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Monoclonal Antibodies

Lanadelumab for Angioedema

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
The Participant will not be considered eligible for the study without meeting all of the applicable population criteria below.
Males and females, 12 years of age and older for participants with non-histaminergic normal C1-INH angioedema at the time of signing of the informed consent form (ICF).
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

Study Summary

This trial will test if lanadelumab can prevent angioedema attacks in people with non-histaminergic angioedema with normal C1-INH and if they tolerate the repeated SC injections.

Eligible Conditions
  • Angioedema

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose and post-dose at days 4, 14, 28, 56, 84, 112, 140, 168 and 182 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Investigator-Confirmed Angioedema Attacks During the Treatment Period of Day 0 Through Day 182
Secondary outcome measures
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
+13 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

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
1,198 Previous Clinical Trials
4,178,276 Total Patients Enrolled
13 Trials studying Angioedema
1,264 Patients Enrolled for Angioedema
ShireLead Sponsor
456 Previous Clinical Trials
97,215 Total Patients Enrolled
43 Trials studying Angioedema
6,052 Patients Enrolled for Angioedema
Takeda Development Center Americas, Inc.Industry Sponsor
56 Previous Clinical Trials
12,135 Total Patients Enrolled
5 Trials studying Angioedema
3,381 Patients Enrolled for Angioedema

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~16 spots leftby Mar 2025