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Table 2 Safety and efficacy results from Phase 1a and 1b studies with lanadelumab

From: An open-label study to evaluate the long-term safety and efficacy of lanadelumab for prevention of attacks in hereditary angioedema: design of the HELP study extension

Study Population N Treatments TEAEs Anti-drug antibodies Efficacy
Phase 1aa Healthy subjects 32 Single dose:
 Placebo
 0.1, 0.3, 1.0, or 3.0 mg/kg lanadelumab
Most common TEAE was headache (25% of both placebo- and lanadelumab-treated patients) None NA
Phase 1bb Patients with HAE 37 Two doses:
 Placebo
 30, 100, 300, or 400 mg lanadelumab
Most common treatment emergent adverse events for lanadelumab versus placebo were angioedema attacks (38 vs 69%), injection site pain (25 vs 23%), and headache (17 vs 23%)
Local AEs in 25 vs 23.1% for lanadelumab and placebo, respectively
3 severe related treatment emergent adverse events: injection site pain (1 patient); headache, night sweats (1 patient)
Positive results in 3/92 (3.3%) post-dose samples from 2/23 patients (8.7%)
None were neutralizing
Angioedema attack rate decreased by 100% in 300 mg group (P < 0.0001) and by 88% in 400 mg group (P = 0.005)
  1. AE adverse event; HAE hereditary angioedema; NA not applicable; TEAE treatment-emergent adverse event
  2. aDX-2930-01 (NCT01923207) [6]
  3. bDX-2930-02 (NCT02093923) [7]