A Study Testing Imeroprubart for Adults with Primary Sjogren’s Disease with Moderate to Severe Symptoms

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What is this study about?

This study involves people with Primary Sjogren’s Disease, a condition where the body’s immune system attacks its own moisture-producing glands, leading to dryness of the eyes and mouth, as well as other symptoms throughout the body. The disease can also affect other organs and cause fatigue and joint pain. The study will test a medication called IMVT-1402, which is given as an injection under the skin, and compare it to placebo. The purpose of this study is to find out how well IMVT-1402 works in reducing the activity of the disease in people who have moderate to severe symptoms affecting various parts of the body.

The study will look at whether IMVT-1402 can help improve the overall disease activity by measuring changes in a scoring system that tracks how different body systems are affected by the disease. Participants will receive either IMVT-1402 or placebo through injections under the skin once a week. The main part of the study will last for 24 weeks, during which doctors will monitor how the disease activity changes from the beginning of the study. The total treatment period can last up to 48 weeks.

People taking part in this study will need to have been diagnosed with Primary Sjogren’s Disease for at least 12 months and have a certain level of disease activity affecting their body systems. They will also need to have specific antibodies in their blood that are commonly found in people with this condition, and they must still have some ability to produce saliva. Throughout the study, participants will have regular visits to check their symptoms and how well the treatment is working.

1 Treatment period begins

Upon joining the study, you will be randomly assigned to one of two groups. One group will receive IMVT-1402, which contains the active substance imeroprubart. The other group will receive a placebo, which looks identical but contains no active substance.

You will not know which treatment you are receiving, and neither will your study doctor. This is called a double-blind study design.

2 Receiving injections

You will receive injections under the skin (subcutaneous injections) once every week.

The medication is provided as a solution for injection.

This treatment schedule will continue throughout the study period.

3 Assessment at week 24

At week 24 of the treatment, your disease activity will be assessed using a scoring system called clinESSDAI.

The clinESSDAI score measures the activity of your condition across different body systems. The change in this score from the beginning of the study will be compared to your score at week 24.

This assessment is the main measure used to determine how well the treatment is working.

4 Completion of the study

The study will continue until all planned assessments are completed.

Throughout the study period, your safety and how well you tolerate the treatment will be monitored.

The study is expected to be completed by February 2028.

Who Can Join the Study?

  • You must have a diagnosis of primary Sjögren’s Disease, which is a condition where your immune system attacks glands that produce moisture, for at least 12 months before joining the study
  • You must meet the standard medical criteria for primary Sjögren’s Disease according to guidelines established in 2016
  • You must have moderate to severe disease activity, measured by a score of at least 5 on a scale called clinESSDAI, which assesses how active your disease is across different body systems
  • You must test positive for SSA/Ro antibodies, which are specific proteins in your blood that indicate your immune system is attacking certain parts of your body
  • You must still have some saliva production, measured as at least 0.01 milliliters per minute when your saliva glands are stimulated during testing
  • You can be male or female to participate in this study

Who Cannot Join the Study?

  • The specific exclusion criteria (reasons why a patient cannot participate in the study) have not been provided in the available information for this clinical trial
  • Patients interested in this study should discuss with their doctor whether they meet the requirements to participate
  • The doctor will review the complete list of conditions and situations that would prevent participation in this research

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Saint Maria Hospital Bucharest Romania
Hospital Santa Maria Della Misericordia Perugia Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
Lukmed 2 Sp. z o.o. Siedlce Poland
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Cracow Poland
Hospital Universitario Basurto Bilbao Spain
Athens Euroclinic S.A. Athens Greece
Reumed Sp. z o.o. Lublin Poland
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH Hamburg Germany
Hospital De Merida Merida Spain
Revita Kft. Budapest Hungary
Complex Rendelo Med Zrt. Szekesfehervar Hungary
Etg Neuroscience Sp. z o.o. Warsaw Poland
Med Polonia Sp. z o.o. Poznan Poland
Ospedale San Raffaele S.r.l. Milan Italy
Universita’ Campus Bio-medico Di Roma Rome Italy
Universita’ Degli Studi Di Verona Verona Italy
Prywatna Praktyka Lekarska Prof. Dr Hab. Med. Paweł Hrycaj Poznan Poland
Myxrdpylg Ioqqcsqbxe Csfcptix Sdqwyvog Sdd z okez Warsaw Poland
Cdlnvnv Mwpwljd Df Dsslyzupqa Sc Twqlrcfap Atlysprtg Nsvoii Szldlb Brasov Romania
Peyxi Dcj mwbk Gqthnlj Nxjku Mls Gpdm Bad Doberan Germany
Ntpwdsgy Ikaekzjs Gstqublvh Rhuypyvsyrcu I Rtnronknjewju Il Pjyla Dt Hbnb Myqi Edyfzemz Rgjbiwr Warsaw Poland
Lxsbl Gfwuwpw Hppmnufq Ol Ahxvfd Athens Greece
Mrkmoajyx Myrjazg gjnmv Munich Germany
Mlhockrzs i Pmkjlpvjq Lfzngdt Srzsia Pmfdixglyfc Cracow Poland
Pwusyelon Bfhug Kzcjvoihoxv Sbzgx Wroclaw Poland
Kssw Sli z omft Wołomin Poland
Egz Loehpf Lublin Poland
Ksdojfby dju Uoapaxncatpu Mhyrhpce Afz Munich Germany
Jstkay Bez Kalocsa Hungary

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
16.11.2025
Greece Greece
Recruiting
16.11.2025
Hungary Hungary
Recruiting
16.11.2025
Italy Italy
Recruiting
16.11.2025
Poland Poland
Not recruiting
16.11.2025
Romania Romania
Recruiting
16.11.2025
Spain Spain
Recruiting
16.11.2025

Trial locations

Investigated drugs:

IMVT-1402 is an investigational medication being tested in this clinical trial. It is given as an injection under the skin once a week. This medication is being studied to see if it can help reduce disease activity in people with primary Sjogren’s disease, which is a condition that affects the body’s moisture-producing glands and can cause various symptoms throughout the body. The study will compare how well this medication works against a placebo to determine if it is effective and safe for treating moderate to severe forms of this disease.

Investigated diseases:

Primary Sjögren’s Disease – Primary Sjögren’s Disease is a chronic autoimmune disorder where the body’s immune system mistakenly attacks its own moisture-producing glands. The condition primarily affects the salivary glands in the mouth and the lacrimal glands in the eyes, leading to reduced production of saliva and tears. Patients commonly experience persistent dry mouth and dry eyes as the main symptoms. As the disease progresses, it can also affect other parts of the body, including joints, skin, and internal organs. The inflammation caused by the immune system gradually damages the glands over time. This condition occurs independently without being associated with other autoimmune diseases.

Trial ID:
2025-520831-18-00
Protocol code:
IMVT-1402-2801
NCT ID:
NCT06979531
Trial Phase:
Therapeutic exploratory (Phase II)

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