RecruitingPhase 1NCT07011043

A Phase 1b Study of Budoprutug in Systemic Lupus Erythematosus (SLE)

A Phase 1b Open-Label, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Budoprutug (TNT119) in Adult Subjects With Systemic Lupus Erythematosus (SLE)

Sponsor

Climb Bio, Inc.

Enrollment

30 participants

Start Date

Jul 10, 2025

Study Type

INTERVENTIONAL

Conditions

Systemic Lupus Erythematosus

Summary

The main objective is to assess the safety and tolerability of budoprutug in adults with SLE. Pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy will also be assessed.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Budoprutug for people with systemic lupus erythematosus. The study is currently recruiting participants at 18 locations. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGBudoprutug

Single IV dose of study product on Day 1 of study

Locations(18)

Climb Bio Investigative Site #100104

Allen, Texas, United States

Climb Bio Investigative Site #100101

San Antonio, Texas, United States

Climb Bio Investigative Site# 359101

Plovdiv, Bulgaria

Climb Bio Investigative Site# 359102

Sofia, Bulgaria

Climb Bio Investigative Site #995102

Tbilisi, Georgia

Climb Bio Investigative Site #995101

Tbilisi, Georgia

Climb Bio Investigative Site# 300102

Exochi, Thessaloniki, Greece

Climb Bio Investigative Site# 300103

Thessaloniki, Thessaloniki, Greece

Climb Bio Investigative Site #100103

Caguas, Puerto Rico

Climb Bio Investigative Site# 400101

Cluj-Napoca, Romania

Climb Bio Investigative Site# 340101

Sabadell, Barcelona, Spain

Climb Bio Investigative Site# 340102

A Coruña, Spain

Climb Bio Investigative Site #380102

Ivano-Frankivsk, Ukraine

Climb Bio Investigative Site #380103

Kyiv, Ukraine

Climb Bio Investigative Site #380106

Kyiv, Ukraine

Climb Bio Investigative Site #380101

Ternopil, Ukraine

Climb Bio Investigative Site #380104

Vinnytsia, Ukraine

Climb Bio Investigative Site #380105

Vinnytsia, Ukraine

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07011043

Related Trials

A Study to Assess Adverse Events, How the Drug Moves Through the Body and Effectiveness of Intravenous Infusions and Subcutaneous Injections of ABBV-519 in Adult Participants With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)

NCT076079646 locations

A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus

NCT06617325230 locations

Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO

NCT0381634552 locations

A Study to Test Whether Different Doses of BI 3000202 Help People With Systemic Lupus Erythematosus (SLE)

NCT07409181139 locations

US Zamto-cel Autoimmune Diseases

NCT067088451 location