Chronic Spontaneous UrticariaPhase 3NCT03907878
A Safety and Efficacy Study of Ligelizumab in the Treatment of CSU in Japanese Patients Inadequately Controlled With H1- Antihistamines
A Phase 3 study testing Ligelizumab in people with Chronic Spontaneous Urticaria, run by Novartis Pharmaceuticals at 11 sites in Japan.
Trial summary
The purpose of this study was to evaluate the safety and efficacy of ligelizumab in adult Japanese subjects with CSU, who remain symptomatic despite treatment with H1-antihistamines (AHs) at locally approved doses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Spontaneous Urticaria
- What is being tested?
- Ligelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 11 sitesJapan
- Study dates
- 13 Apr 2019to 26 Jan 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent must be obtained prior to participation in the study
- Male and female subjects ≥ 18 years of age at the time of screening
- CSU diagnosis for ≥ 6 months
- Diagnosis of CSU refractory to H1-AH at approved doses at the time of Baseline (Visit 110, Day 1), as defined by all of the following:
- The presence of itch and hives for ≥ 6 consecutive weeks at any time prior to Visit 1 (Day -28 to Day -14) despite current use of non-sedating H1-AH (at locally approved doses) during this time period
- UAS7 score (range 0-42) ≥ 16 and HSS7 (range 0-21) ≥ 8 during the 7 days prior to baseline (Visit 110, Day 1)
- Subjects must be on H1-AH at only approved doses for treatment of CSU for starting at Visit 1 (Day -28 to Day -14)
- Willing and able to complete a daily symptom electronic Diary (eDiary) for the duration of the study and adhere to the study visit schedules
Who cannot join
- History of hypersensitivity to any of the study treatments or excipients or to drugs of similar chemical classes (i.e. to murine, chimeric, or human antibodies)
- Subjects having a clearly defined, predominant trigger of their chronic urticaria (CU) (chronic inducible urticaria (CINDU)) including
- urticaria factitia (symptomatic dermographism), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic-, or contact-urticaria
- Diseases, other than chronic urticaria, with urticarial or angioedema symptoms such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), and hereditary or acquired angioedema (e.g., due to C1 inhibitor deficiency)
- Subjects with evidence of helminthic parasitic infection as evidenced by stools being positive for a pathogenic organism according to local guidelines. All subjects will be screened at Visit 1. If stool testing is positive for pathogenic organism, the subject will not enter treatment period and will not be allowed to rescreen
- Any other skin disease associated with chronic itching that might influence in the investigator's opinion the study evaluations and results (e.g. atopic dermatitis, bullous pemphigoid (BP), dermatitis herpetiformis, senile pruritus, etc)
Show all 9Show fewer
- Prior exposure to ligelizumab
- Any H2 antihistamine, Leukotriene Receptor Antagonist (LTRA) (montelukast or zafirlukast) or H1 antihistamines use at greater than approved dose after Visit 1
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Japan11 sites
Novartis Investigative Site
Hiroshima, 734-8551
Novartis Investigative Site
Ichikawa, Chiba, 272-0033
Novartis Investigative Site
Kobe, Hyōgo, 650-0017
Novartis Investigative Site
Machida, Tokyo, 194-0013
Novartis Investigative Site
Neyagawa, Osaka, 572-0838
Novartis Investigative Site
Nishinomiya, Hyōgo, 663-8186
Novartis Investigative Site
Obihiro, Hokkaido, 080 0013
Novartis Investigative Site
Sakai, Osaka, 593-8324
Novartis Investigative Site
tabashi City, Tokyo, 173-8610
Novartis Investigative Site
Yokohama, Kanagawa, 221-0825
Novartis Investigative Site
Yokohama, Kanagawa, 222-0033
About this study
Official title: A Multi-center, Open-label Study to Investigate the Safety/Tolerability and Efficacy of Ligelizumab (QGE031) in the Treatment of Adult Japanese Patients With Chronic Spontaneous Urticaria (CSU) Inadequately Controlled With H1 Antihistamines
The purpose of this study was to evaluate the safety and efficacy of ligelizumab in adult Japanese subjects with CSU, who remain symptomatic despite treatment with H1-antihistamines (AHs) at locally approved doses.
