Chronic Spontaneous UrticariaPhase 4NCT06250400
Efficacy and Safety of Histamine Human Immunoglobulin in the Treatment of Chronic Spontaneous Urticaria (CSU)
A Phase 4 study testing human histaglobulin and Loratadine 10 Mg in people with Chronic Spontaneous Urticaria, run by Hangzhou Grand Biologic Pharmaceutical, Inc..
Trial summary
The goal of this clinical trial is to study patients with chronic spontaneous urticaria. The main question it aims to answer is the efficacy and safety of histamine human immunoglobulin (ShuYangMinNing) in the treatment of chronic spontaneous urticaria. 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?
- human histaglobulin and Loratadine 10 Mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 252 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2024to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Written informed consent must be obtained before any assessment is performed；
- Age ≥ 18 years；
- Meet the diagnostic criteria of chronic spontaneous urticaria from《Guideline for diagnosis and treatment of urticaria in China（2022）》and follow the doctor's advice；the patient had urticaria symptoms in the previous week before enrollment, and UAS7 score(range 0-42) ≥ 7;
- Patients with uncontrolled urticaria are regularly treated with standard single-dose antihistamines regularly for 2 weeks before screening;
Who cannot join
- Pregnant or nursing (lactating) women;
- Patients with malignant tumors, severe liver and kidney diseases, hematological disorders, autoimmune diseases(such as systemic lupus erythematosus, Sjogren's syndrome, dermatomyositis, myositis, systemic vasculitis, systemic sclerosis, rheumatoid arthritis, spondyloarthropathy or other rheumatic immune diseases evaluated by the physician that are not suitable for inclusion), chronic serious infections, diabetic peripheral neuropathy, psychosis, and other diseases or medical histories that may affect normal efficacy evaluation and/or subject safety evaluation；
- History of drug or alcohol abuse;
- Patients who discontinue systemic use of glucocorticoids and other immunosuppressants(such as cyclosporin A, wilfordii , etc.) that affect immune function for less than 4 weeks;Patients who discontinue systemic use of biologics (e.g., omalizumab) for less than 3 months;
- Patients with symptoms of urticaria and/or angioedema, Including but not limited to urticaria vasculitis, serum sickness like reaction, bullous pemphigoid, mastocytosis, neutrophilic urticaria dermatosis, Schnitzler syndrome, autoinflammatory response syndromes (e.g., tumor necrosis factor receptor-associated periodic fever syndrome, familial Mediterranean fever, mevaldate kinase deficiency, etc.);or other chronic itchy skin conditions, such as atopic dermatitis, dermatitis herpetiformis, and pruritus senile;
- Allergic to human immunoglobulin;
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- History of other severe allergic reactions;
- Patients with pathological arrhythmias and a history of organic heart disease; Patients with known or suspected QT prolongation; or patients who are unable to discontinue medications that cause QT prolongation during the trial；
- Subjects whom the investigator considers unsuitable for other reasons.
Trial locations and contacts
No sites are listed yet.
Lisha Li contact
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-Controlled Parallel Study：Clinical Study of Efficacy and Safety of Histamine Human Immunoglobulin (ShuYangMinNing) in the Treatment of Chronic Spontaneous Urticaria (CSU)
The goal of this clinical trial is to study patients with chronic spontaneous urticaria. The main question it aims to answer is the efficacy and safety of histamine human immunoglobulin (ShuYangMinNing) in the treatment of chronic spontaneous urticaria.
- Conditions
- Chronic Spontaneous Urticaria
- Being tested
- human histaglobulin, placebo, Loratadine 10 Mg
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human histaglobulinBiological
once 12 mg/2ml/bottle, 2 subcutaneous injection once a week, using 4 times in a row, a total of 28 d;
placeboBiological
once 12 mg/2ml/bottle, 2 subcutaneous injection once a week, using 4 times in a row, a total of 28 d;
Loratadine 10 MgDrug
orally, 10mg once a day for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment arm will receive a dose of Histamine Human Immunoglobulin 12mg (2ml) s.c. which consists of one injection of Histamine Human Immunoglobulin 12mg(2ml) vial every week for 4 times.
Treatment arm will also receive a dose of loratadine p.o. which consists of one pill of loratadine 10mg every day for 4 weeks. Receives: Biological: human histaglobulin; Drug: Loratadine 10 Mg |
| Placebo | Placebo comparator | Placebo arm will receive placebo which consists of one injection of placebo 12mg(2ml) vial every week for 4 times.
