krakow | Lesser Poland Voivodeship | 30-510 | Poland |
| Twoja Przychodnia - Centrum Medyczne Nowa Sol | Nowa Sól | Lubusz Voivodeship | 67-100 | Poland |
| Medycyna Kliniczna Marzena Waszczak-Jeka | Warsaw | Masovian Voivodeship | 00-874 | Poland |
| Centrum Medyczne AMED | Warsaw | Masovian Voivodeship | 03-291 | Poland |
| Nasz Lekarz Osrodek Badan Klinicznych | Bydgoszcz | 85-065 | Poland |
| Centrym Medyczne AMED oddzial w Lodzi | Lodz | Łódź Voivodeship | 91-365 | Poland |
| Institute of Rheumatology Belgrade | Belgrade | 11000 | Serbia |
| Military Medical Academy | Belgrade | 11000 | Serbia |
| University Clinical Center Kragujevac | Kragujevac | 34000 | Serbia |
| Hospital Universitario A Coruña | A Coruña | 15006 | Spain |
| National Taiwan University Hospital | Taipei | Province of China | 100 | Taiwan |
Participants who received 200 mg Q4W in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study. |
| FG002 | Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W | Participants who received 200 mg Q12W in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo/Daxdilimab 200 mg Q12W | Participants who received placebo in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study. |
| BG001 | Daxdilimab 200 mg Q4W in Parent Study | Participants who received 200 mg Q4W in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study. |
| BG002 | Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W | Participants who received 200 mg Q12W in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. | Posted | Count of Participants | Participants | Up to approximately 56 weeks |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | 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:
| OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. | Posted | Count of Participants | Participants | Up to approximately 56 weeks |
| ||||||||||||||||||||||||||||||||||
| Primary | 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:
| OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. | Posted | Count of Participants | Participants | Up to approximately 56 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | Serum Concentration of Daxdilimab | 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. | PK Analysis Set: all participants who received any dose of daxdilimab in OLE study and had at least 1 measurable PK concentration post dose. Number analyzed represents the number of participants with available data at that time point. | Posted | Mean | Standard Deviation | ug/mL | Week 0 (Week 0 = Day 1), Week 12, Week 24, Week 36, Week 48, Week 56 |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Count | 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. | OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. The overall number of participants analzyed represents the number of participants contributing data to any individual timepoint within the table. | Posted | Mean | Standard Deviation | Percentage change in pDCs count | Week 0 (Week 0 = Day 1), Week 12, Week 24, Week 36, Week 48, Week 56 |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Expressing Anti-drug Antibodies (ADA) | 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. | Any Daxdilimab Analysis Set: all participants who received at least 1 dose of daxdilimab in parent study or OLE study. | Posted | Count of Participants | Participants | Up to approximately 56 weeks |
|
Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo/Daxdilimab 200 mg Q12W | Participants who received placebo in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study. | 0 | 47 | 3 | 47 | 12 | 47 |
| EG001 | Daxdilimab 200 mg Q4W in Parent Study | Participants who received 200 mg Q4W in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study. | 0 | 57 | 5 | 57 | 19 | 57 |
| EG002 | Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W | Participants who received 200 mg Q12W in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study. | 0 | 51 | 5 | 51 | 19 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Cytomegalovirus nephritis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Colorectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Glomerulonephritis minimal lesion | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 3, 2022 | Aug 14, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Black or African American |
|
| White |
|
| Other |
|
|
|
|
|
|
|
|
|
|
|