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New weekly shot aims to tame Sjögren's Flare-Ups

NCT ID NCT06979531

Disease control Sponsor: Immunovant Sciences GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 11, 2026 · Updated 6 times

Summary

This study tests an experimental drug called IMVT-1402 in 180 adults with moderate to severe Sjögren's disease. Participants receive either the drug or a placebo as a weekly injection under the skin for 24 weeks. The goal is to see if the drug can reduce overall disease activity and improve symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IMVT-1402 (a drug injected under the skin once a week)
What this could lead to
If it works, this could lead to a new treatment option that reduces systemic disease activity in people with moderate to severe Sjögren's disease.
What could go wrong
This is a Phase 2b trial, so it is still early. The drug may not prove effective or safe enough to move forward. Side effects are possible, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 74 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Sjogren syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Primary Sjögren's syndrome

Contacts and locations

Locations

  • Site Number - 1000

    Memphis, Tennessee, 38119, United States

  • Site Number - 1001

    Allen, Texas, 75013, United States

  • Site Number - 1002

    Miami, Florida, 33143, United States

  • Site Number - 1004

    Tamarac, Florida, 33321, United States

  • Site Number - 1006

    Mineola, New York, 11501, United States

  • Site Number - 1007

    El Cajon, California, 91910, United States

  • Site Number - 1010

    Houston, Texas, 77407, United States

  • Site Number - 1011

    Houston, Texas, 77030, United States

  • Site Number - 1012

    Chicago, Illinois, 60607, United States

  • Site Number - 1013

    Philadelphia, Pennsylvania, 19104, United States

  • Site Number - 1014

    Fort Collins, Colorado, 80528, United States

  • Site Number - 1015

    Jackson, Tennessee, 38305, United States

  • Site Number - 1016

    Menifee, California, 92586, United States

  • Site Number - 1018

    Hollywood, Florida, 33024, United States

  • Site Number - 1019

    Austin, Texas, 78745, United States

  • Site Number - 1020

    Amarillo, Texas, 79124, United States

  • Site Number - 1021

    Jupiter, Florida, 33458, United States

  • Site Number - 1022

    Arlington, Texas, 75231, United States

  • Site Number - 1023

    Katy, Texas, 77494, United States

  • Site Number - 1024

    Grapevine, Texas, 76034, United States

  • Site Number - 1025

    Tampa, Florida, 33606, United States

  • Site Number - 1026

    Upland, California, 91786, United States

  • Site Number - 1027

    Covina, California, 91722, United States

  • Site Number - 1028

    New Orleans, Louisiana, 70112, United States

  • Site Number - 1029

    Thousand Oaks, California, 91360, United States

  • Site Number - 1030

    Lake Charles, Louisiana, 77469, United States

  • Site Number - 1031

    San Antonio, Texas, 78215, United States

  • Site Number - 1032

    Canton, New York, 13675, United States

  • Site Number - 1033

    Orland Park, Illinois, 60467, United States

  • Site Number - 2000

    Trois-Rivières, Quebec, G8Z 1Y2, Canada

  • Site Number - 2001

    Sherbrooke, Quebec, J1L 0H8, Canada

  • Site Number - 2401

    Santiago de Surco, Lima region, 15023, Peru

  • Site Number - 2402

    Lima, 15811, Peru

  • Site Number - 2403

    Lima, 15076, Peru

  • Site Number - 3000

    Poznan, 61-397, Poland

  • Site Number - 3001

