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Taking people in UkrainePhase 1

Tests budoprutug, a new drug, in adults with lupus

Tests budoprutug's safety in adults aged 18 to 65 with systemic lupus erythematosus.

Key facts

Who runs it
Climb Bio, Inc.
Where
Ivano-Frankivsk, Kyiv, Ternopil, and Vinnytsia, UkraineSee the 6 sitesAlso in 7 other countries, 12 sites
Trial code
Registry title
A Phase 1b Study of Budoprutug in Systemic Lupus Erythematosus (SLE)
Status
Recruiting
Phase
Phase 1
People taking part
30 people, planned
Started
10 Jul 2025
Expected to end
Apr 2027
Type of study
Interventional, 4 groups
Treatments tested
  • Budoprutug
Record updated
27 March 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with active systemic lupus erythematosus (SLE) who did not respond well enough to earlier treatments.

Age
18 to 65 years
Sex
All sexes can join.
Disease stage
Active, seropositive SLE with a SLEDAI 2K score of 8 or higher.
Earlier treatment
Not enough response to at least 2 treatments, including at least one oral immunosuppressive or biologic standard-of-care therapy.
Biomarker or test result
Seropositive disease.

Main reasons for not taking part

  • Active neuropsychiatric SLE
  • History of other inflammatory or autoimmune diseases that need immune suppressive therapy (stable Sjogren's, asthma or autoimmune thyroid disease may be considered)
  • Active systemic infection
  • History of chronic, recurrent, latent or recent serious infections

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Active neuropsychiatric SLE

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

Where in Ukraine

Also in 7 other countries, 12 sites

  • Ivano-FrankivskHospital not named in the registryContact: Climb Bio Study DirectorTaking people
  • KyivHospital not named in the registryContact: Climb Bio Study DirectorTaking people
  • KyivHospital not named in the registryContact: Climb Bio Study DirectorTaking people
  • TernopilHospital not named in the registryContact: Climb Bio Study DirectorTaking people
  • VinnytsiaHospital not named in the registryContact: Climb Bio Study DirectorTaking people
  • VinnytsiaHospital not named in the registryContact: Climb Bio Study DirectorTaking people

About the trial

What the trial wants to find out

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.

The 4 groups in the trial

  • Cohort 1: Dose Level ATreatment being tested

    Treatment: Budoprutug

  • Cohort 2: Dose Level BTreatment being tested

    Treatment: Budoprutug

  • Cohort 3: Dose Level CTreatment being tested

    Treatment: Budoprutug

  • Cohort 4: Dose Level DTreatment being tested

    Treatment: Budoprutug

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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)
Plain-language title
Tests budoprutug, a new drug, in adults with lupusGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07011043, who can take part
Record updated
27 March 2026