BBD-1 for Henoch-Schönlein Purpura

Enrolling by invitation at 1 trial location
Age: Any Age
Sex: Any
Trial Phase: Phase 2
Sponsor: Qifeng Zhang
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BBD-1, a multi-target immune enhancement agent, for individuals with IgA vasculitis. This condition can cause skin redness, itching, joint pain, and sometimes serious kidney issues. The trial aims to determine if BBD-1 can reduce these symptoms and improve quality of life by boosting the immune system. To qualify, participants must have a confirmed diagnosis of IgA vasculitis with symptoms such as purpura (skin rash) or issues affecting the kidneys, joints, or intestines. The trial seeks a better option for those who do not respond well to current treatments. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Is there any evidence suggesting that BBD-1 is likely to be safe for humans?

Research has shown that the BBD-1 treatment is safe for individuals with IgA vasculitis, a type of allergic reaction. Studies have confirmed its effectiveness and safety. After treatment, patients experienced significant improvements. Specifically, reports indicated that itching and pain decreased substantially within just one hour. Within 24 to 96 hours, the skin condition (purpura) improved greatly, often disappearing completely. These findings suggest that BBD-1 is well-tolerated, with no major side effects reported in the studies.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Henoch-Schönlein Purpura, which often include corticosteroids and immunosuppressants, BBD-1 offers a novel approach by enhancing immune response. Researchers are excited about BBD-1 because it targets multiple immune pathways, potentially providing faster relief from symptoms like itching and pain. Remarkably, while conventional treatments can take weeks to show significant effects, BBD-1 has shown the potential to dramatically reduce symptoms within just a few days. This rapid action could mean quicker recoveries and improved quality of life for patients.

What is the effectiveness track record for BBD-1 in treating hypersensitivity (IgA) vasculitis?

Studies have shown that the BBD-1 treatment, which participants in this trial will receive, effectively manages allergic reactions, specifically IgA vasculitis. In earlier research, itching almost disappeared just one hour after treatment, and pain significantly reduced. After 24 hours, the skin rash began to fade; after 48 hours, it became much lighter; and by 72 hours, it mostly disappeared. Within 96 hours, it often met the criteria for being clinically cured. This suggests that BBD-1 could quickly relieve symptoms and improve the quality of life for those affected by this condition.12346

Are You a Good Fit for This Trial?

This trial is for people diagnosed with hypersensitivity (IgA) vasculitis, showing skin symptoms or problems in the kidneys, joints, or intestines. Participants must not be in another clinical trial and need to have social security insurance and give consent.

Inclusion Criteria

I have been diagnosed with IgA vasculitis by a doctor.
I have purpura or problems with my kidneys, joints, or intestines.

Exclusion Criteria

Participation in another intervention trial
Patient did not sign the informed consent form
Patients without social security insurance

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive BBD-1 multi-target immune enhancement targeting agent. Itching and pain are reduced within 1 hour, purpura lightens over 96 hours.

1 week
Daily monitoring for 7 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of purpura disappearance, joint pain relief, and kidney function.

4 weeks
Weekly visits

What Are the Treatments Tested in This Trial?

Interventions

  • BBD-1 Multi-target Immune Enhancement Targeting Agent

Trial Overview

The study is testing a new treatment called BBD-1 Multi-target Immune Enhancement Targeting Agent to see if it helps people with IgA vasculitis. The focus is on how well it works and its safety compared to current treatments.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Allergic reaction (IgA) vasculitisExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Qifeng Zhang

Lead Sponsor

Citations

Evaluate the Effectiveness and Safety of BBD-1 Multi-target ...

Existing research has confirmed that BBD-1 multi-target immune enhancement targeting agent is effective and safe in treating hypersensitivity ...

BBD-1 for Henoch-Schönlein Purpura · Info for Participants

The study is testing a new treatment called BBD-1 Multi-target Immune Enhancement Targeting Agent to see if it helps people with IgA vasculitis.

IgA Vasculitis (Henoch–Schönlein Purpura): An Update ... - PMC

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