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Purpose

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).

Condition

Eligibility

Eligible Ages
Between 18 Years and 74 Years
Eligible Sex
All
Accepts 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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
The Sponsor will also be blinded in the study.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group 1: IMVT-1402 Dose 1
  • Drug: IMVT-1402
    Administered once weekly by subcutaneous injection
Experimental
Group 2: IMVT-1402 Dose 2
  • Drug: IMVT-1402
    Administered once weekly by subcutaneous injection
Placebo Comparator
Placebo
  • Drug: Placebo
    Administered once weekly by subcutaneous injection

Recruiting Locations

Site Number - 1027
Covina, California 91722

Site Number - 1007
El Cajon, California 91910

Site Number - 1016
Menifee, California 92586

Site Number - 1029
Thousand Oaks, California 91360

Site Number - 1026
Upland, California 91786

Site Number - 1014
Fort Collins, Colorado 80528

Site Number - 1018
Hollywood, Florida 33024

Site Number - 1021
Jupiter, Florida 33458

Site Number - 1002
Miami, Florida 33143

Site Number - 1004
Tamarac, Florida 33321

Site Number - 1025
Tampa, Florida 33606

Site Number - 1012
Chicago, Illinois 60607

Site Number - 1033
Orland Park, Illinois 60467

Site Number - 1030
Lake Charles, Louisiana 77469

Site Number - 1028
New Orleans, Louisiana 70112

Site Number - 1032
Canton, New York 13675

Site Number - 1006
Mineola, New York 11501

Site Number - 1013
Philadelphia, Pennsylvania 19104

Site Number - 1015
Jackson, Tennessee 38305

Site Number - 1000
Memphis, Tennessee 38119

Site Number - 1001
Allen, Texas 75013

Site Number - 1020
Amarillo, Texas 79124

Site Number - 1022
Arlington, Texas 75231

Site Number - 1019
Austin, Texas 78745

Site Number - 1024
Grapevine, Texas 76034

Site Number - 1011
Houston, Texas 77030

Site Number - 1010
Houston, Texas 77407

Site Number - 1023
Katy, Texas 77494

Site Number - 1031
San Antonio, Texas 78215

More Details

Status
Recruiting
Sponsor
Immunovant Sciences GmbH

Study Contact

Central Study Contact
18007970414
clinicaltrials@immunovant.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.