Chronic Spontaneous UrticariaPhase 3NCT03328897
Study of Efficacy and Safety of Xolair® (Omalizumab) in Chinese Patients With Chronic Spontaneous Urticaria
A Phase 3 study testing Omalizumab in people with Chronic Spontaneous Urticaria, run by Novartis Pharmaceuticals at 27 sites in China.
Trial summary
The purpose of this study was to demonstrate the efficacy and safety of omalizumab, compared with placebo, as an add-on to H1 antihistamines (H1AH) therapy in adult patients suffering from Chronic Spontaneous Urticaria (CSU) who remained symptomatic despite H1AH therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Spontaneous Urticaria
- What is being tested?
- Omalizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 418 participants
- Where
- 27 sitesChina
- Study dates
- 26 Apr 2017to 24 Sep 2019
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Symptomatic CSU patients with CSU diagnosis for at least 6 months.
- Patients must have been on an approved dose of an H1AH for CSU for at least the 3 consecutive days immediately prior to the Day -14 screening visit
- Patients must have documented current use on the day of the initial screening visit
Main Exclusion Criteria
- Clearly defined underlying etiology for chronic urticarias other than CSU (main manifestation being physical urticaria)
- Other skin disease associated with itch Urticarial vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary or acquired angioedema, lymphoma, leukemia, or generalized cancer
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
China27 sites
Novartis Investigative Site
Beijing, Beijing Municipality, 100039
Novartis Investigative Site
Beijing, 100034
Novartis Investigative Site
Beijing, 100050
Novartis Investigative Site
Beijing, 100191
Novartis Investigative Site
Changsha, Hunan, 410008
Novartis Investigative Site
Chengdu, Sichuan, 610041
Novartis Investigative Site
Chongqing, 400011
Novartis Investigative Site
Chongqing, 400038
Novartis Investigative Site
Fuzhou, Fujian, 350025
Novartis Investigative Site
Guangzhou, Guangdong, 510630
Novartis Investigative Site
Guangzhou, 510000
Novartis Investigative Site
Hangzhou, Zhejiang, 310003
Novartis Investigative Site
Hangzhou, Zhejiang, 310006
Novartis Investigative Site
Hangzhou, Zhejiang, 310016
Novartis Investigative Site
Harbin, Heilongjiang, 150001
Novartis Investigative Site
Nanjing, Jiangsu, 210029
Novartis Investigative Site
Nanjing, 210042
Novartis Investigative Site
Nanning, Guangxi, 530021
Novartis Investigative Site
Shanghai, 200025
Novartis Investigative Site
Shanghai, 200040
Novartis Investigative Site
Shanghai, 200433
Novartis Investigative Site
Shenyang, Liaoning, 110000
Novartis Investigative Site
Suzhou, Jiangsu, 215006
Novartis Investigative Site
Ürümqi, Xinjiang, 830001
Novartis Investigative Site
Wuhan, Hubei, 430022
Novartis Investigative Site
Wuhan, Hubei, 430030
Novartis Investigative Site
Wuxi, Jiangsu
About this study
Official title: A Phase III Study to Evaluate the Efficacy and Safety of Xolair® (Omalizumab) in Chinese Patients With Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment
The purpose of this study was to demonstrate the efficacy and safety of omalizumab, compared with placebo, as an add-on to H1 antihistamines (H1AH) therapy in adult patients suffering from Chronic Spontaneous Urticaria (CSU) who remained symptomatic despite H1AH therapy.
Read the detailed description
This was a randomized, multicenteric, double-blinded, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab as an add-on therapy for the treatment of patients of refractory CSU who remained symptomatic despite approved-dosed H1AH treatment.
The study consisted of three distinct epochs over 24 weeks: Screening epoch (Day -28 to Day -1), Randomized treatment epoch (Day 1 to Week 12) and Post-treatment follow-up epoch (Week 12 to Week 20). Patients were randomized into three treatment groups (omalizumab 300 mg s.c. omalizumab 150 mg s.c. and placebo) in a 2:2:1 ratio, stratified by latent tuberculosis (TB) status at Baseline (Yes/No).
On Day 1, eligible patients were randomly assigned to receive omalizumab (150 mg or 300 mg) or placebo by subcutaneous (s.c.) injection every 4 weeks (on Day 1, Week 4, and Week 8) during the 12-week double-blind randomized-treatment epoch. Patients visited the study center at 4-week intervals. Patients were instructed to stay on the same CSU H1AH treatment at stable dose that they were using during the pre-randomization period during the randomized treatment epoch. They were allowed to use diphenhydramine as rescue medication during all epochs. The last dose of the study drug during the randomized-treatment epoch was administered at Week 8 study visit, however, the last assessment was done at Week 12.
After the completion of the 12-week randomized-treatment epoch, all patients entered an 8-week post-treatment follow-up epoch.
