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
Immunovant Sciences GmbH
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).
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.
Eligibility
- Age range
- 18–74 years
- Sex
- All
- 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…
Interventions
- DrugIMVT-1402
Administered once weekly by subcutaneous injection
- DrugPlacebo
Administered once weekly by subcutaneous injection
Locations (121)
- Site Number - 1027Covina, California
- Site Number - 1007El Cajon, California
- Site Number - 1016Menifee, California
- Site Number - 1029Thousand Oaks, California
- Site Number - 1026Upland, California
- Site Number - 1014Fort Collins, Colorado