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

NCT07433335 | Recruiting Phase 1 DMC

• 2 other identifiers: SR-878-01-0022025-523678-17-00
• Study Type: interventional
• Target: 27
• Locations: 3 countries
• Sites: 4

Brief 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).

Conditions

Rheumatoid Arthritis

Keywords

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

Outcome Measures

Primary Outcomes (3)

• The number of participants with treatment-emergent adverse events (TEAEs), serious adverse events and related TEAEs

  Proportion of participants with treatment-emergent adverse events (TEAEs), serious adverse events and related TEAEs

  Day 1 until day 85

• Dose-limiting toxicities

  The number of participants with dose-limiting toxicities (DLTs)

  Day 1 until day 85

• Maximum tolerated dose

  Determination of the maximum tolerated dose (MTD)

  Day 1 until day 85

Secondary Outcomes (10)

• To determine the pharmacokinetics (PK) as measured by t1/2

  Day 1 until day 85

• To determine the pharmacokinetics (PK) as measured by the area under the serum concentration-time curve (AUC0-85)

  Day 1 to day 85

• To determine the pharmacokinetics (PK) as measured by the area under the serum concentration- time curve (AUC0-inf).

  Day 1 until day 85

• To determine the pharmacokinetics (PK) as measured by the area under the serum concentration- time curve (AUC0-last).

  Day 1 until day 85

• To determine the pharmacokinetics (PK) as measured by Cmax.

  Day 1 until day 85

Study Arms (1)

Verum

EXPERIMENTAL

solution for infusion, administered intravenously

Drug: SR-878

Interventions

SR-878 DRUG

Solution for infusion, administered intravenously

Verum

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SciRhom GmbH: lead
• FGK Clinical Research GmbH: collaborator

Study Sites (4)

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

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Juergen Reess, MD

CONTACT

+4989614241230; clinicaltrials@scirhom.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 25, 2026
• Study Start: April 7, 2026
• Primary Completion (Estimated): February 29, 2028
• Study Completion (Estimated): February 29, 2028
• Last Updated: May 11, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GE (1); MO (1); RO (2)