SR-878 safety and tolerability in people with rheumatoid arthritis

Phase 1b Study to Assess the Safety and Tolerability of SR-878 in Patients With Rheumatoid Arthritis

This study will test whether the experimental drug SR-878 is safe and well tolerated and to find the best dose for adults with rheumatoid arthritis.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: SciRhom GmbH (Industry-sponsored)
• Drugs / interventions: methotrexate
• Locations: 4 sites (Tbilisi and 3 other locations)
• Trial ID: NCT07433335 on ClinicalTrials.gov

What this trial studies

This Phase 1, dose-escalation study enrolls adults with rheumatoid arthritis to test the safety, tolerability, pharmacokinetics, and biomarker effects of SR-878. The trial includes a screening period, an inpatient dosing and observation period (about three days), and outpatient follow-up for a total participation time of up to 113 days. The program will monitor adverse events, blood biomarkers, drug levels, and any immune response to the drug while escalating doses across cohorts. The study was designed after a halted healthy-volunteer study showed a transient rise in inflammation markers, and animal data suggested the reaction may differ in subjects with inflammatory disease like RA.

Who should consider this trial

Good fit: Adults aged 18–60 with a confirmed diagnosis of rheumatoid arthritis for at least three months who are on a stable dose of methotrexate and can comply with a short inpatient stay and study procedures are the intended participants.

Not a fit: People older than 60, those with recent changes in RA therapy, people who cannot comply with inpatient confinement or contraception requirements, or those with disqualifying medical conditions may not benefit or be eligible.

Why it matters

Potential benefit: If successful, SR-878 could offer broader anti-inflammatory effects with potentially fewer side effects than therapies that block only a single pathway.

How similar studies have performed: Drugs that block single inflammatory pathways have clinical benefit in RA, but targeting iRhom2 is a novel approach with limited human data and mainly promising preclinical evidence.

Eligibility criteria

Inclusion Criteria:

1. Written informed consent
2. Men and women aged 18 to 60 years inclusive
3. Body weight ≥45 kg and body mass index ≤32 kg/m²
4. Diagnosis of RA according to the 2010 ACR/EULAR classification criteria, for at least 3 months before Screening
5. Stable dose of MTX for at least 4 weeks before Day 1
6. Ability to comply with the study protocol for the duration of the study, including inpatient confinement for about 3 days
7. Adequate venous access for blood collection
8. Women must not be pregnant or breastfeeding and

   1. 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
   2. 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)
9. 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
10. Disease status appropriate to be included in this exploratory safety study according to the investigator

Exclusion Criteria:

1. Abnormal findings in medical history and physical examination considered to be clinically relevant by the investigator
2. Clinically significant abnormal screening laboratory tests
3. Known active infection with human immunodeficiency virus (HIV), hepatitis B virus, tuberculosis, and/or hepatitis C virus (HCV)
4. Clinically relevant ECG (12 leads) abnormalities
5. Acute infectious diseases within 2 weeks before Screening
6. 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)
7. Relevant history of other renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, hematological, endocrine, inflammatory, chronic infectious, or neurological diseases
8. 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
9. Malignancy in the last 5 years before Screening (except basal or squamous cell skin cancer)
10. History of any chronic inflammatory arthritis with onset prior to the age of 18 or history of acute inflammatory joint disease of a different origin than RA
11. Current or previous (within 30 days or, if applicable, 5 half-lives of the investigational medicinal product (IMP), whatever is longer, before Screening) participation in another clinical study with an investigational drug and/or medical device
12. Known hypersensitivity to the active substance or to any of the excipients of the IMP and auxiliary medicinal products
13. Drug and alcohol abuse
14. Prohibited medication as outlined below
15. Plans to undergo elective procedures or surgeries at any time after signing the informed consent form until end of the study
16. Employees of the sponsor, or employees or relatives of the investigator
17. Individuals committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
18. Legal incapacity or limited legal capacity

Where this trial is running

Tbilisi and 3 other locations

• SciRhom clinical trial site — Tbilisi, Georgia (Recruiting)
• SciRhom clinical trial site — Chisinau, Moldova (Recruiting)
• SciRhom clinical trial site — Bucharest, Romania (Recruiting)
• SciRhom clinical trial site — Cluj-Napoca, Romania (Recruiting)

Study contacts

• Study coordinator: Juergen Reess, MD

Conditions Rheumatoid Arthritis; dose escalation trial; autoimmune; SR-878