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

Phase 2

Not yet recruiting

• Conditions: Primary Sjögren's Syndrome
• Interventions: Drug: IMVT-1402; Drug: Placebo

• Registration Number: NCT06979531
• Lead Sponsor: Immunovant Sciences GmbH

Brief Summary

This is a Phase 2b, multicenter, randomized, double-blinded, placebocontrolled study to assess the efficacy and safety of IMVT-1402 in adult participants with moderate to severe systemic primary Sjogren's disease (SjD). 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. A key secondary endpoint is to evaluate the effects of IMVT-1402 compared to placebo, as measured by the proportion of cliniESSDAI responders (≥ 4 points improvement from baseline) at Week 48.

Detailed Description

The study has 4 periods: screening period (up to 35 days), Treatment Period 1 (24 weeks), Treatment Period 2 (24 weeks), and a Follow-up Period (4 weeks).

Eligible participants will be randomized 1:1:1 to receive IMVT-1402 600 mg, 300 mg, or placebo SC QW for 24 weeks during blinded treatment Period 1. Participants completing Period 1 on study treatment will continue their originally assigned treatment in Period 2.

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

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-13
• Study First Submitted QC: 2025-05-13
• Last Update Submitted: 2025-05-13
• Study First Posted: 2025-05-20
• Last Update Posted: 2025-05-20
• Study Start: 2025-06
• Primary Completion: 2028-07
• Study Completion: 2028-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 180

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 moderately active or highly active level of disease, as defined by clinESSDAI, in the following organ domains: pulmonary, renal, peripheral nervous system, or central nervous system.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: IMVT-1402 Dose 1	IMVT-1402	-
Group 2: IMVT-1402 Dose 2	IMVT-1402	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline in clinESSDAI Score at Week 24 for IMVT-1402 Dose 1 compared to Placebo	Baseline and at Week 24	The clinESSDAI is a tool used in clinical studies to measure the systemic disease activity in participants with primary Sjogren's syndrome.

Secondary Outcome Measures

Name	Time	Method
Proportion of clinESSDAI responders at Week 24 for IMVT-1402 Dose 2 compared to Placebo	Week 24	A clinESSDAI responder is defined as participants having achieved clinESSDAI ≥ 4 points improvement from Baseline.
Proportion of clinESSDAI responders at Week 48 for IMVT-1402 Dose 1 compared to Placebo	Week 48	A clinESSDAI responder is defined as participants having achieved clinESSDAI ≥ 4 points improvement from Baseline.
Proportion of clinESSDAI responders at Week 48 for IMVT-1402 Dose 2 compared to Placebo	Week 48	A clinESSDAI responder is defined as participants having achieved clinESSDAI ≥ 4 points improvement from Baseline.
Proportion of clinESSDAI responders at Week 24 for IMVT-1402 Dose 1 compared to Placebo	Week 24	A clinESSDAI responder is defined as participants having achieved clinESSDAI ≥ 4 points improvement from Baseline.
Change from Baseline in clinESSDAI score at Week 24 for IMVT-1402 Dose 2 compared to Placebo	Baseline, Week 24
Change from baseline in Physician General Assessment of Disease Activity (PhGA) score at Week 24 for IMVT-1402 Dose 1 compared to Placebo	Baseline and at Week 24	The PhGA is a measure of the participant's current disease activity as assessed by the physician or another healthcare professional.
Change from baseline in PhGA score at Week 24 for IMVT-1402 Dose 2 compared to Placebo	Baseline and at Week 24	The PhGA is a measure of the participant's current disease activity as assessed by the physician or another healthcare professional.