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NCT07621809 · ClinicalTrials.gov registry record · Phase 3
Two Arm, Double-blind, Phase III Study Assessing Efficacy and Safety of Ianalumab Versus Placebo, in Participants With Sjögren's Disease With High Symptom Burden
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 570
- Enrollment target
NCT07621809: Recruiting Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT07621809 is a Phase 3 study that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 570 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07621809, a Phase 3 study, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 570 participants
- Enrollment target
Study Summary
The purpose of this study is to demonstrate the efficacy and safety of ianalumab (VAY736) 300 mg administered subcutaneously (s.c.) monthly for 52 weeks in adult participants with Sjögren's disease who have high symptom burden.
Primary Outcome
The Sjögren's Syndrome Symptom Diary (SSSD) oral dryness score is a patient-reported measure assessing severity of mouth dryness. The mouth dryness symptom is scored daily on a numerical scale (higher scores = worse symptoms).
Interventions
- DRUG Placebo
- DRUG VAY736
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 570 participants |
| Start Date | 2026-07-15 |
| Est. Completion | 2033-08-12 |
| Phase | Phase 3 |
What NCT07621809 shows while recruiting
NCT07621809 is an interventional study that assigns participants to a tested intervention. The registered 570 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07621809 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07621809 about?
NCT07621809 is a clinical study titled "Two Arm, Double-blind, Phase III Study Assessing Efficacy and Safety of Ianalumab Versus Placebo, in Participants With Sjögren's Disease With High Symptom Burden". The purpose of this study is to demonstrate the efficacy and safety of ianalumab (VAY736) 300 mg administered subcutaneously (s.c.) monthly for 52 weeks in adult participants with Sjögren's disease who have high symptom burden.
What is the current status of trial NCT07621809?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 570 participants. The study started on 2026-07-15. Estimated completion is 2033-08-12.
What interventions are being tested in trial NCT07621809?
The interventions under investigation include: Placebo (DRUG), VAY736 (DRUG).
Who is sponsoring clinical trial NCT07621809?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07621809's enrollment target sits among peer trials
570 665th of 2000 higher than 1,335 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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