Surovatamig for Rheumatoid Arthritis and Lupus
(ASSURO Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and bodily response to a new treatment called surovatamig, administered as an injection under the skin. Researchers are studying surovatamig for individuals with rheumatoid arthritis (RA) or lupus (SLE), conditions that cause joint pain and inflammation. Participants will receive surovatamig on different dosing schedules to assess its effects. Those with moderate to severe RA or SLE, experiencing symptoms like multiple swollen or tender joints or a history of needing strong medications, might be suitable for this trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.
Will I have to stop taking my current medications?
The trial allows participants to continue certain medications if they are stable for a specified period before the study starts. For RA, you can continue oral prednisone, oral anti-malarials, and certain csDMARDs. For SLE, you can continue oral prednisone, oral anti-malarials, and specific immunosuppressive treatments. Make sure to discuss your current medications with the study team to confirm eligibility.
Is there any evidence suggesting that surovatamig is likely to be safe for humans?
Research shows that surovatamig is being tested for safety and tolerance in people with rheumatoid arthritis and lupus. In earlier studies, participants received different doses to observe their reactions. These studies are in the early stages, so information about side effects and safety remains limited. However, as this is the first phase of trials, researchers primarily focus on ensuring the treatment's safety. They closely monitor for any negative reactions or side effects. Although surovatamig is still in early testing, no serious side effects have been reported so far.12345
Why do researchers think this study treatment might be promising?
Surovatamig is unique because it offers a new approach for treating rheumatoid arthritis and lupus by potentially targeting different immune pathways compared to standard treatments like methotrexate or biologics such as TNF inhibitors. Unlike these existing options, Surovatamig is administered subcutaneously and tested in varying dosing regimens to optimize its effectiveness. Researchers are excited about Surovatamig because it might provide more flexible dosing options and could offer benefits for patients who do not respond well to current therapies.
What evidence suggests that surovatamig might be an effective treatment for rheumatoid arthritis and lupus?
Research has shown that surovatamig yields promising results in treating certain cancers, such as relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL). In these studies, surovatamig proved effective even at very low doses, suggesting it could be a strong treatment option. Although limited data exists on rheumatoid arthritis (RA) and lupus, the treatment targets and removes specific cells, which could benefit autoimmune diseases like RA and lupus. This trial will investigate surovatamig's potential in treating RA and lupus, with participants receiving the treatment subcutaneously in one of three dosing regimens. Ongoing research explores whether the success seen in cancer patients might also apply to these autoimmune conditions.16789
Are You a Good Fit for This Trial?
Adults aged 18-65 with Rheumatoid Arthritis (RA) or Systemic Lupus Erythematosus (SLE), who have not responded well to previous treatments, can join this trial. They must meet specific disease criteria, including a certain number of tender and swollen joints for RA or a clinical SLEDAI-2K score over 4 for SLE, and have positive autoantibody tests.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive surovatamig subcutaneously in single-ascending and step-up dosing cohorts
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Surovatamig
Trial Overview
The study is testing the safety and effects of a new medication called surovatamig when given as an injection under the skin to people with RA or SLE. It will look at how the body processes the drug (pharmacokinetics/PK) and what it does in the body (pharmacodynamics/PD).
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will receive Surovatamig subcutaneously in one of three dosing regimens: once (Part 1), twice (Part 2), or three times (Part 3), depending on the study part.
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Citations
NCT07201558 | Study Evaluating Safety, Tolerability, PK/ ...
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Surovatamig shows promising results in R/R B-ALL patients
Preliminary results from the phase I/II SYRUS trial, presented by Ibrahim Aldoss at #EHA2025, found that surovatamig (AZD0486) achieved an ...
Surovatamig - Drug Targets, Indications, Patents
Key presentations include: Phase I trial of surovatamig: Updated results at three-year follow up from the ongoing first-in-human trial of surovatamig, a ...
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This molecule is highly potent and effective at clearing target cells in vitro at picomolar concentrations. However, its relatively small size ...
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- Q3 2025 Results: Data ... New P1 trial • Immunology • Inflammatory Arthritis • Lupus • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus.
Study evaluating safety, tolerability, PK/PD of surovatamig ...
This open-label, Phase I study will assess the safety and tolerability of surovatamig and characterise its PK and PD following subcutaneous ...
AstraZeneca's New Phase I Study on Surovatamig
' The study aims to evaluate the safety and tolerability of surovatamig, a bispecific T-cell engager, in adults with rheumatoid arthritis (RA) ...
Surovatamig - AstraZeneca - AdisInsight
Surovatamig is a bispecific T-cell engagers, targeting CD19 and CD3 (anti-CD19xCD3), being developed by TeneoTwo (a subsidiary of ...
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