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

Conditions

• Primary Sjögren's Syndrome

Eligibility Criteria

Sex

ALL

Age

18 Years - 74 Years

Healthy Volunteers

Not accepted

Interventions

• IMVT-1402 — DRUG
  Administered once weekly by subcutaneous injection
• Placebo — DRUG
  Administered once weekly by subcutaneous injection

Study Details

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).

Key Dates

Start date

Jun 30, 2025

Status verified

Jun 2026

Primary completion

Jul 31, 2028

Completion

Jul 31, 2029

Study Design

Enrollment

180 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Group 1: IMVT-1402 Dose 1
• Experimental: Group 2: IMVT-1402 Dose 2
• Placebo Comparator: Placebo

Primary Outcome Measure

Change from Baseline in clinESSDAI Score at Week 24 for IMVT-1402 Dose 1 compared to Placebo [ Time Frame: Baseline and at Week 24 ]

Central Contacts

• Central Study Contact
  18007970414
  [email protected]

Locations (29)

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