Trial · NCT04210843
Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab
NCT04210843, Phase 3, Terminated, Novartis Pharmaceuticals; results first posted 2023-07-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab. Trials, record NCT04210843. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04210843
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab
- NCT number
- NCT04210843
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1,033 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Chronic Spontaneous Urticaria
- Interventions
- Ligelizumab
- First posted
- 2019-12-26
- Last updated
- 2024-06-20
- Other registries' IDs
- eudract:2019-001792-37
- Results first posted
- 2023-07-13
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in the Core Studies, With Well-controlled Disease (UAS7 ≤ 6) at Week 12 | Week 12 of the extension study | The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity. A minimum of 4 out of 7 daily scores were needed to calculate the UAS7 values. Otherwise, the weekly score was missing for that week. The percentage of subjects transitioning from CQGE031C2302 and CQGE031C2303 and receiving the same dose regimen as in the core studies with UAS7≤ 6 at Week 12 was estimated using multiple imputation method. The 95% confidence interval was derived based on the Wilson score method with continuity correction. |
| Primary | Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in Core Studies and Who Achieved UAS7≤ 6 at Week 12 in Core Studies, With Well-controlled Disease (UAS7 ≤ 6) at Week 12 of the Extension Study | Week 12 of the extension study | The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals and the intensity of the pruritus over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity. A minimum of 4 out of 7 daily scores were needed to calculate the UAS7 values. Otherwise, the UAS7 was missing for that week. Missing data was considered as non-responder. The percentage of subjects transitioning from core studies (CQGE031C2302 and CQGE031C2303) and receiving the same dose regimen as in the core studies who achieved UAS7 ≤ 6 at week 12 in the core studies with UAS7≤ 6 at Week 12 of the extension study was estimated based on observed data. |
| Secondary | Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in the Core Studies, With Completely Controlled Disease (UAS7 =0) at Week 12 | Week 12 of the extension study | The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity. A minimum of 4 out of 7 daily scores were needed to calculate the UAS7 values. Otherwise, the weekly score was missing for that week. The percentage of subjects transitioning from core studies (CQGE031C2302 and CQGE031C2303) and receiving the same dose regimen as in the core studies with UAS7 = 0 at Week 12 was estimated using multiple imputation method. |
| Secondary | Change From Extension Study Baseline in the UAS7 at Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies | Extension study baseline (Week 0), Week 12 of the extension study | The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity. A negative change score from extension study baseline indicates improvement. A minimum of 4 out of 7 daily scores were needed to calculate the UAS7 values. Otherwise, the weekly score was missing for that week. The absolute change from extension study baseline in the UAS7 at Week 12 was estimated using multiple imputation method. |
| Secondary | Change From Extension Study Baseline in the ISS7 at Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies | Extension study baseline (Week 0), Week 12 of the extension study | The Itch Severity Score (ISS) was recorded by the subject twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). A weekly score (ISS7) was derived by adding up the average daily scores of the 7 preceding days. The ISS7 ranged from 0 to 21. A higher ISS7 indicated more severe itching. A negative change score from baseline indicates improvement. A minimum of 4 out of 7 daily scores were needed to calculate the ISS7 values. Otherwise, the weekly score was missing for that week. The absolute change from extension study baseline in the ISS7 at Week 12 in all subjects from core studies (CQGE031C2302 and CQGE031C2303) receiving the same dose regimen as in the core studies was estimated using multiple imputation method. |
