Trial · NCT05460325
A Study of Lanadelumab (SHP643) in Chinese Participants With Hereditary Angioedema (HAE)
NCT05460325, Phase 3, Completed, Takeda; results first posted 2024-12-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Lanadelumab (SHP643) in Chinese Participants With Hereditary Angioedema (HAE). Trials, record NCT05460325. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05460325
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Lanadelumab (SHP643) in Chinese Participants With Hereditary Angioedema (HAE)
- NCT number
- NCT05460325
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 20 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Hereditary Angioedema (HAE)
- Interventions
- Lanadelumab
- First posted
- 2022-07-15
- Last updated
- 2024-12-13
- Results first posted
- 2024-12-13
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | From first dose of study drug up to end of study (up to Day 210) | TEAE is defined as an adverse event (AE) with onset at the time of or following initial dosing with study drug (lanadelumab), or medical conditions present prior to the start of study drug but increasing in severity or relationship at the time of or following the start of treatment, up to the last follow-up visit. An SAE is any untoward clinical manifestation of signs, symptoms or outcomes whether considered related to investigational product or not and at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, congenital abnormality/birth defect, an important medical event. Hypersensitivity reactions and events of disordered coagulation were considered as AESIs. Adverse events were classified as HAE attack and non-HAE attack reported AEs and are categorized accordingly in this outcome measure. A participant could be counted in more than one category. |
| Primary | Number of Participants With Clinically Meaningful Changes in Clinical Laboratory Parameters | From first dose of study drug up to end of study (up to Day 210) | Laboratory parameters included clinical chemistry, hematology, coagulation, urinalysis, and serology. Clinically meaningful laboratory parameters assessment was based on investigator interpretation. Number of participants with clinically meaningful changes in laboratory parameters (including clinical chemistry, hematology, coagulation, urinalysis, and serology) were reported. |
| Primary | Number of Participants With Clinically Meaningful Changes in Vital Sign Abnormalities | From first dose of study drug up to end of study (up to Day 210) | Vital signs included measurement of blood pressure, heart rate, body temperature, and respiratory rate. Clinically meaningful vital signs assessment was based on investigator interpretation. Number of participants with clinically meaningful changes in vital signs were reported. |
| Primary | Number of Participants With Clinically Meaningful Changes in Electrocardiogram (ECG) | From first dose of study drug up to end of study (up to Day 210) | ECG included heart rate, PR interval, QRS duration, QT interval, corrected QT interval (QTc) interval, QT corrected for heart rate by Fridericia's cube root formula (QTcF) interval, and QT corrected for heart rate by Bazett formula (QTcB) interval. Clinically meaningful ECG assessment was based on investigator interpretation. Number of participants with clinically meaningful changes in ECG were reported. |
| Primary | Number of Participants With Clinically Significant Physical Examination Abnormalities on Day 182 | Day 182 | Physical examination findings by body system were classified as height and weight, general appearance, ears, nose and throat, head and neck, ophthalmological, respiratory, cardiovascular, abdomen, neurological, extremities, dermatological, and lymphatic. Number of participants with clinically significant changes in physical examination findings per investigator interpretation were reported. Only categories with at least one participant with event are reported. |
| Secondary | Plasma Concentrations of Lanadelumab | Anytime on Days 0 and 210; and pre-dose on Days 14, 56, 98, 140, 182 | |
| Secondary | Plasma Kallikrein (pKal) Activity | Anytime on Days 0 and 210; and pre-dose on Days 14, 56, 98, 140, 182 | pKal activity was measured by cleaved high molecular weight kininogen (cHMWK) level (i.e., plasma concentrations of cHMWK). |
