Clinical trial NCT06250400: Efficacy and Safety of Histamine Human Immunoglobulin in the Treatment of Chronic Spontaneous Urticaria (CSU)
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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Chronic Spontaneous Urticaria
Lead sponsor: Hangzhou Grand Biologic Pharmaceutical, Inc.
Sponsor class: INDUSTRY
First posted: 2024-02-09
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Written informed consent must be obtained before any assessment is performed；
2. Age ≥ 18 years；
3. 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;
4. Patients with uncontrolled urticaria are regularly treated with standard single-dose antihistamines regularly for 2 weeks before screening;

Exclusion Criteria:

1. Pregnant or nursing (lactating) women;
2. 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；
3. History of drug or alcohol abuse;
4. 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;
5. 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;
6. Allergic to human immunoglobulin;
7. History of other severe allergic reactions;
8. 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；
9. Subjects whom the investigator considers unsuitable for other reasons.

Primary outcomes:
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)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Time when UAS7 (range 0-42) <7 for the first time
timeFrame: up to 5 weeks
measure: Changes in UAS7 scores(range 0-42) after each dose compared with baseline
timeFrame: up to 5 weeks
measure: Proportion of patients who responded to treatment as assessed by UCT score
timeFrame: up to 5 weeks
measure: Proportion of patients with well-controlled disease as assessed by UCT score
timeFrame: up to 5 weeks
measure: Change in chronic urticaria quality of life questionnaire (CU-Q2oL) score from baseline
timeFrame: up to 5 weeks
measure: Proportion of patients who developed respiratory infections
timeFrame: up to 10 weeks
Other outcomes:
measure: Dosage of loratadine tablets and ebastine tablets
timeFrame: up to 10 weeks
measure: The Amount of Histamine, autoantibodies and FcepsilonRI receptors
timeFrame: up to 10 weeks
Locations:
Study officials:
References: