Phase 1b Study to Assess the Safety and Tolerability of SR-878 in Patients With Rheumatoid Arthritis
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).
• 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
∙ be of non-childbearing potential (postmenopausal \[no menses for 12 months without an alternative medical cause\] or surgically sterilized \[documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy\]) or
‣ if of childbearing potential, must use a highly effective contraceptive method for the duration of the study and have a negative pregnancy test at Screening (blood test) Note: Acceptable highly effective methods of contraception include the intrauterine device; intrauterine hormone-releasing system; bilateral tubal occlusion (must be documented); oral, intravaginal, transdermal, injectable, and implantable methods of hormonal contraception associated with inhibition of ovulation, vasectomized partner (must be documented); or sexual abstinence (only when it is the usual and preferred lifestyle of the participant)
• Men must agree, from start of SR-878 administration until 90 days after SR-878 administration, to refrain from donating sperm and use a male condom when having sexual intercourse with a woman of childbearing potential, who is not currently pregnant, and advise her to use a highly effective contraceptive method
⁃ Disease status appropriate to be included in this exploratory safety study according to the investigator