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)

Conditions

• Active Rheumatoid Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• ELV001 25 mg — DRUG
  25mg from week 0 to week 12 then ELV001 75mg or 125mg per day from week 12 to week 24
• ELV001 75 mg — DRUG
  75mg from week 0 to week 24
• ELV001 125 mg — DRUG
  125mg from week 0 to week 24
• Placebo — DRUG
  Placebo from week 0 to week 12, then ELV001 75mg or 125mg per day from week 12 to week 24.

Study Details

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.

Key Dates

Start date

Feb 18, 2026

Status verified

Apr 2026

Primary completion

Apr 15, 2027

Completion

Mar 31, 2028

Study Design

Enrollment

180 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: ELV001 25 mg QD
• Experimental: ELV001 75 mg QD
• Experimental: ELV001 125 mg QD
• Placebo Comparator: Placebo

Primary Outcome Measure

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

Locations (22)

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