Placebo arm will also receive a dose of loratadine p.o. which consists of one pill of loratadine 10mg every day for 4 weeks. Receives: Biological: placebo; Drug: Loratadine 10 Mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease control rate during the last week of treatment (i.e., proportion of patients with urticaria activity score for 7d（UAS7，range 0-42) < 7 for 7 consecutive days after the last injection)
The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) . The daily UAS is calculated as the average of the morning and evening scores. The urticaria activity score for 7d (UAS7) is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. If UAS7 score is less than 7, it indicates disease control.
A minimum of 4 out of 7 daily scores were needed to calculate the UAS7 values. Otherwise, the weekly score was missing for that week.
The primary outcome measure was disease control rate in the last week of treatment. Chi-square test was used for comparison between groups. Based on the analysis for the main full analysis set (FAS), based on the analysis of the per protocol set（PPS) for supporting analysis.
Measured: through study completion, an average of 1 year
Secondary outcomes (6)
Time when UAS7 (range 0-42) <7 for the first time
The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) . The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity.If UAS7 score is less than 7, it indicates disease control.
Measured: up to 5 weeks
Changes in UAS7 scores(range 0-42) after each dose compared with baseline
The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) . The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity.If UAS7 score is less than 7, it indicates disease control.
Measured: up to 5 weeks
Proportion of patients who responded to treatment as assessed by UCT score
The urticaria control test (UCT) is a recently validated tool for disease control assessment in patients with CSU.Disease control over the past 4 weeks was evaluated retrospectively. The assessment included: ①the occurrence of urticaria symptoms (such as itching, wheals, etc.); ②the impact of quality of life; ③the frequency of symptoms was not sufficiently controlled by the treatment; ④overall disease control status. The score of each item ranged from 0 to 4, and the total score was the sum of the scores of the four questions.A score of 0 indicates that the disease is not under control at all, and a score of 16 indicates that it is under complete control. A total score ≥12 indicated well-controlled urticaria, and a score < 12 indicated poorly controlled urticaria.When UCT increased by ≥ 3 points, the current treatment regimen was effective.
Measured: up to 5 weeks
Proportion of patients with well-controlled disease as assessed by UCT score
The urticaria control test (UCT) is a recently validated tool for disease control assessment in patients with CSU.Disease control over the past 4 weeks was evaluated retrospectively. The assessment included: ① the occurrence of urticaria symptoms (such as itching, wheals, etc.); ② the impact of quality of life; ③ the frequency of symptoms was not sufficiently controlled by the treatment; ④ overall disease control status. The score of each item ranged from 0 to 4, and the total score was the sum of the scores of the four questions.A score of 0 indicates that the disease is not under control at all, and a score of 16 indicates that it is under complete control. A total score ≥12 indicated well-controlled urticaria, and a score < 12 indicated poorly controlled urticaria.When UCT increased by ≥ 3 points, the current treatment regimen was effective.
Measured: up to 5 weeks
Change in chronic urticaria quality of life questionnaire (CU-Q2oL) score from baseline
The Chronic Urticaria Quality of Life Questionnaire(CU-Q2oL) contains 23 items to assess the impairment of health-related quality of life (HR-QOL) in the past 2 weeks from pruritus, swelling, effect on daily activities, sleep problems, limitation and appearance. The scores of 23 items were added and linearly transformed to a total score of 0-100 CU⁃Q2oL can not only use the total score of the questionnaire to represent the overall damage of HR⁃QoL, but also use the score of one aspect (dimension) to represent the damage of specific HR⁃QoL. The higher the score, the more severe the impact of CSU on the patient.
