Phase 3 N=20 Treatment

A Study of Lanadelumab (SHP643) in Chinese Participants With Hereditary Angioedema (HAE)

Hereditary Angioedema (HAE)

Bottom Line

View on ClinicalTrials.gov: NCT05460325 ↗

Enrolled (actual)

Serious AEs

5.0%

Results posted

Dec 2024

Primary outcome: Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) — 15; 3; 1; 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Lanadelumab (Drug)
Age: Pediatric, Adult, Older Adult · 12+ yrs
Sex: All
Sponsor: Takeda
Primary completion: Nov 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)	15; 3; 1; 0; 0; 0	—
PRIMARY Number of Participants With Clinically Meaningful Changes in Clinical Laboratory Parameters	—	—
PRIMARY Number of Participants With Clinically Meaningful Changes in Vital Sign Abnormalities	—	—
PRIMARY Number of Participants With Clinically Meaningful Changes in Electrocardiogram (ECG)	—	—
PRIMARY Number of Participants With Clinically Significant Physical Examination Abnormalities on Day 182	2; 1	—
SECONDARY Plasma Concentrations of Lanadelumab	7.64; 12336.47; 24857.89; 24170.00; 23821.05; 24610.00	—
SECONDARY Plasma Kallikrein (pKal) Activity	10256.419; 4904.964; 3604.136; 3312.706; 2871.364; 3383.672	—
SECONDARY Number of Investigator-Confirmed HAE Attacks During the Efficacy Evaluation Period of Day 0 Through Day 182	0.04	—
SECONDARY Number of Investigator-Confirmed HAE Attacks That Required Acute Treatment During the Efficacy Evaluation Period of Day 0 Through Day 182	0.01	—
SECONDARY Number of Moderate or Severe Investigator-Confirmed HAE Attacks During the Efficacy Evaluation Period of Day 0 Through Day 182	0.01	—
SECONDARY Number of Participants With Maximum Attack Severity During the Efficacy Evaluation Period of Day 0 Through Day 182	18; 1; 1; 0	—
SECONDARY Time to First Investigator-confirmed HAE Attack During the Efficacy Evaluation Period of Day 0 Through Day 182	NA	—
SECONDARY Number of Participants Who Achieved Investigator-confirmed HAE Attack-Free Status During the Efficacy Evaluation Period of Day 0 Through Day 182	18	—
SECONDARY Number of Participants Who Achieved at Least 50%, 70%, 90%, and 100% Reduction in the Investigator-Confirmed Normalized Number of Attacks (NNA) Per 4 Weeks Relative to the Run-in Period NNA	20; 20; 19; 18	—
SECONDARY Number of Participants Who Achieved NNA <1.0 Per 4 Weeks for the Efficacy Evaluation Period of Day 0 Through Day 182	20	—
SECONDARY Number of Participants With Neutralizing or Non-neutralizing Antidrug Antibodies (ADA) in Plasma	1; 0; 0; 1; 1; 3	—
SECONDARY Plasma Concentrations of Lanadelumab by Immunogenicity Result	0.00; 8.04; 24857.89; 24170.00; 16700.00; 24216.67	—
SECONDARY Plasma Kallikrein Activity cHMWK by Immunogenicity Result	13346.780; 10093.768; 3604.136; 3312.706; 3733.890; 2823.446	—
SECONDARY Number of Investigator-confirmed HAE Attacks by Immunogenicity Result During the Efficacy Evaluation Period of Day 0 Through Day 182	0.00; 0.04	—

Summary

The main aim of this study is to evaluate the safety of lanadelumab in Chinese participants with HAE. Participants will be treated with lanadelumab for 26 weeks.

Eligibility Criteria

Inclusion Criteria

Be of Chinese descent, defined as born in China and having Chinese parents and Chinese maternal and paternal grandparents.
The participant is male or female and greater than or equal to (>=) 12 years of age at the time of informed consent.
Documented diagnosis of HAE Type I or Type II based upon all of the following:
Documented clinical history consistent with HAE (subcutaneous [SC] or mucosal, nonpruritic swelling episodes without accompanying urticaria).
Diagnostic testing results obtained during screening by a laboratory (approved by the sponsor) that confirm HAE Type I or Type II: C1 esterase inhibitor (C1-INH) functional level =12 to ) 3* upper limit of normal (ULN), or aspartate aminotransferase (AST) > 3* ULN or bilirubin > 2* ULN (unless the bilirubin is a result of Gilbert's syndrome).
Pregnancy or breast feeding.
Participant has any condition that in the opinion of the investigator or sponsor, may compromise their safety or compliance, preclude successful conduct of the study, or interfere with interpretation of the results (example, history of substance abuse or dependence, significant pre-existing illnesses or major comorbidity the investigator considers may confound the interpretation of the study results).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05460325). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.