NCT07011043PHASE1Recruiting

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

Climb Bio, Inc.

Start Date

7/10/2025

Completion Date

4/1/2027

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

Age Range: 18 years to 65 years

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.

Interventions

DRUG

Budoprutug

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Conditions

Systemic Lupus Erythematosus

Locations

Climb Bio Investigative Site #100104

Allen, Texas 75013

United States

Climb Bio Investigative Site #100101

San Antonio, Texas 78215

United States

Climb Bio Investigative Site# 359101

Plovdiv, 4002

Bulgaria

Climb Bio Investigative Site# 359102

Sofia, 1618

Bulgaria

Climb Bio Investigative Site #995102

Tbilisi, 0112

Georgia

Climb Bio Investigative Site #995101

Tbilisi, 0141

Georgia

Climb Bio Investigative Site# 300102

Exochi, Thessaloniki 57010

Greece

Climb Bio Investigative Site# 300103

Thessaloniki, Thessaloniki 54642

Greece

Climb Bio Investigative Site #100103

Caguas,

Puerto Rico

Climb Bio Investigative Site# 400101

Cluj-Napoca, 400006

Romania

Climb Bio Investigative Site# 340101

Sabadell, Barcelona 08208

Spain

Climb Bio Investigative Site# 340102

A Coruña, 15006

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