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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 day 0, 28, 84, 140 and 182
Awards & highlights

Study 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 ~day 0, 28, 84, 140 and 182
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0, 28, 84, 140 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 Participants with Treatment Emergent Adverse Events (TEAEs)
Secondary outcome measures
Angioedema Quality of life (AE-QoL) Questionnaire
Lanadelumab Injection Report During the Treatment Period of Day 0 Through Day 168
Number of High-Morbidity Angioedema Attacks During the Treatment Period of Day 0 Through Day 182
+5 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

1Treatment groups
Experimental Treatment
Group I: LanadelumabExperimental Treatment1 Intervention
Rollover participants from SHP643-303 (NCT04206605) will receive 300 milligram (mg) of lanadelumab solution in prefilled syringe subcutaneously (SC) for 26 weeks once every 2 weeks (Q2W) or once every 4 weeks (Q4W) if well controlled during SHP643-303 (NCT04206605) with up to 13 doses.
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
97,219 Total Patients Enrolled
43 Trials studying Angioedema
6,056 Patients Enrolled for Angioedema
Takeda Development Center Americas, Inc.Industry Sponsor
56 Previous Clinical Trials
11,957 Total Patients Enrolled
5 Trials studying Angioedema
3,385 Patients Enrolled for Angioedema
Study DirectorStudy DirectorTakeda Development Center Americas
1,207 Previous Clinical Trials
489,607 Total Patients Enrolled
63 Trials studying Angioedema
7,810 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.

Are there any noted risks associated with taking Lanadelumab?

"Lanadelumab is safe according to our 3-point scale at Power. This medication has gone through Phase 3 clinical trials, so there is some evidence of efficacy and multiple rounds of data affirming its safety."

Answered by AI

How many guinea pigs are you testing this on?

"The study sponsor, Takeda Development Center Americas, Inc., needs to recruit 75 eligible patients from various clinical sites. For example, the Clinical Research Center of Alabama in Birmingham, Alabama and Asthma and Allergy Associates, PC in Colorado Springs, Colorado are both participating locations."

Answered by AI

Could you please summarize the research that has been conducted on Lanadelumab?

"Lanadelumab was first studied in 2020 by researchers at Charite University in Berlin, Germany. 13 completed clinical trials later, there are 3 ongoing studies involving this medication. The majority of these investigations are based in Birmingham, Alabama."

Answered by AI

Could you inform me how many hospitals are running this research project?

"In total, 11 clinical trial sites are running this experiment. These locations include the Clinical Research Center of Alabama in Birmingham, Alabama, Asthma and Allergy Associates, PC in Colorado Springs, Colorado, and UCSD Angioedema Center in San Diego, California."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
How old are they?
18 - 65
What site did they apply to?
Clinical Research Center of Alabama
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study of Long-Term Safety and Efficacy of Lanadelumab for Prevention of Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor
2021. "A Study of Long-Term Safety and Efficacy of Lanadelumab for Prevention of Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04444895.
~18 spots leftby Apr 2025
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