Uncontrolled GoutPhase 3NCT07388498
A Double-blind, Randomized Controlled Trial to Investigate the Efficacy, Safety, and Pharmacokinetics of Pegloticase Administration Via Subcutaneous and Intravenous Routes Both With Methotrexate in Participants With Uncontrolled Gout
A Phase 3 study testing Pegloticase and Methotrexate in people with Uncontrolled Gout, run by Amgen at 75 sites in 2 countries.
Trial summary
The primary objective of this trial is to evaluate the effect of pegloticase 18 mg subcutaneously (SC) every two weeks with methotrexate (MTX) versus pegloticase 8 mg intravenously (IV) every two weeks with MTX on the response rate during Month 6, as measured by the sustained normalization of serum uric acid (sUA) to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uncontrolled Gout
- What is being tested?
- Pegloticase and Methotrexate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 75 sitesin 2 countries
- Study dates
- 9 Feb 2026to 18 Jun 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant has provided informed consent before initiation of any trial-specific activities/procedures.
- Age ≥ 18 years or ≥ legal age within the country if it is older than 18 years.
- Participants willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial.
- Participants with uncontrolled gout, as meeting the protocol defined criteria.
Who cannot join
- Glucose-6-phosphate dehydrogenase deficiency (tested at the screening visit).
- Liver transaminase levels (aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) > 1.25 x upper limit of normal (ULN) or albumin < the lower limit of normal (LLN) at the screening visit.
- Uncontrolled diabetes mellitus and/or hemoglobin A1c (HbA1c) > 8%.
- Known intolerance to MTX.
- Participant received prior treatment with pegloticase, another recombinant uricase (ie, rasburicase or pegadricase), or concomitant therapy with a polyethylene glycol (PEG)-conjugated drug.
- A known intolerance to all protocol standard gout flare prophylaxis regimens (ie, participant must be able to tolerate at least 1 of the following: colchicine and/or non-steroidal anti-inflammatory drug and/or low-dose prednisone ≤ 10 mg/day or equivalent dose of other corticosteroid).
- Chronic renal impairment defined as estimated glomerular filtration rate (eGFR) based on Modification of Diet in Renal Disease (MDRD) calculations < 40 mL/min/1.73 m^2 or currently on dialysis.
Trial locations and contacts
75 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
75 sites in 2 countries
United States74 sites, 74 recruiting
- Recruiting
Raymond G Murphy Veteran Affairs Medical Center
Albuquerque, New Mexico, 87108
- Recruiting
Precision Rheumatology
Anaheim, California, 92802
- Recruiting
Orthopedic Physicians Alaska
Anchorage, Alaska, 99508
- Recruiting
Arthritis and Rheumatic Disease Specialties
Aventura, Florida, 33180
- Recruiting
D and H Pompano Research Center
Aventura, Florida, 33180
- Recruiting
Bay Pines Veterans Affairs Healthcare System
Bay Pines, Florida, 33744
- Recruiting
Pioneer Research Solutions Inc
Bellaire, Texas, 77401
- Recruiting
Overlake Arthritis and Osteoperosis Center
Bellevue, Washington, 98004
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
- Recruiting
Greater Chicago Specialty Physicians
Boise, Idaho, 83702
- Recruiting
Arthritis and Osteoporosis Consultants of the Carolinas
Charlotte, North Carolina, 28202
- Recruiting
Joint and Muscle Research Institute
Charlotte, North Carolina, 28204
- Recruiting
Onsite Clinical Solutions, LLC
Charlotte, North Carolina, 28211
- Recruiting
Charter Research
Chicago, Illinois, 60618
- Recruiting
Flourish Research Ravenswood
Chicago, Illinois, 60640
- Recruiting
Advanced Clinical Research Center, LLC dba TriWest Research Associates
Chula Vista, California, 91910
- Recruiting
Kur Research at Columbia Medical Practice
Columbia, Maryland, 21045
- Recruiting
The Ohio State University
Columbus, Ohio, 43203
- Recruiting
Discovery Health Research Center
Coral Springs, Florida, 33065
- Recruiting
Southwest Rheumatology
Dallas, Texas, 75230
- Recruiting
Hillcrest Medical Research
DeLand, Florida, 32720
- Recruiting
Denver Arthritis Clinic PC
Denver, Colorado, 80230
- Recruiting
Research Carolina Elite
Denver, North Carolina, 28037
- Recruiting
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
- Recruiting
Triad Clinical Trials, LLC
Greensboro, North Carolina, 27410
- Recruiting
Bioluminux Clinical Research - Hamilton
Hamilton, New Jersey, 08690
- Recruiting
New Generation of Medical Research
Hialeah, Florida, 33016
- Recruiting
Homestead Associates In Research Inc
Homestead, Florida, 33033
- Recruiting
Research Physicians Network, LLC
Houston, Texas, 77089
- Recruiting
West Tennessee Research Institute
Jackson, Tennessee, 38305
- Recruiting
