Clinical trial NCT07011043: A Phase 1b Study of Budoprutug in Systemic Lupus Erythematosus (SLE)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Systemic Lupus Erythematosus
Keywords: Lupus
SLE
Biologics
Open-label
Monoclonal
Anti-CD19
Lead sponsor: Climb Bio, Inc.
Sponsor class: INDUSTRY
First posted: 2025-06-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This is an open-label study in which subjects will be enrolled into four single-dose ascending cohorts. Each subject's participation will last approximately 198 days, including a 30-day screening period, a 1-day treatment period, and follow-up through Week 24.
Primary purpose: TREATMENT

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.

Detailed description: Budoprutug is a humanized, immunoglobulin (Ig) G1 monoclonal antibody that selectively binds to CD19 and is projected to deplete targeted cells through antibody-dependent cellular cytotoxicity. This Phase 1b, open-label study will evaluate budoprutug administered as a single intravenous infusion in ascending dose cohorts of patients aged 18 years and above with active, seropositive SLE and inadequate response to standard therapy. The study will also assess the pharmacokinetics, pharmacodynamics and early indications of efficacy of budoprutug in SLE, where pharmacodynamics will be evaluated as the change in the number of B cells and immunoglobulins (antibodies) in the blood over time following a single infusion.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Up to Week 24
measure: Incidence of Clinical Laboratory Abnormalities
timeFrame: Up to Week 24
measure: Change from Baseline in Systolic Blood Pressure
timeFrame: Up to Week 24
measure: Change from Baseline in Diastolic Blood Pressure
timeFrame: Up to Week 24
measure: Change from Baseline in Heart Rate
timeFrame: Up to Week 24
measure: Change from Baseline in Respiratory Rate
timeFrame: Up to Week 24
measure: Change from Baseline in Body Temperature
timeFrame: Up to Week 24
measure: Change from Baseline in PR Interval
timeFrame: Up to Week 24
measure: Change from Baseline in QRS Duration
timeFrame: Up to Week 24
measure: Change from Baseline in QT Interval
timeFrame: Up to Week 24
measure: Change from Baseline in QTc Interval
timeFrame: Up to Week 24
Secondary outcomes:
measure: Area Under the Curve (AUC) of Budoprutug
timeFrame: Up to Week 24
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Up to Week 24
measure: Time to Maximum Observed Concentration (Tmax)
timeFrame: Up to Week 24
measure: Terminal Half-Life (T1/2)
timeFrame: Up to Week 24
measure: Apparent Clearance (CL/F) of budoprutug
timeFrame: Up to Week 24
measure: Volume of Distribution (Vd)
timeFrame: Up to Week 24
measure: Change from Baseline in Circulating B Cell Count
timeFrame: Up to Week 24
measure: Incidence of Anti-Drug Antibodies (ADAs)
timeFrame: Up to Week 24
measure: ADA Titer Over Time
timeFrame: Up to Week 24
Other outcomes:
measure: Change from Baseline in BILAG-2004 Score
timeFrame: Up to Week 24
measure: Change from Baseline in SLEDAI-2K Score
timeFrame: Up to Week 24
measure: Change from Baseline in Physician's Global Assessment
timeFrame: Up to Week 24
measure: Proportion of Participants Achieving SRI-4 Response
timeFrame: Up to Week 24
measure: Change from Baseline in Urine Protein Creatinine Ratio (UPCR)
timeFrame: Up to Week 24
measure: Time to Renal Response
timeFrame: Up to Week 24
measure: Proportion of Participants with Complete or Partial Renal Response
timeFrame: Up to Week 24
measure: Change from Baseline in FACIT-Fatigue Score
timeFrame: Up to Week 24
Locations:
city: San Antonio
country: United States
facility: Climb Bio Investigative Site #100101
state: Texas
city: Caguas
country: Puerto Rico
facility: Climb Bio Investigative Site #100103
city: Ivano-Frankivsk
country: Ukraine
facility: Climb Bio Investigative Site #380102
city: Kyiv
country: Ukraine
facility: Climb Bio Investigative Site #380103
city: Kyiv
country: Ukraine
facility: Climb Bio Investigative Site #380106
city: Ternopil
country: Ukraine
facility: Climb Bio Investigative Site #380101
city: Vinnytsia
country: Ukraine
facility: Climb Bio Investigative Site #380104
city: Vinnytsia
country: Ukraine
facility: Climb Bio Investigative Site #380105
Study officials:
affiliation: Climb Bio, Inc.
name: Study Director
role: STUDY_DIRECTOR
References: