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Rheumatoid ArthritisPhase 1ASSURONCT07201558

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

A Phase 1 study testing Surovatamig in people with Rheumatoid Arthritis and Systemic Lupus Erythematosus, run by AstraZeneca at 35 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Surovatamig
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
35 sitesin 10 countries
Study dates
2 Dec 2025to 27 Jun 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • For RA participants, only:
  • <!-- -->
  • Diagnosis of RA as defined by the 2010 EULAR/ACR classification criteria
  • Positive for ≥ 1 disease-specific autoantibody performed by the central laboratory.
  • RF (b) ACPA
Show all 22Show fewer
  • Moderate or severe disease activity defined as:
  • DAS28-CRP > 3.2 AND
  • 4 tender joints and ≥ 4 swollen joints
  • US-Specific Criterion: DAS28-CRP > 3.2 AND ≥ 6 tender joints and ≥ 6 swollen joints 4. Intolerance to or inadequate response following approximately 3 month's treatment or longer to ≥2 b/tsDMARDs (with different mechanisms of action) after failing csDMARD therapy (unless csDMARD therapy is contraindicated). There is no minimum duration for taking a treatment in cases of intolerance.
  • 5. Background standard of care is not a requirement for participation, however, the following therapies are permitted and may be continued during the study (alone or in combination). Any other systemic immunosuppressive treatment or immune modulating biologic drug must be discontinued in line with the washout periods listed in Inclusion Criterion 12:
  • Oral prednisone (or equivalent). Dose must be stable and ≤ 10mg a day for ≥ 2 weeks prior to Day 1. (b) Oral anti-malarial (e.g. hydroxychloroquine ≤ 400 mg a day). Dose must be stable for ≥ 4 weeks prior to Day 1. (c) Treatment with one of the following csDMARDs for ≥ 3 months and at a stable dose for ≥ 4 weeks prior to Day 1. (i) Methotrexate ≤ 25 mg per week, without change of route of administration for 8 weeks prior to Day 1 (ii) Sulfasalazine ≤ 3g/day (iii) Leflunomide ≤ 20 mg/day 3. For SLE participants, only:
  • Diagnosis of SLE as defined by the 2019 EULAR/ACR classification criteria
  • Positive for ≥ 1 disease-specific autoantibody performed by the central laboratory. If autoantibodies are negative on central laboratory test, documented history of test results may be used. (a) ANA immunofluorescent assay test (titer ≥ 1:80) (a) Anti-dsDNA (b) Anti-Sm.
  • Moderate or severe disease activity defined as clinical SLEDAI-2K > 4
  • US-specific criterion: clinical SLEDAI-2K ≥ 6
  • Intolerance to or inadequate response following approximately 3 months treatment or longer ≥ 3 SoC (includes: corticosteroids, anti-malarial drugs, calcineurin inhibitor, methotrexate, azathioprine, leflunomide, mycophenolic acid or its derivatives, cyclophosphamide, belimumab, anifrolumab, telitacicept, or B-cell depleting monoclonal antibodies). There is no minimum duration for taking a treatment in cases of intolerance.
  • Background standard of care is not a requirement for participation, however, the following therapies are permitted and may be continued during the study (alone or in combination). Any other systemic immunosuppressive treatment or immune modulating biologic drug must be discontinued in line with the washout periods listed in Inclusion Criterion 12: (a) Oral prednisone (or equivalent. Dose must be stable and ≤ 20mg a day for ≥ 2 weeks prior to Day 1. (b) Oral anti-malarial (eg, hydroxychloroquine ≤ 400 mg a day). Dose must be stable for ≥ 4 weeks prior to Day 1. (c) Treatment with one of the following immunosuppressive treatments. for ≥ 3 months and at a stable dose for ≥ 4 weeks prior to Day 1. (i) Methotrexate ≤ 25 mg/week, without change of route of administration for 8 weeks prior to Day 1 (ii) Mycophenolate mofetil or equivalent ≤ 2 g/day (dose must be ≤ 2 g/day for 3 months prior to Day 1) (iii) Azathioprine ≤ 200 mg/day (iv) Leflunomide ≤ 20 mg/day (v) Tacrolimus ≤ 0.1 mg/kg/day with maximum dose of 5 mg/day (vi) Cyclosporin ≤ 3 mg/kg/day with maximum dose of 200 mg/day
  • 4. Blood B cells ≥ 50 cells/μL at screening. 5. IgG levels ≥ 6 g/L at screening. 6. Eligibility for re-treatment of previously treated participants only. The following criterion applies only to participants being considered for re-treatment and is not applicable to participants undergoing initial screening for study entry.
  • 1. Participants treated in prior study cohorts who did not experience an IMP-related DLT or discontinue treatment and/or participation due to an IMP-related AE are eligible for re-treatment in Parts 2 and 3. Participants must otherwise meet all protocol-defined eligibility criteria, with the exception of Inclusion Criterion 17 (B cell count), and meet one of the 2 criteria below:
  • Completed the 6-month treatment period OR
  • Completed a minimum of 90 days in the treatment period and have peripheral B cell counts that are ≥ 90% of baseline or above lower limit of normal (LLN)

Who cannot join

  • 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.
  • For RA participants, only:
  • <!-- -->
  • Juvenile idiopathic arthritis or idiopathic arthritis diagnosed before the age of 16.
  • Axial spondylarthritis or any other disease associated with inflammatory arthritis
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  • 4. For SLE participants, only:
  • 1.History of active, severe or unstable neuropsychiatric SLE, except for headache and peripheral neuropathies. 5. Other active or prior documented severe, complex, autoimmune or inflammatory disorders. Exceptions to this exclusion criteria include: (a) Vitiligo or alopecia (b) Hypothyroidism stable on hormone replacement (c) Controlled type I diabetes mellitus on insulin (d) Any chronic skin condition that does not require systemic immunosuppressant or biologic therapy (e) Celiac disease, controlled by diet alone (f) Participants with secondary Sjögren's disease are eligible provided that immunosuppression is primarily prescribed for the disease under study (ie, SLE or RA) and not for secondary Sjögren's. 6. Significant CNS co-morbidity (eg, Parkinson's, stroke, CNS vasculitis, severe brain injury, dementia, neurodegenerative diseases, cerebellar disease, epilepsy/seizure disorders, PML, severe uncontrolled mental illness, psychosis, CNS involvement of autoimmune diseases).
  • 7. Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection.
  • 8. Exclusion Criteria Related to Infection:
  • 1. Any clinical suspicion or diagnosis of active infection at screening. 2. Opportunistic infection that meets criteria to be an SAE within 3 years. 3. Clinically significant chronic infection (for example osteomyelitis, bronchiectasis) with treatment completed less than 2 months prior to signing the ICF (except for chronic nail infections which are not exclusionary) 4. Any infection requiring hospitalisation or treatment with IV anti-infectives with treatment completed less than 4 weeks prior to signing the ICF.
  • 5. Any infection requiring oral anti-infectives within 2 weeks prior to signing the ICF.
  • 6. History of recurrent infection requiring hospitalisation or IV antibiotics (eg, 3 or more of the same type of infection, including systemic fungal infections, over the previous 52 weeks).
  • 9. Participants who, as judged by the Investigator, have evidence of active TB, or latent TB or have a household contact with known diagnosis of current active TB.
  • <!-- -->
  • TB evaluation will be performed according to the local SoC as determined by local guidelines and may include history and physical examinations, chest X-ray, or TB test (eg, purified protein derivative or QuantiFERON® test).
  • Participants with a prior diagnosis of active or latent TB who have documented evidence they have completed a full course of appropriate treatment are not excluded.
  • However, a previous history of multidrug-resistant or extensively drug-resistant TB is exclusionary regardless of treatment status. 10. Participant with human immunodeficiency virus infection (confirmed by central laboratory at screening) 11. Participant with active EBV or CMV, assessed clinically. 12. Participant with evidence of chronic or active hepatitis B defined as HBsAg positive or HBcAB positive (tested at screening visit).
  • 13. Participant with evidence of chronic or active Hepatitis C, meeting any of the criteria below: (a) HCV RNA positive or detectible at screening (b) HCV antibody positive at screening (apart from those with negative HCV RNA >12 weeks after completion of curative antiviral treatment for HCV or those with sustained negative HCV RNA 12 weeks apart following resolution of HCV infection if not treated).
  • 14. Participant positive with COVID-19 PCR at screening. If patients test positive at screening or Day 1 but meet other eligibility criteria, they may be re-tested after ≥ 2 weeks. If this falls within the screening window, then they do not require re-screening.
  • 15. Receipt of any of the following treatments or interventions ever: (a) TCEs, with the exception of surovatamig under the conditions specified in Inclusion Criterion 19 (b) Bone marrow transplant (c) Stem cell transplant (d) Total lymphoid irradiation (e) CAR-T cell therapy (f) Alemtuzumab 16. For females only - currently pregnant (confirmed with positive pregnancy test), planning to become pregnant within the study period, or breast feeding.

