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Tests treatment safety and results for Rheumatoid Arthritis
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 medicine, given as an injection under the skin, being studied as a potential treatment for rheumatoid arthritis.
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 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.
- 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...
- 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. (a) RF (b) ACPA
- Moderate or severe disease activity defined as: DAS28-CRP \> 3.2 AND
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.
- 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 4\. For SLE participants, only: 1.History of active, severe or...
- TB evaluation will be performed according to the local SoC as determined by local guidelines and may include history and physical examinations, chest...
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.
- 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. (a) RF (b) ACPA
- Moderate or severe disease activity defined as: DAS28-CRP \> 3.2 AND
- 4 tender joints and ≥ 4 swollen joints (a) 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...
- 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...
- 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...
- 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...
- 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.
- 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 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. However, a previous history of multidrug-resistant or...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Fullerton, California, United States
- St Louis, Missouri, United States
- Allen, Texas, United States
- Mesquite, Texas, United States
- Birtinya, Australia
- Clayton, Australia
- Edegem, Belgium
- Leuven, Belgium
- Liège, Belgium
- Porto Alegre, Brazil
- Salvador, Brazil
- São Paulo, Brazil
- Beijing, China
- Chengdu, China
- Nanjing, China
- Bonn, Germany
- Jena, Germany
- Mainz, Germany
- München, Germany
+ 12 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 - 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?
Study sites include Birmingham, Alabama, United States; Fullerton, California, United States; St Louis, Missouri, United States; Allen, Texas, United States; Mesquite, Texas, United States; Birtinya, Australia and 26 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.