- Conditions
- Chronic Spontaneous Urticaria
- Being tested
- Omalizumab, Placebo
- Keywords
- Chronic spontaneous urticaria, ISS7, UAS7, omalizumab, China
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmalizumabDrug
Also called IGE025
injection of 150mg or 300 mg
PlaceboDrug
Injection of placebo
| Study group | Role | What they receive |
|---|---|---|
| Omalizumab 300mg | Experimental | patients received a dose of omalizumab 300 mg which consisted of two injections of omalizumab 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8) Receives: Drug: Omalizumab |
| Omalizumab 150mg | Experimental | patients received a dose of omalizumab 150 mg which consisted of one injection of omalizumab 150 mg vial and one injection of placebo 150 mg vial every 4 weeks (Day 1, Week 4 and Week 8) Receives: Drug: Omalizumab |
| Placebo | Placebo comparator | patients received placebo which consisted of two injections of placebo 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline of the Itch Severity Score (ISS7) Score After 12 Weeks of Treatment
The severity of the itch was recorded by the patient twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). Baseline ISS7 was calculated 7 days prior to the first treatment date. A weekly score (ISS7) was derived by adding up the average daily scores of the seven days preceding the visit. The possible range of the weekly score was therefore 0 to 21, where 0 is the best score and 21 is the worst score. The complete itch response was defined as ISS7 = 0.
Itch (Pruritus) Severity Score Scale:
0 = None
- = Mild (minimal awareness, easily tolerated)
- = Moderate (definite awareness, bothersome but tolerable)
- = Severe (difficult to tolerate)
Measured: Baseline, Week 12
Secondary outcomes (7)
Change From Baseline of Urticaria Activity Score (UAS7) After 12 Weeks of Treatment
UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42. A higher urticaria activity score indicates more severe symptoms. A negative change score from baseline indicates improvement.
Measured: Baseline, Week 12
Change From Baseline of Number of Hives Score (NHS7) After 12 Weeks of Treatment
Hives Severity Score (HSS), defined by number of hives, were recorded by the patient twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). A weekly number of hives score (NHS7) was derived by adding up the average daily scores of the seven days preceding the visit. The possible range of the weekly score was therefore 0 to 21. The complete hives response was defined as NHS7 = 0.
Hives Severity Score scale:
0 - None
- Mild (1-6 hives/12 hours)
- Moderate (7-12 hives/12 hours)
- Severe (>12 hives/12 hours)
Measured: Baseline, Week 12
Percentage of Patients With UAS7≤6 at Week 12
UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42. A higher urticaria activity score indicates more severe symptoms. A negative change score from baseline indicates improvement. Week 12 responders were defined as patients who achieved an absolute UAS7 ≤ 6 at Week 12. A patient with missing data at Week 12 was imputed as a responder if the patient was a responder at Week 10 and Week 11, otherwise as a non-responder.
Measured: Week 12
Percentage of Complete Responders (UAS7 = 0) at Week 12
UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42. A higher urticaria activity score indicates more severe symptoms. A negative change score from baseline indicates improvement. Complete responders are defined as participants who achieved UAS7 = 0.
Measured: Week 12
Percentage of Patients With ISS7 Minimally Important Difference (MID) at Week 12
The severity of the itch was recorded by the patient twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). Baseline ISS7 was calculated 7 days prior to the first treatment date. A weekly score (ISS7) was derived by adding up the average daily scores of the seven days preceding the visit. The possible range of the weekly score was therefore 0 to 21, where 0 is the best score and 21 is the worst score. The complete itch response was defined as ISS7 = 0.
Itch (Pruritus) Severity Score Scale:
0 = None
- = Mild (minimal awareness, easily tolerated)
- = Moderate (definite awareness, bothersome but tolerable)
- = Severe (difficult to tolerate)
The ISS7 MID response was defined as a reduction from Baseline in ISS7 of ≥ 5 points.
Measured: Week 12
Change From Baseline of Dermatology Life Quality Index (DLQI) Score After 12 Weeks of Treatment
Dermatology life quality index (DLQI) is a 10-item dermatology- specific health-related quality of life measure. Patients rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives. An overall score was calculated as well as separate scores for the following domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, treatment. Each domain had 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment.
Measured: Week 12
Time to ISS7 MID Response by Week 12
The ISS7 MID response was defined as a reduction from Baseline in ISS7 of ≥ 5 points. Time to ISS7 MID response was the time (in weeks) from the date of the first dose to the date where ISS7 MID response was first achieved during Week 1 to Week 12.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start26 Apr 2017
- Primary completion23 Jul 2019
- Study completion24 Sep 2019
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 418 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03328897
- Sponsor's protocol ID
- CIGE025E2305
- Status last verified
- Oct 2020
- First submitted
- 13 Mar 2017
- Last updated
- 4 Nov 2020
- 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 with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect 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
Publications
Bi XD, Lu BZ, Pan XX, Liu S, Wang JY. Adjunct therapy with probiotics for chronic urticaria in children: randomised placebo-controlled trial. Allergy Asthma Clin Immunol. 2021 Apr 17;17(1):39. doi: 10.1186/s13223-021-00544-3.
