The primary objective of this study is to evaluate the efficacy of 15-week treatment with ALXN2420 versus placebo for decreasing insulin-like growth factor IGF-1 levels, when administered in combination with somatostatin analog (SSA) therapy to adult participants with acromegaly.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
8
Research Site
Torrance, California, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
Pisa, Italy
Research Site
Kaunas, Lithuania
Percentage Change From Baseline in Serum IGF-1 Level at Week 15
Time frame: Baseline, Week 15
Number of Participants Who Achieve Serum IGF-1 Level ≤1.3 Upper Limit of Normal (ULN) at Week 15
Time frame: Week 15
Number of Participants Who Achieve of Serum IGF-1 Level ≤1.0 ULN at Week 15
Time frame: Week 15
Change from Basline in Symptoms as assessed by disease specific questionnaire, at Week 15
Time frame: Baseline, Week 15
Change From Baseline in Serum IGF-1 Level at Week 15
Time frame: Baseline, Week 15
Change From Baseline in 36-item Short Form Survey (SF-36) Summary Scores and Subscores at Week 15
Time frame: Baseline, Week 15
Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) at Week 15
Time frame: Baseline, Week 15
Change From Baseline in Acromegaly Quality of Life (AcroQoL) at Week 15
Time frame: Baseline, Week 15
Change From Baseline in Global Impression of Severity at Week 15 as Assessed by Patient Global Impression of Severity (PGIS) Scale
Time frame: Baseline, Week 15
Global Impression of Change at Week 15 as Assessed by Patient Global Impression of Change (PGIC) Scale
Time frame: Week 15
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Research Site
Vilnius, Lithuania
Research Site
Bucharest, Romania
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
Time frame: Baseline (Day 1) through Week 15
Plasma Concentration of ALXN2420
Time frame: Baseline (Day 1) through Week 15
Number of Participants With Antidrug Antibodies (ADAs)
Time frame: Baseline (Day 1) through Week 15