5 Participants Needed

Lanadelumab for Angioedema

KB
JB
Overseen ByJonathan Bernstein, MD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Bernstein Clinical Research Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

use of lanadelumab in patients with acquired angioedema

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Lanadelumab for treating angioedema?

Research shows that Lanadelumab is effective in preventing attacks of hereditary angioedema (HAE), with 77% of patients being attack-free in a study compared to 3% with a placebo. It also improved the quality of life for patients over a long-term period.12345

Is lanadelumab safe for humans?

Lanadelumab is generally well tolerated in humans, with the most common side effects being mild and temporary reactions at the injection site. It has a low potential for causing immune reactions and is considered a safe option for preventing hereditary angioedema attacks in patients aged 12 and older.13678

How is the drug Lanadelumab different from other treatments for angioedema?

Lanadelumab is unique because it is a fully human monoclonal antibody that targets and inhibits plasma kallikrein, which helps prevent hereditary angioedema attacks. Unlike some other treatments, it is administered subcutaneously (under the skin) and is designed for long-term prevention rather than on-demand treatment.13589

Research Team

JB

Jonathan Bernstein, MD

Principal Investigator

5139314181

Eligibility Criteria

This trial is for patients with acquired angioedema who experience at least one attack per month and have specific lab findings like decreased C1INH, C4, and C1q levels. It's not open to pregnant or breastfeeding women, those with hereditary angioedema types 1 or 2, people allergic to biologics, or anyone with uncontrolled systemic diseases.

Inclusion Criteria

I had at least one attack per month before starting TAA.
I have AAE with recurrent attacks, no skin hives, and specific blood test findings.

Exclusion Criteria

I am not pregnant or breastfeeding.
I have Hereditary Angioedema Type 1 or 2.
History of anaphylaxis or hypersensitivity to biologics
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive open-label lanadelumab for prophylaxis of acquired angioedema

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Lanadelumab
Trial Overview The study tests Lanadelumab (300 mg), a medication intended for long-term prevention of swelling attacks in acquired angioedema. Participants will receive this treatment to see how effective it is in reducing the frequency of their symptoms.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: open-label administrationExperimental Treatment1 Intervention
all subjects receive open-label lanadelumab

Find a Clinic Near You

Who Is Running the Clinical Trial?

Bernstein Clinical Research Center

Lead Sponsor

Trials
4
Recruited
90+

Findings from Research

Lanadelumab significantly reduced the monthly attack rate of hereditary angioedema (HAE) from the first dose, with rates of 0.41-0.76 compared to 2.04 for placebo, indicating its strong efficacy in preventing attacks.
The treatment was well-tolerated, with similar rates of adverse events during the initial and later phases of the study, suggesting that lanadelumab is a safe long-term option for HAE management.
Lanadelumab demonstrates rapid and sustained prevention of hereditary angioedema attacks.Riedl, MA., Maurer, M., Bernstein, JA., et al.[2021]
Long-term treatment with lanadelumab significantly improved health-related quality of life (HRQoL) in patients with hereditary angioedema (HAE), with nearly half of rollover patients achieving a clinically meaningful improvement in their quality of life scores.
A high percentage of patients reported controlled disease and excellent treatment response, indicating that lanadelumab not only reduces attack rates but also enhances overall patient satisfaction and productivity.
Long-term lanadelumab treatment improves health-related quality of life in patients with hereditary angioedema.Lumry, WR., Maurer, M., Weller, K., et al.[2023]
In a study involving 212 patients with hereditary angioedema, lanadelumab significantly reduced the mean attack rate by 87.4%, with patients being attack-free for an average of 97.7% of the treatment days.
The treatment was well-tolerated, with most adverse events being mild and resolving quickly; no serious treatment-related adverse events or deaths were reported, indicating a favorable safety profile for long-term use.
Long-term prevention of hereditary angioedema attacks with lanadelumab: The HELP OLE Study.Banerji, A., Bernstein, JA., Johnston, DT., et al.[2022]

References

Lanadelumab demonstrates rapid and sustained prevention of hereditary angioedema attacks. [2021]
Long-term lanadelumab treatment improves health-related quality of life in patients with hereditary angioedema. [2023]
Long-term prevention of hereditary angioedema attacks with lanadelumab: The HELP OLE Study. [2022]
Using an extended treatment regimen of lanadelumab in the prophylaxis of hereditary angioedema: a single-centre experience. [2022]
Lanadelumab to treat hereditary angioedema. [2019]
Lanadelumab: A Review in Hereditary Angioedema. [2020]
Pharmacokinetics, Pharmacodynamics, and Exposure-Response of Lanadelumab for Hereditary Angioedema. [2021]
Lanadelumab Efficacy, Safety, and Injection Interval Extension in HAE: A Real-Life Study. [2022]
Lanadelumab: First Global Approval. [2021]
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