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Monoclonal Antibodies

Lanadelumab for Angioedema

Phase 3
Waitlist Available
Research Sponsored by Shire
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 days 0, 14, 28, 42, 56, 70, 84, 98, 112, 126, 140, 154, and 168
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial looks at the safety and effectiveness of a drug given as a shot to people with a certain kind of non-histaminergic angioedema who have finished another trial.

Eligible Conditions
  • Angioedema

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 0, 14, 28, 42, 56, 70, 84, 98, 112, 126, 140, 154, and 168
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 0, 14, 28, 42, 56, 70, 84, 98, 112, 126, 140, 154, and 168 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Including Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) During Follow-up
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Including Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) During Treatment Period
Secondary study objectives
Change From Baseline in Total Angioedema Quality of Life (AE-QoL) Questionnaire Total Score at End of Treatment Period
Number of High-Morbidity Angioedema Attacks During the Treatment Period of Day 0 Through Day 182
Number of High-Morbidity Angioedema Attacks During the Treatment Period of Day 0 Through Day 182 in Participants Who Switched Dosing Regimen
+9 more

Side effects data

From 2021 Phase 3 trial • 21 Patients • NCT04070326
18%
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

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Lanadelumab 300 mg Every 2 WeeksExperimental Treatment1 Intervention
Participants received 300 milligrams (mg) lanadelumab subcutaneous (SC) injection, every 2 weeks (Q2W) for up to 26 weeks with an option to switch to lanadelumab 300 mg every 4 weeks (Q4W) if attacks were well-controlled based on the investigator's discretion and consultation with the sponsor's medical monitor.
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?

ShireLead Sponsor
456 Previous Clinical Trials
95,957 Total Patients Enrolled
43 Trials studying Angioedema
4,692 Patients Enrolled for Angioedema
Takeda Development Center Americas, Inc.Industry Sponsor
56 Previous Clinical Trials
10,700 Total Patients Enrolled
5 Trials studying Angioedema
2,146 Patients Enrolled for Angioedema
Study DirectorStudy DirectorTakeda Development Center Americas
1,271 Previous Clinical Trials
503,851 Total Patients Enrolled
66 Trials studying Angioedema
6,558 Patients Enrolled for Angioedema
~16 spots leftby Nov 2025
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