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

Sponsor
SciRhom GmbH
Study ID
NCT07433335
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • SR-878 — DRUG
    Solution for infusion, administered intravenously

Study Details

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).

Key Dates

First listed
Feb 25, 2026
Start date
Apr 7, 2026
Status verified
Apr 2026
Primary completion
Feb 29, 2028
Completion
Feb 29, 2028

Study Design

Enrollment
27 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Verum
    solution for infusion, administered intravenously

Primary Outcome Measure

The number of participants with treatment-emergent adverse events (TEAEs), serious adverse events and related TEAEs [ Time Frame: Day 1 until day 85 ]

Central Contacts

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