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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)

NCT07409103 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-04-23

No results posted yet for this study

Summary

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.

Conditions

  • Active Rheumatoid Arthritis

Interventions

DRUG

ELV001 25 mg

25mg from week 0 to week 12 then ELV001 75mg or 125mg per day from week 12 to week 24

DRUG

ELV001 75 mg

75mg from week 0 to week 24

DRUG

ELV001 125 mg

125mg from week 0 to week 24

DRUG

Placebo

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

Sponsors & Collaborators

  • Elevara Medicines Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-18
Primary Completion
2027-04-15
Completion
2028-03-31
FDA Drug
Yes

Countries

  • United States
  • South Africa

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07409103 on ClinicalTrials.gov