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Sjögren's drug shows promise in safety extension trial

NCT ID NCT06203457

Disease control Sponsor: argenx 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at the long-term safety of efgartigimod in 24 adults with primary Sjögren's syndrome who had already completed a prior trial. Efgartigimod works by lowering certain antibodies that may drive the disease. The main goal was to track side effects over 48 weeks, with a secondary look at whether symptoms improved.

What this could mean

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

Active substance
efgartigimod
What this could lead to
If it works, this could point toward a treatment that reduces disease activity and symptoms in Sjögren's syndrome.
What could go wrong
This is a small, early-phase safety extension study, not designed to prove effectiveness. The drug may not improve symptoms and carries risks like infections due to lowered antibody levels.

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

24 people

The number who actually took part.

Started

Nov 2023

Finished

Feb 2025

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 years and older

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: * Is at least the legal age of consent for clinical trials when signing the ICF * Is capable of providing signed informed consent and complying with protocol requirements * Agrees to use contraceptive measures consistent with local regulations and the following: WOCBP must have a negative urine pregnancy test at baseline before receiving IMP * Has completed the qualifying efgartigimod SjD studies and agrees to continue study drug treatment without interruption in the extension study Exclusion Criteria: * Clinically significant disease (including newly diagnosed malignancy or cardiovascular disease) or intention to have surgery during the study; or any other medical condition that, in the investigator's opinion, would confound the results of the study or put the participant at undue risk * Pregnant or intention to become pregnant during the study * Any severe systemic SjD manifestation that may put the participant at undue risk based on the investigator's opinion

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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

  • Centrum Medyczne Plejady

    Krakow, 30 363, Poland

  • Centrum Medyczne Pratia Poznan

    Skorzewo, 60 185, Poland

  • Clinical Research Center Spółka z ograniczoną odpowiedzialnością Medic-R Sp.k.

    Poznan, 60-848, Poland

  • Debreceni Egyetem

    Debrecen, 4032, Hungary

  • FutureMeds sp zoo

    Wroclaw, 50 088, Poland

  • Klinika Reuma Park Sp zoo Sp K

    Warsaw, 02 665, Poland

  • MCBK SC

    Grodzisk Mazowiecki, 05 825, Poland

  • MICS Centrum Medyczne Warszawa

    Warsaw, 00 874, Poland

  • Narodowy Instytut Geriatrii

    Warsaw, 02637, Poland

  • Universitair Ziekenhuis Gent

    Ghent, 9000, Belgium

  • Vita Verum Medical Egeszsegugyi Szolgaltato Bt.

    Székesfehérvár, 8000, Hungary

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