AngioedemaPhase 4NCT06818474
Lanadelumab in Long-term Prophylaxis of Acquired Angioedema
A Phase 4 study testing Lanadelumab 300 mg in people with Angioedema, run by Bernstein Clinical Research Center at 1 site in United States.
Trial summary
use of lanadelumab in patients with acquired angioedema Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angioedema
- What is being tested?
- Lanadelumab 300 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2024to 1 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of AAE with recurrent attacks without urticaria (decreased C1INH functional, quantitative levels, decreased C4 and decreased C1q levels, no family history of angioedema), presence of anti-C1INH antibody and/or paraproteinemia (e.g. monoclonal gammopathy of unknown significance)
- historical attack rate of >= on attack per month prior to starting tranexamic acid (TAA)
Who cannot join
- History of anaphylaxis or hypersensitivity to biologics
- History of major systemic disease not well controlled in opinion of the PI
- Women who are pregnant or breast feeding
- Concurrent participation in other clinical trials
- HAE Type 1 or 2 and normal complement HAE
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jonathan Bernstein, MD contact
United States1 site, 1 recruiting
- Recruiting
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, 45236
Karen Berendts, 513-354-1746, kberendts@bernsteincrc.com
Jonathan Bernstein, MD
About this study
use of lanadelumab in patients with acquired angioedema
- Conditions
- Angioedema
- Being tested
- Lanadelumab 300 mg
- Medical subject headings
- Angioedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lanadelumab 300 mgBiological
no other intervention
| Study group | Role | What they receive |
|---|---|---|
| open-label administration | Other | all subjects receive open-label lanadelumab Receives: Biological: Lanadelumab 300 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective
Rate of investigator confirmed AAE attacks during study period, as measured by the ACT. AAE attack will be defined as a unique event during which the study subject will progress from no angioedema to symptoms of angioedema and no further angioedema for 24 hours after resolution of the event with rescu therapy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start1 Jun 2024
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AngioedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- all subjects will receive active treatment
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bernstein Clinical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan A. Bernstein, MD, Bernstein Clinical Research Center
- Investigators
- Jonathan Bernstein, MD, Principal investigator, 5139314181
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06818474
- Sponsor's protocol ID
- Tak-02
- Status last verified
- Feb 2025
- First submitted
- 5 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lanadelumab in Long-term Prophylaxis of Acquired Angioedema
- ClinicalTrials.gov ID
- NCT06818474
- Acronym / sponsor ID
- Tak-02
- Conditions
- Angioedema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Bernstein Clinical Research CenterUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
use of lanadelumab in patients with acquired angioedema
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- all subjects will receive active treatment
| Arm | Type | Receives |
|---|---|---|
| open-label administration | Other | Biological: Lanadelumab 300 mgall subjects receive open-label lanadelumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A diagnosis of AAE with recurrent attacks without urticaria (decreased C1INH functional, quantitative levels, decreased C4 and decreased C1q levels, no family history of angioedema), presence of anti-C1INH antibody and/or paraproteinemia (e.g. monoclonal gammopathy of unknown significance)
- historical attack rate of >= on attack per month prior to starting tranexamic acid (TAA)
Key exclusion criteria (5 listed)
- History of anaphylaxis or hypersensitivity to biologics
- History of major systemic disease not well controlled in opinion of the PI
- Women who are pregnant or breast feeding
- Concurrent participation in other clinical trials
- HAE Type 1 or 2 and normal complement HAE
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lanadelumab 300 mgno other intervention | Biological | open-label administration |
Primary outcome
Primary Objective
Time frame: 12 months
Rate of investigator confirmed AAE attacks during study period, as measured by the ACT. AAE attack will be defined as a unique event during which the study subject will progress from no angioedema to symptoms of angioedema and no further angioedema for 24 hours after resolution of the event with rescu therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonathan Bernstein, MD contact
Jonathan Bernstein, MD principal investigator
5139314181
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lanadelumab 300 mg in people with Angioedema, run by Bernstein Clinical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karen Berendts (513-354-1746, kberendts@bernsteincrc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.