IMVT-1402: Administered once weekly by subcutaneous injection
Placebo: Administered once weekly by subcutaneous injection
Study 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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
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 exclusion criteria are defined in the protocol.
Primary outcome measure(s)
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.
Trial sites (96)
Facility
City
Region
Status
Site Number - 1027
Covina
California
Site Number - 1007
El Cajon
California
Site Number - 1016
Menifee
California
Site Number - 1029
Thousand Oaks
California
Site Number - 1026
Upland
California
Site Number - 1014
Fort Collins
Colorado
Site Number - 1018
Hollywood
Florida
Site Number - 1021
Jupiter
Florida
Site Number - 1002
Miami
Florida
Site Number - 1004
Tamarac
Florida
Site Number - 1025
Tampa
Florida
Site Number - 1012
Chicago
Illinois
Site Number - 1033
Orland Park
Illinois
Site Number - 1030
Lake Charles
Louisiana
Site Number - 1028
New Orleans
Louisiana
Site Number - 1032
Canton
New York
Site Number - 1006
Mineola
New York
Site Number - 1013
Philadelphia
Pennsylvania
Site Number - 1015
Jackson
Tennessee
Site Number - 1000
Memphis
Tennessee
Site Number - 1001
Allen
Texas
Site Number - 1020
Amarillo
Texas
Site Number - 1022
Arlington
Texas
Site Number - 1019
Austin
Texas
Site Number - 1024
Grapevine
Texas
Site Number - 1011
Houston
Texas
Site Number - 1010
Houston
Texas
Site Number - 1023
Katy
Texas
Site Number - 1031
San Antonio
Texas
Site number - 5005
Azcuénaga
Buenos Aires
Site Number - 5007
Capital Federal
Buenos Aires
Site Number - 5004
San Miguel de Tucumán
Tucumán Province
Site Number - 5000
Buenos Aires
Argentina
Site Number - 5002
Buenos Aires
Argentina
Site Number - 5003
Buenos Aires
Argentina
Site Number - 5001
Buenos Aires
Argentina
Site number - 5006
Buenos Aires
Argentina
Site Number - 2001
Sherbrooke
Quebec
Site Number - 2000
Trois-Rivières
Quebec
Site Number - 5700
Santiago
Santiago de Chile
+ 56 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.