A Phase II/III, Extension Study of Orally Administered PHA-022121 for Acute Treatment of Angioedema Attacks in Patients with Hereditary Angioedema

Hereditary angioedema

1. AEs, including treatment-emergent adverse events (TEAEs), treatment-related TEAEs, treatment-emergent serious adverse events (TESAEs), treatment-related TESAEs, and TEAEs leading to deucrictibant discontinuation, 4. Vital signs, 2. Clinical laboratory tests, 5. ECG, 3. Physical examination

1. Part A, Efficacy: Time to onset of symptom relief, defined as Patient Global Impression of Change (PGI-C) rating of at least “a little better” for 2 consecutive timepoints within 12 hours post treatment., 2. Part A, Efficacy: Time to substantial symptom relief, defined as achieving PGI-C rating of at least “better” for 2 consecutive timepoints within 12 hours post-treatment, 3. Part A, Efficacy: Time to substantial symptom relief by Patient Global Impression of Severity (PGI-S), defined as achieving ≥1 point reduction in PGI-S from pre-treatment for 2 consecutive timepoints within 12 hours post-treatment., 4. Part A, Efficacy: Time to onset of symptom relief by VAS-3/ VAS-5 (defined as a reduction of ≥30% from pretreatment in VAS composite score, sustained for 2 consecutive timepoints), 5. Part A, Efficacy: Time to symptom relief by VAS (based on achieving ≥50% reduction from pretreatment in VAS composite score sustained for 2 consecutive timepoints)., 6. Part B, Efficacy: Time to onset of symptom relief, defined as Patient Global Impression of Change (PGI C) rating of at least “a little better” for 2 consecutive timepoints within 12 hours post treatment, 7. Part B, Efficacy: Time to substantial symptom relief, defined as achieving PGI-C rating of at least “better” for 2 consecutive timepoints within 12 hours post-treatment, 8. Part B, Efficacy: Time to substantial symptom relief by Patient Global Impression of Severity (PGI-S), defined as achieving ≥1 point reduction in PGI-S from pre-treatment for 2 consecutive timepoints within 12 hours post-treatment, 9. Part B, Efficacy: Time to onset of symptom relief by AMRA (defined as a reduction of ≥30% from pretreatment in AMRA composite score, sustained for 2 consecutive timepoints), 10. Part B, Efficacy: Time to symptom relief by AMRA (based on achieving ≥50% reduction from pretreatment in AMRA composite score sustained for 2 consecutive timepoints).

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