Trial · NCT04180163
Efficacy and Safety of Lanadelumab (SHP643) in Japanese Participants With Hereditary Angioedema (HAE)
NCT04180163, Phase 3, Completed, Shire; results first posted 2022-09-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Lanadelumab (SHP643) in Japanese Participants With Hereditary Angioedema (HAE). Trials, record NCT04180163. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04180163
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Lanadelumab (SHP643) in Japanese Participants With Hereditary Angioedema (HAE)
- NCT number
- NCT04180163
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 12 participants, actual
- Lead sponsor
- Shire
- Conditions
- Hereditary Angioedema (HAE)
- Interventions
- Lanadelumab
- First posted
- 2019-11-27
- Last updated
- 2022-09-30
- Results first posted
- 2022-09-19
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Achieving Attack-Free Status for the Efficacy Evaluation Period of Day 0 Through Day 182 | Day 0 through Day 182 | A participant was considered as attack free during an efficacy evaluation period if the participant had no investigator-confirmed hereditary angioedema (HAE) attacks during that efficacy evaluation period. A HAE attack was defined as the symptoms or signs consistent with an attack in at least 1 of the following locations: peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region), abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea), laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx). Number of participants achieving attack-free status for the efficacy evaluation period of Day 0 through Day 182 were assessed. |
| Secondary | Number of Investigator-Confirmed Hereditary Angioedema (HAE) Attacks During Each of the Efficacy Evaluation Periods | Day 0 through Day 182, Day 0 through Day 364, Day 70 through Day 182, Day 70 through Day 364 | Efficacy evaluation period consisted of four periods: Day 0 (after study drug administration) through Day 182 (the end of Treatment Period A), Day 0 (after study drug administration) through Day 364 (the end of Treatment Period B), presumed steady-state period from Day 70 through Day 182, presumed steady-state period from Day 70 through Day 364. Number of investigator-confirmed HAE attacks during each of the efficacy evaluation periods were assessed. |
| Secondary | Number of Investigator-Confirmed Hereditary Angioedema (HAE) Attacks Requiring Acute Treatment During Each of the Efficacy Evaluation Periods | Day 0 through Day 182, Day 0 through Day 364, Day 70 through Day 182, Day 70 through Day 364 | Efficacy evaluation period consisted of four periods: Day 0 (after study drug administration) through Day 182 (the end of Treatment Period A), Day 0 (after study drug administration) through Day 364 (the end of Treatment Period B), presumed steady-state period from Day 70 through Day 182, presumed steady-state period from Day 70 through Day 364. Number of investigator-confirmed HAE attacks requiring acute treatment during each of the efficacy evaluation periods were assessed. |
| Secondary | Number of Moderate or Severe Investigator-Confirmed Hereditary Angioedema (HAE) Attacks During Each of the Efficacy Evaluation Periods | Day 0 through Day 182, Day 0 through Day 364, Day 70 through Day 182, Day 70 through Day 364 | Severe attack was defined as Grade 3 (some assistance usually required, medical intervention/therapy required, hospitalizations possible), moderate attack was defined as Grade 2 (some assistance may be needed, no or minimal medical intervention/therapy required). Number of investigator-confirmed moderate or severe HAE attacks during the each of efficacy evaluation periods was assessed. Efficacy evaluation period consisted of four periods: Day 0 (after study drug administration) through Day 182 (the end of Treatment Period A), Day 0 (after study drug administration) through Day 364 (the end of Treatment Period B), presumed steady-state period from Day 70 through Day 182, presumed steady-state period from Day 70 through Day 364. |
