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Monoclonal Antibodies
A Study of Lanadelumab in Teenagers and Adults to Prevent Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor (C1-INH)
Phase 3
Waitlist Available
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose and post-dose at days 4, 14, 28, 56, 84, 112, 140, 168 and 182
Awards & highlights
Pivotal Trial
Summary
This trial tests if lanadelumab injections can prevent swelling attacks in teenagers and adults with a specific type of swelling disorder. The medication works by blocking a protein that causes these attacks. Participants will receive regular injections over several months.
Eligible Conditions
- Angioedema
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-dose and post-dose at days 4, 14, 28, 56, 84, 112, 140, 168 and 182
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose and post-dose at days 4, 14, 28, 56, 84, 112, 140, 168 and 182
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Investigator-Confirmed Angioedema Attacks During the Treatment Period of Day 0 Through Day 182
Secondary study objectives
Number of Investigator-Confirmed Angioedema Attacks During the Presumed Steady State Period of Day 70 Through Day 182
Angioedema
Number of Investigator-Confirmed Moderate or Severe Angioedema Attacks During the Treatment Period of Day 0 Through Day 182
+12 moreSide effects data
From 2021 Phase 3 trial • 21 Patients • NCT0407032618%
Nasal congestion
18%
Injection site erythema
18%
Injection site pain
18%
Joint injury
9%
Injection site injury
9%
Injection site reaction
9%
Nasopharyngitis
9%
Asymptomatic COVID-19
9%
Skin laceration
9%
Headache
9%
Oropharyngeal discomfort
9%
Oropharyngeal pain
9%
Erythema
9%
Skin abrasion
9%
Abdominal pain
9%
Administration site pain
9%
Rhinitis
9%
Adenoiditis
9%
Affect lability
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lanadelumab 150 mg, q4wks
Lanadelumab 150 mg, q2wks
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Lanadelumab 300mgExperimental Treatment1 Intervention
Participants received 300 mg of lanadelumab solution in a prefilled syringe (PFS) as SC injection once (q2w) for up to 6 months.
Group II: PlaceboPlacebo Group1 Intervention
Participants received placebo-matching lanadelumab subcutaneous (SC) injection once every 2 weeks (q2w) for up to 7 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lanadelumab
2021
Completed Phase 3
~770
Find a Location
Who is running the clinical trial?
TakedaLead Sponsor
1,238 Previous Clinical Trials
4,148,941 Total Patients Enrolled
15 Trials studying Angioedema
1,222 Patients Enrolled for Angioedema
ShireLead Sponsor
456 Previous Clinical Trials
95,954 Total Patients Enrolled
43 Trials studying Angioedema
4,688 Patients Enrolled for Angioedema
Takeda Development Center Americas, Inc.Industry Sponsor
56 Previous Clinical Trials
10,696 Total Patients Enrolled
5 Trials studying Angioedema
2,142 Patients Enrolled for Angioedema
Study DirectorStudy DirectorTakeda
1,281 Previous Clinical Trials
500,425 Total Patients Enrolled
66 Trials studying Angioedema
6,554 Patients Enrolled for Angioedema