Measured: up to 5 weeks
Proportion of patients who developed respiratory infections
Assess the proportion of patients who developed respiratory infections during the study
Measured: up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start31 Mar 2024 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Spontaneous UrticariaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Grand Biologic Pharmaceutical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250400
- Sponsor's protocol ID
- I-23PJ2191
- Status last verified
- Jan 2024
- First submitted
- 15 Jan 2024
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-Controlled Parallel Study：Clinical Study of Efficacy and Safety of Histamine Human Immunoglobulin (ShuYangMinNing) in the Treatment of Chronic Spontaneous Urticaria (CSU)
- ClinicalTrials.gov ID
- NCT06250400
- Acronym / sponsor ID
- I-23PJ2191
- Conditions
- Chronic Spontaneous Urticaria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Hangzhou Grand Biologic Pharmaceutical, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2024 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to study patients with chronic spontaneous urticaria. The main question it aims to answer is the efficacy and safety of histamine human immunoglobulin (ShuYangMinNing) in the treatment of chronic spontaneous urticaria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Biological: human histaglobulin, Drug: Loratadine 10 MgTreatment arm will receive a dose of Histamine Human Immunoglobulin 12mg (2ml) s.c. which consists of one injection of Histamine Human Immunoglobulin 12mg(2ml) vial every week for 4 times. Treatment arm will also receive a dose of loratadine p.o. which consists of one pill of loratadine 10mg every day for 4 weeks. |
| Placebo | Placebo comparator | Biological: placebo, Drug: Loratadine 10 MgPlacebo arm will receive placebo which consists of one injection of placebo 12mg(2ml) vial every week for 4 times. Placebo arm will also receive a dose of loratadine p.o. which consists of one pill of loratadine 10mg every day for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent must be obtained before any assessment is performed；
- Age ≥ 18 years；
- Meet the diagnostic criteria of chronic spontaneous urticaria from《Guideline for diagnosis and treatment of urticaria in China（2022）》and follow the doctor's advice；the patient had urticaria symptoms in the previous week before enrollment, and UAS7 score(range 0-42) ≥ 7;
- Patients with uncontrolled urticaria are regularly treated with standard single-dose antihistamines regularly for 2 weeks before screening;
Key exclusion criteria (9 listed)
- Pregnant or nursing (lactating) women;
- Patients with malignant tumors, severe liver and kidney diseases, hematological disorders, autoimmune diseases(such as systemic lupus erythematosus, Sjogren's syndrome, dermatomyositis, myositis, systemic vasculitis, systemic sclerosis, rheumatoid arthritis, spondyloarthropathy or other rheumatic immune diseases evaluated by the physician that are not suitable for inclusion), chronic serious infections, diabetic peripheral neuropathy, psychosis, and other diseases or medical histories that may affect normal efficacy evaluation and/or subject safety evaluation；
- History of drug or alcohol abuse;
- Patients who discontinue systemic use of glucocorticoids and other immunosuppressants(such as cyclosporin A, wilfordii , etc.) that affect immune function for less than 4 weeks;Patients who discontinue systemic use of biologics (e.g., omalizumab) for less than 3 months;
- Patients with symptoms of urticaria and/or angioedema, Including but not limited to urticaria vasculitis, serum sickness like reaction, bullous pemphigoid, mastocytosis, neutrophilic urticaria dermatosis, Schnitzler syndrome, autoinflammatory response syndromes (e.g., tumor necrosis factor receptor-associated periodic fever syndrome, familial Mediterranean fever, mevaldate kinase deficiency, etc.);or other chronic itchy skin conditions, such as atopic dermatitis, dermatitis herpetiformis, and pruritus senile;
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 |
|---|---|---|
| human histaglobulinonce 12 mg/2ml/bottle, 2 subcutaneous injection once a week, using 4 times in a row, a total of 28 d; | Biological | Treatment |
| placeboonce 12 mg/2ml/bottle, 2 subcutaneous injection once a week, using 4 times in a row, a total of 28 d; | Biological | Placebo |
| Loratadine 10 Mgorally, 10mg once a day for 4 weeks | Drug | Placebo, Treatment |
Primary outcome
Disease control rate during the last week of treatment (i.e., proportion of patients with urticaria activity score for 7d（UAS7，range 0-42) < 7 for 7 consecutive days after the last injection)
Time frame: through study completion, an average of 1 year
The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) . The daily UAS is calculated as the average of the morning and evening scores. The urticaria activity score for 7d (UAS7) is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. If UAS7 score is less than 7, it indicates disease control. A minimum of 4 out of 7 daily scores were needed to calculate the UAS7 values. Otherwise, the weekly score was missing for that week. The primary outcome measure was disease control rate in the last week of treatment. Chi-square test was used for comparison between groups. Based on the analysis for the main full analysis set (FAS), based on the analysis of the per protocol set（PPS) for supporting analysis.
6 secondary outcomes
Time when UAS7 (range 0-42) <7 for the first time
Time frame: up to 5 weeks
Changes in UAS7 scores(range 0-42) after each dose compared with baseline
Time frame: up to 5 weeks
Proportion of patients who responded to treatment as assessed by UCT score
Time frame: up to 5 weeks
Proportion of patients with well-controlled disease as assessed by UCT score
Time frame: up to 5 weeks
Change in chronic urticaria quality of life questionnaire (CU-Q2oL) score from baseline
Time frame: up to 5 weeks
Proportion of patients who developed respiratory infections
Time frame: up to 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Lisha Li contact
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing human histaglobulin and Loratadine 10 Mg in people with Chronic Spontaneous Urticaria, run by Hangzhou Grand Biologic Pharmaceutical, Inc..
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 4 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: status not confirmed, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kai Guan (010-69156874, dr_guankai@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease control rate during the last week of treatment (i.e., proportion of patients with urticaria activity score for 7d（UAS7，range 0-42) < 7 for 7 consecutive days after the last injection) (time frame: through study completion, an average of 1 year). 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 9 Feb 2024.