Pilot Trial of Ustekinumab for Primary Sjögren's Syndrome (NCT04093531) | Clinical Trial Compass
CompletedPhase 1
Pilot Trial of Ustekinumab for Primary Sjögren's Syndrome
United States12 participantsStarted 2020-01-15
Plain-language summary
This pilot study will make a preliminary determination of the safety of ustekinumab in patients with Primary Sjogren's Syndrome (PSS) and assess the response of systemic measures of inflammation (biomarkers).
Who can participate
Age range18 Years – 75 Years
SexALL
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A subject who has met all of the following criteria is eligible for participation in the study:
* Has provided written informed consent
* Between the ages of 18-75 years (inclusive)
* Body weight ≥ 40 kg
* Meets the 2016 ACR EULAR criteria (score \>4)
* 3 points- Labial salivary gland with focal lymphocytic sialadenitis and focus score of \>1 foci/4 mm2‡
* 3 Points- Anti-SSA/Ro positive
* 1 Point- Ocular Staining Score \>5 in at least 1 eye
* 1 Point- Schirmer's test \<5 mm/5 minutes in at least 1 eye
* 1 Point- Unstimulated whole saliva flow rate \<0.1 ml/minute
* If taking prednisone (or equivalent corticosteroid), the dose must be ≤ 10 mg/day and stable for at least 4 weeks prior to baseline visit
* If taking hydroxychloroquine, the dose must be stable for at least 12 weeks prior to baseline.
* If taking a cholinergic stimulant (e.g. pilocarpine, cevimeline), the dose must be stable for at least 4 weeks prior to baseline.
* If a male of reproductive potential, must agree to practice two highly effective forms of contraception during the study (one of which must be a barrier method) and be able to continue contraception for 20 weeks after his last dose of study agent Subject must also agree not to donate sperm up to 20 weeks after his last dose of study agent.
* If a female of childbearing potential, must agree to practice two highly effective forms of contraception during the study (one of which must be a barrier method) and able to continue contraception for 2…
What they're measuring
1
Change in The European League Against Rheumatism (EULAR) Sjogren's Syndrome Patient Reported Index (ESSPRI) Score From Baseline to Week 24