The purpose of this study is to evaluate the effectiveness, safety and tolerability of Afimetoran in participants with active Systemic Lupus Erythematosus (SLE). The extension period will provide additional long-term safety and efficacy data and enable those participants initially randomized to placebo to receive treatment with Afimetoran.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
248
Specified dose on specified days
Specified dose on specified days
Proportion of participants that achieve an SLE (Systemic Lupus Erythematosus) Responder Index (4) (SRI(4)) response at Week 48
Time frame: Up to 48 Weeks
Proportion of participants that achieve a British Isles Lupus Assessment Group (BILAG)-based Combine Lupus Assessment (BICLA) response at Week 24 and Week 48
Time frame: Up to 48 Weeks
Proportion of participants who achieve an SRI(4) response at Week 24
Time frame: Up to 24 Weeks
Proportion of participants who achieve a Lupus Low Disease Activity State (LLDAS) response at Week 24 and Week 48
Time frame: Up to 48 Weeks
Proportion of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index; Activity (CLASI-A) score ≥ 10 at baseline who achieve a decrease of ≥ 50% from baseline CLASI-A score (CLASI-50) response at Week 24 and Week 48
Time frame: Up to 48 Weeks
Proportion of participants with 6 or more swollen joints and 6 or more tender joints at baseline who achieve a ≥ 50% reduction from baseline in both swollen and tender joints at Week 24 and Week 48
Time frame: Up to 48 Weeks
Mean change from baseline in swollen joint count using the 28-joint count at Week 24 and Week 48 in participants with ≥ 2 swollen joints at baseline
Time frame: Up to 48 Weeks
Mean change from baseline in tender joint count at Week 24 and Week 48 using the 28- joint count in participants with ≥ 2 tender joints at baseline
Time frame: Up to 48 Weeks
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La Jolla, California, United States
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San Diego, California, United States
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Woodland Hills, California, United States
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Clearwater, Florida, United States
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Kissimmee, Florida, United States
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Orlando, Florida, United States
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Ormond Beach, Florida, United States
...and 137 more locations
Change from baseline in PGA score of disease activity at Week 24 and Week 48
PGA = Physician Global Assessment of disease activity (score of "0" indicating no disease activity and higher scores indicating higher disease activity)
Time frame: Up to 48 Weeks
Proportion of participants who achieve CS reduction or maintenance to ≤ 7.5 mg per day at Week 48
Time frame: Up to 48 Weeks
Change in participant reported disease activity from baseline to Week 24 and Week 48 according to the 36-item Short Form Health Questionnaire (SF-36)
The SF-36 was designed as an indicator of health status in population surveys, and health policy evaluations, and for use as an outcome measure in clinical practice and research. Scores for each domain range from 0 to 100, with high scores indicating a better health status.
Time frame: Up to 48 Weeks
Number of participants with Adverse Events (AEs)
Time frame: Up to 100 Weeks
Number of participants with Serious Adverse Events (SAEs)
Time frame: Up to 100 Weeks
Number of participants with clinical laboratory abnormalities
Time frame: Up to 100 Weeks
Number of participants with physical examination abnormalities
Time frame: Up to 100 Weeks
Number of participants with vital sign abnormalities
Time frame: Up to 100 Weeks
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 52 Weeks