| Secondary | Change From Extension Study Baseline in the HSS7 at Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies | Extension study baseline (Week 0), Week 12 of the extension study | The Hive Severity Score (HSS) was recorded by the subject twice daily in their eDiary, on a scale of 0 (none) to 3 (\> 12 hives/12 hours). A weekly score (HSS7) was derived by adding up the average daily scores of the 7 preceding days. The HSS7 ranged from 0 to 21 A higher HSS7 indicated a greater number of hives. A negative change score from baseline indicates improvement. A minimum of 4 out of 7 daily scores were needed to calculate the HSS7 values. Otherwise, the weekly score was missing for that week. The absolute change from extension study baseline in the HSS7 at Week 12 in all subjects from core studies (CQGE031C2302 and CQGE031C2303) receiving the same dose regimen as in the core studies was estimated using multiple imputation method. |
| Secondary | Cumulative Number of Angioedema-free Weeks (AAS7=0) up to Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies | From extension study baseline (Week 0) up to Week 12 of the extension study | The Weekly angioedema activity score (AAS) is a validated tool to assess occurrence of episodes of angioedema. If the subject reported the occurrence of angioedema ("opening question") with "no", AAS score for this day was 0. If "yes" was the answer to the opening question, the subject continued to answer questions about the duration, severity and impact on daily functioning and appearance of the angioedema. A score between 0 and 3 was assigned to every answer field. The AAS7 was the weekly sum of the daily AAS. AAS7 scores ranged from 0-105. Higher score indicated more severe disease. AAS7 in all subjects from core studies (CQGE031C2302 and CQGE031C2303) receiving the same dose regimen as in the core studies was estimated using multiple imputation method. The imputed AAS7 = 0 was used for the cumulative number of weeks that subjects achieved AAS7 = 0 response calculation |
| Secondary | Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in the Core Studies, With DLQI = 0-1 at Week 12 | Week 12 of the extension study | The Dermatology Life Quality Index (DLQI) is a 10-item dermatology-specific quality of life (QoL) measure. Subjects rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives thinking about the previous 7 days. An overall score was calculated and ranged from 0 to 30. Higher scores indicated worse disease-related QoL. A DLQI score of 0 or 1 indicated that there was no impact of a skin disease on the patient's life. The percentage of subjects from core studies (CQGE031C2302 and CQGE031C2303) receiving the same dose regimen as in the core studies with DLQI = 0-1 at Week 12 was estimated using multiple imputation method. |
| Secondary | Percentage of Subjects With Well-controlled Disease (UAS7 ≤ 6) 12 Weeks After Starting Self-administration | Week 24 of the extension study | The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity. A minimum of 4 out of 7 daily scores were needed to calculate the UAS7 values. Otherwise, the weekly score was missing for that week. Missing data was considered as non-responder in the analysis. The percentage of subjects with UAS7≤ 6 at Week 24 (i.e., 12 weeks after starting self-administration) was estimated based on observed data. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in the Core Studies, With Well-controlled Disease (UAS7 ≤ 6) at Week 12 | Week 12 of the extension study | Ligelizumab retreatment subpopulation: Participants transitioning from core studies (CQGE031C2302 and CQGE031C2303) who received at least one dose of study treatment and were treated with the same dosage of ligelizumab in the extension study as in the two core studies. Only participants with non-missing UAS7 scores (based on the data after the missing data imputation) for Week 12 were included in this analysis. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in the Core Studies, With Completely Controlled Disease (UAS7 =0) at Week 12 | Week 12 of the extension study | Ligelizumab retreatment subpopulation: Participants transitioning from studies CQGE031C2302 and CQGE031C2303 who received at least one dose of study treatment and were treated with the same dosage of ligelizumab in the extension study as in the two core studies (CQGE031C2302 and CQGE031C2303). Only participants with non-missing UAS7 scores (based on the data after the missing data imputation) for Week 12 were included in this analysis. | Percentage of participants | NUMBER |
| SECONDARY | Change From Extension Study Baseline in the UAS7 at Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies | Extension study baseline (Week 0), Week 12 of the extension study | Ligelizumab retreatment subpopulation: Participants transitioning from studies CQGE031C2302 and CQGE031C2303 who received at least one dose of study treatment and were treated with the same dosage of ligelizumab in the extension study as in the two core studies (CQGE031C2302 and CQGE031C2303). Only participants with non-missing UAS7 scores (based on the data after the missing data imputation) for Week 12 were included in this analysis. | Score on a scale | MEAN |
