Trial · NCT04206605
A Study of Lanadelumab in Teenagers and Adults to Prevent Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor (C1-INH)
NCT04206605, Phase 3, Completed, Takeda; results first posted 2023-12-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Lanadelumab in Teenagers and Adults to Prevent Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor (C1-INH). Trials, record NCT04206605. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04206605
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Lanadelumab in Teenagers and Adults to Prevent Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor (C1-INH)
- NCT number
- NCT04206605
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 77 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Angioedema
- Interventions
- Placebo, Lanadelumab
- First posted
- 2019-12-20
- Last updated
- 2023-12-27
- Other registries' IDs
- eudract:2019-001703-20
- Results first posted
- 2023-12-27
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Investigator-Confirmed Angioedema Attacks During the Treatment Period of Day 0 Through Day 182 | Day 0 through Day 182 | An angioedema 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). Attack rate was calculated for each participant as the number of attacks occurring during the specified period divided by the number of days the participant contributed to the specified period multiplied by 28 days. Number of investigator-confirmed angioedema attacks during the treatment period of Day 0 through Day 182 was assessed. |
| Secondary | Number of Participants Achieving Attack-Free Status During the Treatment Period of Day 0 Through Day 182 | Day 0 through Day 182 | An angioedema 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). A participant was considered as attack free during a time period if the participant has no investigator-confirmed angioedema attacks during that time period. For participants who discontinue the study prior to completion of the analysis period, participants were classified as attack-free or not based on the observed contribution to the analysis period. Number of participants achieving attack-free status during the treatment period of day 0 through day 182 was assessed. |
| Secondary | Number of Investigator-Confirmed Moderate or Severe Angioedema Attacks During the Treatment Period of Day 0 Through Day 182 | Day 0 Through Day 182 | Angioedema attack was defined as symptoms or signs consistent with an attack in at least 1 of the following locations: peripheral angioedema (cutaneous swelling involving an extremity, 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 tongue, palate, uvula, or larynx). Overall severity of the participant's angioedema attack was determined by site using the following definitions: 1. Mild: Transient or mild discomfort; 2. Moderate: Mild to moderate limitation in activity some assistance needed; 3. Severe: Marked limitation in activity, assistance required. Attack rate was calculated for each participant as the number of attacks occurring during the specified period divided by number of days the participant contributed to the specified period multiplied by 28 days. |
| Secondary | Number of Investigator-Confirmed Angioedema Attacks During the Presumed Steady State Period of Day 70 Through Day 182 | Day 70 through Day 182 | An angioedema 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 investigator-confirmed angioedema attacks during the presumed steady state period of day 70 through day 182 were assessed. Attack rate was calculated for each participant as the number of attacks occurring during the specified period divided by the number of days the participant contributed to the specified period multiplied by 28 days. |
| Secondary | Number of Participants Achieving Attack-Free Status During the Presumed Steady State Period of Day 70 Through Day 182 | Day 70 through Day 182 | An angioedema 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). A participant was considered as attack free during a time period if the participant has no investigator-confirmed angioedema attacks during that time period. For participants who discontinue the study prior to completion of the analysis period, participants were classified as attack-free or not based on the observed contribution to the analysis period. Number of participants achieving attack-free status during the presumed steady state period of day 70 through day 182 was assessed. |
| Secondary | Number of Participants With Maximum Attack Severity During Treatment Period of Day 0 Through Day 182 | Day 0 through Day 182 | An angioedema 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 with maximum attack severity during treatment period of day 0 through day 182 was assessed. Angioedema attack severity was calculated per participant based on the severity categories as follows: No attack, Mild, Moderate, and Severe. |
