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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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

A Study to Assess the Safety and Tolerability of SR-878 in Patients With Rheumatoid Arthritis (NCT07433335) is a Phase 1 interventional studying Rheumatoid Arthritis, sponsored by SciRhom GmbH. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Rheumatoid Arthritis, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 27 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Written willing to sign a consent form 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 Who Should NOT Join This Trial: 1. Abnormal findings in medical history and physical examination considered to be clinically relevant by the investigator ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

SR-878

Solution for infusion, administered intravenously

Locations (4)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

SciRhom clinical trial site
Tbilisi, Georgia
SciRhom clinical trial site
Chisinau, Moldova
SciRhom clinical trial site
Bucharest, Romania
SciRhom clinical trial site
Cluj-Napoca, Romania

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07433335), the sponsor (SciRhom GmbH), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07433335 clinical trial studying?

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). The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07433335?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07433335?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07433335. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07433335. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.