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ELV001 for Active Rheumatoid Arthritis

This study is testing different doses of ELV001 to see how safe and effective it is for people with active rheumatoid arthritis (a condition causing joint pain and swelling). You might be able to join if you are between 18 and 75 years old and your rheumatoid arthritis hasn't improved enough with methotrexate and TNF inhibitors (common arthritis medications). The study will look at how much your disease activity score (a measure of your arthritis symptoms) changes between the start of the study and week 12. The study plans to enroll about 180 people. The current recruitment status is unclear.

Study design
This is a Phase 2, randomized, double-blind (meaning neither you nor your doctor will know which treatment you receive), placebo-controlled study. It involves about 180 participants.
What's involved
The study lasts for 32 weeks, including a 4-week screening period, a 24-week treatment period, and a 4-week safety follow-up.
Compensation
Not stated in the trial record.
Follow-up
There is a 4-week safety follow-up period after the 24-week treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07409103

A Study to Assess the Safety and Efficacy of Different Doses of ELV001 to Treat Active Rheumatoid Arthritis in Patients With an Inadequate Response to Methotrexate and Tumor Necrosis Factor Inhibition (START SYNERGY)

Recruiting
PHASE2Ages 18–75InterventionalTreatment
Elevara Medicines Limited
~180 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:ELV001 25 mgELV001 75 mgELV001 125 mgPlacebo

At a glance

Recruiting sites
30 of 30 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Disease activity score 28- C-reactive protein between Baseline and Week 12.
Measured over From Baseline to week 12

Conditions

Active Rheumatoid Arthritis

Explore related trials

Rheumatoid Arthritis

Where it's being run

30 sites across 14 states
Texas6
Florida5
Arizona3
Gauteng3
North Carolina2
Pennsylvania2
Capetown2
California1

Who to contact

Dr. Daniel Kreutz
[email protected]
480-626-6652
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Serious (requiring hospitalization, and/or parenteral antibiotic treatment),
Opportunistic, as defined in (Winthrop et al. 2015) (note, Herpes zoster infection is considered active and ongoing until all vesicles are dry and crusted over),
Chronic (duration of symptoms, signs, and/or treatment of 6 weeks or longer),
Recurring (including, but not limited to herpes simplex, herpes zoster, recurring cellulitis, chronic osteomyelitis). Participants with recurrent nonserious infections such as cellulitis and uncomplicated orolabial and/or genital herpes may be enrolled at the discretion of the Investigator when deemed not to place participants at an increased risk of complications. 18. Have any of the following:
Human immunodeficiency virus (HIV) infection,
Current infection with hepatitis B virus (HBV) (ie, positive for hepatitis B surface antigen and/or polymerase chain reaction \[PCR\] positive for HBV DNA),
Current infection with hepatitis C virus (HCV) (ie, positive for HCV RNA),
Active tuberculosis (TB). 19. Have or have had latent TB infection (LTBI) that has not been treated with a complete course of appropriate therapy as defined by the World Health Organization (WHO) and/or the United States Centers for Disease Control and Prevention (CDC). Participants with LTBI who have been adequately treated are eligible for the study. 20. Current or recent acute active infection (ie, participants must have had no symptoms and/or signs of confirmed or suspected infection and must have completed any appropriate anti-infective treatment within 30 days of Baseline); or fever of 100.5°F (38°C) or above at Screening or Baseline. 21. Any other concurrent severe and/or uncontrolled medical, surgical or psychiatric and/or social condition which, in the view of the Investigator, could compromise the participant's safety or ability to participate in the study and make them unsuitable for participation. 22. Use of other investigational medicinal products within 12 weeks or at least 5 half-lives (whichever is longer) before study drug administration. 23. Women who are pregnant or breast-feeding or planning to become pregnant during the study.

What this trial measures

  • Change in Disease activity score 28- C-reactive protein between Baseline and Week 12.From Baseline to week 12

    Change in Disease Activity Score (Disease activity score 28- C-reactive protein) from Baseline to Week 12, comparing placebo with the highest ELV001 dose group, Score less than 2.6 indicates disease in remission, score more than 5.1 indicates very active disease