PubMed 33865434
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study to Evaluate the Efficacy and Safety of Xolair® (Omalizumab) in Chinese Patients With Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment
- ClinicalTrials.gov ID
- NCT03328897
- Acronym / sponsor ID
- CIGE025E2305
- Conditions
- Chronic Spontaneous Urticaria
- Keywords
- Chronic spontaneous urticaria, ISS7, UAS7, omalizumab, China
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 418 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2017 (actual)
- Primary completion
- 23 Jul 2019 (actual)
- Study completion
- 24 Sep 2019 (actual)
- First posted
- 1 Nov 2017 (actual)
- Results
- Posted 4 Nov 2020
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 demonstrate the efficacy and safety of omalizumab, compared with placebo, as an add-on to H1 antihistamines (H1AH) therapy in adult patients suffering from Chronic Spontaneous Urticaria (CSU) who remained symptomatic despite H1AH therapy.
Detailed description
This was a randomized, multicenteric, double-blinded, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab as an add-on therapy for the treatment of patients of refractory CSU who remained symptomatic despite approved-dosed H1AH treatment.
The study consisted of three distinct epochs over 24 weeks: Screening epoch (Day -28 to Day -1), Randomized treatment epoch (Day 1 to Week 12) and Post-treatment follow-up epoch (Week 12 to Week 20). Patients were randomized into three treatment groups (omalizumab 300 mg s.c. omalizumab 150 mg s.c. and placebo) in a 2:2:1 ratio, stratified by latent tuberculosis (TB) status at Baseline (Yes/No).
On Day 1, eligible patients were randomly assigned to receive omalizumab (150 mg or 300 mg) or placebo by subcutaneous (s.c.) injection every 4 weeks (on Day 1, Week 4, and Week 8) during the 12-week double-blind randomized-treatment epoch. Patients visited the study center at 4-week intervals. Patients were instructed to stay on the same CSU H1AH treatment at stable dose that they were using during the pre-randomization period during the randomized treatment epoch. They were allowed to use diphenhydramine as rescue medication during all epochs. The last dose of the study drug during the randomized-treatment epoch was administered at Week 8 study visit, however, the last assessment was done at Week 12.
After the completion of the 12-week randomized-treatment epoch, all patients entered an 8-week post-treatment follow-up epoch.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Omalizumab 300mg | Experimental | Drug: Omalizumabpatients received a dose of omalizumab 300 mg which consisted of two injections of omalizumab 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8) |
| Omalizumab 150mg | Experimental | Drug: Omalizumabpatients received a dose of omalizumab 150 mg which consisted of one injection of omalizumab 150 mg vial and one injection of placebo 150 mg vial every 4 weeks (Day 1, Week 4 and Week 8) |
| Placebo | Placebo comparator | Drug: Placebopatients received placebo which consisted of two injections of placebo 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| OmalizumabAlso: IGE025injection of 150mg or 300 mg | Drug | Omalizumab 150mg, Omalizumab 300mg |
| PlaceboInjection of placebo | Drug | Placebo |
Primary outcome
Change From Baseline of the Itch Severity Score (ISS7) Score After 12 Weeks of Treatment
Time frame: Baseline, Week 12
The severity of the itch was recorded by the patient twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). Baseline ISS7 was calculated 7 days prior to the first treatment date. A weekly score (ISS7) was derived by adding up the average daily scores of the seven days preceding the visit. The possible range of the weekly score was therefore 0 to 21, where 0 is the best score and 21 is the worst score. The complete itch response was defined as ISS7 = 0. Itch (Pruritus) Severity Score Scale: 0 = None 1. = Mild (minimal awareness, easily tolerated) 2. = Moderate (definite awareness, bothersome but tolerable) 3. = Severe (difficult to tolerate)
7 secondary outcomes
Change From Baseline of Urticaria Activity Score (UAS7) After 12 Weeks of Treatment
Time frame: Baseline, Week 12
Change From Baseline of Number of Hives Score (NHS7) After 12 Weeks of Treatment
Time frame: Baseline, Week 12
Percentage of Patients With UAS7≤6 at Week 12
Time frame: Week 12
Percentage of Complete Responders (UAS7 = 0) at Week 12
Time frame: Week 12
Percentage of Patients With ISS7 Minimally Important Difference (MID) at Week 12
Time frame: Week 12
Change From Baseline of Dermatology Life Quality Index (DLQI) Score After 12 Weeks of Treatment
Time frame: Week 12
Time to ISS7 MID Response by Week 12
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33865434Bi XD, Lu BZ, Pan XX, Liu S, Wang JY. Adjunct therapy with probiotics for chronic urticaria in children: randomised placebo-controlled trial. Allergy Asthma Clin Immunol. 2021 Apr 17;17(1):39. doi: 10.1186/s13223-021-00544-3.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect 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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
27 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 Omalizumab in people with Chronic Spontaneous Urticaria, run by Novartis Pharmaceuticals at 27 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in China. 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. Some participants in this study may receive a placebo. 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 4 Nov 2020). 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?
Change From Baseline of the Itch Severity Score (ISS7) Score After 12 Weeks of Treatment (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03328897, which also lists 1 linked publication.
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 4 Nov 2020.