Phase 1
N=12
Pilot Trial of Ustekinumab for Primary Sjögren's Syndrome
Primary Sjögren Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT04093531 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Change in The European League Against Rheumatism (EULAR) Sjogren's Syndrome Patient Reported Index (ESSPRI) Score From Baseline to Week 24 — -0.125 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Ustekinumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in The European League Against Rheumatism (EULAR) Sjogren's Syndrome Patient Reported Index (ESSPRI) Score From Baseline to Week 24 |
-0.125 | — |
| SECONDARY Change in the Short Form Health Survey (SF-36) Patient Reported Outcome Measure Between Day 0 and Week 24 |
11.1; 7.5; 5.25; 0.6 | — |
| SECONDARY Change in Mean Serum Biomarkers of Inflammation From Baseline to Week 24 |
6.984; 12.62; 111.3; 0.02175; -0.3912; 3.054 | — |
| SECONDARY Total Score of the EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) |
2.86; 1.75 | — |
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).
Eligibility Criteria
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 10 mg/day.
- A definite diagnosis of RA, SLE, systemic sclerosis, or dermatomyositis.
- A history of alcohol or substance abuse.
- A history of head and neck radiation therapy, sarcoidosis, or graft-versus-host disease.
- A history of malignancy, except for a resected basal or major squamous cell carcinoma, cervical dysplasia, or in situ cervical cancer Grade I, within the last five years.
- Abnormal laboratory results for the following parameters at the baseline visit:
- Absolute neutrophil count (ANC): 1.5x upper limit of normal
- ALT: > 1.5x upper limit of normal.
- A psychiatric disorder rendering the subject incapable of providing informed consent.
- Plans for foreign travel to countries other than Canada or Western Europe within the treatment period.
- Inability or unwillingness to follow the protocol
- Any condition or treatment that, in the opinion of the investigator, places the subject at an unacceptable risk as a participant in the trial.
Data sourced from ClinicalTrials.gov (NCT04093531). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.