Last updated 11 days ago
Efficacy and Safety of IMVT-1402 in Adult Participants With Primary Sjogren's Disease With Moderate to Severe Systemic Disease Activity
180 patients around the world
Available in Chile, Peru, Argentina, United States, Mexico, Brazil, Colombia
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
5Research sites
180Patients around the world
This study is for people with
Rare diseases
Sjogren's syndrome
Requirements for the patient
To 74 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
CER Instituto Médico - Quilmes, Buenos Aires
Recruiting
Centro Médico Arsema
Recruiting
Centro Médico Santa María de la Salud
Recruiting
Mautalen - Salud e Investigación - CABA
Recruiting
CIER - Centro de Investigación en Enfermedades Reumáticas
Recruiting
SponsorImmunovant Sciences GmbH
Study typeInterventional
Conditions
Sjogren's syndrome
Requirements
To 74 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06979531
