Phase 2 Sjogren's Syndrome Trial, Recruiting NCT06979531 Sponsor: Immunovant Sciences GmbH Condition: Sjogren's Syndrome
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Phase 2 Sjogren's Syndrome Trial, Recruiting

NCT06979531
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with primary Sjögren's disease for at least 12 months before the screening visit, and your diagnosis meets the recognised 2016 international classification standards for the condition.
  • Your Sjögren's disease is considered moderately to severely active, based on a specific scoring system used by the study doctor at the screening visit.
  • A blood test at the screening visit shows you have a specific antibody associated with Sjögren's disease, called SSA/Ro antibody.
  • You still produce at least a very small amount of saliva, as measured by a saliva flow test at the screening visit.

Who may not be able to join:

  • You have a form of Sjögren's disease that is caused by or linked to another condition, or you have another confirmed autoimmune or inflammatory disease (such as rheumatoid arthritis, lupus, or similar conditions) that the study doctor believes could make it harder to assess your Sjögren's symptoms.
  • You have a history of certain blood protein disorders, multiple myeloma, or non-Hodgkin's lymphoma, or you have been diagnosed with any cancer within the last 5 years or currently have an active cancer.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 18007970414

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Immunovant Sciences GmbH
Registry
ClinicalTrials.gov
Start date
30 June 2025
Est. completion
1 July 2028

Where this trial is recruiting

🇦🇷 Argentina 🇧🇷 Brazil 🇨🇦 Canada 🇨🇱 Chile 🇨🇴 Colombia 🇩🇪 Germany 🇬🇷 Greece 🇭🇺 Hungary 🇮🇹 Italy 🇲🇽 Mexico 🇵🇪 Peru 🇵🇱 Poland 🇷🇴 Romania 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Change from Baseline in clinESSDAI Score at Week 24 for IMVT-1402 Dose 1 compared to Placebo

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov