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

Recruiting now · Phase 1

Conditions studied: Systemic Lupus Erythematosus

In brief

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.

Key facts

Study ID

NCT07011043

Run by

Climb Bio, Inc.

People needed

30

Starts

2025-07-10

Expected to finish

2027-04-01

Last updated by the study team

2026-03-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Climb Bio Investigative Site #100104 — Allen, Texas, United States (enrolling)
• Climb Bio Investigative Site #100101 — San Antonio, Texas, United States (enrolling)
• Climb Bio Investigative Site# 359101 — Plovdiv, Bulgaria (enrolling)
• Climb Bio Investigative Site# 359102 — Sofia, Bulgaria (enrolling)
• Climb Bio Investigative Site #995102 — Tbilisi, Georgia (enrolling)
• Climb Bio Investigative Site #995101 — Tbilisi, Georgia (enrolling)
• Climb Bio Investigative Site# 300102 — Exochi, Thessaloniki, Greece (enrolling)
• Climb Bio Investigative Site# 300103 — Thessaloniki, Thessaloniki, Greece (enrolling)
• Climb Bio Investigative Site #100103 — Caguas, Puerto Rico (enrolling)
• Climb Bio Investigative Site# 400101 — Cluj-Napoca, Romania (enrolling)
• Climb Bio Investigative Site# 340101 — Sabadell, Barcelona, Spain (enrolling)
• Climb Bio Investigative Site# 340102 — A Coruña, Spain (enrolling)
• Climb Bio Investigative Site #380102 — Ivano-Frankivsk, Ukraine (enrolling)
• Climb Bio Investigative Site #380103 — Kyiv, Ukraine (enrolling)
• Climb Bio Investigative Site #380106 — Kyiv, Ukraine (enrolling)
• Climb Bio Investigative Site #380101 — Ternopil, Ukraine (enrolling)
• Climb Bio Investigative Site #380104 — Vinnytsia, Ukraine (enrolling)
• Climb Bio Investigative Site #380105 — Vinnytsia, Ukraine (enrolling)

Full record on ClinicalTrials.gov

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