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Sjogren's SyndromePhase 1R-2487-SjD-01NCT06297213

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

A Phase 1 study testing R-2487 in people with Sjogren's Syndrome and Sjögren, run by Rise Therapeutics LLC at 2 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
R-2487
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
2 sitesUnited States
Study dates
1 Nov 2026to 30 Nov 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 22Show fewer
  • 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.
  • Proteinuria ≥3+.
  • Total bilirubin (T-bili), aspartate aminotransferase (AST), alanine aminotransferase (ALT) more than 1.5 times upper limit of normal (ULN).
  • Previously diagnosed hepatic cirrhosis (Child Pugh A or higher) or previously diagnosed significant liver fibrosis (> F3)
  • Any form of vaccination in the last 30 days, to include but not limited to influenza, COVID, shingles, tetanus, hepatitis, pneumonia, HPV, DPT, MMR, and polio.
  • Subjects should not receive any of the following medications:
  • Rituximab or belimumab within 6 months prior to Day 1 Abatacept within 3 months prior to Day 1 Infliximab, Adalimumab, Certolizumab, Tocilizumab, Cyclosporine, or Mycophenolate mofetil within 2 months prior to Day 1 Etanercept, Anakinra, Immunoglobulin, or blood products within 28 days prior to Day 1
  • Prior immunotherapy, including systemic corticosteroids, such prednisone, biologics, Janus kinase (JAK) inhibitors (such as tofacitinib, or upadacitinib), ozanimod, or investigational therapy must have completed at least 5 half-lives or 30 days, whichever is longer, prior to Day 0, unless otherwise specified. In the case of cell-depleting therapies, such as B or T cell depletion, cell counts must have recovered to acceptable or baseline levels (use of licensed agents for indications not listed in the package insert is permitted).

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Janet Stephens, PhD contact

650-417-8556

jstephens@risetherapeutics.com

Christian Freguia, PhD contact

2159231818

cfreguia@risetherapeutics.com

United States2 sites

  • University of Michigan - Michigan Medicine

    Ann Arbor, Michigan, 48109

    April Lucas, 734-615-9865, aplucas@med.umich.edu

    Sara McCoy, MD

  • The Johns Hopkins Jerome L. Greene Sjögren's Syndrome Center Johns Hopkins University - Rheumatology Department

    Baltimore, Maryland, 21224

    Priya Patel, 410-550-9821, ppate132@jh.edu

    Alan Baer, MD

Other trials in United States

About this study

Official title: A Single and Repeat Dosing Study of the Safety, Drug Exposure and Clinical Activity of R-2487 in Patients With Sjogren's Syndrome (SjD)

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.

Being tested
R-2487
Keywords
Sjogren's Syndrome
Medical subject headings
Sjogren's Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • R-2487Drug

    Also called Probiotic

    R-2487 DP

Study groups in NCT06297213
Study groupRoleWhat they receive
Open LabelOtherProbiotic
Receives: Drug: R-2487

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Baseline through Week 4

Secondary outcomes (2)

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

    Change from Baseline in Disease Activity Score at Week 4 to assess the disease severity of Sjogren's syndrome using data without laboratory results

    Measured: Baseline through Week 4

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

    Baseline Short Form Health Survey-36 (SF-36) Score over time. The Baseline Short Form Health Survey is the numerical sum of 36 patient reported outcome parameters of quality of life. The higher the score the more favorable the reflection of the quality of life.

    Measured: Baseline through week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2024
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion30 Aug 2029 (estimated)
  4. Study completion30 Nov 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06297213
Sponsor's protocol ID
R-2487-SjD-01
Acronym
R-2487-SjD-01
Status last verified
Nov 2026
First submitted
28 Feb 2024
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing R-2487 in people with Sjogren's Syndrome and Sjögren, run by Rise Therapeutics LLC at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Janet Stephens, PhD (650-417-8556, jstephens@risetherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of adverse events and their relationship to R-2487 (probiotic) administration (time frame: Baseline through Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06297213.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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