The study population consisted of 66 male and female subjects aged ≥ 18 years who were diagnosed with CSU and who remained symptomatic despite the use of H1-AH.
This was a Phase III multi-center, open-label, single arm study. There was a screening period of up to 28 days, a 52 week treatment period, and a 12 week post-treatment follow-up period.
Read the detailed description
This was a Phase III multi-center, open-label, single arm study. The study consisted of 3 distinct periods:
Screening period (Day -28 to Day -14): Subjects who gave informed consent were assessed for eligibility during this period which lasted for up to 4 weeks.
Treatment period (52 weeks): Subjects had site visits every 4 weeks during this period to receive study drug and complete on-site assessments.
Post-treatment follow-up period (12 weeks): Subject had site visits every 4 weeks with the final visit occurring 16 weeks after the last treatment dose. No study treatment was given during the period.
This study was designed to obtain safety data of QGE031 in 66 Japanese CSU patients.
- Conditions
- Chronic Spontaneous Urticaria
- Being tested
- Ligelizumab
- Keywords
- CSU, chronic spontaneous urticaria, Japanese, QGE031, Anti-IgE, Ligelizumab, Japan
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LigelizumabBiological
Also called QGE031
Liquid in vial
| Study group | Role | What they receive |
|---|---|---|
| Ligelizumab 120 mg per 1 mL qw4 | Experimental | Subjects received one subcutaneous injection every 4 weeks at 13 visits during the treatment period Receives: Biological: Ligelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of Ligelizumab 120 mg q4w Treatment for 12 Months
Participants with treatment emergent adverse events (AEs) and serious adverse events (SAEs) summary for entire study (64 weeks)
An AE is any untoward medical occurrence, unfavorable, or unintended sign (including an abnormal laboratory finding), symptom, disease, or injury, temporally associated with the use of a marketed or investigational medicinal product, gene therapy, theragnostic product, or medical device, in patients, clinical-trial subjects, device users, or other persons, whether or not it is considered to be related to or due to the product.
Measured: 64 weeks
Secondary outcomes (8)
UAS7 Change From Baseline Over Time
Mean change from baseline in UAS7 score over time is assessed as absolute change from baseline of UAS7 by visit up to end of study.
The Urticaria Activity Score (UAS) is the sum of Hive Severity Score (HSS) and Itch Severiry Score (ISS).
The HSS has a scale of 0 (none) to 3 (> 12 hives/12 hours). A weekly score (HSS7) is derived by adding up the average daily scores of the preceding 7 days. So the range is 0-21; and negative change = improvement.
The ISS also has a scale of 0 (none) to 3 (severe/difficult to tolerate). A weekly score (ISS7) is derived by adding up the average daily scores of the preceding 7 days. Score range is 0-21; and a negative change from baseline indicates improvement.
The UAS7 is the sum of the HSS7 score and the ISS7 score, and has a possible range in score of 0-42. A negative change from baseline indicates improvement.
Measured: Baseline, Weeks 12, 24, 52, and 64
HSS7 Change From Baseline Over Time
The HSS has a scale of 0 (none) to 3 (> 12 hives/12 hours):
0 (None)
- (1-6 hives/12 hours)
- (7-12 hives/12 hours)
- (> 12 hives/12 hours)
A weekly score (HSS7) is derived by adding up the average daily scores of the preceding 7 days.
Score range is 0-21; and a negative change indicates improvement.
Measured: Baseline, Weeks 12, 24, 52, and 64
ISS7 Change From Baseline Over Time
The ISS has a scale of 0 (none) to 3 (severe):
0 None
- Mild (minimal awareness, easily tolerated)
- Moderate (definite awareness, bothersome but tolerable)
- Severe (difficult to tolerate)
The ISS also has a scale of 0 (none) to 3 (severe/difficult to tolerate). A weekly score (ISS7) is derived by adding up the average daily scores of the preceding 7 days. So the score range of ISS7 is 0-21; and a negative change from baseline indicates improvement.
