Efficacy and Safety of Histamine Human Immunoglobulin in the Treatment of Chronic Spontaneous Urticaria (CSU)

Hangzhou Grand Biologic Pharmaceutical

Status and phase: Not yet enrolling; Phase 4

Conditions: Chronic Spontaneous Urticaria

Treatments: Biological: human histaglobulin; Drug: Loratadine 10 Mg; Biological: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06250400

I-23PJ2191

Details and patient eligibility

About

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.

Enrollment: 252 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

252 participants in 2 patient groups, including a placebo group

Treatment

Experimental group

Description:

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.

Treatment:

Drug: Loratadine 10 Mg

Biological: human histaglobulin

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Loratadine 10 Mg

Biological: placebo