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Recruiting NCT07011043

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

Phase I Interventional Systemic Lupus Erythematosus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Budoprutug.
Who it may be relevant to
Registry conditions: Systemic Lupus Erythematosus. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Bulgaria, Georgia, Greece, Puerto Rico +3
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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.

Interventions

  • Drug Budoprutug
    Single IV dose of study product on Day 1 of study

Primary outcome measures

  • 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]
Secondary outcome measures (9)
  • Area Under the Curve (AUC) of Budoprutug [Time frame: Up to Week 24]
  • Maximum Observed Plasma Concentration (Cmax) [Time frame: Up to Week 24]
  • Time to Maximum Observed Concentration (Tmax) [Time frame: Up to Week 24]
  • Terminal Half-Life (T1/2) [Time frame: Up to Week 24]
  • Apparent Clearance (CL/F) of budoprutug [Time frame: Up to Week 24]
  • Volume of Distribution (Vd) [Time frame: Up to Week 24]
  • Change from Baseline in Circulating B Cell Count [Time frame: Up to Week 24]
  • Incidence of Anti-Drug Antibodies (ADAs) [Time frame: Up to Week 24]
  • ADA Titer Over Time [Time frame: Up to Week 24]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • Active neuropsychiatric SLE.
  • 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.
  • Active systemic infection or history of chronic, recurrent, latent, or recent serious infections.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Ukraine · 6 centers
  • Climb Bio Investigative Site #380102 — Ivano-Frankivsk
  • Climb Bio Investigative Site #380103 — Kyiv
  • Climb Bio Investigative Site #380106 — Kyiv
  • Climb Bio Investigative Site #380101 — Ternopil
  • Climb Bio Investigative Site #380104 — Vinnytsia
  • Climb Bio Investigative Site #380105 — Vinnytsia
United States · 2 centers
  • Climb Bio Investigative Site #100104 — Allen
  • Climb Bio Investigative Site #100101 — San Antonio
Bulgaria · 2 centers
  • Climb Bio Investigative Site# 359101 — Plovdiv
  • Climb Bio Investigative Site# 359102 — Sofia
Georgia · 2 centers
  • Climb Bio Investigative Site #995102 — Tbilisi
  • Climb Bio Investigative Site #995101 — Tbilisi
Greece · 2 centers
  • Climb Bio Investigative Site# 300102 — Exochi
  • Climb Bio Investigative Site# 300103 — Thessaloniki
Spain · 2 centers
  • Climb Bio Investigative Site# 340101 — Sabadell
  • Climb Bio Investigative Site# 340102 — A Coruña
Puerto Rico · 1 center
  • Climb Bio Investigative Site #100103 — Caguas
Romania · 1 center
  • Climb Bio Investigative Site# 400101 — Cluj-Napoca

Identifiers

NCT: NCT07011043 · TNT119-SLE-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