Clinical trial NCT06031415: Study of GS-0272 in Participants With Rheumatoid Arthritis
Official title: A Multicenter, Randomized, Placebo-Controlled Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of Multiple Ascending Doses of GS-0272 in Adult Participants With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2023-09-11
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: Key Inclusion Criteria:

* Age limit for the Republic of Korea for male or nonpregnant female is between 19 and 75 years of age.

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 (Active RA Cohort)-Specific Inclusion Criteria:

* 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.

Key Exclusion Criteria:

* 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.

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

Primary outcomes:
measure: Percentage of Participants Experiencing Adverse Events (AEs)
timeFrame: First dose up to Week 12 plus 70 days
measure: Percentage of Participants Experiencing Serious Adverse Events (SAEs)
timeFrame: First dose up to Week 12 plus 70 days
measure: Percentage of Participants With Laboratory Abnormalities
timeFrame: First dose up to Week 12 plus 70 days
measure: Pharmacokinetics (PK) of GS-0272: AUCtau
timeFrame: Day 1 predose through Day 197
measure: PK of GS-0272: Cmax
timeFrame: Day 1 predose through Day 197
measure: PK of GS-0272: Tmax
timeFrame: Day 1 predose through Day 197
Secondary outcomes:
measure: Prevalence of Antidrug Antibodies (ADAs) for GS-0272
timeFrame: Baseline (Day 1) through Day 197
measure: Incidence of ADAs for GS-0272
timeFrame: Baseline (Day 1) through Day 197
measure: Part B: Change from Baseline in Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) in Participants with Moderate-to-Severe RA
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Arizona Arthritis & Rheumatology Associates P.C.
state: California
city: Palo Alto
country: United States
facility: Stanford School of Medicine, Division of Immunology & Rheumatology
state: California
city: Upland
country: United States
facility: 1238 E. Arrow Hwy
state: California
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Houston
country: United States
facility: Accurate Clinical Research, Inc.
state: Texas
city: Mesquite
country: United States
facility: 1600 Republic Parkway
state: Texas
city: Tbilisi
country: Georgia
facility: ARENSIA Exploratory Medicine LLC
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Chisinau
country: Moldova, Republic of
facility: IMSP Republican Clinical Hospital "Timofei Mosneaga", ARENSIA E.M.
city: Cambridge
country: United Kingdom
facility: Cambridge Clinical Research Centre, Rheumatology Research Unit - E6, Addenbrookes Hospital
city: London
country: United Kingdom
facility: Kings College Hospital
city: Southampton
country: United Kingdom
facility: NIHR Wellcome Trust Clinical Research Facility, University Hospital Southampton NHS Foundation Trust
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: