Study Evaluating Safety, Tolerability, PK/PD of Surovatamig in Adult RA or SLE Participants
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAstraZeneca
About this trial
This open-label, Phase I study will assess the safety and tolerability of surovatamig and characterise its PK and PD following subcutaneous administration to participants with RA or SLE.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant must be 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 65 years of age, inclusive, at the time of signing the informed consent.
Diagnosis of RA as defined by the 2010 EULAR/ACR classification criteria
Positive for ≥ 1 disease-specific autoantibody performed by the central laboratory.
4 tender joints and ≥ 4 swollen joints
Disqualifiers
Any complications of disease under study that are judged by the Investigator to be life or organ threatening or to require treatments which are not permitted in the protocol, including but not limited to: (a) Active severe SLE-driven renal disease. (b) Severe lung or cardiac involvement. (c) History of, or current diagnosis of, catastrophic or severe APS (eg, diagnosis of an arterial or central/pulmonary venous clot) within 1 year prior to signing the ICF. Participants with clinically evident APS which is adequately controlled by anticoagulants or aspirin for at least 12 weeks can be recruited into the study. (d) Rapidly progressive and/or severe ILD or ILD that requires oxygen supplementation/therapy (of any type). (e) Felty's syndrome
History of HLH/MAS.
Juvenile idiopathic arthritis or idiopathic arthritis diagnosed before the age of 16.
Axial spondylarthritis or any other disease associated with inflammatory arthritis
Trial design
Design model
Sequential
Treatments tested in this trial
Surovatamig
Biological/VaccineSurovatamig is a bispecific T-cell engager administered subcutaneously. This is an open-label, dose-escalation study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of Surovatamig in adult participants with rheumatoid arthritis (RA) or systemic lupus erythematosus (SLE). The study consists of up to three parts: Part 1 (SAD): Single ascending dose - participants receive one dose of Surovatamig. Part 2 (sSUD): Single step-up dosing - participants receive two doses. Part 3 (dSUD): Double step-up dosing - participants receive three doses. Participants are assigned to a study part based on protocol-defined criteria. The study includes follow-up for a minimum of 179 days post-first dose, with extended monitoring up to 12 months for certain participants.
Treatment groups
48 Participants
are divided into 1 treatment groupGroup A: SurovatamigExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety evaluation of surovatamig: Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs)
Number and percentage of participants with adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)
Time frame
Day 1 to end of the study (up to 52 weeks)2
Safety evaluation of surovatamig: Frequency of dose limiting toxicities (DLTs).
Number and percentage of participants with DLTs (dose-limiting toxicities) as defined in the study protocol
Time frame
Day 1 to end of the study (up to 52 weeks)3
Safety of surovatamig: Incidence of AEs/SAEs leading to discontinuation of surovatamig
Number of participants with AEs/SAEs leading to discontinuation of surovatamig
Time frame
Day 1 to end of the study (up to 52 weeks)4
Tolerability of surovatamig: Incidence of treatment-related vital signs abnormalities
Number and percentage of participants with treatment-related vital signs abnormalities
Time frame
Day 1 to end of the study (up to 52 weeks)Secondary outcomes
1
Serum Pharmacokinetics (PK) parameters of surovatamig - Cmax
Maximum observed serum drug concentration (Cmax)
Time frame
From Day 1 through Day 1802
Absolute counts at Day 180 in blood CD20+ B-cells
Absolute counts in peripheral CD20+ B cells
Time frame
Day 1803
Serum Pharmacokinetics (PK) parameters of surovatamig - AUC0-last
Area under the serum concentration time curve from time zero to the time of last quantifiable analyte concentration (AUClast)
Time frame
From Day 1 through Day 1804
Serum Pharmacokinetics (PK) parameters of surovatamig - AUCinf
Area under the serum concentration time curve from time zero to infinity (Part 1 only)
Time frame
From Day 1 through Day 180Sponsors and contacts
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Source ClinicalTrials.gov