Study of GS-0272 in Participants With Rheumatoid Arthritis or Systemic Lupus Erythematosus

Study Purpose

The goals of this clinical study are to learn more about the study drug, GS-0272, and its safety and tolerability following multiple doses in participants with rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). The primary objectives of this study are to assess the safety and tolerability of multiple ascending subcutaneous (SC) doses of GS-0272 and to characterize the pharmacokinetics of GS-0272 following multiple SC doses of GS-0272, in participants with RA or SLE.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

Key

Inclusion Criteria:

Part A (Rheumatoid Arthritis (RA) Cohorts)-Specific

Inclusion Criteria:

- Diagnosis of RA at least 3 months prior to screening fulfilling the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria.

- Ongoing treatment with 1 or 2 conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) for at least 12 weeks prior to the first dose of study drug, with a stable dose for at least 4 weeks prior to the first dose of study drug, as follows: - Individuals must not be on a biologic disease-modifying antirheumatic drugs (bDMARD)/targeted synthetic disease-modifying antirheumatic drug (tsDMARD) at Day 1 or during the study and must discontinue b/tsDMARD use for at least 4 weeks (with the exception of rituximab, which must be discontinued for at least 16 weeks) prior to the first dose of study drug.

Part B (Systemic Lupus Erythematosus (SLE) Cohort)-Specific

Inclusion Criteria:

- Fulfill EULAR/ACR 2019 classification criteria for SLE at least 24 weeks prior to the first dose of study drug.

- Individuals using protocol-permitted nonbiologic immunosuppressive/immunomodulatory agents (antimalarials, methotrexate (MTX), azathioprine, cyclosporine, leflunomide, minocycline, mycophenolate mofetil, mycophenolic acid, dapsone, and oral [not topical] tacrolimus) for the treatment of SLE must maintain stable dose(s) for at least 4 weeks prior to the first dose of study drug and through the end of study.

Key

Exclusion Criteria:

- Meet any of the protocol-specified infection criteria (hepatitis C, Hepatitis B, HIV, tuberculosis, others).

- Highly active SLE (including but not limited to lupus nephritis (with significant increases in urine protein/creatinine ratio over clinical baseline, recent worsening or creatinine clearance, and/or pyuria/hematuria), neuropsychiatric SLE, and/or vasculitis) that could put the individual at risk per investigator's judgment.

- Exposure to cyclophosphamide or any biologic lupus therapy within 8 weeks prior to the first dose of study drug.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06031415
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Gilead Sciences
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Gilead Study Director
Principal Investigator Affiliation	Gilead Sciences
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Georgia, Moldova, Republic of, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Rheumatoid Arthritis, Systemic Lupus Erythematosus
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Part A: Rheumatoid Arthritis (RA) Cohorts: GS-0272 or Placebo

Part A will include participants with RA. Part A will have 3 cohorts. Each cohort in Part A will be randomized in a 3:1 ratio to receive either ascending doses of GS-0272 or placebo for 12 weeks. Dosing will begin in Cohort 1. Cohorts 2 and 3 will be initiated upon review of blinded safety data from the preceding cohort.

Experimental: Part B: Systemic Lupus Erythematosus (SLE) Cohort: GS-0272 or Placebo

Part B will include participants with SLE. Part B will have only 1 cohort (Cohort 4). Participants in Cohort 4 will be randomized in a 3:1 ratio to receive either GS-0272 or placebo for 12 weeks.

Interventions

Drug: - GS-0272

Administered subcutaneously

Drug: - Placebo

Administered subcutaneously

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Clinical Research of West Florida, Inc., Clearwater, Florida

Status

Not yet recruiting

Address

Clinical Research of West Florida, Inc.

Clearwater, Florida, 33765

Site Contact

[email protected]

1-833-445-3230 (GILEAD-0)

Altoona Center for Clinical Research, Duncansville, Pennsylvania

Status

Recruiting