A Phase 2b, Multicenter, Double-blind, Placebo-controlled Randomized Withdrawal Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Active, Difficult-to-Treat, ACPA-Positive Rheumatoid Arthritis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515973-82-00

Acronym

IMVT-1402-2601

Enrollment

168

Registered

2025-05-30

Start date

2025-06-23

Completion date

Unknown

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ACPA-Positive Rheumatoid Arthritis

Brief summary

Proportion of participants who achieve ACR20 response at Week 28.

Detailed description

Change in Clinical Disease Activity Index (CDAI) score from Week 16 to Week 28., Change in Simplified Disease Activity Index (SDAI) score from week 16 to Week 28

Interventions

DRUGPlacebo is identical to IMP but with no active substance

DRUGIMVT-1402

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Proportion of participants who achieve ACR20 response at Week 28.	—

Secondary

Measure	Time frame
Change in Clinical Disease Activity Index (CDAI) score from Week 16 to Week 28., Change in Simplified Disease Activity Index (SDAI) score from week 16 to Week 28	—

Countries

Bulgaria, Czechia, Germany, Hungary, Poland, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026