This study is an open-label, uncontrolled study design to evaluate the long-term safety and tolerability of treatment with CC-93538. The study will enroll participants who participated in the CC-93538-EE-001 or CC-93538-DDI-001 studies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
367
CC-93538
Number of Participants With Treatment Emergent Adverse Events (TEAE)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization.
Time frame: From first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months)
Number of Participants With Clinically Significant Maximum Post Baseline Shifts in Laboratory Parameters
Blood samples were collected to assess clinical significant shifts in laboratory parameters. "Normal to High" means at baseline the value is Normal and maximum post baseline value is High.
Time frame: From first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months)
Number of Participants With Clinically Meaningful Mean Changes in Vital Signs and Physical Parameters
SBP (Systolic blood Pressure) and DBP (Diastolic Blood Pressure) measured in mmHg and Heart rates measured in beats per minute.
Time frame: From first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months)
Number of Participants With Incidence of Treatment Emergent Anti-CEN Antibodies
Blood samples were collected to assess Anti-CEN antibodies. Post-Baseline ADA Positive define as 1) at least 1 positive post-baseline given baseline is negative or missing; or 2) at least 1 positive post-baseline with titer \>= 4-fold baseline titer given positive baseline.
Time frame: From first dose until study completion, early discontinuation, or loss of follow up, whichever occurs first (Up to approximately 36 months)
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