Budoprutug for Lupus
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the safety of a new treatment called budoprutug for people with lupus, a condition where the immune system attacks the body. Researchers seek to understand how the body handles different doses of the medication and its effects on lupus symptoms. The trial includes four groups, each receiving a different dose of budoprutug to determine which is safest and most effective. Individuals with long-standing lupus, active symptoms, and poor response to other treatments might be suitable candidates for this trial. As a Phase 1 trial, this research focuses on understanding how budoprutug works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that budoprutug is likely to be safe for humans?
Research has shown that budoprutug is under investigation for safety in various trials. Some trials focus on individuals with systemic lupus erythematosus (SLE), an autoimmune disease. The primary goal is to assess how well participants tolerate the treatment and identify any side effects.
This trial is in its early stages, so researchers are still collecting initial safety data. Early-stage trials typically evaluate a treatment's safety and potential side effects. Although detailed public information from these studies is not yet available, the trial's phase indicates that safety is a primary concern.
While detailed data remains limited, testing budoprutug in multiple trials suggests it is considered potentially safe enough for further exploration. This trial will provide researchers with insights into how participants respond to different doses of budoprutug.12345Why do researchers think this study treatment might be promising for lupus?
Researchers are excited about Budoprutug for lupus because it offers a new approach to managing the condition. Unlike current standard treatments, which often include corticosteroids and immunosuppressants that can have significant side effects, Budoprutug is designed to target specific pathways involved in the autoimmune response. This targeted mechanism may reduce symptoms more effectively and with fewer side effects. Additionally, Budoprutug's potential for better precision in modulating the immune system could lead to improved outcomes for patients who don't respond well to existing therapies.
What evidence suggests that budoprutug might be an effective treatment for lupus?
Research has shown that budoprutug is a specially designed antibody targeting a protein called CD19, found on certain immune cells. By attaching to CD19, budoprutug aims to reduce these immune cells, potentially lessening lupus symptoms. Early studies are testing budoprutug for its effects on systemic lupus erythematosus (SLE), a type of lupus. While more data is needed to confirm its effectiveness, its action suggests it could help manage lupus symptoms by reducing harmful immune cell activity. Participants in this trial will receive different dose levels of budoprutug to evaluate its safety and efficacy.12678
Who Is on the Research Team?
Study Director
Principal Investigator
Climb Bio, Inc.
Are You a Good Fit for This Trial?
Adults aged 18 to 65 with a confirmed diagnosis of Systemic Lupus Erythematosus (SLE) according to specific criteria, who have active disease and haven't responded well to at least two standard treatments, including an oral immunosuppressive or biologic therapy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single intravenous infusion of budoprutug in ascending dose cohorts
Follow-up
Participants are monitored for safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- Budoprutug
Trial Overview
The trial is testing the safety and how well people tolerate Budoprutug in adults with SLE. It will also look into how the body processes the drug, its effects on the body, and initial signs if it's working for treating SLE.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Climb Bio, Inc.
Lead Sponsor
Citations
1.
ir.eliemtx.com
ir.eliemtx.com/news-releases/news-release-details/climb-bio-reports-third-quarter-2025-financial-results-andClimb Bio Reports Third Quarter 2025 Financial Results ...
Data from this trial is expected to provide insights into budoprutug activity after a single intravenous dose and will also help to inform ...
A Phase 1b Study of Budoprutug in Systemic Lupus ...
Budoprutug is a humanized, immunoglobulin (Ig) G1 monoclonal antibody that selectively binds to CD19 and is projected to deplete targeted cells through ...
Climb Bio Reports Second Quarter 2025 Financial Results ...
We have now dosed patients in both the ITP and SLE clinical trials of budoprutug, our anti-CD19 monoclonal antibody, and achieved regulatory ...
A Phase 1b Study of Budoprutug in Systemic Lupus ...
The main objective is to assess the safety and tolerability of budoprutug in adults with SLE. Pharmacokinetics, pharmacodynamics, and preliminary clinical ...
Budoprutug for Lupus · Recruiting Participants for Phase ...
The main objective is to assess the safety and tolerability of budoprutug in adults with SLE. Pharmacokinetics, pharmacodynamics, and preliminary clinical ...
6.
eliemtx.gcs-web.com
eliemtx.gcs-web.com/news-releases/news-release-details/climb-bio-present-data-american-society-nephrology-asn-kidneyClimb Bio to Present Data at American Society of Nephrology ...
Climb Bio is evaluating budoprutug in multiple clinical trials across three lead indications—primary membranous nephropathy (pMN), immune ...
7.
trial.medpath.com
trial.medpath.com/clinical-trial/6750918e134bf091/nct06570434-safety-tolerability-budoprutug-systemic-lupus-erythematosusPhase 1b/2a in SLE With Budoputug | MedPath
The purpose of the study is to determine the safety, tolerability, and pharmacokinetics of budoprutug in participants with SLE.
Climb Bio Reports First Quarter 2025 Financial Results and ...
This open-label, dose-ranging trial is designed to further evaluate the efficacy and safety of budoprutug in pMN. ... lupus erythematosus ...
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