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Not yet recruitingNCT06297213R-2487-SjD-01Updated Nov 6, 2026

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

A Phase 1 interventional study of R-2487 in Sjogren's Syndrome, Sjögren and Sjögren Syndrome, Unspecified, sponsored by Rise Therapeutics LLC. Not yet recruiting at 2 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Rise Therapeutics LLC · Phase 1, Interventional, and Treatment

Updated Nov 6, 2026First site in United StatesTitle changed+4 moreGo to Updates ↓

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Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 111 studies in Sjogren's Syndrome with a site in United States — 23 open to participants now, 29 under way, 8 of them phase 3. Sjogren's Syndrome · United States.

Planned enrollment
46th of 76
36 · median 57
Started
2026
with 6 others
Phase 1
15 of 111
5 open now
Primary completion
2029-08
later than 18 of 27 live
Registered
93rd of 111
by date

Among the 111 studies in Sjogren's Syndrome with a site in United States, this one is the 46th largest by planned enrollment of the 76 interventional ones that give a count, is one of 7 that started in 2026, is one of 15 in phase 1, reaches primary completion later than 18 of the 27 other live ones, and was the 93rd registered.

Sjogren's Syndrome

330 studies on the registry are indexed under Sjogren's Syndrome; 99 are open to participants now.

Browse Sjogren's Syndrome studies →

Open to participants now

23 of the 111 studies in Sjogren's Syndrome with a site in United States are open now. Recruiting first, the newest first:

18 more — sign in →

All 23 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 67 Sjogren's Syndrome studies recruiting now, 26 (39%) set no upper age limit and 25 (37%) stop at 75 or younger; 9 take children under 18; 11 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 111 studies in Sjogren's Syndrome with a site in United States, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Sjogren's Syndrome
  • Sjögren
  • Sjögren Syndrome, Unspecified

Browse trials for

Keywords

  • Sjogren's Syndrome
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of SS according to American-European Consensus Group Criteria
  • Able to provide
  • 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 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 product.
  • The use of probiotics prior to study enrollment is accepted; however, during the course of the study, the use of probiotics is forbidden.

Exclusion criteria

Exclusion Criteria:

  • No known active overlapping or associated other 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 or previous malignancy within the last 5 years prior to screening (except documented history of cured non- 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 (HIV), hepatitis A virus (HAV), virus (HBV), or 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 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:

level \< 9.0 g/dL

Absolute white blood cell (WBC) count of \<3.0×109/L (\<3000/mm3), or of \<1.2×109/L (\<1200/mm3), or absolute lymphocyte count of \<0.8×109/L (\<800/mm3).

Thrombocytopenia, defined by count \<100×109/L (\<100,000/mm3)

Chronic kidney disease defined as Estimated (eGFR) \<60 mL/min/1.73m2, based on the age appropriate calculation.

Proteinuria ≥3+.

Total (T-bili), (AST), alanine aminotransferase (ALT) more than 1.5 times (ULN).

Previously diagnosed hepatic cirrhosis ( 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 , 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).
Terms in these criteria, in plain language(18)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (estimated)

Study arms

  • Other
    Open Label

    Probiotic

    Drug: R-2487

Interventions

  • DrugR-2487

    R-2487 DP

    Also known as: Probiotic

06

What researchers measure

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)

    Time frame: Baseline through Week 4

Secondary outcomes

  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

    Time frame: 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.

    Time frame: Baseline through week 4

07

Study locations

2 sites
  • The Johns Hopkins Jerome L. Greene Sjögren's Syndrome Center Johns Hopkins University - Rheumatology Department
    Baltimore, Maryland 21224, United States
    • Priya Patel · Contactppate132@jh.edu · 410-550-9821
    • Alan Baer, MD · Principal investigator
  • University of Michigan - Michigan Medicine
    Ann Arbor, Michigan 48109, United States
08

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Start is estimated for Nov 2026; primary completion for Aug 2029, 33 months later.

Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 28, 2026: start Jun 2026 → Nov 2026, primary completion Aug 2028 → Aug 2029 and completion Aug 2028 → Nov 2029.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Feb 28, 2024
First posted
Mar 7, 2024
StartEst.
Nov 1, 2026was Jun 2026
Primary completionEst.
Aug 30, 2029was Aug 2028
CompletionEst.
Nov 30, 2029was Aug 2028
Last update
Nov 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
2 sites added — first site in United States
Show 2 added (2 United States)
  • The Johns Hopkins Jerome L. Greene Sjögren's Syndrome Center Johns Hopkins University - Rheumatology Department · Baltimore, United States
  • University of Michigan - Michigan Medicine · Ann Arbor, United States
Nov 6, 2026
Start date
Jun 1, 2026→Nov 1, 2026
Sep 28, 2026
Primary completion
Aug 30, 2028→Aug 30, 2029
Sep 28, 2026
Study completion
Aug 30, 2028→Nov 30, 2029
Sep 28, 2026
Title
R-2487 in Patients With Sjogren's Syndrome (SSSjD)
Nov 6, 2026
Show all 2 updates
  1. Nov 6, 2026
    2 sites added — first site in United States
    Show 2 added (2 United States)
    • The Johns Hopkins Jerome L. Greene Sjögren's Syndrome Center Johns Hopkins University - Rheumatology Department · Baltimore, United States
    • University of Michigan - Michigan Medicine · Ann Arbor, United States
    Title R-2487 in Patients With Sjogren's Syndrome (SSSjD)
    + 1 other change: verification date
  2. Sep 28, 2026
    Start date Jun 1, 2026→Nov 1, 2026
    Primary completion Aug 30, 2028→Aug 30, 2029
    Study completion Aug 30, 2028→Nov 30, 2029
    + 2 other changes: verification date and oversight details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06297213
Lead sponsor
Rise Therapeutics LLC
Responsible party
Sponsor
First posted
Mar 7, 2024
Start date
Nov 1, 2026 (estimated)
Primary completion
Aug 30, 2029 (estimated)
Completion
Nov 30, 2029 (estimated)
Last update
Nov 6, 2026

Study contacts

Janet Stephens, PhD
Contact
jstephens@risetherapeutics.com
650-417-8556
Christian Freguia, PhD
Contact
cfreguia@risetherapeutics.com
2159231818

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Probiotic

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