RecruitingPhase 1NCT07201558

Study Evaluating Safety, Tolerability, PK/PD of Surovatamig in Adult RA or SLE Participants

An Open-label, Phase I Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Surovatamig Following Single-ascending Dose and Step-up Dose Administration to Adult Participants With Rheumatoid Arthritis or Systemic Lupus Erythematosus


Sponsor

AstraZeneca

Enrollment

48 participants

Start Date

Dec 2, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called surovatamig in adults with either rheumatoid arthritis (RA) or lupus (SLE) — both are autoimmune conditions where the immune system mistakenly attacks the body's own tissues. The goal is to evaluate safety, tolerability, and early signs of effectiveness. **You may be eligible if...** - You are 18–65 years old with a confirmed diagnosis of RA or lupus - For RA: you have moderate to severe disease activity, positive autoantibodies (RF or ACPA), and have not responded well to at least 2 different biologic or targeted therapies - For lupus: you have active disease despite prior treatment **You may NOT be eligible if...** - You have serious infections or immunodeficiency - You have significant organ damage that would make the study drug unsafe - You are pregnant or planning to become pregnant during the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALSurovatamig

Surovatamig 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.


Locations(19)

Research Site

Birmingham, Alabama, United States

Research Site

Fullerton, California, United States

Research Site

Allen, Texas, United States

Research Site

Birtinya, Australia

Research Site

Clayton, Australia

Research Site

Antwerp, Belgium

Research Site

Porto Alegre, Brazil

Research Site

Beijing, China

Research Site

Nanjing, China

Research Site

Bonn, Germany

Research Site

Mainz, Germany

Research Site

München, Germany

Research Site

Barcelona, Spain

Research Site

Córdoba, Spain

Research Site

Madrid, Spain

Research Site

Kaohsiung City, Taiwan

Research Site

Kyiv, Ukraine

Research Site

Ternopil, Ukraine

Research Site

Vinnytsia, Ukraine

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NCT07201558


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