Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04605978 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of S95011 in Primary Sjögren's Syndrome Patients
A Phase 2 study, sponsored by Institut de Recherches Internationales Servier.
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
NCT04605978: Completed Phase 2 study, sponsored by Institut de Recherches Internationales Servier.
NCT04605978 is a Phase 2 study that has completed, run by Institut de Recherches Internationales Servier. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04605978, a Phase 2 study, has completed, sponsored by Institut de Recherches Internationales Servier.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the effect of multiple intravenous infusions of S95011 compared to placebo in reducing disease activity in patients with primary Sjögren's syndrome.
Primary Outcome
Efficacy criterion Eular Sjögren Syndrome Disease Activity index (ESSDAI) is a physician-administered clinical index which has been validated to objectively assess systemic manifestations in Primary Sjögren's Syndrome patients. Scores range from 0 - 123, with a lower score representing less disease activity.
Interventions
- DRUG S95011 concentrate for solution for infusion
- DRUG Placebo concentrate for solution for infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2021-08-03 |
| Est. Completion | 2023-05-09 |
| Phase | Phase 2 |
What the finished NCT04605978 record still lists
NCT04605978 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 2 interventions - of which S95011 concentrate for solution for infusion is the first listed.
NCT04605978 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04605978 about?
NCT04605978 is a clinical study titled "Efficacy and Safety of S95011 in Primary Sjögren's Syndrome Patients". The purpose of this study is to assess the effect of multiple intravenous infusions of S95011 compared to placebo in reducing disease activity in patients with primary Sjögren's syndrome.
What is the current status of trial NCT04605978?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2021-08-03. Estimated completion is 2023-05-09.
What interventions are being tested in trial NCT04605978?
The interventions under investigation include: S95011 concentrate for solution for infusion (DRUG), Placebo concentrate for solution for infusion (DRUG).
Who is sponsoring clinical trial NCT04605978?
This trial is sponsored by Institut de Recherches Internationales Servier, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04605978's enrollment target sits among peer trials
48 1265th of 2000 higher than 718 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01765777 · 48 participants · NA
Efficacy of Osteopathic Manipulative Medicine (OMM) and Phototherapy for Patients With Chronic Lower Back Pain
- NCT03073343 · 48 participants · NA
A Prospective, Randomized, Open Label Trial of Two Doses of Oral Betaine
- NCT03431064 · 48 participants
Lung Recruitment Maneuver as a Potential Predictor of Fluid Responsiveness in Mechanically Ventilated Pediatric Patients
- NCT03514602 · 48 participants · NA
Maternal Smoking Cessation and Pediatric Obesity Prevention
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI