Chronic Spontaneous Urticaria
Conditions
Keywords
QGE031, chronic, spontaneous, Urticaria, CSU, adults, Safety, ligelizumab
Brief summary
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
Detailed description
A safety extension study to evaluate the long-term safety of QGE031 in Chronic Spontaneous Urticaria patients
Interventions
BIOLOGICALLigelizumab
QGE031 240 mg s.c. q4w
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients eligible for inclusion in this study have to fulfill all of the following criteria: 1. Written informed consent must be obtained before any assessment is performed. 2. Patients who complete the treatment epoch in study CQGE031C2201 and complete at least Visit 203 (Week 32 of the follow-up epoch, ≥16 weeks after last injection) and present with active disease as defined by UAS7 ≥12. 3. Patients must not have any missing eDiary entries in the 7 days prior to Visit 301 (patients are allowed to repeat until this criterion is met). 4. Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules.
Exclusion criteria
Clearly defined underlying etiology for chronic urticaria other than chronic spontaneous urticaria * Evidence of parasitic infection * Any other skin diseases than chronic spontaneous urticaria with chronic itching * Contraindications to or hypersensitivity to fexofenadine, loratadine, cetirizine, or epinephrine * History of anaphylaxis * History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study * History of hypersensitivity to any of the study drugs or its components of similar chemical classes * Pregnant or nursing (lactating) women Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
Countries
Australia, Canada, Germany, Greece, Japan, Russia, Spain, Taiwan, United Kingdom, United States
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| Ligelizumab QGE031 240 mg s.c. q4w x 13 treatments | 226 |
| Total | 226 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 8 |
| Overall Study | Lack of Efficacy | 8 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Pregnancy | 3 |
| Overall Study | Protocol Violation | 3 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Ligelizumab |
|---|---|
| Age, Continuous | 44.5 years STANDARD_DEVIATION 12.69 |
| Age, Customized <65 years | 211 participants |
| Age, Customized >= 65 years | 15 participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0.4 Percentage of participants |
| Race/Ethnicity, Customized Asian | 22.6 Percentage of participants |
| Race/Ethnicity, Customized Black or African American | 1.3 Percentage of participants |
| Race/Ethnicity, Customized Other | 2.7 Percentage of participants |
| Race/Ethnicity, Customized Unknown | 0.9 Percentage of participants |
| Race/Ethnicity, Customized White | 72.1 Percentage of participants |
| Sex/Gender, Customized Female | 75.2 Percentage of Participants |
| Sex/Gender, Customized Male | 24.8 Percentage of Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 226 | 0 / 226 |
| other Total, other adverse events | 133 / 226 | 38 / 226 |
| serious Total, serious adverse events | 15 / 226 | 6 / 226 |
Outcome results
Primary
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
Population: Safety Set: All 226 subjects who received at least one dose of study drug during this open-label study were included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ligelizumab | Number of Participants With at Least One Treatment Emergent Adverse Event (AE) | 190 Participants |
Secondary
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
Population: Safety Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ligelizumab | Number and Proportion of Participants Who Achieved UAS7≤ 6 | Baseline | 1 Participants |
| Ligelizumab | Number and Proportion of Participants Who Achieved UAS7≤ 6 | Week 52 | 138 Participants |
| Ligelizumab | Number and Proportion of Participants Who Achieved UAS7≤ 6 | Week 100 | 64 Participants |
Secondary
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
Population: Safety Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ligelizumab | Percentage of Subjects Having Achieved UAS7 ≤ 6 | Baseline | 0.44 percentage of participants |
| Ligelizumab | Percentage of Subjects Having Achieved UAS7 ≤ 6 | Week 52 | 61.06 percentage of participants |
| Ligelizumab | Percentage of Subjects Having Achieved UAS7 ≤ 6 | Week 100 | 28.32 percentage of participants |