Trial · NCT02649218
A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) Patients
NCT02649218, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2020-08-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) Patients. Trials, record NCT02649218. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02649218
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) Patients
- NCT number
- NCT02649218
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 226 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Chronic Spontaneous Urticaria
- Interventions
- Ligelizumab
- First posted
- 2016-01-07
- Last updated
- 2021-10-11
- Other registries' IDs
- eudract:2015-003636-13
- Results first posted
- 2020-08-14
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With at Least One Treatment Emergent Adverse Event (AE) | Within 16 weeks after Week 48 | The primary objective of this study was to assess the long-term safety of one-year treatment of QGE031 in adult Chronic Spontaneous Urticaria (CSU) patients who completed the core study CQGE031C2201 using the following evaluations: number of participants with treatment emergent AEs of non-serious and serious nature including any events of special interest. |
| Secondary | Percentage of Subjects Having Achieved UAS7 ≤ 6 | Baseline, Week 52 and Week 100 | The secondary objective of this study was to assess the long-term efficacy of QGE031 in adult CSU patients who completed the CQGE031C2201 study using the following evaluations: Sustained remission defined as maintaining (Urticaria Activity Score) UAS7 ≤ 6 over 48 weeks post-treatment follow up epoch among the participants achieving remission at the end of treatment epoch. |
| Secondary | Number and Proportion of Participants Who Achieved UAS7≤ 6 | Baseline, Week 52, Week 100 | Summary of subjects with UAS7 ≤ 6. The long term efficacy of one-year treatment of ligelizumab 240 mg s.c. q4w is assessed by number and proportion of participants who achieved well controlled disease (UAS7≤ 6) at end of the treatment period (Week 52) and end of follow up period (Week 100). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With at Least One Treatment Emergent Adverse Event (AE) | Within 16 weeks after Week 48 | Safety Set: All 226 subjects who received at least one dose of study drug during this open-label study were included. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Subjects Having Achieved UAS7 ≤ 6 | Baseline, Week 52 and Week 100 | Safety Set | percentage of participants | NUMBER |
| SECONDARY | Number and Proportion of Participants Who Achieved UAS7≤ 6 | Baseline, Week 52, Week 100 | Safety Set | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With at Least One Treatment Emergent Adverse Event (AE) | Ligelizumab | 190 | Participants | ||
| Percentage of Subjects Having Achieved UAS7 ≤ 6 | Ligelizumab | Baseline | 0.44 | 95% Confidence Interval 0 to 2.4 | percentage of participants |
| Percentage of Subjects Having Achieved UAS7 ≤ 6 | Ligelizumab | Week 52 | 61.06 | 95% Confidence Interval 54.4 to 67.5 | percentage of participants |
| Percentage of Subjects Having Achieved UAS7 ≤ 6 | Ligelizumab | Week 100 | 28.32 | 95% Confidence Interval 22.5 to 34.7 | percentage of participants |
| Number and Proportion of Participants Who Achieved UAS7≤ 6 | Ligelizumab | Baseline | 1 | Participants | |
| Number and Proportion of Participants Who Achieved UAS7≤ 6 | Ligelizumab | Week 52 | 138 | Participants | |
| Number and Proportion of Participants Who Achieved UAS7≤ 6 | Ligelizumab | Week 100 | 64 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ligelizumab | 226 | |
| Overall Study | COMPLETED | Ligelizumab | 201 | |
| Overall Study | NOT COMPLETED | Ligelizumab | 25 |
Source ClinicalTrials.gov
Adverse events96
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 | Injection site erythema | General disorders | QGE031 240 mg q4w (TEAE) | 13 | 226 | |
| other | Injection site erythema | General disorders | QGE031 240 mg q4w (Non-TEAE) | 0 | 226 | |
| other | Nasopharyngitis | Infections and infestations | QGE031 240 mg q4w (TEAE) | 57 | 226 | |
| other | Nasopharyngitis | Infections and infestations | QGE031 240 mg q4w (Non-TEAE) | 10 | 226 | |
| other | Sinusitis | Infections and infestations | QGE031 240 mg q4w (TEAE) | 13 | 226 | |
| other | Sinusitis | Infections and infestations | QGE031 240 mg q4w (Non-TEAE) | 2 | 226 | |
| other | Upper respiratory tract infection | Infections and infestations | QGE031 240 mg q4w (TEAE) | 23 | 226 | |
| other | Upper respiratory tract infection | Infections and infestations | QGE031 240 mg q4w (Non-TEAE) | 3 | 226 | |
| other | Urinary tract infection | Infections and infestations | QGE031 240 mg q4w (TEAE) | 12 | 226 | |
| other | Urinary tract infection | Infections and infestations | QGE031 240 mg q4w (Non-TEAE) | 3 | 226 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | QGE031 240 mg q4w (TEAE) | 1 | 226 |
| Total, all-cause mortality | QGE031 240 mg q4w (Non-TEAE) | 0 | 226 |
| Total, other adverse events | QGE031 240 mg q4w (TEAE) | 133 | 226 |
| Total, other adverse events | QGE031 240 mg q4w (Non-TEAE) | 38 | 226 |
| Total, serious adverse events | QGE031 240 mg q4w (TEAE) | 15 | 226 |
| Total, serious adverse events | QGE031 240 mg q4w (Non-TEAE) | 6 | 226 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| QGE031 240 mg q4w (TEAE) vs QGE031 240 mg q4w (Non-TEAE): deaths from any cause | Trial comparisons |
| QGE031 240 mg q4w (TEAE) vs QGE031 240 mg q4w (Non-TEAE): 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.
GET https://conductscience.org/api/trials/v1/NCT02649218
GET https://conductscience.org/api/trials/v1/NCT02649218/events?page=2