Trial · NCT05460325
Outcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| 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 |
| SECONDARY | Number of Participants With Maximum Attack Severity 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). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to First Investigator-confirmed HAE Attack 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). | days | MEDIAN |
| SECONDARY | Number of Participants Who Achieved Investigator-confirmed HAE Attack-Free Status 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). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Achieved at Least 50%, 70%, 90%, and 100% Reduction in the Investigator-Confirmed Normalized Number of Attacks (NNA) Per 4 Weeks Relative to the Run-in Period NNA | Day 0 through Day 182 | The FAS included all participants who received at least 1 dose of lanadelumab (IP). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Achieved NNA <1.0 Per 4 Weeks for 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). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Neutralizing or Non-neutralizing Antidrug Antibodies (ADA) in Plasma | Anytime on Days 0 and 210; and pre-dose on Days 56, 98, 140, 182 | The FAS included all participants who received at least 1 dose of lanadelumab (IP). Number analyzed is the number of participants with data available for analyses at the specified timepoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Plasma Concentrations of Lanadelumab by Immunogenicity Result | Anytime on Days 0 and 210; and pre-dose on Days 56, 98, 140, 182 | The 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. | ng/mL | MEAN |
| SECONDARY | Plasma Kallikrein Activity cHMWK by Immunogenicity Result | Anytime on Days 0 and 210; and pre-dose on Days 56, 98, 140, 182 | The 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 by Immunogenicity Result 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). Number analyzed is the number of participants with data available for analyses at the specified timepoint. | attacks/month | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05460325/outcomes