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โ† Trials
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A Phase 1b/2a Study of Budoprutug in Systemic Lupus Erythematosus (SLE)

RecruitingPhase 1, Phase 2Ages 18 Years - 65 YearsAllClimb Bio, Inc.
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In plain words

What the trial is, and whether it could suit you

Budoprutug is a humanized, immunoglobulin (Ig) G1 monoclonal antibody that selectively binds to CD19 and is projected to deplete targeted cells through antibody-dependent cellular cytotoxicity. This Phase 1b/2a, open-label study will evaluate budoprutug in ascending dose cohorts of patients aged 18 years and above with active, seropositive SLE and inadequate response to standard therapy. The study will also assess the pharmacokinetics, pharmacodynamics and early indications of efficacy of budoprutug in SLE, where pharmacodynamics will be evaluated as the change in the number of B cells and immunoglobulins (antibodies) in the blood over time. Budoprutug will be administered as two (2) IV infusions 14 days apart in ascending dose cohorts.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 \>=6 at screening 4. Inadequate response to at least one therapeutic intervention Exclusion Criteria: 1. Active neuropsychiatric SLE. 2. Active lupus nephritis type III or IV that is expected to require induction therapy during the study or recently treated with induction therapy within 12 weeks. 3. Prior diagnosis of, or fulfills diagnostic criteria for, other autoimmune or inflammatory disease that may confound clinical assessments or increase subject risk in the study 4. Active systemic infection or history of chronic, recurrent, latent, or recent serious infections.
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What it tests

  • Budoprutug
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Where

10 sites
Mianyang Central Hospital
Mianyang, China
Baoji Central Hospital
Baoji, China
Peking University People's Hospital
Beijing, China
The First Affiliated Hospital of Bengbu Medical College
Bengbu, China
Xiangya Second Hospital of Central South University
Changsha, China
The First Affiliated Hospital of the University of Science
Hefei, China
The First Affiliated Hospital of Nanchang
Nanchang, China
The Second Affiliated Hospital of Soochow University
Suzhou, China

โ€ฆand 2 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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