Acromegaly
Conditions
Brief summary
Percentage change from baseline in serum IGF-1 level at Week 15
Detailed description
1_Number of Participants Who Achieve Serum IGF-1 Level ≤1.3 Upper Limit of Normal (ULN) at Week 15, 2_Number of Participants Who Achieve Serum IGF-1 Level ≤1.0 ULN at Week 15, 3_Change From Baseline in Symptoms, as Assessed by disease specific questionnaire, at Week 15, 4_Change From Baseline in Serum IGF-1 Level at Week 15, 5_Change From Baseline in 36-item Short Form Survey (SF-36) Summary Scores and Subscores at Week 15, 6_Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) at Week 15, 7_Change from baseline in Acromegaly Quality of Life (AcroQoL) at Week 15, 8_Change From Baseline in Global Impression of Severity at Week 15 as Assessed by Patient Global Impression of Severity (PGIS) Scale, 9_Global Impression of Change at Week 15 as Assessed by Patient Global Impression of Change (PGIC) Scale, 10_Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Adverse Events (AEs) Leading to Study Intervention Discontinuation or Interruption through Week 15, 11_Plasma Concentration of ALXN2420 over time through Week 15, 12_Number of Participants With Antidrug Antibodies (ADAs) through Week 15
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change from baseline in serum IGF-1 level at Week 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1_Number of Participants Who Achieve Serum IGF-1 Level ≤1.3 Upper Limit of Normal (ULN) at Week 15, 2_Number of Participants Who Achieve Serum IGF-1 Level ≤1.0 ULN at Week 15, 3_Change From Baseline in Symptoms, as Assessed by disease specific questionnaire, at Week 15, 4_Change From Baseline in Serum IGF-1 Level at Week 15, 5_Change From Baseline in 36-item Short Form Survey (SF-36) Summary Scores and Subscores at Week 15, 6_Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) at Week 15, 7_Change from baseline in Acromegaly Quality of Life (AcroQoL) at Week 15, 8_Change From Baseline in Global Impression of Severity at Week 15 as Assessed by Patient Global Impression of Severity (PGIS) Scale, 9_Global Impression of Change at Week 15 as Assessed by Patient Global Impression of Change (PGIC) Scale, 10_Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Adverse Events (AEs) Leading to Study Intervention | — |
Countries
Denmark, Hungary, Italy, Lithuania, Netherlands, Poland, Romania