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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 · Phase 2 · Elevara Medicines Limited · registry updated 2026-10-23

Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.

This is a Phase 2 randomized, double-blind, placebo-controlled study with a total duration of 32 weeks from Screening to End-of-Study (EOS) Visit. Approximately 180 participants are planned to be enrolled. The number of participants can be extended to maximally 220 to account for dropouts during the study.

Inclusion

  • Provided written informed consent to participate to the study and are able and willing to adhere to the study protocol.
  • Male or female, 18 to 75 years of age, at the time of signing the informed consent.
  • Body mass index (BMI) between 18.5 and 32.0 kg/m2 and minimum weight of 50 kg at the Screening Visit.
  • Have a diagnosis of adult onset RA and fulfill the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria (Aletaha et al. 2010) for at least 6 months prior to Screening.
  • Have active RA defined by a DAS28-CRP ≥ 3.2 and the presence of ≥ 3 swollen joints (based on 66 joint count) and ≥ 3 tender joints (based on 68 joint count) at Screening and Baseline. The distal interphalangeal joint should be evaluated but not included in the total count to determine eligibility.
  • Have C-reactive protein (CRP) ≥ upper limit of normal (ULN) at Screening.

Exclusion

  • Class IV RA according to ACR revised response criteria.
  • Have been treated with more than 1 previous bDMARDs or tsDMARDs, excluding the current TNFi.
  • Has a secondary non-response to the TNFi due to anti-drug antibodies, as assessed by the Investigator.
  • Have a dose change of MTX or TNFi within the last 3 months before Baseline, or a dose change of hydroxychloroquine or oral prednisolone within the last 4 weeks before Baseline.
  • Have oral prednisone \> 7.5 mg/day equivalent or parenteral corticosteroids within the last 4 weeks before Baseline.
  • Have intra-articular corticosteroids within the last 4 weeks before Baseline.

Open NCT07409103 on ClinicalTrials.govAll conditions