A Single and Repeat Dosing Study of the Safety, Drug Exposure and Clinical Activity of R-2487 in Patients With Rheumatoid Arthritis

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Ages 18-75 years (Inclusive).

• Able to provide written informed consent.

• Men or women (not nursing or pregnant) who have active RA, defined as symptoms of RA prior to screening and have satisfied the ACR/EULAR 2010 criteria for the classification of RA prior to signing the informed consent.

• Subjects must have a CDAI \> 10.0 at screening and have at least 3 tender and at least 3 swollen joints (excluding distal interphalangeal) at screening and at Day 1, based on the DAS28 joint count.

• Subjects may be able to be on hydroxychloroquine, methotrexate, and leflunomide. Sulfasalazine use is not permitted.

• Subjects may have received targeted synthetic DMARDs such as tofacitinib, baricitinib, and investigational therapies for RA if they have been washed out for 1 month prior to screening.

• Subjects receiving oral corticosteroids must be on a stable dose and at the equivalent of ≤10 mg prednisone daily for at least 4 weeks. Subjects may not receive an IM, IV or IA administration of a corticosteroid within 4 weeks prior to screening visit or initiation of therapy.

• All male and female subjects who are biologically capable of having children must agree to use a 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 study drug. Any pregnancy that occurs in the female partner of a male subject in the trial must be reported if it occurs at any time during the study.

• Refrain from receiving any type of vaccinations during the study period (to include but not limited to influenza, COVID, shingles, tetanus, hepatitis, pneumonia, HPV, DPT, MMR, and polio).

Locations
United States
California
University of California, San Diego
RECRUITING
San Diego
Florida
St.Jude Clinical Research
RECRUITING
Doral
AP Medical Research
RECRUITING
Miami
Pennsylvania
Altoona Center for Research
RECRUITING
Duncansville
Texas
Prolato Clinical Research Center
RECRUITING
Houston
Contact Information
Primary
Janet Stephens, PhD
jstephens@risetherapeutics.com
6504178556
Backup
Christian Freguia, PhD
cfreguia@risetherapeutics.com
2159231818
Time Frame
Start Date: 2023-10-19
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 73
Treatments
Experimental: Four (4) week open label dose for Rheumatoid Arthritis patients
R-2487 DP administered daily for 28 days
Experimental: Six (6) week open label dose for Rheumatoid Arthritis patients
R-2487 DP administered daily for 42 days
Experimental: Four (4) week open label dose for Rheumatoid Arthritis with Secondary Sjorgrens Syndrome patients
R-2487 DP administered daily for 28 days
Related Therapeutic Areas
Sponsors
Leads: Rise Therapeutics LLC

This content was sourced from clinicaltrials.gov