Evaluate the Effectiveness and Safety of BBD-1 Multi-target Immune Enhancement Targeting Agent in the Treatment of Hypersensitivity Reaction (IgA) Vasculitis

NCT07595367 | Enrolling By Invitation Phase 2 FDA Drug

• 2 other identifiers: BBD-1Funding BBD-1
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 2

Brief Summary

Hypersensitivity (IgA) vasculitis is a common vascular allergic disease, the cause of which is not yet clear, and may involve infection, immune disorders, heredity and other factors. It belongs to the category of immune diseases. The disease can be divided into simple type, abdominal type, joint type, renal type and mixed type allergic purpura according to the location of the disease. The annual incidence rate is about 6.1 to 55.9 cases per 100000 people. The highest incidence rate is among children aged 2 to 6 years. When the kidneys are affected, this condition is called IgAV nephritis (IgAVN), affecting approximately 20% to 80% of IgAV patients, making it one of the most common secondary glomerular diseases in this population. At the same time, skin redness, itching, and joint pain caused by hypersensitivity reaction (IgA) vasculitis also seriously affect the quality of life of patients. Most IgAVN cases are mild or self limiting; However, some patients may experience severe kidney involvement, manifested as nephrotic syndrome, significant proteinuria, elevated serum creatinine levels, hypertension, persistent proteinuria, and kidney biopsy results showing more than 50% crescent shaped involvement. Research has shown that approximately 10% to 20% of patients with moderate to severe proteinuria caused by IgAVN may develop end-stage renal disease (ESRD), and persistent proteinuria has been identified as an independent risk factor for poor prognosis of IgAVN. At present, clinical treatment mainly relies on nonsteroidal anti-inflammatory drugs, glucocorticoids, anti allergic and antihistamines, anticoagulants, corticosteroids, calcineurin inhibitors (CNI), mycophenolate mofetil (MMF), cyclophosphamide (CTX), and other immunosuppressants. However, some patients may not respond well to conventional treatment, and long-term use of these drugs may lead to various adverse reactions, including infections, metabolic disorders, and growth disorders.

Conditions

Allergic Reaction (IgA) Vasculitis

Keywords

Allergic reaction (IgA) vasculitis

Outcome Measures

Primary Outcomes (1)

• Allergic reaction (IgA) vasculitis

  1. The disappearance of palpable purpura is a direct manifestation of recovery. Observe whether there are new subcutaneous bleeding points on the patient's body, and whether the original purpura color gradually changes from purple red to yellow brown until it disappears. Some patients may have temporary pigmentation, but it will not continue to expand or recur. 2. Joint pain disappears. Patients with hypersensitivity reaction (IgA) vasculitis answered in the questionnaire that the swollen joint pain was relieved and their mobility was restored, indicating that the inflammation was under control. Diagnosis can also be made through C-reactive protein testing. 3. No proteinuria (24-hour urine protein below 0.4g/24 hours). Urine routine examination can detect protein indicators in urine to evaluate kidney function. 4. The serum albumin level is 35g-55g/L. Serum creatinine is below 1.24mg/dL. Perform blood biochemical tests on serum albumin and serum creatinine to evaluate renal function.

  7 days

Study Arms (1)

Allergic reaction (IgA) vasculitis

EXPERIMENTAL

Existing research has confirmed that BBD-1 multi-target immune enhancement targeting agent is effective and safe in treating hypersensitivity reaction (IgA) vasculitis. After one hour of intervention therapy with BBD-1 multi-target immune enhancement targeting agent, itching basically disappeared and pain was significantly reduced. After 24 hours, the purpura became lighter, and after 48 hours, the purpura became significantly lighter. After 72 hours, the purpura basically disappeared, and after 96 hours, it reached the clinical cure standard.

Drug: BBD-1 Multi target Immune Enhancement Targeting Agent

Interventions

BBD-1 Multi target Immune Enhancement Targeting Agent DRUG

Existing research has confirmed that BBD-1 multi-target immune enhancement targeting agent is effective and safe in treating hypersensitivity reaction (IgA) vasculitis. After one hour of intervention therapy with BBD-1 multi-target immune enhancement targeting agent, itching basically disappeared and pain was significantly reduced. After 24 hours, the purpura became lighter, and after 48 hours, the purpura became significantly lighter. After 72 hours, the purpura basically disappeared, and after 96 hours, it reached the clinical cure standard.

Allergic reaction (IgA) vasculitis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Medically confirmed hypersensitivity vasculitis with IgA deposition IgA vasculitis
• Purpura and/or involvement of at least one organ in the kidneys, joints, or intestines

You may not qualify if:

• Participate in another intervention trial
• The patient did not sign the informed consent form
• Patients without social security insurance

Sponsors & Collaborators

• Qifeng Zhang: lead

Study Sites (2)

Forest ecological agriculture

Baltimore, Maryland, 21287, United States

Location

Forest ecological agriculture

Liaocheng, Shandong, 252000, China

Location

MeSH Terms

Conditions

Hypersensitivity; Vasculitis

Condition Hierarchy (Ancestors)

Immune System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: R&D Director

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 19, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

US (1); CN (1)