Trial locations and contacts

35 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

35 sites in 10 countries

United States6 sites, 5 recruiting

  • Research Site

    Allen, Texas, 75013

    Recruiting

  • Research Site

    Birmingham, Alabama, 35233

    Withdrawn

  • Research Site

    Fullerton, California, 92835

    Recruiting

  • Research Site

    Mesquite, Texas, 75150

    Recruiting

  • Research Site

    Plantation, Florida, 33324

    Not yet recruiting

  • Research Site

    St Louis, Missouri, 63110

    Not yet recruiting

Other trials in United States

Germany5 sites, 4 recruiting

  • Research Site

    Bonn, 53127

    Recruiting

  • Research Site

    Jena, 07747

    Recruiting

  • Research Site

    Mainz, 55131

    Withdrawn

  • Research Site

    München, D-80336

    Not yet recruiting

  • Research Site

    Münster, 48149

    Not yet recruiting

Other trials in Germany

Belgium4 sites, 4 recruiting

  • Research Site

    Edegem, 2650

    Recruiting

  • Research Site

    Leuven, 3000

    Not yet recruiting

  • Research Site

    Liège, 4000

    Recruiting

  • Research Site

    Merksem (Antwerpen), 2170

    Recruiting

Other trials in Belgium

Taiwan4 sites, 4 recruiting

  • Research Site

    Kaohsiung City, 83301

    Recruiting

  • Research Site

    Taichung, 402

    Recruiting

  • Research Site

    Taipei, 100

    Recruiting

  • Research Site

    Taoyuan, 333

    Recruiting

Other trials in Taiwan

Brazil3 sites, 3 recruiting

  • Research Site

    Porto Alegre, 90035-903

    Recruiting

  • Research Site

    Salvador, 41253-190

    Recruiting

  • Research Site

    São Paulo, 05652-900

    Not yet recruiting

Other trials in Brazil

China3 sites, 3 recruiting

  • Research Site

    Beijing, 100034

    Recruiting

  • Research Site

    Chengdu, 610041

    Recruiting

  • Research Site

    Nanjing, 210008

    Recruiting

Other trials in China

Spain3 sites, 3 recruiting

  • Research Site

    Barcelona, 08025

    Recruiting

  • Research Site

    Córdoba, 14004

    Recruiting

  • Research Site

    Madrid, 28034

    Recruiting

Other trials in Spain

Ukraine3 sites, 3 recruiting

  • Research Site

    Kyiv, 04050

    Recruiting

  • Research Site

    Ternopil, 46002

    Recruiting

  • Research Site

    Vinnytsia, 21018

    Recruiting

Other trials in Ukraine

Australia2 sites, 2 recruiting

  • Research Site

    Birtinya, 4575

    Recruiting

  • Research Site

    Clayton, 3168

    Recruiting

Other trials in Australia

United Kingdom2 sites, 2 recruiting

  • Research Site

    London, EC1M 6BQ

    Not yet recruiting

  • Research Site

    London, SE1 9RT

    Recruiting

Other trials in United Kingdom

About this study

Official title: 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

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.

Read the detailed description

This is an open-label, Phase I, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of surovatamig administered subcutaneously in adult participants aged 18 to 65 years with rheumatoid arthritis or systemic lupus erythematosus. The study includes single-ascending dose cohorts in adult participants with RA (Part 1) and step-up dosing cohorts in adult participants with RA or SLE (Parts 2 and 3).

Being tested
Surovatamig
Keywords
adult participants, rheumatoid arthritis, systemic lupus erythematosus, surovatamig
Medical subject headings
Arthritis, Rheumatoid, Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SurovatamigBiological

    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.

Study groups in NCT07201558
Study groupRoleWhat they receive
SurovatamigExperimentalParticipants 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.
Receives: Biological: Surovatamig

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Day 1 to end of the study (up to 52 weeks)

  5. Tolerability of surovatamig: Incidence of treatment-related clinical laboratory abnormalities

    Number of participants with treatment-related clinical laboratory abnormalities

    Measured: Day 1 to end of the study (up to 52 weeks)

  6. Tolerability of surovatamig: Number of participants with abnormal ECG

    Number and percentage of participants with abnormal ECG.

    Measured: From baseline through Day 180.

Secondary outcomes (4)

  1. Serum Pharmacokinetics (PK) parameters of surovatamig - Cmax

    Maximum observed serum drug concentration (Cmax)

    Measured: From Day 1 through Day 180

  2. Absolute counts at Day 180 in blood CD20+ B-cells

    Absolute counts in peripheral CD20+ B cells

    Measured: Day 180

  3. 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)

    Measured: From Day 1 through Day 180

  4. Serum Pharmacokinetics (PK) parameters of surovatamig - AUCinf

    Area under the serum concentration time curve from time zero to infinity (Part 1 only)

    Measured: From Day 1 through Day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2025
  2. Study start2 Dec 2025
  3. Primary completion27 Jun 2028 (estimated)
  4. Study completion27 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
This is an open-label study consisting of up to 3 parts: SAD (Part 1), sSUD (Part 2), and optional dSUD (Part 3). Depending on the assigned study part, participants will either receive surovatamig once (Part 1), twice (Part 2), or three times (Part 3).
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07201558
Sponsor's protocol ID
D740AC00001
Other IDs
2025-522273-10-00, 2025
Acronym
ASSURO
Status last verified
Oct 2026
First submitted
30 Sep 2025
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Surovatamig in people with Rheumatoid Arthritis and Systemic Lupus Erythematosus, run by AstraZeneca at 35 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States, Germany, Belgium, Taiwan, Brazil and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety evaluation of surovatamig: Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs) (time frame: Day 1 to end of the study (up to 52 weeks)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07201558.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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