| Secondary | Number of Investigator-Confirmed Moderate or Severe Angioedema Attacks During the Presumed Steady State Period of Day 70 Through Day 182 | Day 70 through Day 182 | An angioedema 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). Attack rate was calculated for each participant as the number of attacks occurring during the specified period divided by the number of days the participant contributed to the specified period multiplied by 28 days. Number of investigator-confirmed moderate or severe angioedema attacks during the presumed steady state period of day 70 through day 182 were assessed. |
| Secondary | Number of Participants With Maximum Attack Severity During Presumed Steady State Period of Day 70 Through Day 182 | Day 70 through Day 182 | An angioedema 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 with maximum attack severity during the presumed steady state period of day 70 through day 182 was assessed. Angioedema attack severity was calculated per participant based on the severity categories as follows: No attack, Mild, Moderate, and Severe. |
| Secondary | Time to First Angioedema Attack After Day 0 Through Day 182 | Day 0 Through Day 182 | The time to the first angioedema 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 angioedema attack after the first dose for the efficacy evaluation period of Day 0 through Day 182. Participants with attacks occurring were the events. Participants who discontinue/complete the study prior to having an angioedema attack were censored. The data is reported for baseline angioedema attack rate groups i.e. 1 to \< 2 Attacks/Month and \>=2 Attacks/Month. |
| Secondary | Time to First Angioedema Attack After Day 70 Through Day 182 | Day 70 through Day 182 | The time to the first angioedema 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 angioedema attack after the first dose for the efficacy evaluation period of Day 70 through Day 182. Participants with attacks occurring were the events. Participants who discontinue/complete the study prior to having an angioedema attack were censored. The data is reported for baseline angioedema attack rate groups i.e. 1 to \< 2 Attacks/Month and \>=2 Attacks/Month. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Investigator-Confirmed Angioedema Attacks During the Treatment Period of Day 0 Through Day 182 | Day 0 through Day 182 | Full Analysis Set (FAS) included all randomized participants who received any exposure to the investigational product (IP) during the treatment period (Day 0 through Day 182). | attacks/month | MEAN |
| SECONDARY | Number of Participants Achieving Attack-Free Status During the Treatment Period of Day 0 Through Day 182 | Day 0 through Day 182 | FAS included all randomized participants who receive any exposure to the IP during the treatment period (Day 0 through Day 182). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Investigator-Confirmed Moderate or Severe Angioedema Attacks During the Treatment Period of Day 0 Through Day 182 | Day 0 Through Day 182 | FAS included all randomized participants who receive any exposure to the IP during the treatment period (Day 0 through Day 182). | attacks/month | MEAN |
| SECONDARY | Number of Investigator-Confirmed Angioedema Attacks During the Presumed Steady State Period of Day 70 Through Day 182 | Day 70 through Day 182 | Steady State (SS)-FAS included all randomized participants who received any exposure to the investigational product during the presumed steady state period (Day 70 through Day 182). | attacks/month | MEAN |
| SECONDARY | Number of Participants Achieving Attack-Free Status During the Presumed Steady State Period of Day 70 Through Day 182 | Day 70 through Day 182 | SS-FAS included all randomized participants who received any exposure to the investigational product during the presumed steady state period (Day 70 through Day 182). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Maximum Attack Severity During Treatment Period of Day 0 Through Day 182 | Day 0 through Day 182 | FAS included all randomized participants who receive any exposure to the IP during the treatment period (Day 0 through Day 182). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Investigator-Confirmed Moderate or Severe Angioedema Attacks During the Presumed Steady State Period of Day 70 Through Day 182 | Day 70 through Day 182 | SS-FAS included all randomized participants who received any exposure to the investigational product during the presumed steady state period (Day 70 through Day 182). | attacks/month | MEAN |
| SECONDARY | Number of Participants With Maximum Attack Severity During Presumed Steady State Period of Day 70 Through Day 182 | Day 70 through Day 182 | SS-FAS included all randomized participants who received any exposure to the investigational product during the presumed steady state period (Day 70 through Day 182). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to First Angioedema Attack After Day 0 Through Day 182 | Day 0 Through Day 182 | FAS included all randomized participants who receive any exposure to the IP during the treatment period (Day 0 through Day 182). Number analyzed are the number of participants with attacks occurring as events. | days | MEDIAN |