| Secondary | Number of Investigator-Confirmed HAE Attacks During the Efficacy Evaluation Period of Day 0 Through Day 182 | Day 0 through Day 182 | An HAE attack was confirmed by following symptoms or signs consistent with an attack in at least one of the following locations: 1) Peripheral angioedema: cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region; 2) Abdominal angioedema: abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea; 3) Laryngeal angioedema: stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx. Treatment period attack rate per month is calculated as the number of investigator-confirmed HAE attacks occurring during that treatment period divided by number of days the participant contributed to that treatment period multiplied by 28 days. |
| Secondary | Number of Investigator-Confirmed HAE Attacks That Required Acute Treatment During the Efficacy Evaluation Period of Day 0 Through Day 182 | Day 0 through Day 182 | An HAE attack was confirmed by following symptoms/signs consistent with an attack in atleast one of the following locations:1)Peripheral angioedema:cutaneous swelling involving an extremity,the face,neck,torso,and/or genitourinary region;2)Abdominal angioedema:abdominal pain,with/without abdominal distention,nausea,vomiting,or diarrhea;3)Laryngeal angioedema:stridor,dyspnea, difficulty speaking,difficulty swallowing,throat tightening,or swelling of the tongue,palate,uvula,or larynx.Acute HAE attacks were managed per the investigator's usual care, including use of individualized acute therapy/rescue medications.Acute therapy/rescue medications included Firazyr, fresh frozen plasma (FFP), or other local standard of care.Treatment period attack rate per month is calculated as the number of investigator-confirmed HAE attacks requiring acute treatment occurring during that treatment period divided by number of days the participant contributed to that treatment period multiplied by 28 days. |
| Secondary | Number of Moderate or Severe Investigator-Confirmed HAE Attacks During the Efficacy Evaluation Period of Day 0 Through Day 182 | Day 0 through Day 182 | The severity of the investigator-confirmed HAE attacks was defined per the HAE attack assessment and reporting procedures (HAARP) definitions: severe (marked limitation in activity, assistance required), moderate (mild to moderate limitation in activity, some assistance needed). Treatment period attack rate per month is calculated as the number of moderate or severe investigator-confirmed HAE attacks occurring during that treatment period divided by number of days the participant contributed to that treatment period multiplied by 28 days. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | From first dose of study drug up to end of study (up to Day 210) | The FAS included all participants who received at least 1 dose of lanadelumab (IP). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Meaningful Changes in Clinical Laboratory Parameters | From first dose of study drug up to end of study (up to Day 210) | The FAS included all participants who received at least 1 dose of lanadelumab (IP). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Meaningful Changes in Vital Sign Abnormalities | From first dose of study drug up to end of study (up to Day 210) | The FAS included all participants who received at least 1 dose of lanadelumab (IP). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Meaningful Changes in Electrocardiogram (ECG) | From first dose of study drug up to end of study (up to Day 210) | The FAS included all participants who received at least 1 dose of lanadelumab (IP). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Physical Examination Abnormalities on Day 182 | Day 182 | The FAS included all participants who received at least 1 dose of lanadelumab (IP). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Plasma Concentrations of Lanadelumab | Anytime on Days 0 and 210; and pre-dose on Days 14, 56, 98, 140, 182 | The Pharmacokinetic (PK) Set included all participants in the FAS who had at least 1 evaluable post-dose PK concentration value. Number analyzed is the number of participants with data available for analyses at the specified timepoint. | nanograms per milliliter (ng/mL) | MEAN |
| SECONDARY | Plasma Kallikrein (pKal) Activity | Anytime on Days 0 and 210; and pre-dose on Days 14, 56, 98, 140, 182 | The Pharmacodynamic (PD) Set included all participants in the FAS who had at least 1 evaluable post-dose PD concentration value. Number analyzed is the number of participants with data available for analyses at the specified timepoint. | ng/mL | MEAN |
