Study of Surovatamig for Rheumatoid Arthritis or Lupus
This study is testing a new medication called Surovatamig for adults with rheumatoid arthritis (RA) or systemic lupus erythematosus (SLE). Surovatamig is given as a shot under the skin. The main goal of this study is to see how safe Surovatamig is and how well your body tolerates it. Researchers will also look at how the drug moves through your body (pharmacokinetics or PK) and what effects it has (pharmacodynamics or PD). You can join if you are between 18 and 65 years old and have been diagnosed with RA or SLE. The study will measure any side effects, serious problems, or reasons people stop taking the drug over a period of up to 52 weeks.
- Study design
- This is an open-label, Phase I study with 48 planned participants. It will involve different groups receiving increasing doses of Surovatamig.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety evaluations from Day 1 up to 52 weeks after starting the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study Evaluating Safety, Tolerability, PK/PD of Surovatamig in Adult RA or SLE Participants
At a glance
Conditions
Where it's being run
34 sites across 13 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Safety evaluation of surovatamig: Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs)Day 1 to end of the study (up to 52 weeks)
Number and percentage of participants with adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)
- Safety evaluation of surovatamig: Frequency of dose limiting toxicities (DLTs).Day 1 to end of the study (up to 52 weeks)
Number and percentage of participants with DLTs (dose-limiting toxicities) as defined in the study protocol
- Safety of surovatamig: Incidence of AEs/SAEs leading to discontinuation of surovatamigDay 1 to end of the study (up to 52 weeks)
Number of participants with AEs/SAEs leading to discontinuation of surovatamig
- Tolerability of surovatamig: Incidence of treatment-related vital signs abnormalitiesDay 1 to end of the study (up to 52 weeks)
Number and percentage of participants with treatment-related vital signs abnormalities
- Tolerability of surovatamig: Incidence of treatment-related clinical laboratory abnormalitiesDay 1 to end of the study (up to 52 weeks)
Number of participants with treatment-related clinical laboratory abnormalities
- Tolerability of surovatamig: Number of participants with abnormal ECGFrom baseline through Day 180.
Number and percentage of participants with abnormal ECG.