Primary Sjögren's Syndrome
Conditions
Keywords
Sjogren Disease, IMVT-1402, Imeroprubart
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 (clinESSDAI) at Week 24. The total duration of study participation is expected to be up to 105 weeks for an individual participant.
Interventions
DRUGIMVT-1402
Administered once weekly by subcutaneous injection
DRUGPlacebo
Administered once weekly by subcutaneous injection
Sponsors
Immunovant Sciences GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The Sponsor will also be blinded in the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
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, inadequately treated fibromyalgia, other confirmed connective tissue, rheumatic, or systemic inflammatory autoimmune disease including but not limited to, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, dermatomyositis, or polymyositis, that in the opinion of the Investigator, is likely to interfere with the ability to assess primary SjD manifestations. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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. |
| 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. |
Countries
Argentina, Canada, Chile, Germany, Greece, Hungary, Italy, Peru, Poland, Romania, Spain, United Kingdom, United States
Outcome results
None listed