A Phase 2 interventional study of IMVT-1402 and Placebo in Primary Sjögren's Syndrome, sponsored by Immunovant Sciences GmbH. Active, not recruiting at 96 sites in 13 countries. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Immunovant Sciences GmbH · Phase 2, Interventional, and Treatment
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).
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.
Immunovant Sciences GmbH is the lead sponsor of 19 studies on the registry; 5 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 5 (45%) have results posted.
Counted across the registry records on this site, refreshed daily.
Additional inclusion criteria are defined in the protocol.
Exclusion Criteria:
Additional exclusion criteria are defined in the protocol.
Drug: IMVT-1402
Drug: IMVT-1402
Drug: Placebo
Administered once weekly by subcutaneous injection
Administered once weekly by subcutaneous injection
Change from Baseline in clinESSDAI Score at Week 24 for IMVT-1402 Dose 1 compared to Placebo
The clinESSDAI is a tool used in clinical studies to measure the systemic disease activity in participants with primary Sjogren's syndrome.
Time frame: Baseline and at Week 24
Proportion of clinESSDAI responders at Week 24 for IMVT-1402 Dose 1 compared to Placebo
A clinESSDAI responder is defined as participants having achieved clinESSDAI ≥ 4 points improvement from Baseline.
Time frame: Week 24
Change from Baseline in clinESSDAI score at Week 24 for IMVT-1402 Dose 2 compared to Placebo
Time frame: Baseline, Week 24
Proportion of clinESSDAI responders at Week 24 for IMVT-1402 Dose 2 compared to Placebo
A clinESSDAI responder is defined as participants having achieved clinESSDAI ≥ 4 points improvement from Baseline.
Time frame: Week 24
Proportion of clinESSDAI responders at Week 48 for IMVT-1402 Dose 1 compared to Placebo
A clinESSDAI responder is defined as participants having achieved clinESSDAI ≥ 4 points improvement from Baseline.
Time frame: Week 48
Proportion of clinESSDAI responders at Week 48 for IMVT-1402 Dose 2 compared to Placebo
A clinESSDAI responder is defined as participants having achieved clinESSDAI ≥ 4 points improvement from Baseline.
Time frame: Week 48
Change from baseline in Physician General Assessment of Disease Activity (PhGA) score at Week 24 for IMVT-1402 Dose 1 compared to Placebo
The PhGA is a measure of the participant's current disease activity as assessed by the physician or another healthcare professional.
Time frame: Baseline and at Week 24
Change from baseline in PhGA score at Week 24 for IMVT-1402 Dose 2 compared to Placebo
The PhGA is a measure of the participant's current disease activity as assessed by the physician or another healthcare professional.
Time frame: Baseline and at Week 24
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Immunovant Sciences GmbH