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Monoclonal Antibodies

Ustekinumab for Sjögren's Syndrome

Phase 1

Waitlist Available

Led By Ummara Shah, MD

Research Sponsored by University of Rochester

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety of ustekinumab, a medication that reduces inflammation, in patients with Primary Sjögren's Syndrome (PSS). PSS is a condition where the immune system causes chronic inflammation. Ustekinumab helps by blocking certain proteins in the immune system to reduce this inflammation. It has been approved for the treatment of other conditions like psoriasis, psoriatic arthritis, and Crohn's disease.

Eligible Conditions

Sjögren's Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in The European League Against Rheumatism (EULAR) Sjogren's Syndrome Patient Reported Index (ESSPRI) Score From Baseline to Week 24

Secondary study objectives

Change in Mean Serum Biomarkers of Inflammation From Baseline to Week 24

Change in the Short Form Health Survey (SF-36) Patient Reported Outcome Measure Between Day 0 and Week 24

Total Score of the EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)

Side effects data

From 2018 Phase 4 trial • 43 Patients • NCT02187172

50%

Upper respiratory infection

27%

Common cold

Skin and subcutaneous tissue disorders

Fracture

Anxiety

Dizziness

Back pain

Urinary tract infection

Toothache

Rash/Rash Acneiform/Maculo-Papular

Hypertension

Pain/Pain in extremity

100%

80%

60%

40%

20%

Study treatment Arm

Ustekinumab (Stelara)

Placebo (RCT Period)

Placebo (Active Treatment Period)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: UstekinumabExperimental Treatment1 Intervention

All subjects will receive an intravenous loading dose of 6 mg/kg at their baseline visit. 650mg acetaminophen and 60mg allegra will be given as premedication to the infusion. All patients will receive 90mg ustekinumab by a subcutaneous injection at all subsequent dosing visits. Subcutaneous injections do not require any premedication. Drug will be administered by qualified personnel.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ustekinumab

2015

Completed Phase 4

~4080

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