R-2487 in Patients With Sjogren's Syndrome (SS)

NCT06297213 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: R-2487-SS-01
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this study is to determine the safety and tolerability of orally taken probiotic (R-2487) in patients with Sjogren's Syndrome. Patients will take an oral dosage of probiotic (R-2487) and physicians will assess and measure their Sjogren's Syndrome. Blood and fecal evaluations of inflammation and assessment of probiotic (R-2487) on fecal level will also be measured.

Conditions

Sjogren's Syndrome; Sjögren; Sjögren Syndrome, Unspecified

Keywords

Sjogren's Syndrome

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events and their relationship to R-2487 (probiotic) administration

  To assess the number of participants with treatment-related adverse events after taking R-2487 (probiotic)

  Baseline through Week 4

Secondary Outcomes (2)

• Change in disease activity through Clinical European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ClinESSDAI)

  Baseline through Week 4

• Change in Patient reported general health questionnaire Short Form Health Survey-36(SF-36)

  Baseline through week 4

Study Arms (1)

Open Label

OTHER

Probiotic

Drug: R-2487

Interventions

R-2487 DRUG

R-2487 DP

Also known as: Probiotic

Open Label

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of SS according to American-European Consensus Group Criteria
• Able to provide informed consent
• Subjects receiving prednisone (10 mg or less/day) must be on a stable dose for more than 2 weeks
• All male and female subjects who are biologically capable of having children must agree to use medically acceptable method of birth control for the duration of the study. All female subjects who are biologically capable of having children must have a negative pregnancy test result before administration of investigational product.
• The use of probiotics prior to study enrollment is accepted; however, during the course of the study, the use of probiotics is forbidden.

You may not qualify if:

• No known active overlapping or associated other autoimmune disease
• Prior allogenic or autologous bone marrow or organ transplantation
• Subjects with prior irradiation to the head and neck, including radioactive iodine treatment for hyperthyroidism
• Subjects who have a present malignancy or previous malignancy within the last 5 years prior to screening (except documented history of cured non-metastatic squamous or basal cell skin carcinoma or cervical carcinoma in situ). Subjects who had a screening procedure that is suspicious for malignancy, and in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory or other diagnostic evaluations.
• Subjects with positive results for human immunodeficiency virus (HIV), hepatitis A virus (HAV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
• Subjects with active viral, bacterial, or fungal infection, or history of severe opportunistic infection within the preceding 3 months, or COVID-19 infection in the past 3 months
• Subjects with evidence of active or latent tuberculosis
• Active infection of the salivary or lacrimal glands
• Prior immunotherapy, biologics, or investigational therapy must have completed at least 5 half-lives or 30 days, whichever is longer, prior to the first dose of R-2487 DP
• Pregnant or breastfeeding women
• Current clinical findings of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, endocrine, neurological, or cerebral disease with laboratory values as following:
• Hemoglobin level \< 9.0 g/dL
• Absolute white blood cell (WBC) count of \<3.0×109/L (\<3000/mm3), or absolute neutrophil count of \<1.2×109/L (\<1200/mm3), or absolute lymphocyte count of \<0.8×109/L (\<800/mm3).
• Thrombocytopenia, defined by platelet count \<100×109/L (\<100,000/mm3)
• Chronic kidney disease defined as Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m2, based on the age appropriate calculation.

Sponsors & Collaborators

• Rise Therapeutics LLC: lead

MeSH Terms

Conditions

Sjogren's Syndrome

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Janet Stephens, PhD

CONTACT

650-417-8556; jstephens@risetherapeutics.com

Christian Freguia, PhD

CONTACT

2159231818; cfreguia@risetherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 7, 2024
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): August 30, 2028
• Study Completion (Estimated): August 30, 2028
• Last Updated: September 4, 2025

Record last verified: 2025-08