| Secondary | Number of Participants With Maximum Hereditary Angioedema (HAE) Attack Severity During Each of the Efficacy Evaluation Periods | Day 0 through Day 182, Day 0 through Day 364, Day 70 through Day 182, Day 70 through Day 364 | Efficacy evaluation period consisted of four periods: Day 0 (after study drug administration) through Day 182 (the end of Treatment Period A), Day 0 (after study drug administration) through Day 364 (the end of Treatment Period B), presumed steady-state period from Day 70 through Day 182, presumed steady-state period from Day 70 through Day 364. Number of participants with maximum HAE attack severity during each of the efficacy evaluation periods was assessed. HAE attack severity was calculated per participant based on the severity categories as follows: No attack, Mild, Moderate, and Severe. |
| Secondary | Number of High-Morbidity Investigator-Confirmed Hereditary Angioedema (HAE) Attacks During Each of the Efficacy Evaluation Periods | Day 0 through Day 182, Day 0 through Day 364, Day 70 through Day 182, Day 70 through Day 364 | A high morbidity HAE attack was defined as any attack that has at least 1 of the following characteristics: severe, results in hospitalization (except hospitalization for observation \<24 hours), hemodynamically significant (systolic blood pressure \<90, requires intravenous (IV) hydration, or associated with syncope or near syncope) or laryngeal. Number of high-morbidity investigator-confirmed HAE attacks during each of the 4 efficacy evaluation periods (Treatment Period A, Overall Treatment Period, Presumed Steady-state Period for Treatment Period A and Overall Presumed Steady-state Period) were assessed. |
| Secondary | Time to First Hereditary Angioedema (HAE) Attack After Day 0 for the Efficacy Evaluation Period | Day 0 through Day 182 | The time to the first HAE attack (days) after Day 0 for the efficacy evaluation period of Day 0 through Day 182 was calculated from the date and time of the first dose of lanadelumab for the efficacy evaluation period (Day 0 through Day 182) to the date and time of the first in HAE attack after the first open-label dose for the efficacy evaluation period of Day 0 through Day 182. Kaplan-Meier Method was used for analysis and the Kaplan Meier estimate expressed as time (in days) to first HAE attack After Day 0 for Treatment Period A (Day 0 through Day 182) is presented. |
| Secondary | Time to First Hereditary Angioedema (HAE) Attack After Day 0 for the Efficacy Evaluation Period | Day 70 through Day 182 | The time to the first HAE attack (days) after Day 0 for the efficacy evaluation period of Day 70 through Day 182 was calculated from the date and time of the first dose of lanadelumab for the efficacy evaluation period (Day 70 through Day 182) to the date and time of the first in HAE attack after the first open-label dose for the efficacy evaluation period of Day 70 through Day 182. Kaplan-Meier Method was used for analysis and the Kaplan Meier estimate expressed as time (in days) to first HAE attack After Day 0 for presumed steady-state period for Treatment Period A (Day 70 through Day 182) is presented. |
| Secondary | Number of Participants Achieving at Least 50%, 70% and 90% Reduction in the Investigator-Confirmed Normalized Number of Attacks (NNA) Per 4 Weeks Relative to the Run-in Period NNA for Each of Efficacy Evaluation Periods | Day 0 through Day 182, Day 0 through Day 364, Day 70 through Day 182, Day 70 through Day 364 | Run- in Period was 4 weeks and may have been extended up to 8 weeks to determine participants' Baseline attack rate. The normalized number of investigator-confirmed HAE attacks (NNA) during each efficacy evaluation period will be expressed as a monthly (28 days) HAE attack rate. Number of participants achieving at least 50%, 70% and 90% reduction in the investigator-confirmed NNA per 4 weeks relative to the Run-in Period normalized NNA for each of the 4 efficacy evaluation periods (Treatment Period A, Overall Treatment Period, Presumed Steady-state Period for Treatment Period A, and Overall Presumed Steady-state Period) were assessed. For each participant, the percentage reduction was calculated as the run-in period attack rate minus the treatment period attack rate divided by the run-in period attack rate, multiplied by 100. The responder categories were not mutually exclusive, participants may appear in more than one category as applicable based on their percentage reduction. |