University of Kansas Medical Center
Kansas City, Missouri, 64128
- Recruiting
Texas Arthritis & Rheumatology Associates
Katy, Texas, 77450
- Recruiting
Biopharma Informatic, LLC
Katy, Texas, 77494
- Recruiting
June DO PC
Lansing, Michigan, 48910
- Recruiting
Decision Management International Research
Largo, Florida, 33774
- Recruiting
Cape Fear Arthritis Care, PLLC
Leland, North Carolina, 28451
- Recruiting
Epic Clinical Research
Lewisville, Texas, 75057
- Recruiting
Veterans Affairs Long Beach Health Care System
Long Beach, California, 90822
- Recruiting
Clinical Trials Management, LLC, d/b/a Flourish Research
Mandeville, Louisiana, 70471
- Recruiting
Spatium Urgent Care
Marietta, Georgia, 30066
- Recruiting
Saint Lukes Intermountain Research Center
Meridian, Idaho, 83642
- Recruiting
Pharmax Research Clinic
Miami, Florida, 33126
- Recruiting
Well Pharma Medical Research Corp
Miami, Florida, 33143
- Recruiting
D and H National Research Centers
Miami, Florida, 33155
- Recruiting
Advanced Clinical Research
Miami, Florida, 33156
- Recruiting
Entrust Clinical Research
Miami, Florida, 33176
- Recruiting
Felicidad Medical Research
Miami, Florida, 33184
- Recruiting
Paramount Medical Research and Consulting LLC
Middleburg Heights, Ohio, 44130
- Recruiting
Vista Clinical Research
Newnan, Georgia, 30265
- Recruiting
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73111
- Recruiting
Buffalo Rheumatology and Medicine
Orchard Park, New York, 14127
- Recruiting
MD Medical Research
Oxon Hill, Maryland, 20745
- Recruiting
Integral Rheumatology and Immunology Specialists
Plantation, Florida, 33324
- Recruiting
Health Concepts
Rapid City, South Dakota, 57702
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23298
- Recruiting
Be Well Clinical Studies
Round Rock, Texas, 78681
- Recruiting
Clinical Research Institute of Michigan
Saint Clair Shores, Michigan, 48081
- Recruiting
Accellacare Salisbury
Salisbury, North Carolina, 28144
- Recruiting
Inspire Santa Fe Medical Group
Santa Fe, New Mexico, 87505
- Recruiting
Unity Health Searcy Medical Center
Searcy, Arkansas, 72143
- Recruiting
Carolina Research Center Inc
Shelby, North Carolina, 28150
- Recruiting
Shelby Clinical Research
Shelby, North Carolina, 28150
- Recruiting
Siena Research Network
Sugar Land, Texas, 77479
- Recruiting
Articularis Healthcare Group Inc dba Low Country Rheumatology
Summerville, South Carolina, 29486
- Recruiting
D and H Tamarac Research Center
Tamarac, Florida, 33321
- Recruiting
Nodal Medical Center Research
Tampa, Florida, 33607
- Recruiting
ClinPro Research Solutions LLC
Tampa, Florida, 33609
- Recruiting
GCP Clinical Research, LLC
Tampa, Florida, 33609
- Recruiting
Advanced Rheumatology of Houston
The Woodlands, Texas, 77382
- Recruiting
Oakland Medical Research Center
Troy, Michigan, 48085
- Recruiting
Solace Clinical Research
Tustin, California, 92780
- Recruiting
Jiva Health
Walnut Creek, California, 94598
- Recruiting
Willow Rheumatology and Wellness
Willowbrook, Illinois, 60527
- Recruiting
Conquest Research - Winter Park
Winter Park, Florida, 32789
Puerto Rico1 site, 1 recruiting
- Recruiting
Caribbean Health Research Center
San Juan, 00917
About this study
Official title: A Phase 3, Multicenter, Double-blind, Randomized Controlled Study Evaluating the Efficacy and Safety of Pegloticase Administered by Subcutaneous Injection Compared With Pegloticase Administered by Intravenous Injection, Both Administered Concurrently With Methotrexate Weekly, in Participants With Uncontrolled Gout
The primary objective of this trial is to evaluate the effect of pegloticase 18 mg subcutaneously (SC) every two weeks with methotrexate (MTX) versus pegloticase 8 mg intravenously (IV) every two weeks with MTX on the response rate during Month 6, as measured by the sustained normalization of serum uric acid (sUA) to < 6 mg/dL for at least 80% of the time during Month 6.
- Conditions
- Uncontrolled Gout
- Being tested
- Pegloticase, Methotrexate
- Keywords
- Uncontrolled Gout, Pegloticase, KRYSTEXXA, Kadence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PegloticaseDrug
Also called KRYSTEXXA
Participants will receive pegloticase either SC or IV.
MethotrexateDrug
Also called MTX
MTX will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Pegloticase SC with MTX | Experimental | Participants will receive pegloticase SC every two weeks with MTX. Receives: Drug: Pegloticase; Drug: Methotrexate |
| Pegloticase IV with MTX | Experimental | Participants will receive pegloticase IV every two weeks with MTX. Receives: Drug: Pegloticase; Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Achieving Month 6 Response at Weeks 20, 21, 22, 23, and 24
Defined as Achieving and Maintaining sUA < 6 mg/dL for at Least 80% of the Time During Month 6.
