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Phase 1b Study of Budoprutug for Systemic Lupus Erythematosus

This study is testing a new treatment called budoprutug for adults with active Systemic Lupus Erythematosus (SLE), a chronic autoimmune disease. Budoprutug is a monoclonal antibody (a type of protein that targets specific cells) designed to reduce certain cells in the body. The main goal is to see if budoprutug is safe and well-tolerated. Researchers will also look at how the body processes the drug, its effects on the immune system, and any early signs of improvement in SLE symptoms. You might be able to join if you are 18-65 years old, have active SLE, and haven't responded well to at least two other treatments. This study plans to enroll 30 participants, but its current recruitment status is unclear.

Study design
This is a Phase 1b, open-label study, meaning both you and the researchers will know you are receiving budoprutug. It will involve about 30 participants and will test different doses of the drug.
What's involved
You would receive a single intravenous (IV) infusion of budoprutug on Day 1 of the study. Researchers will then monitor you for up to 24 weeks to check for side effects and changes in your health.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for up to 24 weeks after receiving the treatment to monitor for side effects and other health changes.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07011043

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

Recruiting
PHASE1Ages 18–65InterventionalTreatment
Climb Bio, Inc.
~30 participants
Updated 2026-03-27 on ClinicalTrials.gov
What's tested:Budoprutug

At a glance

Recruiting sites
18 of 18 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Measured over Up to Week 24
+10 more outcomes measured

Conditions

Systemic Lupus Erythematosus

Explore related trials

Systemic Lupus Erythematosus

Where it's being run

18 sites across 9 states
Ukraine6
Texas2
Bulgaria2
Georgia2
Thessaloniki2
Puerto Rico1
Romania1
Barcelona1

Study leadership

  • Study Director · STUDY_DIRECTOR · Climb Bio, Inc.

Who to contact

Climb Bio Study Director
[email protected]
+1 866 857 2596
Email the study team

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What this trial measures

  • Incidence of Treatment-Emergent Adverse Events (TEAEs)Up to Week 24

    Number of participants experiencing TEAEs, graded per NCI CTCAE v5.0.

  • Incidence of Clinical Laboratory AbnormalitiesUp to Week 24

    Number of participants with clinically significant laboratory abnormalities.

  • Change from Baseline in Systolic Blood PressureUp to Week 24

    Mean change from baseline in systolic blood pressure (mmHg).

  • Change from Baseline in Diastolic Blood PressureUp to Week 24

    Mean change from baseline in diastolic blood pressure (mmHg).

  • Change from Baseline in Heart RateUp to Week 24

    Mean change from baseline in heart rate (bpm).

  • Change from Baseline in Respiratory RateUp to Week 24

    Mean change from baseline in respiratory rate.

  • Change from Baseline in Body TemperatureUp to Week 24

    Mean change from baseline in body temperature (°C).

  • Change from Baseline in PR IntervalUp to Week 24

    Mean change from baseline in PR interval (ms).

  • Change from Baseline in QRS DurationUp to Week 24

    Mean change from baseline in QRS duration (ms).

  • Change from Baseline in QT IntervalUp to Week 24

    Mean change from baseline in QT interval (ms).

  • Change from Baseline in QTc IntervalUp to Week 24

    Mean change from baseline in corrected QT interval (QTc).