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

Phase 2Not Yet RecruitingNCT07564596

Climb Bio, Inc.30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Systemic Lupus Erthematosus

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Incidence of Treatment-Emergent Adverse Events (TEAEs)

Number of participants experiencing TEAEs, graded per NCI CTCAE v6.0.

Time frame: Up to week 28

Incidence of Clinical Laboratory Abnormalities

Number of participants with clinically significant laboratory abnomalities.

Time frame: Up to week 28

Incidence of dose-limiting toxicities (DLTs)

Number of incidences of dose-limiting toxicities (DLTs)

Time frame: up to 28 weeks

Change from Baseline in Systolic Blood Pressure

Mean change from baseline in diastolic blood pressure (mmHg).

Time frame: Up to week 28

Change from Baseline in Diastolic Blood Pressure

Mean change from baseline in systolic blood pressure (mmHg).

Time frame: up to 28 weeks

Change from Baseline in Heart Rate

Mean change from baseline in heart rate (bpm).

Time frame: up to 28 weeks

Change from Baseline in Respiratory Rate

Mean change from baseline in respiratory rate

Time frame: up to 28 weeks

Change from Baseline in Body Temperature

Mean change from baseline in body temperature (°C)

Time frame: up to 28 weeks

Change from Baseline in PR Interval

Mean change from baseline in PR interval (ms)

Time frame: up to 28 weeks

Change from Baseline in QRS Duration

Mean change from baseline in QRS duration (ms)

Time frame: up to 28 weeks

Change from Baseline in QT Interval

Mean change from baseline in QT interval (ms)

Time frame: up to 28 weeks

Change from Baseline in QTc Interval

Mean change from baseline in corrected QT interval (QTc)

Time frame: up to 28 weeks

Secondary Outcomes

Area Under the Curve (AUC)

Measurement of the area under the drug concentration-time curve

Time frame: Up to week 28

Terminal Half-Life (T1/2)

Measurement of the terminal half-life in days

Time frame: Up to week 28

Incidence of Anti-Drug Antibodies (ADAs)

Number of participants with detectable ADAs.

Time frame: Up to week 28

ADA Titer Over Time

Measurement of ADA titer over time

Time frame: Up to week 28

Change from Baseline in CD20+ B-cell Count

Change in absolute peripheral B-cell count

Time frame: Up to week 28

Change from Baseline in SLEDAI-2K Score

Measurement of change in SLEDAI-2K score from baseline

Time frame: up to 28 weeks

Change from Baseline in Urine Protein Creatinine Ratio (UPCR)

Measurement of change in UPCR from baseline

Time frame: up to 28 weeks

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts