DB-2304 for Systemic Lupus Erythematosus
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore the effects of a new treatment, DB-2304, in people with lupus, a disease where the immune system attacks the body. Researchers are testing different doses of DB-2304 to assess its safety and effectiveness. Participants with active lupus skin disease or those on stable lupus treatments might be suitable for this study. The trial also includes healthy volunteers for comparison. As a Phase 1/Phase 2 trial, participants will help researchers understand how the treatment works and measure its effectiveness in an initial group.
Will I have to stop taking my current medications?
The trial requires that participants with Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus continue their current stable treatment regimen for at least 1 month before joining the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that DB-2304 has been tested in both healthy adults and people with systemic lupus erythematosus (SLE). In these studies, DB-2304 was generally well-tolerated. The trials examined the drug's pharmacokinetics and its effects on the body.
Some early reports mention mild side effects, but serious side effects were rare. These initial studies aimed to find the right dose and check for any immediate safety issues.
Prednisone, a well-known treatment, has a long history of use. It is generally safe under a doctor's guidance, although it can cause side effects like weight gain and mood changes with long-term use.
Overall, both treatments have shown an acceptable safety profile in the studies conducted so far. Researchers will closely monitor participants in the current trial to further assess safety.12345Why are researchers excited about this trial's treatments?
DB-2304 is unique because it targets systemic lupus erythematosus (SLE) in a potentially new way. While most current treatments for SLE, like prednisone, focus on suppressing the immune system broadly to reduce inflammation, DB-2304 might work by targeting specific pathways involved in the disease. This specific targeting could mean fewer side effects compared to traditional immunosuppressants. Researchers are excited because this approach could offer a more precise treatment option, potentially improving outcomes for patients with SLE.
What evidence suggests that this trial's treatments could be effective for lupus?
Research has shown that DB-2304, a new antibody-based treatment, could help with conditions like lupus. In lab and animal studies, it demonstrated strong effects by targeting and controlling specific genes important in lupus. Previous studies with similar treatments have shown positive results in reducing lupus symptoms, suggesting DB-2304 might also be effective. Designed to be stronger than earlier drugs, it may offer better results. Although still in early stages, these findings provide hope for its effectiveness in treating lupus.12367
Who Is on the Research Team?
Lily Hu
Principal Investigator
DualityBio Inc.
Are You a Good Fit for This Trial?
This trial is for healthy adults and those with Systemic Lupus Erythematosus (SLE) who understand the study and consent to participate. They must meet specific SLE criteria, have no significant medical findings, agree to use effective contraception, and be willing to follow the study protocol.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive DB-2304 for injection across multiple dose levels
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- DB-2304
- Prednisone
Trial Overview
The trial is testing a new medication called DB-2304 against Prednisone and a placebo in people with SLE. It's designed to see if DB-2304 is safe and how it affects the body compared to standard treatment or an inactive substance.
How Is the Trial Designed?
8
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
DualityBio Inc.
Lead Sponsor
Citations
NCT06625671 | A Phase 1 Study of DB-2304 in Healthy ...
A Randomized, Double-Blind, Placebo- and Positive-Controlled, Single Ascending Dose and Multiple Ascending Dose Phase 1 Study to Evaluate the Safety, ...
DB-2304, an Immunomodulatory Antibody‒drug ...
DB-2304 has clearly demonstrated greater in vitro and in vivo potency with synergistic effects on the regulation of both type I interferon genes and ...
First Patient Dosed in Phase I/IIa Study of DualityBio's ...
It aims to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD), and preliminary clinical activity of DB-2304 for ...
An immunomodulatory antibody-drug conjugate (ADC) ...
Although anti-BDCA2 antibody therapy reduced disease activity in SLE patients, its clinical efficacy needs further improvement. We developed a ...
5.
acrabstracts.org
acrabstracts.org/abstract/db-2304-a-novel-anti-bdca2-monoclonal-antibody-drug-conjugate-displayed-great-potency-in-suppression-of-pdc-functions/DB-2304, a Novel anti-BDCA2 Monoclonal Antibody Drug ...
BIIB059, an anti-BDCA2 monoclonal antibody developed by Biogen, has demonstrated clinical efficacy in CLE and SLE patients. Nevertheless, the results of its ...
DB-2304 - Drug Targets, Indications, Patents
A randomized, double-blind, placebo- and positive-controlled, single ascending dose and multiple ascending dose phase 1 study to evaluate the safety, ...
Systemic Lupus Erythematosus (DBCOND0027960)
A Phase 1 Study of DB-2304 in Healthy Adults and SLE Participants. DB-2304 ... Safety and Efficacy of Telitacicept in the Treatment of Systemic Lupus ...
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