Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
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RecruitingPhase 2interventionalRules rewrite

Phase 2: testing ELV001 25 mg for Active Rheumatoid Arthritis

This is a Phase 2 randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study with a total duration of 32 weeks from Screening to End-of-Study (EOS) Visit. Approximately 180 participants are planned to be enrolled.

Official registry: https://clinicaltrials.gov/study/NCT07409103 · Elevara Medicines Limited · enrollment listed as 180

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are ELV001 25 mg, ELV001 75 mg, or ELV001 125 mg. The registry lists allocation as randomized. This is a Phase 2 randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study with a total duration of 32 weeks from Screening to End-of-Study (EOS) Visit.

They plan to enroll about 180 people at 32 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety and Efficacy of ELV001 as Add-on Therapy in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate and Tumor Necrosis Factor Inhibition (START SYNERGY)

Interventions: ELV001 25 mg, ELV001 75 mg, ELV001 125 mg, Placebo

Primary outcome (registry wording): Change in Disease activity score 28- C-reactive protein between Baseline and Week 12.

Who it is for (from inclusion criteria)

  • Ages 18 Years to 75 Years
  • Body mass index (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 C-reactive protein (a blood inflammation marker (CRP)) ≥ upper limit of normal (ULN) at Screening
  • Have adequate hematologic function at Screening AND at Baseline
  • Have adequate liver and renal function at Screening
  • Female participants of childbearing potential must:
  • Have a negative serum pregnancy test at Screening and a negative urine pregnancy test within 24 hours prior to first dosing

Contact

No central phone on the registry card. Use the official listing to reach a site.

Sites listed on ClinicalTrials.gov

32 listed

+ 11 sites outside the US on the same record

Related recruiting trials in this snapshot

FAQ about this NCT record

Is NCT07409103 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07409103?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07409103?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

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