Recruiting
Phase 1

Budoprutug

Sponsor:

Climb Bio, Inc.

Code:

NCT07011043

Conditions

Systemic Lupus Erythematosus

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Budoprutug

Study Details

Brief 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.

Conditions

Systemic Lupus Erythematosus

Study ID

NCT07011043

Start date

Jul 10, 2025

Status verified date

Mar, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Aged 18 to 65 years at the time of consent.
2. Diagnosis of SLE according to the 2019 European League Against. Rheumatism and the American College of Rheumatology (ACR) classification criteria.
3. Active, seropositive disease, with SLEDAI 2K >=8.
4. Inadequate response to at least 2 therapeutic interventions, including at least one oral immunosuppressive or biologic standard-of care therapy.

Exclusion Criteria:

1. Active neuropsychiatric SLE.
2. History of inflammatory or autoimmune diseases including, but not limited to, rheumatoid arthritis, scleroderma, myositis, vasculitis, inflammatory bowel disease, or other conditions that require immune suppressive therapy. Subjects with stable concurrent Sjogren's, asthma, or autoimmune thyroid disease may be considered for participation.
3. Active systemic infection or history of chronic, recurrent, latent, or recent serious infections.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1: Dose Level A

experimental: Cohort 2: Dose Level B

experimental: Cohort 3: Dose Level C

experimental: Cohort 4: Dose Level D

Interventions

Budoprutug

Single IV dose of study product on Day 1 of study

Primary outcome measure

  • Incidence of Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to Week 24 ]
  • Incidence of Clinical Laboratory Abnormalities [ Time Frame: Up to Week 24 ]
  • Change from Baseline in Systolic Blood Pressure [ Time Frame: Up to Week 24 ]
  • Change from Baseline in Diastolic Blood Pressure [ Time Frame: Up to Week 24 ]
  • Change from Baseline in Heart Rate [ Time Frame: Up to Week 24 ]
  • Change from Baseline in Respiratory Rate [ Time Frame: Up to Week 24 ]
  • Change from Baseline in Body Temperature [ Time Frame: Up to Week 24 ]
  • Change from Baseline in PR Interval [ Time Frame: Up to Week 24 ]
  • Change from Baseline in QRS Duration [ Time Frame: Up to Week 24 ]
  • Change from Baseline in QT Interval [ Time Frame: Up to Week 24 ]
  • Change from Baseline in QTc Interval [ Time Frame: Up to Week 24 ]

Central Contacts and Locations

Central contacts

Locations

Climb Bio Investigative Site #100104

Recruiting

Allen, Texas, United States, 75013

Climb Bio Investigative Site #100101

Recruiting

San Antonio, Texas, United States, 78215

More Information

Sponsor

Climb Bio, Inc.

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Keywords

  • Lupus
  • SLE
  • Biologics
  • Open-label
  • Monoclonal
  • Anti-CD19

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Climb Bio, Inc. on 2026-03-27.