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A Phase 1b Study of Budoprutug in Systemic Lupus Erythematosus (SLE)
Led by Climb Bio, Inc. · Updated on 2026-03-27
30
Participants Needed
18
Research Sites
90 weeks
Total Duration
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AI-Summary
What this Trial Is About
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
Official Title
A Phase 1b Study of Budoprutug in Systemic Lupus Erythematosus (SLE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 65 years at the time of consent
- Diagnosis of SLE according to 2019 EULAR and ACR classification criteria
- Active, seropositive disease with SLEDAI 2K score of 8 or higher
- Inadequate response to at least 2 therapeutic interventions, including at least one oral immunosuppressive or biologic therapy
You will not qualify if you...
- Active neuropsychiatric SLE
- History of inflammatory or autoimmune diseases such as rheumatoid arthritis, scleroderma, myositis, vasculitis, inflammatory bowel disease, or other conditions needing immune suppressive therapy
- Active systemic infection or history of chronic, recurrent, latent, or recent serious infections
- Subjects with stable Sjogren's, asthma, or autoimmune thyroid disease may be considered
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
Climb Bio Investigative Site #100104
Allen, Texas, United States, 75013
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2
Climb Bio Investigative Site #100101
San Antonio, Texas, United States, 78215
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3
Climb Bio Investigative Site# 359101
Plovdiv, Bulgaria, 4002
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4
Climb Bio Investigative Site# 359102
Sofia, Bulgaria, 1618
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5
Climb Bio Investigative Site #995102
Tbilisi, Georgia, 0112
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6
Climb Bio Investigative Site #995101
Tbilisi, Georgia, 0141
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7
Climb Bio Investigative Site# 300102
Exochi, Thessaloniki, Greece, 57010
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8
Climb Bio Investigative Site# 300103
Thessaloniki, Thessaloniki, Greece, 54642
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9
Climb Bio Investigative Site #100103
Caguas, Puerto Rico
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10
Climb Bio Investigative Site# 400101
Cluj-Napoca, Romania, 400006
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11
Climb Bio Investigative Site# 340101
Sabadell, Barcelona, Spain, 08208
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12
Climb Bio Investigative Site# 340102
A Coruña, Spain, 15006
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13
Climb Bio Investigative Site #380102
Ivano-Frankivsk, Ukraine
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14
Climb Bio Investigative Site #380103
Kyiv, Ukraine
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15
Climb Bio Investigative Site #380106
Kyiv, Ukraine
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16
Climb Bio Investigative Site #380101
Ternopil, Ukraine
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17
Climb Bio Investigative Site #380104
Vinnytsia, Ukraine
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18
Climb Bio Investigative Site #380105
Vinnytsia, Ukraine
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Research Team
C
Climb Bio Study Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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