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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
155
Daxdilimab will be administered subcutaneously as two injections for each dose.
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.
Time frame: 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).
Time frame: 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).
Time frame: Up to approximately 56 weeks
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.
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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
Clinical Research of West Florida Inc - Tampa
Tampa, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Bluegrass Community Research Inc
Lexington, Kentucky, United States
NYU Langone Ambulatory Care Brooklyn Heights
Brooklyn, New York, United States
DJL Clinical Research
Charlotte, North Carolina, United States
Paramount Medical Research and Consulting LLC
Middleburg Heights, Ohio, United States
...and 42 more locations
Time frame: 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
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.
Time frame: 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.
Time frame: Up to approximately 56 weeks