A Phase 2 interventional study of Ligelizumab in Chronic Spontaneous Urticaria, sponsored by Novartis Pharmaceuticals. Completed at 67 sites in 10 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-10-11.
Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Treatment
A safety extension study to evaluate the long-term safety of QGE031 240 mg s.c. given every 4 weeks for 52 weeks in Chronic Spontaneous Urticaria (CSU) patients who completed study CQGE031C2201
A safety extension study to evaluate the long-term safety of QGE031 in Chronic Spontaneous Urticaria patients
237 studies on the registry are indexed under Urticaria; 26 are open to participants now.
This study's enrollment of 226 is above the median of 61 across 174 interventional studies indexed under Urticaria.
Browse Urticaria studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients eligible for inclusion in this study have to fulfill all of the following criteria:
Exclusion Criteria:
Clearly defined underlying etiology for chronic urticaria other than chronic spontaneous urticaria
QGE031 240 mg s.c. q4w x 13 treatments
Biological: Ligelizumab
QGE031 240 mg s.c. q4w
Also known as: QGE031
Number of Participants With at Least One Treatment Emergent Adverse Event (AE)
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.
Time frame: Within 16 weeks after Week 48
Percentage of Subjects Having Achieved UAS7 ≤ 6
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.
Time frame: Baseline, Week 52 and Week 100
Number and Proportion of Participants Who Achieved UAS7≤ 6
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).
Time frame: Baseline, Week 52, Week 100
Of the subjects who completed core study (NCT02477332) that were eligible for extension study, 237 were screened; 226 were enrolled to open-label treatment epoch; 201 (88.9%) completed treatment epoch; 209 (92.5%) entered the post-treatment follow-up epoch and 152 (67.3%) completed the post-treatment follow-up epoch
| Milestone | Ligelizumab |
|---|---|
| Started | 226 |
| Completed | 201 |
| Not completed | 25 |
| Withdrew: Adverse event | 8 |
| Withdrew: Lack of efficacy | 8 |
| Withdrew: Pregnancy | 3 |
| Withdrew: Protocol violation | 3 |
| Withdrew: Physician decision | 1 |
| Withdrew: Withdrawal by subject | 2 |
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.
| Participants | Ligelizumab |
|---|---|
| Number of Participants With at Least One Treatment Emergent Adverse Event (AE) | 190 |
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.
| percentage of participants | Ligelizumab |
|---|---|
| Baseline | 0.44 (0 to 2.4) |
| Week 52 | 61.06 (54.4 to 67.5) |
| Week 100 | 28.32 (22.5 to 34.7) |
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).
| Participants | Ligelizumab |
|---|---|
| Baseline | 1 |
| Week 52 | 138 |
| Week 100 | 64 |
Collected over Within 16 weeks after Week 48. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| QGE031 240 mg q4w (TEAE) | 1/226 (0.4%) | 15/226 (6.6%) | 133/226 (58.8%) |
| QGE031 240 mg q4w (Non-TEAE) | 0/226 (0%) | 6/226 (2.7%) | 38/226 (16.8%) |
| Event | QGE031 240 mg q4w (TEAE) | QGE031 240 mg q4w (Non-TEAE) |
|---|---|---|
| Angina pectorisCardiac disorders | 1/226 | 0/226 |
| Supraventricular tachycardiaCardiac disorders | 1/226 | 0/226 |
| VertigoEar and labyrinth disorders | 1/226 | 0/226 |
| GastritisGastrointestinal disorders | 1/226 | 0/226 |
| HaemorrhoidsGastrointestinal disorders | 1/226 | 0/226 |
| Mouth cystGastrointestinal disorders | 1/226 | 0/226 |
| Non-cardiac chest painGeneral disorders | 1/226 | 0/226 |
| CholecystitisHepatobiliary disorders | 1/226 | 0/226 |
| Cholecystitis chronicHepatobiliary disorders | 1/226 | 0/226 |
| HypersensitivityImmune system disorders | 1/226 | 0/226 |
| Event | QGE031 240 mg q4w (TEAE) | QGE031 240 mg q4w (Non-TEAE) |
|---|---|---|
| NasopharyngitisInfections and infestations | 57/226 | 10/226 |
| HeadacheNervous system disorders | 29/226 | 2/226 |
| Upper respiratory tract infectionInfections and infestations | 23/226 | 3/226 |
| UrticariaSkin and subcutaneous tissue disorders | 23/226 | 18/226 |
| Back painMusculoskeletal and connective tissue disorders | 16/226 | 2/226 |
| Injection site erythemaGeneral disorders | 13/226 | 0/226 |
| SinusitisInfections and infestations | 13/226 | 2/226 |
| Urinary tract infectionInfections and infestations | 12/226 | 3/226 |
| Blood creatinine increasedInvestigations | 12/226 | 1/226 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 12/226 | 1/226 |
The Safety set (SS) included all subjects who received at least one dose of study drug during this open-label study.
| Age, Continuous(years) | Ligelizumab |
|---|---|
| Mean | 44.5 ± 12.69 |
| Age, Customized(participants) | Ligelizumab |
|---|---|
| <65 years | 211 |
| >= 65 years | 15 |
| Sex/Gender, Customized(Percentage of Participants) | Ligelizumab |
|---|---|
| Female | 75.2 |
| Male | 24.8 |
| Race/Ethnicity, Customized(Percentage of participants) | Ligelizumab |
|---|---|
| Asian | 22.6 |
| Black or African American | 1.3 |
| White | 72.1 |
| American Indian or Alaska Native | 0.4 |
| Unknown | 0.9 |
| Other | 2.7 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided — Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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