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

NCT06250400 | Unknown Phase 4

• 1 other identifier: I-23PJ2191
• Study Type: interventional
• Target: 252
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Spontaneous Urticaria

Outcome Measures

Primary Outcomes (1)

• 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.

  through study completion, an average of 1 year

Secondary Outcomes (6)

• Time when UAS7 (range 0-42) <7 for the first time

  up to 5 weeks

• Changes in UAS7 scores(range 0-42) after each dose compared with baseline

  up to 5 weeks

• Proportion of patients who responded to treatment as assessed by UCT score

  up to 5 weeks

• Proportion of patients with well-controlled disease as assessed by UCT score

  up to 5 weeks

• Change in chronic urticaria quality of life questionnaire (CU-Q2oL) score from baseline

  up to 5 weeks

Other Outcomes (2)

• Dosage of loratadine tablets and ebastine tablets

  up to 10 weeks

• The Amount of Histamine, autoantibodies and FcepsilonRI receptors

  up to 10 weeks

Study Arms (2)

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.

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.

Biological: placebo; Drug: Loratadine 10 Mg

Interventions

human histaglobulin BIOLOGICAL

once 12 mg/2ml/bottle, 2 subcutaneous injection once a week, using 4 times in a row, a total of 28 d;

Treatment

placebo BIOLOGICAL

once 12 mg/2ml/bottle, 2 subcutaneous injection once a week, using 4 times in a row, a total of 28 d;

Placebo

Loratadine 10 Mg DRUG

orally, 10mg once a day for 4 weeks

Placebo; Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• Pregnant or nursing (lactating) women;
• 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;
• 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.

Sponsors & Collaborators

• Hangzhou Grand Biologic Pharmaceutical, Inc.: lead

MeSH Terms

Conditions

Chronic Urticaria

Interventions

Loratadine

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyproheptadine; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Central Study Contacts

Kai Guan

CONTACT

010-69156874; dr_guankai@126.com

Lisha Li

CONTACT

13661359318

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: February 9, 2024
• Study Start: March 31, 2024
• Primary Completion: July 1, 2025
• Study Completion: December 31, 2025
• Last Updated: February 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share