Measured: Baseline, Weeks 12, 24, 52, and 64
Percentage of Participants Who Achieved the Complete UAS7 = 0 Response Over Time
Assessed as the proportion of subjects achieving UAS7 = 0 over time.
The UAS7 has a possible range in score of 0-42, and its complete response (complete urticaria control) was defined as UAS7 = 0
Measured: Weeks 12, 24, 52, and 64
Percentage of Participants Who Achieved the Complete HSS7 = 0 Response Over Time
The proportion of subjects achieving HSS7 = 0 (complete absence of hives) over time
The HSS has a scale of 0 (none) to 3 (> 12 hives/12 hours). A weekly score (HSS7) is derived by adding up the average daily scores of the preceding 7 days. So the range is 0-21; and negative change = improvement.
Measured: Weeks 12, 24, 52, and 64
Percentage of Participants Who Achieved the Complete ISS7 = 0 Response Over Time
The ISS also has a scale of 0 (none) to 3 (severe/difficult to tolerate). A weekly score (ISS7) is derived by adding up the average daily scores of the preceding 7 days. Score range is 0-21; and a negative change from baseline indicates improvement.
Measured: Weeks 12, 24, 52, and 64
Change From Baseline in the Dermatology Life Quality Index (DLQI)
Assessed by absolute change from baseline of DLQI up to end of study. Score range is from 0-30:
0-1 No effect on patients life 2-5 Small effect on patients life 6-10 Moderate effect on patients life 11-20 Very large effect on patients life 21-30 Extremely large effect on patients life
A negative change indicates improvement.
Measured: Baseline, Weeks 12, 24, 52 and 64
Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) = 0/1 by Visit up to End of Study
Percentage of participants who achieved DLQI = 0/1 by visit up to end of study, assessed by absolute change from baseline of DLQI up to end of study. Score range is from 0-30:
0-1 No effect on patients life 2-5 Small effect on patients life 6-10 Moderate effect on patients life 11-20 Very large effect on patients life 21-30 Extremely large effect on patients life
A negative change indicates improvement.
Measured: Weeks 12, 24, 52, and 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start13 Apr 2019
- Primary completion26 Jan 2022
- Study completion26 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Spontaneous UrticariaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03907878
- Sponsor's protocol ID
- CQGE031C1301
- Status last verified
- Mar 2025
- First submitted
- 5 Apr 2019
- Last updated
- 6 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label Study to Investigate the Safety/Tolerability and Efficacy of Ligelizumab (QGE031) in the Treatment of Adult Japanese Patients With Chronic Spontaneous Urticaria (CSU) Inadequately Controlled With H1 Antihistamines
- ClinicalTrials.gov ID
- NCT03907878
- Acronym / sponsor ID
- CQGE031C1301
- Conditions
- Chronic Spontaneous Urticaria
- Keywords
- CSU, chronic spontaneous urticaria, Japanese, QGE031, Anti-IgE, Ligelizumab, Japan
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 13 Apr 2019 (actual)
- Primary completion
- 26 Jan 2022 (actual)
- Study completion
- 26 Jan 2022 (actual)
- First posted
- 9 Apr 2019 (actual)
- Results
- Posted 8 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate the safety and efficacy of ligelizumab in adult Japanese subjects with CSU, who remain symptomatic despite treatment with H1-antihistamines (AHs) at locally approved doses.
The study population consisted of 66 male and female subjects aged ≥ 18 years who were diagnosed with CSU and who remained symptomatic despite the use of H1-AH.
This was a Phase III multi-center, open-label, single arm study. There was a screening period of up to 28 days, a 52 week treatment period, and a 12 week post-treatment follow-up period.
Detailed description
This was a Phase III multi-center, open-label, single arm study. The study consisted of 3 distinct periods:
Screening period (Day -28 to Day -14): Subjects who gave informed consent were assessed for eligibility during this period which lasted for up to 4 weeks.