Measured: Month 6 (Weeks 20, 21, 22, 23, and 24)
Secondary outcomes (4)
Number of Participants With Serious Injection Site Reactions Through Week 48
Measured: Up to Week 48
Number of Participants With Serious Adjudicated Infusion Reactions (Including Adjudicated Anaphylaxis) Through Week 48
Measured: Up to Week 48
Number of Participants With Adjudicated Anaphylaxis Through Week 48
Measured: Up to Week 48
Serum Concentrations of Pegloticase Following SC and IV Administration
Measured: Up to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start9 Feb 2026
- Primary completion18 Jun 2028 (estimated)
- Study completion18 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncontrolled GoutStudies of the same condition, open and under way.
- More trials run by AmgenThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07388498
- Sponsor's protocol ID
- 20230219
- Status last verified
- Oct 2026
- First submitted
- 29 Jan 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Double-blind, Randomized Controlled Study Evaluating the Efficacy and Safety of Pegloticase Administered by Subcutaneous Injection Compared With Pegloticase Administered by Intravenous Injection, Both Administered Concurrently With Methotrexate Weekly, in Participants With Uncontrolled Gout
- ClinicalTrials.gov ID
- NCT07388498
- Acronym / sponsor ID
- 20230219
- Conditions
- Uncontrolled Gout
- Keywords
- Uncontrolled Gout, Pegloticase, KRYSTEXXA, Kadence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 9 Feb 2026 (actual)
- Primary completion
- 18 Jun 2028 (estimated)
- Study completion
- 18 Jun 2028 (estimated)
- First posted
- 5 Feb 2026 (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 primary objective of this trial is to evaluate the effect of pegloticase 18 mg subcutaneously (SC) every two weeks with methotrexate (MTX) versus pegloticase 8 mg intravenously (IV) every two weeks with MTX on the response rate during Month 6, as measured by the sustained normalization of serum uric acid (sUA) to < 6 mg/dL for at least 80% of the time during Month 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pegloticase SC with MTX | Experimental | Drug: Pegloticase, Drug: MethotrexateParticipants will receive pegloticase SC every two weeks with MTX. |
| Pegloticase IV with MTX | Experimental | Drug: Pegloticase, Drug: MethotrexateParticipants will receive pegloticase IV every two weeks with MTX. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant has provided informed consent before initiation of any trial-specific activities/procedures.
- Age ≥ 18 years or ≥ legal age within the country if it is older than 18 years.
- Participants willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial.
- Participants with uncontrolled gout, as meeting the protocol defined criteria.
Key exclusion criteria (7 listed)
- Glucose-6-phosphate dehydrogenase deficiency (tested at the screening visit).
- Liver transaminase levels (aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) > 1.25 x upper limit of normal (ULN) or albumin < the lower limit of normal (LLN) at the screening visit.
- Uncontrolled diabetes mellitus and/or hemoglobin A1c (HbA1c) > 8%.
- Known intolerance to MTX.
- Participant received prior treatment with pegloticase, another recombinant uricase (ie, rasburicase or pegadricase), or concomitant therapy with a polyethylene glycol (PEG)-conjugated drug.
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 |
|---|---|---|
| PegloticaseAlso: KRYSTEXXAParticipants will receive pegloticase either SC or IV. | Drug | Pegloticase IV with MTX, Pegloticase SC with MTX |
| MethotrexateAlso: MTXMTX will be administered orally. | Drug | Pegloticase IV with MTX, Pegloticase SC with MTX |
Primary outcome
Number of Participants Achieving Month 6 Response at Weeks 20, 21, 22, 23, and 24
Time frame: Month 6 (Weeks 20, 21, 22, 23, and 24)
Defined as Achieving and Maintaining sUA < 6 mg/dL for at Least 80% of the Time During Month 6.
4 secondary outcomes
Number of Participants With Serious Injection Site Reactions Through Week 48
Time frame: Up to Week 48
Number of Participants With Serious Adjudicated Infusion Reactions (Including Adjudicated Anaphylaxis) Through Week 48
Time frame: Up to Week 48
Number of Participants With Adjudicated Anaphylaxis Through Week 48
Time frame: Up to Week 48
Serum Concentrations of Pegloticase Following SC and IV Administration
Time frame: Up to Week 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Related trials for Uncontrolled Gout
Active, not recruitingPhase 2
Evaluation of Efficacy and Safety of AR882 and XOI Co-administration in Uricase Treatment Failed Patients
Gout, Gouty Arthritis
RecruitingPhase 1
A Phase Ib Clinical Trial of Peguricase for Injection With Methotrexate in Patients With Uncontrolled Gout.
Gout
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.
MD study director
Amgen
75 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pegloticase and Methotrexate in people with Uncontrolled Gout, run by Amgen at 75 sites in 2 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 75 sites in United States, Puerto Rico. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amgen Call Center (866-572-6436, medinfo@amgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Achieving Month 6 Response at Weeks 20, 21, 22, 23, and 24 (time frame: Month 6 (Weeks 20, 21, 22, 23, and 24)). 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 19 Oct 2026.