| Secondary | Number of Participants Achieving Normalized Number of Attacks (NNA) <1.0 Per 4 Weeks, <0.75 Per 4 Weeks, <0.50 Per 4 Weeks and <0.25 Per 4 Weeks for Each of the Efficacy Evaluation Periods | Day 0 through Day 182, Day 0 through Day 364, Day 70 through Day 182, Day 70 through Day 364 | The NNA (investigator-confirmed) during each efficacy evaluation period was expressed as a monthly (28 days) HAE attack rate. Number of participants achieving NNA \<1.0 per 4 weeks, \<0.75 per 4 weeks, \<0.50 per 4 weeks, and \<0.25 per 4 weeks for each of the 4 efficacy evaluation periods (Treatment Period A, Overall Treatment Period, Presumed Steady-state Period for Treatment Period A, and Overall Presumed Steady-state Period) were assessed. The responder categories were not mutually exclusive, participants may appear in more than one category as applicable based on their HAE attack rate. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Achieving Attack-Free Status for the Efficacy Evaluation Period of Day 0 Through Day 182 | Day 0 through Day 182 | FAS included all participants who received at least 1 dose of IMP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Investigator-Confirmed Hereditary Angioedema (HAE) Attacks During Each of the Efficacy Evaluation Periods | Day 0 through Day 182, Day 0 through Day 364, Day 70 through Day 182, Day 70 through Day 364 | FAS included all participants who received at least 1 dose of IMP. | HAE attacks | NUMBER |
| SECONDARY | Number of Investigator-Confirmed Hereditary Angioedema (HAE) Attacks Requiring Acute Treatment During Each of the Efficacy Evaluation Periods | Day 0 through Day 182, Day 0 through Day 364, Day 70 through Day 182, Day 70 through Day 364 | FAS included all participants who received at least 1 dose of IMP. | HAE attacks | NUMBER |
| SECONDARY | Number of Moderate or Severe Investigator-Confirmed Hereditary Angioedema (HAE) Attacks During Each of the Efficacy Evaluation Periods | Day 0 through Day 182, Day 0 through Day 364, Day 70 through Day 182, Day 70 through Day 364 | FAS included all participants who received at least 1 dose of IMP. | HAE attacks | NUMBER |
| SECONDARY | Number of Participants With Maximum Hereditary Angioedema (HAE) Attack Severity During Each of the Efficacy Evaluation Periods | Day 0 through Day 182, Day 0 through Day 364, Day 70 through Day 182, Day 70 through Day 364 | FAS included all participants who received at least 1 dose of IMP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of High-Morbidity Investigator-Confirmed Hereditary Angioedema (HAE) Attacks During Each of the Efficacy Evaluation Periods | Day 0 through Day 182, Day 0 through Day 364, Day 70 through Day 182, Day 70 through Day 364 | FAS included all participants who received at least 1 dose of IMP. | HAE attacks | NUMBER |
| SECONDARY | Time to First Hereditary Angioedema (HAE) Attack After Day 0 for the Efficacy Evaluation Period | Day 0 through Day 182 | FAS included all participants who received at least 1 dose of IMP. | days | MEDIAN |
| SECONDARY | Time to First Hereditary Angioedema (HAE) Attack After Day 0 for the Efficacy Evaluation Period | Day 70 through Day 182 | FAS included all participants who received at least 1 dose of IMP. | days | MEDIAN |
| SECONDARY | Number of Participants Achieving at Least 50%, 70% and 90% Reduction in the Investigator-Confirmed Normalized Number of Attacks (NNA) Per 4 Weeks Relative to the Run-in Period NNA for Each of Efficacy Evaluation Periods | Day 0 through Day 182, Day 0 through Day 364, Day 70 through Day 182, Day 70 through Day 364 | FAS included all participants who received at least 1 dose of IMP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Achieving Normalized Number of Attacks (NNA) <1.0 Per 4 Weeks, <0.75 Per 4 Weeks, <0.50 Per 4 Weeks and <0.25 Per 4 Weeks for Each of the Efficacy Evaluation Periods | Day 0 through Day 182, Day 0 through Day 364, Day 70 through Day 182, Day 70 through Day 364 | FAS included all participants who received at least 1 dose of IMP. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group157
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Achieving Attack-Free Status for the Efficacy Evaluation Period of Day 0 Through Day 182 | Lanadelumab 300 mg q2w or q4w | 5 | Participants | ||
| Number of Investigator-Confirmed Hereditary Angioedema (HAE) Attacks During Each of the Efficacy Evaluation Periods | Lanadelumab 300 mg q2w or q4w | Day 0 Through Day 182 | 92 | HAE attacks | |
| Number of Investigator-Confirmed Hereditary Angioedema (HAE) Attacks During Each of the Efficacy Evaluation Periods | Lanadelumab 300 mg q2w or q4w | Day 0 Through Day 364 | 189 | HAE attacks | |
