A Study to Assess the Safety and Tolerability of SR-878 in Patients With Rheumatoid Arthritis (NCT07433335) | Clinical Trial Compass
RecruitingPhase 1
A Study to Assess the Safety and Tolerability of SR-878 in Patients With Rheumatoid Arthritis
Georgia, Moldova, Romania27 participantsStarted 2026-04-07
Plain-language summary
SR-878 is a newly developed medicine that aims to treat autoimmune disorders. It inhibits a protein (iRhom2), that regulates enzymes that are involved in the production of cytokines (small proteins that are crucial in controlling the activity of immune system cells). The aim of this clinical trial is to find a suitable safe and effective SR-878 dose for patients with rheumatoid arthritis. The study will include a screening period, an inpatient treatment period, and an outpatient follow-up period. The study duration for an individual participant is up to 113 days (about 16 weeks).
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Written informed consent
✓. Men and women aged 18 to 60 years inclusive
✓. Body weight ≥45 kg and body mass index ≤32 kg/m²
✓. Diagnosis of RA according to the 2010 ACR/EULAR classification criteria, for at least 3 months before Screening
✓. Stable dose of MTX for at least 4 weeks before Day 1
✓. Ability to comply with the study protocol for the duration of the study, including inpatient confinement for about 3 days
✓. Adequate venous access for blood collection
✓. Women must not be pregnant or breastfeeding and
Exclusion criteria
✕. Abnormal findings in medical history and physical examination considered to be clinically relevant by the investigator
✕. Acute infectious diseases within 2 weeks before Screening
✕. History or presence of any autoimmune disease other than RA, chronic inflammatory condition, or clinically significant (in the opinion of the Investigator) atopic allergy (eg, asthma, urticaria, eczematous dermatitis, allergic rhinitis)
✕. Relevant history of other renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, hematological, endocrine, inflammatory, chronic infectious, or neurological diseases
✕. History of anaphylaxis to drugs or major allergic reactions in general, which in the view of the investigator may compromise the safety of the participant