NCT07011043

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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
11mo left

Started Jul 2025

Geographic Reach
8 countries

18 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Jul 2025Apr 2027

First Submitted

Initial submission to the registry

May 6, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 8, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

July 10, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

1.7 years

First QC Date

May 6, 2025

Last Update Submit

March 24, 2026

Conditions

Systemic Lupus Erythematosus

Keywords

LupusSLEBiologicsOpen-labelMonoclonalAnti-CD19

Outcome Measures

Primary Outcomes (11)

  • Incidence of Treatment-Emergent Adverse Events (TEAEs)

    Number of participants experiencing TEAEs, graded per NCI CTCAE v5.0.

    Up to Week 24

  • Incidence of Clinical Laboratory Abnormalities

    Number of participants with clinically significant laboratory abnormalities.

    Up to Week 24

  • Change from Baseline in Systolic Blood Pressure

    Mean change from baseline in systolic blood pressure (mmHg).

    Up to Week 24

  • Change from Baseline in Diastolic Blood Pressure

    Mean change from baseline in diastolic blood pressure (mmHg).

    Up to Week 24

  • Change from Baseline in Heart Rate

    Mean change from baseline in heart rate (bpm).

    Up to Week 24

  • Change from Baseline in Respiratory Rate

    Mean change from baseline in respiratory rate.

    Up to Week 24

  • Change from Baseline in Body Temperature

    Mean change from baseline in body temperature (°C).

    Up to Week 24

  • Change from Baseline in PR Interval

    Mean change from baseline in PR interval (ms).

    Up to Week 24

  • Change from Baseline in QRS Duration

    Mean change from baseline in QRS duration (ms).

    Up to Week 24

  • Change from Baseline in QT Interval

    Mean change from baseline in QT interval (ms).

    Up to Week 24

  • Change from Baseline in QTc Interval

    Mean change from baseline in corrected QT interval (QTc).

    Up to Week 24

Secondary Outcomes (9)

  • Area Under the Curve (AUC) of Budoprutug

    Up to Week 24

  • Maximum Observed Plasma Concentration (Cmax)

    Up to Week 24

  • Time to Maximum Observed Concentration (Tmax)

    Up to Week 24

  • Terminal Half-Life (T1/2)

    Up to Week 24

  • Apparent Clearance (CL/F) of budoprutug

    Up to Week 24

  • +4 more secondary outcomes

Other Outcomes (8)

  • Change from Baseline in BILAG-2004 Score

    Up to Week 24

  • Change from Baseline in SLEDAI-2K Score

    Up to Week 24

  • Change from Baseline in Physician's Global Assessment

    Up to Week 24

  • +5 more other outcomes

Study Arms (4)

Cohort 1: Dose Level A

EXPERIMENTAL
Drug: Budoprutug

Cohort 2: Dose Level B

EXPERIMENTAL
Drug: Budoprutug

Cohort 3: Dose Level C

EXPERIMENTAL
Drug: Budoprutug

Cohort 4: Dose Level D

EXPERIMENTAL
Drug: Budoprutug

Interventions

BudoprutugDRUG

Single IV dose of study product on Day 1 of study

Also known as: TNT119
Cohort 1: Dose Level ACohort 2: Dose Level BCohort 3: Dose Level CCohort 4: Dose Level D

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Climb Bio Investigative Site #100104

Allen, Texas, 75013, United States

RECRUITING

Climb Bio Investigative Site #100101

San Antonio, Texas, 78215, United States

RECRUITING

Climb Bio Investigative Site# 359101

Plovdiv, 4002, Bulgaria

RECRUITING

Climb Bio Investigative Site# 359102

Sofia, 1618, Bulgaria

RECRUITING

Climb Bio Investigative Site #995102

Tbilisi, 0112, Georgia

RECRUITING

Climb Bio Investigative Site #995101

Tbilisi, 0141, Georgia

RECRUITING

Climb Bio Investigative Site# 300102

Exochi, Thessaloniki, 57010, Greece

RECRUITING

Climb Bio Investigative Site# 300103

Thessaloniki, Thessaloniki, 54642, Greece

RECRUITING

Climb Bio Investigative Site #100103

Caguas, Puerto Rico

RECRUITING

Climb Bio Investigative Site# 400101

Cluj-Napoca, 400006, Romania

RECRUITING

Climb Bio Investigative Site# 340101

Sabadell, Barcelona, 08208, Spain

RECRUITING

Climb Bio Investigative Site# 340102

A Coruña, 15006, Spain

RECRUITING

Climb Bio Investigative Site #380102

Ivano-Frankivsk, Ukraine

RECRUITING

Climb Bio Investigative Site #380103

Kyiv, Ukraine

RECRUITING

Climb Bio Investigative Site #380106

Kyiv, Ukraine

RECRUITING

Climb Bio Investigative Site #380101

Ternopil, Ukraine

RECRUITING

Climb Bio Investigative Site #380104

Vinnytsia, Ukraine

RECRUITING

Climb Bio Investigative Site #380105

Vinnytsia, Ukraine

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Study Director

    Climb Bio, Inc.

    STUDY DIRECTOR

Central Study Contacts

Climb Bio Study Director

CONTACT

+1 866 857 2596clinicaltrials@climbbio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2025

First Posted

June 8, 2025

Study Start

July 10, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations

GE(2)US(2)GR(2)ES(2)UA(6)RO(1)BU(2)PR(1)