Comparison · NCT04206605-9124c4cb
Lanadelumab 300 mg vs Placebo: Number of Participants Achieving Attack-Free Status During the Treatment Period of Day 0 Through Day 182
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Lanadelumab 300 mg vs Placebo: Number of Participants Achieving Attack-Free Status During the Treatment Period of Day 0 Through Day 182. Trial comparisons, record NCT04206605-9124c4cb. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04206605-9124c4cb
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.04 | 0.011 | 0.135 | wilson | |
| Risk in group 2 | 0.037 | 0.00657 | 0.183 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00296 | -0.146 | 0.102 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.08 | 0.103 | 11.4 | log | |
| Odds ratio, group 1 over group 2 | 1.08 | 0.0937 | 12.5 | log | |
| Number needed to treat, for one more participant with the outcome on Lanadelumab 300 mg than on Placebo | 337 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Lanadelumab 300 mg | Participants received 300 mg of lanadelumab solution in a prefilled syringe (PFS) as SC injection once q2w for up to 26 weeks. | 2 | 50 | OG001 |
| Group 2 | Placebo | Participants received placebo-matching lanadelumab subcutaneous (SC) injection once q2w for up to 26 weeks. | 1 | 27 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Achieving Attack-Free Status During the Treatment Period of Day 0 Through Day 182
- Description
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.
- Time frame
- Day 0 through Day 182
- Population
- FAS included all randomized participants who receive any exposure to the IP during the treatment period (Day 0 through Day 182).
Source ClinicalTrials.gov
Trial
- 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
- Phases
- PHASE3
- Conditions
- Angioedema
- Interventions
- Placebo, Lanadelumab
- Lead sponsor
- Takeda
- Results first posted
- 2023-12-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04206605?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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