| Number of Investigator-Confirmed Hereditary Angioedema (HAE) Attacks During Each of the Efficacy Evaluation Periods | Lanadelumab 300 mg q2w or q4w | Day 70 Through Day 182 | 55 | HAE attacks | |
| Number of Investigator-Confirmed Hereditary Angioedema (HAE) Attacks During Each of the Efficacy Evaluation Periods | Lanadelumab 300 mg q2w or q4w | Day 70 Through Day 364 | 152 | HAE attacks | |
| Number of Investigator-Confirmed Hereditary Angioedema (HAE) Attacks Requiring Acute Treatment During Each of the Efficacy Evaluation Periods | Lanadelumab 300 mg q2w or q4w | Day 0 Through Day 182 | 79 | HAE attacks | |
| Number of Investigator-Confirmed Hereditary Angioedema (HAE) Attacks Requiring Acute Treatment During Each of the Efficacy Evaluation Periods | Lanadelumab 300 mg q2w or q4w | Day 0 Through Day 364 | 168 | HAE attacks | |
| Number of Investigator-Confirmed Hereditary Angioedema (HAE) Attacks Requiring Acute Treatment During Each of the Efficacy Evaluation Periods | Lanadelumab 300 mg q2w or q4w | Day 70 Through Day 182 | 46 | HAE attacks | |
| Number of Investigator-Confirmed Hereditary Angioedema (HAE) Attacks Requiring Acute Treatment During Each of the Efficacy Evaluation Periods | Lanadelumab 300 mg q2w or q4w | Day 70 Through Day 364 | 135 | HAE attacks | |
| Number of Moderate or Severe Investigator-Confirmed Hereditary Angioedema (HAE) Attacks During Each of the Efficacy Evaluation Periods | Lanadelumab 300 mg q2w or q4w | Day 0 Through Day 182 | 72 | HAE attacks |
1 to 10 of 157Source ClinicalTrials.gov
See all 157 results by groupParticipant flow12
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 q2w or q4w | 12 | |
| Run-in Period (4 or up to 8 Weeks) | COMPLETED | Lanadelumab 300 mg q2w or q4w | 12 | |
| Run-in Period (4 or up to 8 Weeks) | NOT COMPLETED | Lanadelumab 300 mg q2w or q4w | 0 | |
| Treatment Period A (Weeks 1 to 26) | STARTED | Lanadelumab 300 mg q2w or q4w | 12 | |
| Treatment Period A (Weeks 1 to 26) | COMPLETED | Lanadelumab 300 mg q2w or q4w | 12 | |
| Treatment Period A (Weeks 1 to 26) | NOT COMPLETED | Lanadelumab 300 mg q2w or q4w | 0 | |
| Treatment Period B (Weeks 27 to 52) | STARTED | Lanadelumab 300 mg q2w or q4w | 12 | |
| Treatment Period B (Weeks 27 to 52) | COMPLETED | Lanadelumab 300 mg q2w or q4w | 12 | |
| Treatment Period B (Weeks 27 to 52) | NOT COMPLETED | Lanadelumab 300 mg q2w or q4w | 0 | |
| Safety Follow-up Period (Weeks 53 to 56) | STARTED | Lanadelumab 300 mg q2w or q4w | 12 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events390
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 | Palpitations | Cardiac disorders | Treatment Period A: Non-HAE | 1 | 12 | |
| other | Palpitations | Cardiac disorders | Treatment Period A: HAE | 0 | 12 | |
| other | Palpitations | Cardiac disorders | Treatment Period B: Non-HAE | 1 | 12 | |
| other | Palpitations | Cardiac disorders | Treatment Period B: HAE | 0 | 12 | |
| other | Palpitations | Cardiac disorders | Safety Follow-up Period: Non-HAE | 0 | 12 | |
| other | Palpitations | Cardiac disorders | Safety Follow-up Period: HAE | 0 | 12 | |
| other | Vertigo | Ear and labyrinth disorders | Treatment Period A: Non-HAE | 1 | 12 | |
| other | Vertigo | Ear and labyrinth disorders | Treatment Period A: HAE | 0 | 12 | |
| other | Vertigo | Ear and labyrinth disorders | Treatment Period B: Non-HAE | 1 | 12 | |
| other | Vertigo | Ear and labyrinth disorders | Treatment Period B: HAE | 0 | 12 |
1 to 10 of 390Source ClinicalTrials.gov
See all 390 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Period A: Non-HAE | 0 | 12 |
| Total, all-cause mortality | Treatment Period A: HAE | 0 | 12 |
| Total, all-cause mortality | Treatment Period B: Non-HAE | 0 | 12 |
| Total, all-cause mortality | Treatment Period B: HAE | 0 | 12 |
| Total, all-cause mortality | Safety Follow-up Period: Non-HAE | 0 | 12 |
| Total, all-cause mortality | Safety Follow-up Period: HAE | 0 | 12 |
| Total, other adverse events | Treatment Period A: Non-HAE | 10 | 12 |
| Total, other adverse events | Treatment Period A: HAE | 7 | 12 |
| Total, other adverse events | Treatment Period B: Non-HAE | 9 | 12 |
| Total, other adverse events | Treatment Period B: HAE | 8 | 12 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
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.
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