Treatment period (52 weeks): Subjects had site visits every 4 weeks during this period to receive study drug and complete on-site assessments.
Post-treatment follow-up period (12 weeks): Subject had site visits every 4 weeks with the final visit occurring 16 weeks after the last treatment dose. No study treatment was given during the period.
This study was designed to obtain safety data of QGE031 in 66 Japanese CSU patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ligelizumab 120 mg per 1 mL qw4 | Experimental | Biological: LigelizumabSubjects received one subcutaneous injection every 4 weeks at 13 visits during the treatment period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed informed consent must be obtained prior to participation in the study
- Male and female subjects ≥ 18 years of age at the time of screening
- CSU diagnosis for ≥ 6 months
- Diagnosis of CSU refractory to H1-AH at approved doses at the time of Baseline (Visit 110, Day 1), as defined by all of the following:
- Willing and able to complete a daily symptom electronic Diary (eDiary) for the duration of the study and adhere to the study visit schedules
Key exclusion criteria (9 listed)
- History of hypersensitivity to any of the study treatments or excipients or to drugs of similar chemical classes (i.e. to murine, chimeric, or human antibodies)
- Subjects having a clearly defined, predominant trigger of their chronic urticaria (CU) (chronic inducible urticaria (CINDU)) including
- Diseases, other than chronic urticaria, with urticarial or angioedema symptoms such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), and hereditary or acquired angioedema (e.g., due to C1 inhibitor deficiency)
- Subjects with evidence of helminthic parasitic infection as evidenced by stools being positive for a pathogenic organism according to local guidelines. All subjects will be screened at Visit 1. If stool testing is positive for pathogenic organism, the subject will not enter treatment period and will not be allowed to rescreen
- Any other skin disease associated with chronic itching that might influence in the investigator's opinion the study evaluations and results (e.g. atopic dermatitis, bullous pemphigoid (BP), dermatitis herpetiformis, senile pruritus, etc)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LigelizumabAlso: QGE031Liquid in vial | Biological | Ligelizumab 120 mg per 1 mL qw4 |
Primary outcome
Safety and Tolerability of Ligelizumab 120 mg q4w Treatment for 12 Months
Time frame: 64 weeks
Participants with treatment emergent adverse events (AEs) and serious adverse events (SAEs) summary for entire study (64 weeks) An AE is any untoward medical occurrence, unfavorable, or unintended sign (including an abnormal laboratory finding), symptom, disease, or injury, temporally associated with the use of a marketed or investigational medicinal product, gene therapy, theragnostic product, or medical device, in patients, clinical-trial subjects, device users, or other persons, whether or not it is considered to be related to or due to the product.
8 secondary outcomes
UAS7 Change From Baseline Over Time
Time frame: Baseline, Weeks 12, 24, 52, and 64
HSS7 Change From Baseline Over Time
Time frame: Baseline, Weeks 12, 24, 52, and 64
ISS7 Change From Baseline Over Time
Time frame: Baseline, Weeks 12, 24, 52, and 64
Percentage of Participants Who Achieved the Complete UAS7 = 0 Response Over Time
Time frame: Weeks 12, 24, 52, and 64
Percentage of Participants Who Achieved the Complete HSS7 = 0 Response Over Time
Time frame: Weeks 12, 24, 52, and 64
Percentage of Participants Who Achieved the Complete ISS7 = 0 Response Over Time
Time frame: Weeks 12, 24, 52, and 64
Change From Baseline in the Dermatology Life Quality Index (DLQI)
Time frame: Baseline, Weeks 12, 24, 52 and 64
Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) = 0/1 by Visit up to End of Study
Time frame: Weeks 12, 24, 52, and 64
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Plain Language Trial Summary is Available at www.novctrd.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ligelizumab in people with Chronic Spontaneous Urticaria, run by Novartis Pharmaceuticals at 11 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of Ligelizumab 120 mg q4w Treatment for 12 Months (time frame: 64 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.