Adults With Active Sjögren’s Syndrome Needed for Research Treatment Study! (NEPTUNUS-1)
D
Domenick Zero, DDS, MS
Primary Investigator
Not Recruiting
18 years - 100 years
All
Phase
3
6 participants needed
1 Location
Brief description of study
Do you or someone you know suffer from active Sjögren’s syndrome? JOIN OUR STUDY!
Sjögren’s (pronounced show-grins) syndrome is an autoimmune disorder in which the immune system attacks and destroys the glands that make tears and saliva, causing extreme chronic dry eyes, dry mouth and other symptoms.
Researchers at Indiana University School of Dentistry and the Oral Health Research Institute (OHRI) are looking for adults to take part in a study to help test a new, investigational medication for persons with Sjögren’s syndrome. The medicine under investigation targets the underlying process of the condition, which may help those affected by the condition. This study will compare the study drug ianalumab and a placebo (no active treatment) to see which one works best.
Participation involves study visits to the OHRI on IU campus in Indianapolis, IN.
Compensation for time and travel will be provided.
Detailed description of study
What Will Happen During Study Participation
- If you are interested in participating, you will first need to attend a screening visit to see if you qualify (2-4 hrs).
- If you qualify, you will be randomly assigned, to take either the study medication or a placebo.
- You will be asked to attend additional study visits (2-3 hrs each) at the OHRI (once a month for about 13 months).
- Post-study treatment follow up will be up to approx. 2 years. The 5 initial visits will be planned every month, but subsequent visits will be less frequent (3-6 months apart).
Incentive/Compensation
- You will be monetarily compensated for travel for all study visits.
*All study procedures, risks and benefits (including compensation amounts) will be explained at the study visit. The study clinician will make the final determination of your eligibility to participate.
Additional Information
Study title: A randomized, double-blind, placebo controlled, 2-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjögren’s syndrome (NEPTUNUS-1)
To learn more about PI Domenick Zero, DDS, MS and his research interests, please visit this link:
https://dentistry.iu.edu/research/primary_investigators/zero_pi_page.html
IU School of Dentistry Oral Health Research Institute (OHRI):
https://dentistry.iu.edu/research/oral-health-research-institute/index.html
Questions?
If you have questions about this study, please call the Oral Health Research Institute Recruitment Line at (317) 278-8838 and reference the Sjögren’s Syndrome Study or send an email to: ds-ohri@iu.edu
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Sjogren's Syndrome
-
Age: 18 years - 100 years
-
Gender: All
Inclusion Criteria:
- Diagnosed with Sjögren's syndrome within 7.5 years ago
Exclusion Criteria:
- Prior use of immunosuppressant drugs
- Presence of another autoimmune rheumatic disease that is active and constitutes the
- Active viral, bacterial or other infections requiring systemic treatment at the time of screening or randomization, or history of recurrent clinically significantbacterial infections
- History of major organ, hematopoietic stem cell or bone marrow transplant
- History of malignancy of any organ system (other than localized basal cell carcinomahe skin or in situ cervical cancer or Sjögren's related lymphoma), treated oruntreated, within the past 5 years, regardless of whether there is evidence of localurrence or metastases.
- Pregnant or nursing (lactating) women
- Any surgical, medical (e.g., uncontrolled hypertension, heart failure, diabetesus, immunodeficiency, HIV, Hepatitis B or C, history of sarcoidosis) psychiatric or additional physical condition that the Investigator feelsy jeopardize the patient in case of participation in this study
Updated on
01 Aug 2024.
Study ID: CVAY736A2301, OHRI-NOVARTIS-NEPTUNUS, 16218
