The Kadence Study
A Clinical Research Opportunity for Patients with Uncontrolled Gout
Support Research and Patients by Learning About the Kadence Study Designed to Study the Safety, Tolerability, and Efficacy of the Study Drug Administered Subcutaneously for Adult Patients with Uncontrolled Gout
The Kadence Study
The purpose of this study is to evaluate the safety and efficacy of the study drug administered subcutaneously compared to the study drug administered intravenously. If approved, the subcutaneous administration of the study drug may offer a more convenient approach to managing uncontrolled gout.
Participants will complete a 4-week run-in period, taking methotrexate. If participants do not tolerate it, they will then be discontinued from the study and continue with safety follow-up visits via phone or email.
The study will then include a 48-week treatment period where participants will receive the study drug alongside methotrexate.
All participants will receive the study drug subcutaneously or intravenously, and a placebo administered using the other method so researchers can compare the effects of two different delivery methods of the study drug.
Participants must meet the following criteria:
18 years of age or older
Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the study (15 months).
Willing to stop taking current oral gout urate lowering therapy at least 7 days before the run-in period and remain off them while receiving the study drug.
Diagnosis of uncontrolled gout, defined as meeting the following criteria:
Hyperuricemia during the screening period (sUA ≥ 7 mg/dL).
Failure to maintain normalization of sUA with xanthine oxidase inhibitors at the maximum medically appropriate dose, or with a contraindication to xanthine oxidase inhibitor therapy based on medical record review or participant interview.
At least one of the following symptoms of gout:
At least 1 tophus
Frequent gout flares (2 or more in the past year)
Chronic gouty arthritis
Participants are not eligible if they:
Have received prior treatment with pegloticase or a uricase enzyme
Weigh more than 352 lbs.
Have known history of skin conditions, such as eczema and atopic dermatitis, near the injection site (abdomen)
Have chronic liver disease
Have poor kidney function or on dialysis
Have uncontrolled diabetes
History of malignancy within 5 years other than non-melanoma skin cancer or in situ carcinoma of the cervix
Other eligibility criteria apply and will be evaluated by a principal investigator.
Participants will be expected to:
Visit the study site approximately 31 times over 15 months. They will have follow-up visits with the study team to investigate their response to the study drug.
What the Kadence Study Offers
By enrolling in this study, patients may take part in research evaluating the subcutaneous delivery method of the study drug and how well it lowers uric acid levels and manages signs and symptoms. Participating in this study may help researchers learn more about the study drug delivered subcutaneously for
uncontrolled gout.
Healthcare Professionals
Role in Clinical Research
HCPs play a key role in supporting patients and their families as they decide if clinical research is right for them.
By offering your knowledge, insights, and resources to patients, you provide them with the tools to make the best decision.
If you have a patient who may be interested in this study and may be eligible, you can:
Complete the “Contact PatientWing” form below. We’ll contact you and discuss how your patient can get involved.
If you have patients who may be a good fit for the study or are interested in being an investigator (working on this study), please contact PatientWing!
About PatientWing
Our mission to bring better treatments to more people faster starts with you. We help sponsors find patients to participate in their clinical studies. With our focus on rare and serious conditions and expertise in navigating the enrollment process, we're here for patients every step of the way.
Contact PatientWing
If you have a patient who may be eligible, we would love to speak with you! Please submit the information below so our team can reach out. There is no obligation to you or your patient, by submitting this form.