| SECONDARY | Number of Investigator-Confirmed HAE Attacks During the Efficacy Evaluation Period of Day 0 Through Day 182 | Day 0 through Day 182 | The FAS included all participants who received at least 1 dose of lanadelumab (IP). | attacks/month | MEAN |
| SECONDARY | Number of Investigator-Confirmed HAE Attacks That Required Acute Treatment During the Efficacy Evaluation Period of Day 0 Through Day 182 | Day 0 through Day 182 | The FAS included all participants who received at least 1 dose of lanadelumab (IP). | attacks/month | MEAN |
| SECONDARY | Number of Moderate or Severe Investigator-Confirmed HAE Attacks During the Efficacy Evaluation Period of Day 0 Through Day 182 | Day 0 through Day 182 | The FAS included all participants who received at least 1 dose of lanadelumab (IP). | attacks/month | MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group67
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | Lanadelumab 300 mg | TEAEs: Non-Angioedema Attack | 15 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | Lanadelumab 300 mg | TEAEs: Angioedema Attack | 3 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | Lanadelumab 300 mg | SAEs: Non-Angioedema Attack | 1 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | Lanadelumab 300 mg | SAEs: Angioedema Attack | 0 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | Lanadelumab 300 mg | AESIs: Non-Angioedema Attack | 0 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | Lanadelumab 300 mg | AESIs: Angioedema Attack | 0 | Participants | |
| Number of Participants With Clinically Meaningful Changes in Clinical Laboratory Parameters | Lanadelumab 300 mg | 0 | Participants | ||
| Number of Participants With Clinically Meaningful Changes in Vital Sign Abnormalities | Lanadelumab 300 mg | 0 | Participants | ||
| Number of Participants With Clinically Meaningful Changes in Electrocardiogram (ECG) | Lanadelumab 300 mg | 0 | Participants | ||
| Number of Participants With Clinically Significant Physical Examination Abnormalities on Day 182 | Lanadelumab 300 mg | Dermatologic System | 2 | Participants |
1 to 10 of 67Source ClinicalTrials.gov
See all 67 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Run-in Period (4 or up to 8 Weeks) | STARTED | Lanadelumab 300 mg | 20 | |
| Run-in Period (4 or up to 8 Weeks) | COMPLETED | Lanadelumab 300 mg | 20 | |
| Run-in Period (4 or up to 8 Weeks) | NOT COMPLETED | Lanadelumab 300 mg | 0 | |
| Treatment Period (Weeks 1 to 26) | STARTED | Lanadelumab 300 mg | 20 | |
| Treatment Period (Weeks 1 to 26) | COMPLETED | Lanadelumab 300 mg | 20 | |
| Treatment Period (Weeks 1 to 26) | NOT COMPLETED | Lanadelumab 300 mg | 0 | |
| Safety Follow-up Period (Weeks 27 to 30) | STARTED | Lanadelumab 300 mg | 20 | |
| Safety Follow-up Period (Weeks 27 to 30) | COMPLETED | Lanadelumab 300 mg | 20 | |
| Safety Follow-up Period (Weeks 27 to 30) | NOT COMPLETED | Lanadelumab 300 mg | 0 |
Source ClinicalTrials.gov
Adverse events13
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain upper | Gastrointestinal disorders | Lanadelumab 300 mg | 2 | 20 | |
| other | Blood uric acid increased | Investigations | Lanadelumab 300 mg | 2 | 20 | |
| other | COVID-19 | Infections and infestations | Lanadelumab 300 mg | 10 | 20 | |
| other | Dizziness | Nervous system disorders | Lanadelumab 300 mg | 2 | 20 | |
| other | Hepatic function abnormal | Hepatobiliary disorders | Lanadelumab 300 mg | 2 | 20 | |
| other | Hypertension | Vascular disorders | Lanadelumab 300 mg | 2 | 20 | |
| other | Injection site pain | General disorders | Lanadelumab 300 mg | 4 | 20 | |
| other | Injection site swelling | General disorders | Lanadelumab 300 mg | 3 | 20 | |
| other | Nasopharyngitis | Infections and infestations | Lanadelumab 300 mg | 2 | 20 | |
| other | Nausea | Gastrointestinal disorders | Lanadelumab 300 mg | 3 | 20 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lanadelumab 300 mg | 0 | 20 |
| Total, other adverse events | Lanadelumab 300 mg | 14 | 20 |
| Total, serious adverse events | Lanadelumab 300 mg | 1 | 20 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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The record and each of its lists are JSON, twenty rows a page. No key.
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