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ACTIVE NOT RECRUITING Phase 2

A Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Participants With Sjögren's

NCT06928142 · View on ClinicalTrials.gov ↗

Study Summary

This is a phase 2 study to evaluate the effects of sibeprenlimab 400 mg administered subcutaneously (SC) every 4 (Q4) weeks as an add-on to background treatment in participants with Sjögren's disease.

Conditions Studied

Interventions

  • OTHER Placebo
  • BIOLOGICAL Sibeprenlimab

Study Locations (20)

Texas

  • Allen Arthritis — Allen
  • Tekton Research, LLC — Austin
  • Advanced Rheumatology of Houston — Houston
  • Accurate Clinical Research - Houston — Houston
  • Accurate Clinical Management, LLC — Katy
  • R & H Clinical Research — Katy

Florida

  • Bay Area Arthritis and Osteoporosis — Brandon
  • Clinical Research of West Florida Inc — Clearwater
  • GNP Research - Florida — Cooper City
  • Vantage Clinical Trials - Tampa - ClinEdge - PPDS — Tampa

California

  • Medvin Clinical Research - Riverside — Riverside
  • Medvin Clinical Research - Tujunga — Tujunga

Illinois

  • OrthoIllinois, LTD — Rockford
  • Arnold Arthritis and Rheumatology — Skokie

Louisiana

  • Ochsner Clinic Foundation — Baton Rouge

Massachusetts

  • Tufts University School of Dental Medicine — Boston

New Mexico

  • Albuquerque Center for Rheumatology — Albuquerque

New York

  • Bradenton Research Center Inc — The Bronx

Trial Details

FieldValue
Enrollment Target 83 participants
Start Date 2025-04-23
Est. Completion 2027-06-04
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06928142

The ClinicalTrials.gov registry entry for NCT06928142 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 83 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 79 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Sjogren Disease appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06928142 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Texas, Florida, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06928142 about?

NCT06928142 is a clinical study titled "A Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Participants With Sjögren's". This is a phase 2 study to evaluate the effects of sibeprenlimab 400 mg administered subcutaneously (SC) every 4 (Q4) weeks as an add-on to background treatment in participants with Sjögren's disease.

What is the current status of trial NCT06928142?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 83 participants. The study started on 2025-04-23. Estimated completion is 2027-06-04.

What conditions does trial NCT06928142 study?

This clinical trial studies the following conditions: Sjogren Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06928142?

The interventions under investigation include: Placebo (OTHER), Sibeprenlimab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06928142?

This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 79 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06928142 being conducted?

This trial has 20 study locations across California, Florida, Illinois, Louisiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial