NCT07011043 A Phase 1b Study of Budoprutug in Systemic Lupus Erythematosus (SLE)
| NCT ID | NCT07011043 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Climb Bio, Inc. |
| Condition | Systemic Lupus Erythematosus |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-07-10 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2025-07-10 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion 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. Exclusion Criteria: 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.
Contact & Investigator
Study Director
STUDY DIRECTOR
Climb Bio, Inc.
Frequently Asked Questions
Who can join the NCT07011043 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Systemic Lupus Erythematosus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07011043 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07011043 currently recruiting?
Yes, NCT07011043 is actively recruiting participants. Contact the research team at clinicaltrials@climbbio.com for enrollment information.
Where is the NCT07011043 trial being conducted?
This trial is being conducted at Allen, United States, San Antonio, United States, Plovdiv, Bulgaria, Sofia, Bulgaria and 11 additional locations.
Who is sponsoring the NCT07011043 clinical trial?
NCT07011043 is sponsored by Climb Bio, Inc.. The principal investigator is Study Director at Climb Bio, Inc.. The trial plans to enroll 30 participants.
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