Rheumatoid ArthritisPhase 1MARASLENCT06031415
Study of GS-0272 in Participants With Rheumatoid Arthritis
A Phase 1 study testing GS-0272 in people with Rheumatoid Arthritis, run by Gilead Sciences at 24 sites in 5 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- GS-0272
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 24 sitesin 5 countries
- Study dates
- 28 Sep 2023to 11 May 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
Trial locations and contacts
24 sites in 5 countries.
24 sites in 5 countries
United States14 sites
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765
Precision Comprehensive Clinical Research Solutions
Colleyville, Texas, 76034
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Arizona Arthritis & Rheumatology Associates P.C.
Glendale, California, 85306
Accurate Clinical Research, Inc.
Houston, Texas, 77089
Precision Comprehensive Clinical Research Solutions
Irving, Texas, 75061
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
1600 Republic Parkway
Mesquite, Texas, 75150
Greater Chicago Specialty Physicians/ Clinical Investigation Specialists
Niles, Illinois, 60714
Stanford School of Medicine, Division of Immunology & Rheumatology
Palo Alto, California, 94304
Summit Headlands LLC
Portland, Oregon, 97210
Greater Chicago Specialty Physicians/Clinical Investigation Specialists, Inc.
Schaumburg, Illinois, 60195
1238 E. Arrow Hwy
Upland, California, 91786
PA Regional Center for Arthritis and Osteoporosis Research
Wyomissing, Pennsylvania, 19610
United Kingdom5 sites
Cambridge Clinical Research Centre, Rheumatology Research Unit - E6, Addenbrookes Hospital
Cambridge, CB2 0QQ
University Hospitals Coventry & Warwickshire NHS Trust
Coventry, CV2 2DX
Kings College Hospital
London, SE5 9RS
Simbec Research Limited
Merthyr Tydfil, CF48 4DR
NIHR Wellcome Trust Clinical Research Facility, University Hospital Southampton NHS Foundation Trust
Southampton, SO16 6YD
South Korea3 sites
Chungnam National University Hospital
Daejeon, 35015
Seoul National University Hospital
Seoul, 110 744
Ajou University Hospital
Suwon, 16499
Moldova1 site
IMSP Republican Clinical Hospital "Timofei Mosneaga", ARENSIA E.M.
Chisinau, MD-2025
About this study
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
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
- Being tested
- GS-0272, Placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS-0272Drug
Administered subcutaneously (for Part A) Administered intravenously or subcutaneously (for Part B)
PlaceboDrug
Administered subcutaneously (for Part A) Administered intravenously or subcutaneously (for Part B)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: GS-0272; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Experiencing Adverse Events (AEs)
Measured: First dose up to Week 12 plus 70 days
Percentage of Participants Experiencing Serious Adverse Events (SAEs)
Measured: First dose up to Week 12 plus 70 days
Percentage of Participants With Laboratory Abnormalities
Measured: 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.
Measured: Day 1 predose through Day 197
PK of GS-0272: Cmax
Cmax is defined the maximum observed plasma drug concentration.
Measured: Day 1 predose through Day 197
PK of GS-0272: Tmax
Tmax is defined as the time to maximum observed concentration.
Measured: Day 1 predose through Day 197
Secondary outcomes (3)
Prevalence of Antidrug Antibodies (ADAs) for GS-0272
Prevalence of ADAs will be measured as the proportion of participants who had at least one positive ADA sample (baseline or post-baseline) among all participants evaluable for ADA prevalence.
Measured: Baseline (Day 1) through Day 197
Incidence of ADAs for GS-0272
ADA incidence will be measured as the proportion of participants who have treatment-emergent ADA sample (post-baseline) among all participants evaluable for ADA incidence.
Measured: 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
Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), participant's global assessment of disease activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity) and CRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity.
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start28 Sep 2023
- Primary completion11 May 2026
- Study completion11 May 2026
Why it stopped: Study terminated due to lack of efficacy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031415
- Sponsor's protocol ID
- GS-US-666-6692
- Acronym
- MARASLE
- Status last verified
- May 2026
- First submitted
- 4 Sep 2023
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06031415
- Acronym / sponsor ID
- MARASLE / GS-US-666-6692
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to lack of efficacy.
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- 11 May 2026 (actual)
- Study completion
- 11 May 2026 (actual)
- First posted
- 11 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: Rheumatoid Arthritis (RA) Cohorts: GS-0272 or Placebo | Experimental | Drug: GS-0272, Drug: PlaceboPart 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. |
| Part B: Active RA Cohort: GS-0272 or Placebo | Experimental | Drug: GS-0272, Drug: PlaceboPart 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GS-0272Administered subcutaneously (for Part A) Administered intravenously or subcutaneously (for Part B) | Drug | Part A: Rheumatoid Arthritis (RA) Cohorts: GS-0272 or Placebo, Part B: Active RA Cohort: GS-0272 or Placebo |
| PlaceboAdministered subcutaneously (for Part A) Administered intravenously or subcutaneously (for Part B) | Drug | Part A: Rheumatoid Arthritis (RA) Cohorts: GS-0272 or Placebo, Part B: Active RA Cohort: GS-0272 or Placebo |
Primary outcome
Percentage of Participants Experiencing Adverse Events (AEs)
Time frame: First dose up to Week 12 plus 70 days
Percentage of Participants Experiencing Serious Adverse Events (SAEs)
Time frame: First dose up to Week 12 plus 70 days
Percentage of Participants With Laboratory Abnormalities
Time frame: First dose up to Week 12 plus 70 days
Pharmacokinetics (PK) of GS-0272: AUCtau
Time frame: Day 1 predose through Day 197
AUCtau is defined as the area under the concentration versus time curve over the dosing interval.
PK of GS-0272: Cmax
Time frame: Day 1 predose through Day 197
Cmax is defined the maximum observed plasma drug concentration.
PK of GS-0272: Tmax
Time frame: Day 1 predose through Day 197
Tmax is defined as the time to maximum observed concentration.
3 secondary outcomes
Prevalence of Antidrug Antibodies (ADAs) for GS-0272
Time frame: Baseline (Day 1) through Day 197
Incidence of ADAs for GS-0272
Time frame: 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
Time frame: Baseline, Week 12
Results and safety
The study was stopped early (reason given: Study terminated due to lack of efficacy.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
24 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GS-0272 in people with Rheumatoid Arthritis, run by Gilead Sciences at 24 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, United Kingdom, South Korea, Georgia, Moldova. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study terminated due to lack of efficacy.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Experiencing Adverse Events (AEs) (time frame: First dose up to Week 12 plus 70 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.