Chronic Spontaneous UriticariaPhase 3NCT02329223
Study of Efficacy and Safety of Omalizumab in Refractory Chronic Spontaneous Urticaria Patients
A Phase 3 study testing Omalizumab in people with Chronic Spontaneous Uriticaria, run by Novartis Pharmaceuticals at 39 sites in 2 countries.
Trial summary
This was a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult participants 12 - 75 years who received the diagnosis of refractory chronic… Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Chronic Spontaneous Uriticaria
- 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
- 218 participants
- Where
- 39 sitesin 2 countries
- Study dates
- Dec 2014to Dec 2015
- 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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of chronic spontaneous urticaria refractory to H1 antihistamine at the time of randomization
- Chronic spontaneous urticaria diagnosis for 6 months
Who cannot join
- Weight less than 20 kg
- 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
- Previous treatment with omalizumab
- Contraindications to diphenhydramine
Show all 10Show fewer
- History of anaphylactic shock
- History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study
- History of hypersensitivity to omalizumab or to drugs of similar chemical classes
- Pregnant or nursing (lactating) women
Trial locations and contacts
39 sites in 2 countries.
39 sites in 2 countries
Japan25 sites
Novartis Investigative Site
Hiroshima, Hiroshima, 734-8551
Novartis Investigative Site
Hitachi, Ibaraki, 317-0077
Novartis Investigative Site
Izumo, Shimane, 693-8501
Novartis Investigative Site
Kamimashi-gun, Kumamoto, 861-3101
Novartis Investigative Site
Kawasaki, Kanagawa, 213-8507
Novartis Investigative Site
Kobe, Hyōgo, 650-0017
Novartis Investigative Site
Kodaira, Tokyo, 187-8510
Novartis Investigative Site
Kofu, Yamanashi, 400-8506
Novartis Investigative Site
Machida, Tokyo, 194-0013
Novartis Investigative Site
Meguro-ku, Tokyo, 153-8515
Novartis Investigative Site
Minato-ku, Tokyo, 107-6206
Novartis Investigative Site
Nagano, Nagano, 381-8551
Novartis Investigative Site
Nishinomiya, Hyōgo, 663-8186
Novartis Investigative Site
Osaka, Osaka, 532-0003
Novartis Investigative Site
Ōta-ku, Tokyo, 143-0023
Novartis Investigative Site
Saitama, Saitama, 330-0854
Novartis Investigative Site
Sakai, Osaka, 593-8324
Novartis Investigative Site
Shinagawa-ku, Tokyo, 141-8625
Novartis Investigative Site
Shinjuku-ku, Tokyo, 161-8521
Novartis Investigative Site
Takamatsu, Kagawa-ken, 760-0017
Novartis Investigative Site
Toyoake, Aichi-ken, 470-1192
Novartis Investigative Site
Yokohama, Kanagawa, 221-0825
Novartis Investigative Site
Yokohama, Kanagawa, 231-0868
Novartis Investigative Site
Yokohama, Kanagawa, 236-0004
Novartis Investigative Site
Yokosuka, Kanagawa, 238-8558
South Korea14 sites
Novartis Investigative Site
Busan, 602-715
Novartis Investigative Site
Daegu, 705-703
Novartis Investigative Site
Gwangju, 501-757
Novartis Investigative Site
Hwaseong-si, Gyeonggi-do, 445-170
Novartis Investigative Site
Incheon, 405-760
Novartis Investigative Site
Seongnam-si, Gyeonggi-do, 13620
Novartis Investigative Site
Seoul, Korea, 05505
Novartis Investigative Site
Seoul, Korea, 06591
Novartis Investigative Site
Seoul, Korea, 152-703
Novartis Investigative Site
Seoul, Seoul, 156-755
Novartis Investigative Site
Seoul, 120-752
Novartis Investigative Site
Seoul, 130-872
Novartis Investigative Site
Suwon, Gyeonggi-do, 443-380
Novartis Investigative Site
Wŏnju, Gangwon-do, 220-701
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Omalizumab in Patients With Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite H1 Antihistamine Therapy
This was a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult participants 12 - 75 years who received the diagnosis of refractory chronic spontaneous uriticaria and who remained symptomatic despite standard-dosed non-sedating H1 antihistamine treatment.
- Conditions
- Chronic Spontaneous Uriticaria
- Being tested
- Omalizumab, Placebo
- Keywords
- Chronic spontaneous uriticaria, Omalizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmalizumabBiological
Also called Xolair
Omalizumab was supplied as a lyophilized, sterile powder in a single-use vial.
PlaceboOther
Placebo was supplied as a lyophilized, sterile powder in a single-use vial without study drug.
| Study group | Role | What they receive |
|---|---|---|
| Omalizumab 300 mg | Experimental | Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period. Receives: Biological: Omalizumab |
| Omalizumab 150 mg | Experimental | Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period. Receives: Biological: Omalizumab |
| Placebo | Placebo comparator | Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Weekly Itch Severity Score at Week 12
The weekly itch severity score is a component of the Urticaria Activity Score 7 (UAS7) composite score. The UAS7 is a composite score of the number of wheals (hives) and the severity of the itch. The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score from baseline indicates improvement.
Measured: Baseline to Week 12
Secondary outcomes (8)
Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at Week 12
The UAS7 is a composite score of the number of wheals (hives) and the severity of the itch. The UAS7 is determined by the sum of the daily urticaria activity scores over 7 days and ranges from 0 to 42. The daily urticaria activity score is the average of the morning and evening urticaria activity scores and ranges from 0 to 6. The urticaria activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticaria activity scores over the 7 days prior to the first treatment. A higher urticaria activity score indicates more severe symptoms. A negative change score from baseline indicates improvement.
