✅ This trial is currently recruiting volunteers
If you think you might be eligible, speak to your GP or specialist about this trial before applying.
Status
Recruiting
Phase
PHASE1
Participants
ALL
Age Range
18 Years โ 65 Years
About This Trial
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.
Who Can Join?
Inclusion Criteria: 1. 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. 2. For RA participants, only: 1. Diagnosis of RA as defined by the 2010 EULAR/ACR classification criteria 2. Positive for โฅ 1 disease-specific autoantibody performed by the central laboratory. (a) RF (b) ACPA 3. Moderate or severe disease activity defined as: DAS28-CRP > 3.2 AND * 4 tender joints and โฅ 4 swollen joints (a) US-Specific Criterion: DAS28-CRP > 3.2 AND โฅ 6 tender joints and โฅ 6 swollen joints 4. Intolerance to or inadequate response following approximately 3 month's treatment or longer to โฅ2 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.…
⚠ Always speak to your doctor before applying to any clinical trial.
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