NCT06979531

Efficacy and Safety of IMVT-1402 in Adult Participants With Primary Sjogren's Disease With Moderate to Severe Systemic Disease Activity

A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Primary Sjogren's Disease With Moderate to Severe Systemic Disease Activity

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Immunovant Sciences GmbH · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2b, multicenter, randomized, double-blinded, placebo-controlled study to assess the efficacy and safety of IMVT-1402 in adult participants with moderate to severe systemic primary Sjogren's disease (SjD).

Detailed description

The primary objective is to evaluate the efficacy, safety, and tolerability of IMVT-1402 compared to placebo, as measured by the change from baseline of Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (clinESSDAI) at Week 24. The total duration of study participation is expected to be up to 105 weeks for an individual participant.

Conditions

• Primary Sjögren's Syndrome

Interventions

Type	Name	Description
DRUG	IMVT-1402	Administered once weekly by subcutaneous injection
DRUG	Placebo	Administered once weekly by subcutaneous injection

Timeline

• Start date: 2025-06-30
• Primary completion: 2028-07-01
• Completion: 2029-07-01
• First posted: 2025-05-20
• Last updated: 2026-04-09

Locations

121 sites across 16 countries: United States, Argentina, Brazil, Canada, Chile, Colombia, Germany, Greece, Hungary, Italy, Mexico, Peru, Poland, Romania, Spain, United Kingdom

Regulatory

• FDA-regulated drug study