    Warsaw, 02-637, Poland

  • Site Number - 3002

    Wroclaw, 50-556, Poland

  • Site Number - 3003

    Warsaw, 02-665, Poland

  • Site Number - 3004

    Lodz, 91-363, Poland

  • Site Number - 3005

    Lublin, 20-607, Poland

  • Site Number - 3006

    Warsaw, 00-874, Poland

  • Site Number - 3007

    Poznan, 60-693, Poland

  • Site Number - 3008

    Bydgoszcz, 85-065, Poland

  • Site Number - 3009

    Warsaw, 02-677, Poland

  • Site Number - 3010

    Krakow, 30-363, Poland

  • Site Number - 3011

    Siedlce, 08-110, Poland

  • Site Number - 3012

    Wołomin, 05-200, Poland

  • Site Number - 3013

    Wroclaw, 52-416, Poland

  • Site Number - 3014

    Lodz, 31-426, Poland

  • Site Number - 3015

    Lublin, 20-412, Poland

  • Site Number - 3900

    Athens, 11527, Greece

  • Site Number - 3901

    Athens, 11521, Greece

  • Site Number - 5000

    Buenos Aires, B1646GHP, Argentina

  • Site Number - 5001

    Buenos Aires, C1417EYH, Argentina

  • Site Number - 5002

    Buenos Aires, B1878DVB, Argentina

  • Site Number - 5003

    Buenos Aires, C1111AAJ, Argentina

  • Site Number - 5004

    San Miguel de Tucumán, Tucumán Province, T4000, Argentina

  • Site Number - 5007

    Capital Federal, Buenos Aires, C1055AAF, Argentina

  • Site Number - 5700

    Santiago, Santiago de Chile, 7500571, Chile

  • Site Number - 5701

    Santiago, Santiago de Chile, 7510047, Chile

  • Site Number - 5702

    Santiago, Santiago de Chile, 7500571, Chile

  • Site Number - 5703

    Santiago, Santiago de Chile, 7500587, Chile

  • Site Number - 5704

    Santiago, Santiago de Chile, 8331143, Chile

  • Site Number - 5705

    Osorno, 8380456, Chile

  • Site Number - 5706

    Viña del Mar, Valparaiso, 2520000, Chile

  • Site Number - 5707

    Valdivia, 5110683, Chile

  • Site Number - 6000

    Catania, 95121, Italy

  • Site Number - 6001

    Milan, 20132, Italy

  • Site Number - 6002

    Palermo, 90129, Italy

  • Site Number - 6003

    Rome, 00128, Italy

  • Site Number - 6005

    Perugia, 06132, Italy

  • Site Number - 6500

    Hamburg, 20095, Germany

  • Site Number - 6501

    Hanover, 30625, Germany

  • Site Number - 6503

    Heidelberg, 69120, Germany

  • Site Number - 6504

    Bad Doberan, 18209, Germany

  • Site Number - 6505

    Munich, 81667, Germany

  • Site Number - 7000

    Swindon, SN3 6BB, United Kingdom

  • Site Number - 7001

    Truro, TR1 3LJ, United Kingdom

  • Site Number - 7002

    London, NW3 2QG, United Kingdom

  • Site Number - 7003

    Liverpool, L9 7AL, United Kingdom

  • Site Number - 7004

    Cambridge, CB2 0QQ, United Kingdom

  • Site Number - 7101

    Córdoba, 14004, Spain

  • Site Number - 7102

    Mérida, 06800, Spain

  • Site Number - 7103

    Bilbao, 48013, Spain

  • Site Number - 7104

    Valencia, 46010, Spain

  • Site Number - 7106

    Cadiz, 11139, Spain

  • Site Number - 7500

    Bucharest, 011172, Romania

  • Site Number - 7501

    Cluj-Napoca, 400000, Romania

  • Site Number - 7502

    Brasov, 500283, Romania

  • Site Number - 7550

    Budapest, 1027, Hungary

  • Site Number - 7551

    Kalocsa, 6300, Hungary

  • Site Number - 7552

    Hódmezővásárhely, 6800, Hungary

  • Site Number - 7553

    Székesfehérvár, 8000, Hungary

  • Site number - 5005

    Azcuénaga, Buenos Aires, C1128AAF, Argentina

  • Site number - 5006

    Buenos Aires, C1427CCL, Argentina

  • Site number - 6502

    Munich, 80336, Germany

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Other studies related to the condition(s) this trial covers.