| SECONDARY | Time to First Angioedema Attack After Day 70 Through Day 182 | Day 70 through Day 182 | SS-FAS included all randomized participants who received any exposure to the investigational product during the presumed steady state period (Day 70 through Day 182). Number analyzed are the number of participants with attacks occurring as events. | days | MEDIAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group455
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Investigator-Confirmed Angioedema Attacks During the Treatment Period of Day 0 Through Day 182 | Placebo | 1.63 | Standard Deviation 1.357 | attacks/month | |
| Number of Investigator-Confirmed Angioedema Attacks During the Treatment Period of Day 0 Through Day 182 | Lanadelumab 300 mg | 2.17 | Standard Deviation 2.062 | attacks/month | |
| Number of Participants Achieving Attack-Free Status During the Treatment Period of Day 0 Through Day 182 | Placebo | 1 | Participants | ||
| Number of Participants Achieving Attack-Free Status During the Treatment Period of Day 0 Through Day 182 | Lanadelumab 300 mg | 2 | Participants | ||
| Number of Investigator-Confirmed Moderate or Severe Angioedema Attacks During the Treatment Period of Day 0 Through Day 182 | Placebo | 1.10 | Standard Deviation 0.984 | attacks/month | |
| Number of Investigator-Confirmed Moderate or Severe Angioedema Attacks During the Treatment Period of Day 0 Through Day 182 | Lanadelumab 300 mg | 1.45 | Standard Deviation 1.711 | attacks/month | |
| Number of Investigator-Confirmed Angioedema Attacks During the Presumed Steady State Period of Day 70 Through Day 182 | Placebo | 1.37 | Standard Deviation 1.231 | attacks/month | |
| Number of Investigator-Confirmed Angioedema Attacks During the Presumed Steady State Period of Day 70 Through Day 182 | Lanadelumab 300 mg | 2.05 | Standard Deviation 2.211 | attacks/month | |
| Number of Participants Achieving Attack-Free Status During the Presumed Steady State Period of Day 70 Through Day 182 | Placebo | 4 | Participants | ||
| Number of Participants Achieving Attack-Free Status During the Presumed Steady State Period of Day 70 Through Day 182 | Lanadelumab 300 mg | 3 | Participants |
1 to 10 of 455Source ClinicalTrials.gov
See all 455 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 27 | |
| Overall Study | STARTED | Lanadelumab 300 mg | 50 | |
| Overall Study | Steady State Full Analysis Set (SS-FAS) | Placebo | 27 | |
| Overall Study | Steady State Full Analysis Set (SS-FAS) | Lanadelumab 300 mg | 49 | |
| Overall Study | COMPLETED | Placebo | 26 | |
| Overall Study | COMPLETED | Lanadelumab 300 mg | 49 | |
| Overall Study | NOT COMPLETED | Placebo | 1 | |
| Overall Study | NOT COMPLETED | Lanadelumab 300 mg | 1 |
Source ClinicalTrials.gov
Adverse events50
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 | Lymphadenopathy | Blood and lymphatic system disorders | Placebo | 2 | 27 | 2 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Lanadelumab 300 mg | 1 | 50 | 1 |
| other | Constipation | Gastrointestinal disorders | Placebo | 2 | 27 | 3 |
| other | Constipation | Gastrointestinal disorders | Lanadelumab 300 mg | 1 | 50 | 1 |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Placebo | 0 | 27 | 0 |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Lanadelumab 300 mg | 3 | 50 | 3 |
| other | Nausea | Gastrointestinal disorders | Placebo | 3 | 27 | 8 |
| other | Nausea | Gastrointestinal disorders | Lanadelumab 300 mg | 4 | 50 | 4 |
| other | Fatigue | General disorders | Placebo | 2 | 27 | 9 |
| other | Fatigue | General disorders | Lanadelumab 300 mg | 4 | 50 | 13 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 27 |
| Total, all-cause mortality | Lanadelumab 300 mg | 0 | 50 |
| Total, other adverse events | Placebo | 27 | 27 |
| Total, other adverse events | Lanadelumab 300 mg | 49 | 50 |
| Total, serious adverse events | Placebo | 1 | 27 |
| Total, serious adverse events | Lanadelumab 300 mg | 7 | 50 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40469312 | DERIVED |
Source PubMed
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lanadelumab 300 mg vs Placebo: Number of Participants Achieving Attack-Free Status During the Presumed Steady State Period of Day 70 Through Day 182 | Trial comparisons |
| Lanadelumab 300 mg vs Placebo: Number of Participants Achieving Attack-Free Status During the Treatment Period of Day 0 Through Day 182 | Trial comparisons |
| Lanadelumab 300 mg vs Placebo: deaths from any cause | Trial comparisons |
| Lanadelumab 300 mg vs Placebo: serious adverse events | Trial comparisons |
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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