Rheumatoid Arthritis study: Surovatamig
Official title Study Evaluating Safety, Tolerability, PK/PD of Surovatamig in Adult RA or SLE Participants
ClinicalTrials.gov ID: NCT07201558
What this study is testing
What is Surovatamig?
Surovatamig is an investigational once‑subcutaneous injectable medicine being studied for rheumatoid arthritis and systemic lupus erythematosus.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether surovatamig is safe and how it behaves in the body.
- Who it's for
- You may be able to join if you are an adult with rheumatoid arthritis or systemic lupus erythematosus.
- What's involved
- You will receive injections of surovatamig under the skin and have blood tests to check how the drug works.
- Time commitment
- The study lasts a few weeks and includes several clinic visits for injections and blood draws.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- Diagnosis of RA as defined by the 2010 EULAR/ACR classification criteria
- Positive for ≥ 1 disease-specific autoantibody performed by the central laboratory. (a) RF (b) ACPA
- Moderate or severe disease activity defined as: DAS28-CRP \> 3.2 AND
- Diagnosis of SLE as defined by the 2019 EULAR/ACR classification criteria
You likely can't join if
- 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...
- 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 4\.
- TB evaluation will be performed according to the local SoC as determined by local guidelines and may include history and physical examinations, chest...
- Participants with a prior diagnosis of active or latent TB who have documented evidence they have completed a full course of appropriate treatment...
See the full eligibility criteria
- 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. (a) RF (b) ACPA
- Moderate or severe disease activity defined as: DAS28-CRP \> 3.2 AND
- 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.
- Moderate or severe disease activity defined as clinical SLEDAI-2K \> 4 (a) 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...
- 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)
- 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...
- 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 4\. For SLE participants, only: 1.History of active, severe or unstable neuropsychiatric SLE, except for headache and peripheral...
- 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®...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Fullerton, California, United States
- Allen, Texas, United States
- Mesquite, Texas, United States
- Birtinya, Australia
- Clayton, Australia
- Edegem, Belgium
- Liège, Belgium
- Merksem (Antwerpen), Belgium
- Porto Alegre, Brazil
- Salvador, Brazil
- Beijing, China
- Chengdu, China
- Nanjing, China
- Bonn, Germany
- Jena, Germany
- Barcelona, Spain
- Córdoba, Spain
- Madrid, Spain
- Kaohsiung City, Taiwan
- Taichung, Taiwan
+ 6 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Fullerton, California, United States; Allen, Texas, United States; Mesquite, Texas, United States; Birtinya, Australia; Clayton, Australia; Edegem, Belgium and 20 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.