Measured: Baseline to Week 12
Change From Baseline in the Weekly Number of Hives Score at Week 12
The weekly hives score is the sum of the daily hives scores over 7 days and ranges from 0 to 21. The number of hives is measured twice daily (morning and evening) on a scale of 0 (none) to 3 (> 12 hives per 12 hours). The daily hives score is the average of the morning and evening scores. The Baseline score is the sum of the daily hives scores over the 7 days prior to the first treatment. A higher score indicates more hives. A negative change score indicates improvement.
Measured: Baseline to Week 12
Percentage of Participants With a UAS7 Score ≤ 6 at Week 12
The UAS7 is a composite score of the number of wheals (hives) and the severity of the itch. The UAS7 is determined by the sum of the daily urticaria activity scores over 7 days and ranges from 0 to 42. The daily urticaria activity score is the average of the morning and evening urticaria activity scores and ranges from 0 to 6. The urticaria activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticaria activity scores over the 7 days prior to the first treatment. A higher urticaria activity score indicates more severe symptoms.
Measured: Week 12
Change From Baseline in the Weekly Size of the Largest Hive Score at Week 12
The weekly size of the largest hive score is the sum of the daily size of the largest hive scores over 7 days and ranges from 0 to 21. The daily size of the largest hive score is assessed twice daily (morning and evening) on a scale of 0 (none) to 3 (> 2.5 cm). The daily size of the largest hive score is the average of the morning and evening scores. The Baseline weekly size of the largest hive score is calculated over the 7 days prior to the first treatment. A higher score indicates larger hives. A negative change score from baseline indicates a reduction in hive size.
Measured: Baseline to Week 12
Percentage of Weekly Itch Severity Score Minimally Important Difference (MID) Responders at Week 12
Weekly itch severity score MID response is defined as a reduction from baseline in weekly itch severity score of ≥ 5 points.
Measured: Week 12
Percentage of Complete Responders (UAS7 = 0) at Week 12
Complete responders are defined as participants who achieved UAS7 = 0.
Measured: Week 12
Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12
The DLQI is a 10-item dermatology-specific health-related quality of life measure. Participants rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives on a scale of 0 (Not at all) to 3 (Very much). The overall DLQI is the sum of the responses to the 10 items and ranges from 0 to 30. A lower score indicates a better quality of life. A negative change score from baseline indicates improvement.
Measured: Baseline to Week 12
Percentage of Participants With Production of Anti-omalizumab Antibody
Serum samples were collected for anti-omalizumab antibody testing.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2015
- Study completionDec 2015
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 UriticariaStudies 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
- 218 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
- NCT02329223
- Sponsor's protocol ID
- CIGE025E2306
- Status last verified
- Sep 2016
- First submitted
- 15 Dec 2014
- Last updated
- 21 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Omalizumab in Patients With Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite H1 Antihistamine Therapy
- ClinicalTrials.gov ID
- NCT02329223
- Acronym / sponsor ID
- CIGE025E2306
- Conditions
- Chronic Spontaneous Uriticaria
- Keywords
- Chronic spontaneous uriticaria, Omalizumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 31 Dec 2014 (estimated)
- Results
- Posted 20 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult participants 12 - 75 years who received the diagnosis of refractory chronic spontaneous uriticaria and who remained symptomatic despite standard-dosed non-sedating H1 antihistamine treatment.
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 300 mg | Experimental | Biological: OmalizumabParticipants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period. |
| Omalizumab 150 mg | Experimental | Biological: OmalizumabParticipants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period. |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of chronic spontaneous urticaria refractory to H1 antihistamine at the time of randomization
- Chronic spontaneous urticaria diagnosis for 6 months
Key exclusion criteria (10 listed)
- Weight less than 20 kg
- 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
- Previous treatment with omalizumab
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: XolairOmalizumab was supplied as a lyophilized, sterile powder in a single-use vial. | Biological | Omalizumab 150 mg, Omalizumab 300 mg |
| PlaceboPlacebo was supplied as a lyophilized, sterile powder in a single-use vial without study drug. | Other | Placebo |
Primary outcome
Change From Baseline in the Weekly Itch Severity Score at Week 12
Time frame: Baseline to Week 12
The weekly itch severity score is a component of the Urticaria Activity Score 7 (UAS7) composite score. The UAS7 is a composite score of the number of wheals (hives) and the severity of the itch. The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score from baseline indicates improvement.
8 secondary outcomes
Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at Week 12
Time frame: Baseline to Week 12
Change From Baseline in the Weekly Number of Hives Score at Week 12
Time frame: Baseline to Week 12
Percentage of Participants With a UAS7 Score ≤ 6 at Week 12
Time frame: Week 12
Change From Baseline in the Weekly Size of the Largest Hive Score at Week 12
Time frame: Baseline to Week 12
Percentage of Weekly Itch Severity Score Minimally Important Difference (MID) Responders at Week 12
Time frame: Week 12
Percentage of Complete Responders (UAS7 = 0) at Week 12
Time frame: Week 12
Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12
Time frame: Baseline to Week 12
Percentage of Participants With Production of Anti-omalizumab Antibody
Time frame: Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
39 sites in 2 countries: 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 Uriticaria, run by Novartis Pharmaceuticals at 39 sites in 2 countries.
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 2 inclusion and 10 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 21 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Japan, South Korea. 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 20 Sep 2016). 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 in the Weekly Itch Severity Score at Week 12 (time frame: Baseline to Week 12). 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 21 Sep 2016.