A Phase 1b Study of Budoprutug in Systemic Lupus Erythematosus (SLE)
ConditionSystemic Lupus Erythematosus
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorClimb Bio, Inc.
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
Budoprutug
DrugSingle IV dose of study product on Day 1 of study
Treatment groups
30 Participants
are divided into 4 treatment groupsGroup A: Cohort 1: Dose Level AExperimental treatment 1 intervention
Group B: Cohort 2: Dose Level BExperimental treatment 1 intervention
Group C: Cohort 3: Dose Level CExperimental treatment 1 intervention
Group D: Cohort 4: Dose Level DExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Number of participants experiencing TEAEs, graded per NCI CTCAE v5.0.
Time frame
Up to Week 242
Incidence of Clinical Laboratory Abnormalities
Number of participants with clinically significant laboratory abnormalities.
Time frame
Up to Week 243
Change from Baseline in Systolic Blood Pressure
Mean change from baseline in systolic blood pressure (mmHg).
Time frame
Up to Week 244
Change from Baseline in Diastolic Blood Pressure
Mean change from baseline in diastolic blood pressure (mmHg).
Time frame
Up to Week 24Secondary outcomes
1
Area Under the Curve (AUC) of Budoprutug
Measurement of the area under the drug concentration-time curve.
Time frame
Up to Week 242
Maximum Observed Plasma Concentration (Cmax)
Measurement of the maximum observed plasma concentration.
Time frame
Up to Week 243
Time to Maximum Observed Concentration (Tmax)
Measurement of the time to maximum observed concentration.
Time frame
Up to Week 244
Terminal Half-Life (T1/2)
Measurement of the terminal half-life in days.
Time frame
Up to Week 24Other outcomes
1
Change from Baseline in BILAG-2004 Score
Measurement of change in BILAG-2004 score from baseline.
Time frame
Up to Week 242
Change from Baseline in SLEDAI-2K Score
Measurement of change in SLEDAI-2K score from baseline.
Time frame
Up to Week 243
Change from Baseline in Physician's Global Assessment
Measurement of change in Physician's Global Assessment score from baseline.
Time frame
Up to Week 244
Proportion of Participants Achieving SRI-4 Response
Percentage of participants achieving SRI-4 response.
Time frame
Up to Week 24Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov