Clinical trial NCT06979531: Efficacy and Safety of IMVT-1402 in Adult Participants With Primary Sjogren's Disease With Moderate to Severe Systemic Disease Activity
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Primary Sjögren's Syndrome
Keywords: Sjogren Disease
IMVT-1402
Lead sponsor: Immunovant Sciences GmbH
Sponsor class: INDUSTRY
First posted: 2025-05-20
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 (cliniESSDAI) at Week 24.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in clinESSDAI Score at Week 24 for IMVT-1402 Dose 1 compared to Placebo
timeFrame: Baseline and at Week 24
Secondary outcomes:
measure: Proportion of clinESSDAI responders at Week 24 for IMVT-1402 Dose 1 compared to Placebo
timeFrame: Week 24
measure: Change from Baseline in clinESSDAI score at Week 24 for IMVT-1402 Dose 2 compared to Placebo
timeFrame: Baseline, Week 24
measure: Proportion of clinESSDAI responders at Week 24 for IMVT-1402 Dose 2 compared to Placebo
timeFrame: Week 24
measure: Proportion of clinESSDAI responders at Week 48 for IMVT-1402 Dose 1 compared to Placebo
timeFrame: Week 48
measure: Proportion of clinESSDAI responders at Week 48 for IMVT-1402 Dose 2 compared to Placebo
timeFrame: Week 48
measure: Change from baseline in Physician General Assessment of Disease Activity (PhGA) score at Week 24 for IMVT-1402 Dose 1 compared to Placebo
timeFrame: Baseline and at Week 24
measure: Change from baseline in PhGA score at Week 24 for IMVT-1402 Dose 2 compared to Placebo
timeFrame: Baseline and at Week 24
Other outcomes:
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