| SECONDARY | Change From Extension Study Baseline in the ISS7 at Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies | Extension study baseline (Week 0), Week 12 of the extension study | Ligelizumab retreatment subpopulation: Participants transitioning from studies CQGE031C2302 and CQGE031C2303 who received at least one dose of study treatment and were treated with the same dosage of ligelizumab in the extension study as in the two core studies (CQGE031C2302 and CQGE031C2303). Only participants with non-missing UAS7 scores (based on the data after the missing data imputation) for Week 12 were included in this analysis. | Score on a scale | MEAN |
| SECONDARY | Change From Extension Study Baseline in the HSS7 at Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies | Extension study baseline (Week 0), Week 12 of the extension study | Ligelizumab retreatment subpopulation: Participants transitioning from studies CQGE031C2302 and CQGE031C2303 who received at least one dose of study treatment and were treated with the same dosage of ligelizumab in the extension study as in the two core studies (CQGE031C2302 and CQGE031C2303). Only participants with non-missing UAS7 scores (based on the data after the missing data imputation) for Week 12 were included in this analysis. | Score on a scale | MEAN |
| SECONDARY | Cumulative Number of Angioedema-free Weeks (AAS7=0) up to Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies | From extension study baseline (Week 0) up to Week 12 of the extension study | Ligelizumab retreatment subpopulation: Participants transitioning from studies CQGE031C2302 and CQGE031C2303 who received at least one dose of study treatment and were treated with the same dosage of ligelizumab in the extension study as in the two core studies (CQGE031C2302 and CQGE031C2303). Only participants with non-missing UAS7 scores (based on the data after the missing data imputation) for Week 12 were included in this analysis. | Weeks | MEAN |
| SECONDARY | Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in the Core Studies, With DLQI = 0-1 at Week 12 | Week 12 of the extension study | Ligelizumab retreatment subpopulation: Participants transitioning from studies CQGE031C2302 and CQGE031C2303 who received at least one dose of study treatment and were treated with the same dosage of ligelizumab in the extension study as in the two core studies (CQGE031C2302 and CQGE031C2303). Only participants with non-missing UAS7 scores (based on the data after the missing data imputation) for Week 12 were included in this analysis. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Subjects With Well-controlled Disease (UAS7 ≤ 6) 12 Weeks After Starting Self-administration | Week 24 of the extension study | Self-administration subpopulation: Participants transitioning from preceding studies (CQGE031C2302, CQGE031C2303, CQGE031C2202 and CQGE031C1301) who had at least one injection of study treatment with PFS administered by the participant herself/himself or caregiver either in clinic or outside of clinic | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in Core Studies and Who Achieved UAS7≤ 6 at Week 12 in Core Studies, With Well-controlled Disease (UAS7 ≤ 6) at Week 12 of the Extension Study | Week 12 of the extension study | Ligelizumab responder retreatment subpopulation: Participants transitioning from core studies (CQGE031C2302 and CQGE031C2303) who received at least one dose of study treatment, were treated with the same dosage of ligelizumab in the extension study as in the two core studies and achieved UAS7 ≤ 6 at week 12 in the core studies. Only participants with non-missing UAS7 scores based on observed data for Week 12 were included in this analysis. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in the Core Studies, With Well-controlled Disease (UAS7 ≤ 6) at Week 12 | Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS | 53.5 | 95% Confidence Interval 48.72 to 58.54 | Percentage of participants | |
| Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in the Core Studies, With Well-controlled Disease (UAS7 ≤ 6) at Week 12 | Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS | 57.5 | 95% Confidence Interval 52.71 to 62.57 | Percentage of participants | |
| Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in the Core Studies, With Completely Controlled Disease (UAS7 =0) at Week 12 | Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS | 37.3 | 95% Confidence Interval 31.63 to 43.04 | Percentage of participants | |
| Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in the Core Studies, With Completely Controlled Disease (UAS7 =0) at Week 12 | Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS | 41.5 | 95% Confidence Interval 35.61 to 47.36 | Percentage of participants | |
| Change From Extension Study Baseline in the UAS7 at Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies | Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS | -19.83 | Standard Error 13.12 | Score on a scale | |
| Change From Extension Study Baseline in the UAS7 at Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies | Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS | -20.41 | Standard Error 12.94 | Score on a scale | |
| Change From Extension Study Baseline in the ISS7 at Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies | Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS | -9.12 | Standard Error 6.35 | Score on a scale | |
| Change From Extension Study Baseline in the ISS7 at Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies | Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS | -9.46 | Standard Error 6.55 | Score on a scale | |
| Change From Extension Study Baseline in the HSS7 at Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies | Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS | -10.71 | Standard Error 7.50 | Score on a scale | |
| Change From Extension Study Baseline in the HSS7 at Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies | Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS | -10.95 | Standard Error 7.11 | Score on a scale |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Half Treatment Period (52 Weeks) | STARTED | Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS | 290 | |
| First Half Treatment Period (52 Weeks) | STARTED | Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS | 743 | |
| First Half Treatment Period (52 Weeks) | COMPLETED | Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS | 140 | |
| First Half Treatment Period (52 Weeks) | COMPLETED | Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS | 369 | |
| First Half Treatment Period (52 Weeks) | NOT COMPLETED | Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS | 150 | |
| First Half Treatment Period (52 Weeks) | NOT COMPLETED | Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS | 374 | |
| Second Half Treatment Period (52 Weeks) | STARTED | Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS | 77 | |
| Second Half Treatment Period (52 Weeks) | STARTED | Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS | 206 | |
| Second Half Treatment Period (52 Weeks) | COMPLETED | Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS | 1 | |
| Second Half Treatment Period (52 Weeks) | COMPLETED | Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS | 2 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events648
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 | Pyrexia | General disorders | TRT1A Ligelizumab 72 mg LIVI-ligelizumab 120 mg PFS | 2 | 288 | |
| other | Pyrexia | General disorders | TRT1A Ligelizumab 120 mg LIVI-ligelizumab 120 mg PFS | 10 | 745 | |
| other | Pyrexia | General disorders | TRT1A Total | 12 | 1,033 | |
| other | Pyrexia | General disorders | TRT1B Ligelizumab 72 mg LIVI - Ligelizumab 120 mg PFS | 5 | 263 | |
| other | Pyrexia | General disorders | TRT1B Ligelizumab 120 mg LIVI - Ligelizumab 120 mg PFS | 26 | 684 | |
| other | Pyrexia | General disorders | TRT1B Total | 31 | 947 | |
| other | Pyrexia | General disorders | TRT2 Ligelizumab 72 mg LIVI - Ligelizumab 120 mg PFS | 0 | 77 | |
| other | Pyrexia | General disorders | TRT2 Ligelizumab 120 mg LIVI - Ligelizumab 120 mg PFS | 5 | 206 | |
| other | Pyrexia | General disorders | TRT2 Total | 5 | 283 | |
| other | Pyrexia | General disorders | Entire Study Ligelizumab 72 mg LIVI - Ligelizumab 120 mg PFS | 7 | 288 |
1 to 10 of 648Source ClinicalTrials.gov
See all 648 adverse eventsAdverse event totals36
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TRT1A Ligelizumab 72 mg LIVI-ligelizumab 120 mg PFS | 0 | 288 |
| Total, all-cause mortality | TRT1A Ligelizumab 120 mg LIVI-ligelizumab 120 mg PFS | 0 | 745 |
| Total, all-cause mortality | TRT1A Total | 0 | 1,033 |
| Total, all-cause mortality | TRT1B Ligelizumab 72 mg LIVI - Ligelizumab 120 mg PFS | 0 | 263 |
| Total, all-cause mortality | TRT1B Ligelizumab 120 mg LIVI - Ligelizumab 120 mg PFS | 3 | 684 |
| Total, all-cause mortality | TRT1B Total | 3 | 947 |
| Total, all-cause mortality | TRT2 Ligelizumab 72 mg LIVI - Ligelizumab 120 mg PFS | 0 | 77 |
| Total, all-cause mortality | TRT2 Ligelizumab 120 mg LIVI - Ligelizumab 120 mg PFS | 0 | 206 |
| Total, all-cause mortality | TRT2 Total | 0 | 283 |
| Total, all-cause mortality | Entire Study Ligelizumab 72 mg LIVI - Ligelizumab 120 mg PFS | 0 | 288 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 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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