RecruitingPhase 1NCT07433335

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

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

Sponsor

SciRhom GmbH

Enrollment

27 participants

Start Date

Apr 7, 2026

Study Type

INTERVENTIONAL

Conditions

Rheumatoid Arthritis

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).

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria12

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

Exclusion Criteria18

Abnormal findings in medical history and physical examination considered to be clinically relevant by the investigator
Clinically significant abnormal screening laboratory tests
Known active infection with human immunodeficiency virus (HIV), hepatitis B virus, tuberculosis, and/or hepatitis C virus (HCV)
Clinically relevant ECG (12 leads) abnormalities
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
Malignancy in the last 5 years before Screening (except basal or squamous cell skin cancer)
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
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
Known hypersensitivity to the active substance or to any of the excipients of the IMP and auxiliary medicinal products
Drug and alcohol abuse
Prohibited medication as outlined below
Plans to undergo elective procedures or surgeries at any time after signing the informed consent form until end of the study
Employees of the sponsor, or employees or relatives of the investigator
Individuals committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
Legal incapacity or limited legal capacity