Skip to content
DataLookout
Start free
Menu

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)

StatusRecruiting
PhasePhase 2
Primary completion (estimated)
Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 4 versions: 4 with changes below. See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 30 → 34 locations
    • Eligibility criteria expanded, about 47 words
    • Secondary endpoints: details revised at 6 of 20 entries
  2. Study sites: 29 to 30v3
  3. Recruitment opened
    • Trial sites expanded: 0 → 29 locations
    • Start date changed from estimate of Jan 31, 2026 to Feb 18, 2026
    v2
  4. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

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

Secondary (20)

Incidence and severity of TEAEs, SAEs, and AESIs.
Incidence and severity of SUSARs
Change from Baseline in 12-lead ECG parameters (including QTcF)
Change from Baseline in vital signs (Respiratory Rate)
Change from Baseline in laboratory parameters (hematology, biochemistry, coagulation, and urinalysis).'
Show 15 moreShow less
Percentage of participants reaching remission and low disease activity as defined by Disease activity score 28- C-reactive protein at Week 12 and at Week 24.
Percentage of participants reaching ACR20/ACR50/ACR70 at Week 12 and at Week 24
Change from Baseline to Week 12 and to Week24 in swollen joint count, tender joint count
Change From baseline to Weeks12 and 24 in Short form health survey36,
Assessment of any correlation between dose and disease activity scores.
Plasma drug and metabolite concentrations - area under the curve (AUC)
Plasma drug and metabolite concentration - maximum concentration (Cmax)
Change from Baseline in vital signs (Body Temperature)
Change from Baseline in vital signs (Blood Pressure)
Change from Baseline in vital signs (Heart Rate)
Change from Baseline to Week 12 and to Week 24 in simplified disease activity index (SDAI).
Change from Baseline to Week 12 and to Week 24 in Clinical disease activity index (CDAI).
participant's global assessments: disease activity (VAS),and arthritis pain (VAS)
Change from Baseline to Week 12 and to Week 24 in Health Assessment Questionnaire-Disability Index (HAQ-DI).
Functional Assessment of Chronic illness Therapy

Arms and interventions

ELV001 25 mg QDExperimental
ELV001 75 mg QDExperimental
ELV001 125 mg QDExperimental
PlaceboPlacebo comparator

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

Sites

34 sites in 3 countries

United States 22, South Africa 8, Serbia 4