Study of GS-0272 in Participants With Rheumatoid Arthritis

NCT06031415 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: GS-US-666-6692
• Study Type: interventional
• Target: 55
• Locations: 5 countries
• Sites: 24

Brief Summary

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). The primary objectives of this study are to assess the safety and tolerability of multiple ascending doses of GS-0272 and to characterize the pharmacokinetics of GS-0272 following multiple doses of GS-0272, in participants with RA.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (6)

• Percentage of Participants Experiencing Adverse Events (AEs)

  First dose up to Week 12 plus 70 days

• Percentage of Participants Experiencing Serious Adverse Events (SAEs)

  First dose up to Week 12 plus 70 days

• Percentage of Participants With Laboratory Abnormalities

  First dose up to Week 12 plus 70 days

• Pharmacokinetics (PK) of GS-0272: AUCtau

  AUCtau is defined as the area under the concentration versus time curve over the dosing interval.

  Day 1 predose through Day 197

• PK of GS-0272: Cmax

  Cmax is defined the maximum observed plasma drug concentration.

  Day 1 predose through Day 197

• PK of GS-0272: Tmax

  Tmax is defined as the time to maximum observed concentration.

  Day 1 predose through Day 197

Secondary Outcomes (3)

• Prevalence of Antidrug Antibodies (ADAs) for GS-0272

  Baseline (Day 1) through Day 197

• Incidence of ADAs for GS-0272

  Baseline (Day 1) through Day 197

• Part B: Change from Baseline in Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) in Participants with Moderate-to-Severe RA

  Baseline, Week 12

Study Arms (2)

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

EXPERIMENTAL

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.

Drug: GS-0272; Drug: Placebo

Part B: Active RA Cohort: GS-0272 or Placebo

EXPERIMENTAL

Part B will include participants with moderate-to-severe RA. Part B will have only 1 cohort (Cohort 4). Participants in Cohort 4 will be randomized in a 2:1 ratio to receive either GS-0272 or placebo for 12 weeks.

Drug: GS-0272; Drug: Placebo

Interventions

GS-0272 DRUG

Administered subcutaneously (for Part A) Administered intravenously or subcutaneously (for Part B)

Part A: Rheumatoid Arthritis (RA) Cohorts: GS-0272 or Placebo; Part B: Active RA Cohort: GS-0272 or Placebo

Placebo DRUG

Administered subcutaneously (for Part A) Administered intravenously or subcutaneously (for Part B)

Part A: Rheumatoid Arthritis (RA) Cohorts: GS-0272 or Placebo; Part B: Active RA Cohort: GS-0272 or Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age limit for the Republic of Korea for male or nonpregnant female is between 19 and 75 years of age.
• 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.
• Participant is seropositive as demonstrated by a positive anti-cyclic citrullinated peptide (anti-CCP) antibody and/or positive rheumatoid factor at screening.
• Participant has an elevated high-sensitivity C-reactive protein (hsCRP) greater than upper limit of normal (ULN).
• Participant has 6 or more swollen and 6 or more tender joints as assessed on the SJC66/TJC68. Distal interphalangeal joints will not be counted towards the 6 joint eligibility.
• Participant has had inadequate response or intolerance to at least 1 but not more than 3 bDMARD/tsDMARD therapeutics with no more than 2 MOAs. A lack of response is defined as documented continued or recurrent disease activity after at least 12 weeks of treatment of RA.

You may not qualify if:

• Meet any of the protocol-specified infection criteria (hepatitis C, Hepatitis B, HIV, tuberculosis, others).
• Inadequate response or intolerance to more than 3 bDMARDs/tsDMARDs with more than 2 MOAs.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (24)

Arizona Arthritis & Rheumatology Associates P.C.

Glendale, California, 85306, United States

Location

Stanford School of Medicine, Division of Immunology & Rheumatology

Palo Alto, California, 94304, United States

Location

1238 E. Arrow Hwy

Upland, California, 91786, United States

Location

Clinical Research of West Florida, Inc.

Clearwater, Florida, 33765, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Greater Chicago Specialty Physicians/ Clinical Investigation Specialists

Niles, Illinois, 60714, United States

Location

Greater Chicago Specialty Physicians/Clinical Investigation Specialists, Inc.

Schaumburg, Illinois, 60195, United States

Location

Summit Headlands LLC

Portland, Oregon, 97210, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

PA Regional Center for Arthritis and Osteoporosis Research

Wyomissing, Pennsylvania, 19610, United States

Location

Precision Comprehensive Clinical Research Solutions

Colleyville, Texas, 76034, United States

Location

Accurate Clinical Research, Inc.

Houston, Texas, 77089, United States

Location

Precision Comprehensive Clinical Research Solutions

Irving, Texas, 75061, United States

Location

1600 Republic Parkway

Mesquite, Texas, 75150, United States

Location

ARENSIA Exploratory Medicine LLC

Tbilisi, 0112, Georgia

Location

IMSP Republican Clinical Hospital "Timofei Mosneaga", ARENSIA E.M.

Chisinau, MD-2025, Moldova

Location

Chungnam National University Hospital

Daejeon, 35015, South Korea

Location

Seoul National University Hospital

Seoul, 110 744, South Korea

Location

Ajou University Hospital

Suwon, 16499, South Korea

Location

Cambridge Clinical Research Centre, Rheumatology Research Unit - E6, Addenbrookes Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

University Hospitals Coventry & Warwickshire NHS Trust

Coventry, CV2 2DX, United Kingdom

Location

Kings College Hospital

London, SE5 9RS, United Kingdom

Location

Simbec Research Limited

Merthyr Tydfil, CF48 4DR, United Kingdom

Location

NIHR Wellcome Trust Clinical Research Facility, University Hospital Southampton NHS Foundation Trust

Southampton, SO16 6YD, United Kingdom

Location

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 11, 2023
• Study Start: September 28, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GE (1); KR (3); GB (5); US (14); MO (1)