RECRUITING

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

Description

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.

Conditions

Systemic Lupus Erythematosus
Talk to us

Related Conditions:

Systemic Lupus Erythematosus

Study Overview

On this page

Study Details

Study 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.

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)

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

Condition
Systemic Lupus Erythematosus
Intervention / Treatment

-

Contacts and Locations

San Antonio

Climb Bio Investigative Site #100101, San Antonio, Texas, United States, 78215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Climb Bio, Inc.,

Study Director, STUDY_DIRECTOR, Climb Bio, Inc.

Study Record Dates

2027-04