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

Last updated: January 5, 2026
Sponsor: Climb Bio, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Cutaneous Lupus Erythematosus

Musculoskeletal Diseases

Systemic Lupus Erythematosus

Treatment

Budoprutug

Clinical Study ID

NCT07011043
TNT119-SLE-101
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 theAmerican 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 oneoral immunosuppressive or biologic standard-of care therapy.

Exclusion

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 stableconcurrent Sjogren's, asthma, or autoimmune thyroid disease may be considered forparticipation.

  3. Active systemic infection or history of chronic, recurrent, latent, or recentserious infections.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Budoprutug
Phase: 1
Study Start date:
July 10, 2025
Estimated Completion Date:
April 30, 2027

Study 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.

Connect with a study center

  • Climb Bio Investigative Site# 359101

    Plovdiv 728193, 4002
    Bulgaria

    Active - Recruiting

  • Climb Bio Investigative Site# 359102

    Sofia 727011, 1618
    Bulgaria

    Active - Recruiting

  • Climb Bio Investigative Site #995101

    Tbilisi 611717, 0141
    Georgia

    Active - Recruiting

  • Climb Bio Investigative Site #995102

    Tbilisi 611717, 0112
    Georgia

    Active - Recruiting

  • Climb Bio Investigative Site# 300102

    Exochi 7646358, Thessaloniki 57010
    Greece

    Site Not Available

  • Climb Bio Investigative Site# 300103

    Thessaloniki 734077, Thessaloniki 54642
    Greece

    Site Not Available

  • Climb Bio Investigative Site #100103

    Caguas,
    Puerto Rico

    Site Not Available

  • Climb Bio Investigative Site #100103

    Caguas 4563008,
    Puerto Rico

    Active - Recruiting

  • Climb Bio Investigative Site# 400101

    Cluj-Napoca 681290, 400006
    Romania

    Active - Recruiting

  • Climb Bio Investigative Site# 340101

    Sabadell 3111199, Barcelona 08208
    Spain

    Site Not Available

  • Climb Bio Investigative Site# 340102

    A Coruña 3119841, 15006
    Spain

    Site Not Available

  • Climb Bio Investigative Site #380102

    Ivano-Frankivsk,
    Ukraine

    Site Not Available

  • Climb Bio Investigative Site #380102

    Ivano-Frankivsk 707471,
    Ukraine

    Active - Recruiting

  • Climb Bio Investigative Site #380103

    Kyiv,
    Ukraine

    Active - Recruiting

  • Climb Bio Investigative Site #380106

    Kyiv,
    Ukraine

    Site Not Available

  • Climb Bio Investigative Site #380103

    Kyiv 703448,
    Ukraine

    Active - Recruiting

  • Climb Bio Investigative Site #380106

    Kyiv 703448,
    Ukraine

    Active - Recruiting

  • Climb Bio Investigative Site #380101

    Ternopil,
    Ukraine

    Site Not Available

  • Climb Bio Investigative Site #380101

    Ternopil 691650,
    Ukraine

    Active - Recruiting

  • Climb Bio Investigative Site #380104

    Vinnytsia,
    Ukraine

    Site Not Available

  • Climb Bio Investigative Site #380105

    Vinnytsia,
    Ukraine

    Active - Recruiting

  • Climb Bio Investigative Site #380104

    Vinnytsia 689558,
    Ukraine

    Active - Recruiting

  • Climb Bio Investigative Site #380105

    Vinnytsia 689558,
    Ukraine

    Active - Recruiting

  • Climb Bio Investigative Site #100101

    San Antonio, Texas 78215
    United States

    Site Not Available

  • Climb Bio Investigative Site #100104

    Allen 4670300, Texas 4736286 75013
    United States

    Active - Recruiting

  • Climb Bio Investigative Site #100101

    San Antonio 4726206, Texas 4736286 78215
    United States

    Active - Recruiting

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