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

Immunovant

Status and phase: Enrolling; Phase 2

Conditions: Primary Sjögren's Syndrome

Treatments: Drug: IMVT-1402; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06979531

2025-520831-18-00 (EU Trial (CTIS) Number)

IMVT-1402-2801

Details and patient eligibility

About

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).

Full 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 (cliniESSDAI) at Week 24.

The total duration of study participation is expected to be up to 57 weeks for an individual participant.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with a diagnosis of primary SjD for at least 12 months prior to the Screening Visit and meet classification criteria for primary SjS according to the 2016 American College of Rheumatology/ European League Against Rheumatism Classification Criteria for Primary Sjogren's Syndrome at the time of screening.
• Participants with moderate to severe systemic disease activity as determined by a clinESSDAI total score ≥ 5 at the Screening Visit.
• Participants are seropositive for antibodies to Sjogren's Syndrome A (SSA)/Anti-Sjogren's Syndrome A (Ro) at the Screening Visit.
• Participants have residual salivary flow as measured by stimulated whole salivary flow rate ≥ 0.01 milliliters per minute (mL/min) at the Screening Visit.

Additional inclusion criteria are defined in the protocol.

Exclusion criteria

• Participants with a diagnosis of secondary SjD or an autoimmune disease other than primary SjD that constitutes the principal illness, including but not limited to, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, dermatomyositis, pre-existing fibromyalgia or polymyositis, at the Screening Visit.
• Participants with a history of clinically significant monoclonal gammopathy, including but not limited to monoclonal gammopathy of undetermined significance, history of multiple myeloma or non-Hodgkin's lymphoma, or have an active malignancy or history of malignancy within 5 years prior to the Screening Visit.

Additional exclusion criteria are defined in the protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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180 participants in 3 patient groups, including a placebo group

Group 1: IMVT-1402 Dose 1

Experimental group

Treatment:

Drug: IMVT-1402

Group 2: IMVT-1402 Dose 2

Experimental group

Treatment:

Drug: IMVT-1402

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo