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RECRUITING

NCT06979531

PHASE2

Efficacy and Safety of IMVT-1402 in Adult Participants With Primary Sjogren's Disease With Moderate to Severe Systemic Disease Activity

Sponsor: Immunovant Sciences GmbH

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 74 Years

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2025-06-30

Completion Date

2029-07

Last Updated

2026-04-09

Healthy Volunteers

Conditions

Primary Sjögren's Syndrome

Interventions

DRUG

IMVT-1402

Administered once weekly by subcutaneous injection

DRUG

Placebo

Administered once weekly by subcutaneous injection

Locations (121)

Site Number - 1027

Covina, California, United States

Site Number - 1007

El Cajon, California, United States

Site Number - 1016

Menifee, California, United States

Site Number - 1029

Thousand Oaks, California, United States

Site Number - 1026

Upland, California, United States

Site Number - 1014

Fort Collins, Colorado, United States

Site Number - 1018

Hollywood, Florida, United States

Site Number - 1021

Jupiter, Florida, United States

Site Number - 1002

Miami, Florida, United States

Site Number - 1004

Tamarac, Florida, United States

Site Number - 1025

Tampa, Florida, United States

Site Number - 1012

Chicago, Illinois, United States

Site Number - 1033

Orland Park, Illinois, United States

Site Number - 1030

Lake Charles, Louisiana, United States

Site Number - 1028

New Orleans, Louisiana, United States

Site Number - 1032

Canton, New York, United States

Site Number - 1006

Mineola, New York, United States

Site Number - 1013

Philadelphia, Pennsylvania, United States

Site Number - 1015

Jackson, Tennessee, United States

Site Number - 1000

Memphis, Tennessee, United States

Site Number - 1001

Allen, Texas, United States

Site Number - 1020

Amarillo, Texas, United States

Site Number - 1022

Arlington, Texas, United States

Site Number - 1019

Austin, Texas, United States

Site Number - 1024

Grapevine, Texas, United States

Site Number - 1011

Houston, Texas, United States

Site Number - 1010

Houston, Texas, United States

Site Number - 1023

Katy, Texas, United States

Site Number - 1031

San Antonio, Texas, United States

Site number - 5005

Azcuénaga, Buenos Aires, Argentina

Site Number - 5007

Capital Federal, Buenos Aires, Argentina

Site Number - 5008

San Isidro, Buenos Aires, Argentina

Site Number - 5004

San Miguel de Tucumán, Tucumán Province, Argentina

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 - 5506

Vitória, Espírito Santo, Brazil

Site Number - 5504

Salvador, Estado de Bahia, Brazil

Site Number - 5500

Juiz de Fora, Minas Gerais, Brazil

Site Number - 5501

Curitiba, Paraná, Brazil

Site Number - 5503

Porto Alegre, Rio Gtande Do Sul, Brazil

Site Number - 5505

Porto Alegre, Rio Gtande Do Sul, Brazil

Site Number - 2001

Sherbrooke, Quebec, Canada

Site Number - 2000

Trois-Rivières, Quebec, Canada

Site Number - 5706

Viña del Mar, Región de Valparaíso, Chile

Site Number - 5700