Would you like to participate in a clinical research study for gout?
We are inviting you to take part in a clinical research study for adults who have hard-to-treat, or chronic refractory gout. All study-related visits, tests, and investigational drug will be provided at no cost. In addition, compensation for time and travel may be provided. No health insurance is required.
The DISSOLVE I Study is testing an investigational drug, called SEL-212, to see whether it could help people with refractory (or hard-to-treat) gout.
You may qualify for the DISSOLVE I Study if you:
- Are 19–80 years of age (women must not be able to have children)
- Have ongoing symptoms of gout despite treatment
- Have experienced 3 or more flare-ups within the last 18 months, OR have gouty arthritis OR gout tophi
- Have not participated in another clinical trial within the last 30 days or recently had surgery
Sign Up
What happens if I sign up?We will match you to a clinical research study location in your area that needs participants with gout or notify you when one becomes available. The study team will then contact you and you may have the opportunity to participate if qualified.
If you think you might like to participate in the DISSOLVE I Study or would like more information, please enter your information below so we can see if you may qualify and can contact you about the study. Keep in mind that participation is entirely voluntary. If you do decide to take part in a clinical research study, you may change your mind about participating at any time.
About the DISSOLVE I Study
The DISSOLVE I Study will enroll around 105 participants with gout at approximately 40 study centers across the United States.
Participants will receive all study-related visits, tests, and investigational drug from a team of medical professionals at no cost.
The study will include approximately 8-15 visits to an investigational site in your area over approximately 55 weeks.
The DISSOLVE I Study is made up of 3 parts:
Screening: To determine whether you can take part, you will be invited to a study center to undergo tests and assessments.
Study treatment: If eligible, you will receive SEL-212 or placebo and undergo further tests. This part lasts up to 48 weeks.
Follow-up: 4 weeks after your last dose of SEL-212 or placebo, the study team will contact you via telephone to check on your health and well-being.
Participants who qualify to take part in the study may receive compensation for time and travel.
Who can take part in the DISSOLVE I Study?
You may be able to take part in the study if you:
- Are 19–80 years of age (women must not be able to have children)
- Have ongoing symptoms of gout despite treatment
- Have experienced 3 or more flare-ups within the last 18 months, OR have gouty arthritis OR gout tophi
- Have not participated in another clinical trial within the last 30 days or recently had surgery
All study-related care will be provided by a team of medical professionals.
In this study, researchers will be evaluating the efficacy of an investigational drug for refractory (or hard-to-treat) gout.
Frequently Asked Questions
What are clinical research studies?
Clinical research studies are carried out to discover whether an investigational drug:
- Is safe to take
- Has any side effects
- Is effective (works) for its intended purpose
Why is the DISSOLVE I Study being carried out?
Currently approved treatments for chronic refractory gout often lead to an unwanted immune response. This means the body produces anti-drug antibodies (ADAs) that reduce the effectiveness of these treatments. ADAs can also cause serious allergic reactions, such as dizziness or shortness of breath. Available treatments are usually given every 2 weeks, so people with this type of gout require frequent medical care.
The DISSOLVE I Study is testing an investigational drug, called SEL-212, to see whether it could help people with chronic refractory gout. Two different doses of SEL-212 given once a month will be compared with placebo. A placebo looks like the investigational drug but contains no active medication.
What will the DISSOLVE I Study involve?
At each visit, you will undergo tests to see how you are responding to the study drug. Tests may include:
- Collection of blood samples
- An ECG, which measures the electrical activity of your heart
- Assessment of your joints
- Completion of questionnaires to determine how gout is impacting your life
- Filling out a weekly diary recording any gout flare-ups
- Chest X-ray
If eligible to take part, a computer will randomly assign you to one of three study treatment groups:
Study treatment group 1 will receive a higher dose of SEL-212.
Study treatment group 2 will receive a lower dose of SEL-212.
Study treatment group 3 will receive placebo.
You will have a 66% chance of receiving SEL-212 and a 33% chance of receiving placebo. You cannot choose which study drug to take. Neither you nor the study team will know whether you are taking the investigational drug or placebo. However, if you take placebo during the study treatment period, you may be able to enter an open-label extension, during which you will receive SEL-212 only.
The DISSOLVE I Study will last up to 55 weeks and is made up of 3 parts:
Screening: To determine whether you can take part, you will be invited to a study center to undergo tests and assessments.
Study treatment: If eligible, you will receive SEL-212 or placebo, once a month, and undergo further tests. This part lasts up to 48 weeks.
Follow-up: 4 weeks after your last dose of SEL-212 or placebo, the study team will contact you via telephone to check on your health and well-being.
Will I be compensated for time and travel?
Participants who qualify to take part in the study may receive compensation for time and travel. Please discuss this with the study team when they contact you.
Is there a cost to participate?
There is no cost to participate in the DISSOLVE I Study. If you qualify, all study-related visits, tests, and investigational drug will be provided at no cost.
What else do I need to consider?
The research team will be able to explain more about what the DISSOLVE I Study will involve, and it is up to you to decide if you want to take part. Participation in this study is voluntary. Whether or not you decide to participate in this study will not affect your current or future relationships with your doctors. If you decide to participate, you are free to withdraw at any time without affecting those relationships.
How far is the investigational site?
We match you to an investigational site within a close travel distance from your home. If we are not running the study in your area currently, with your permission, we will keep you in our database and reach out once a study in your area becomes available. If, at any time, you decided you no longer want your information stored, you can opt out and we will delete your details.
About Gout
Gout is a common and complicated form of arthritis that can affect anyone. It is characterized by sudden and severe attacks of pain, swelling and tenderness in the joints, commonly at the base of the big toe.1
A gout attack typically occurs suddenly, often waking people up in the middle of the night with intense and burning pain as if the joint were on fire. The affected joint may quickly become so tender and swollen that even the slightest amount of weight or pressure can be unbearable.
Gout symptoms tend to come and go, usually occurring in the middle of the night. The symptoms include:
- Intense joint pain
- Discomfort that can last from a few days or up to a week
- Redness, inflammation and tenderness
- Limited motion with a warm sensation
Gout is a form of inflammatory arthritis that develops when urate crystals build up in a person's joint, causing sudden severe episodes of pain, tenderness, redness, warmth and swelling. These urate crystals form when the body has a high level of uric acid. Because urates are a by-product of purines (a substance found naturally in the body), certain foods and health conditions may put certain people at risk. If too much uric acid is produced, a sharp, needle-like urate crystal could develop in a joint or surrounding tissue, in turn causing pain and inflammation.2
Factors that increase the uric acid level in your body (the cause of gout) include:
Diet. Eating a diet that involves a large consumption of meat, seafood, and heavily sweetened beverages may also put people at risk. Alcoholic beverages are especially known for being a risk factor.
Obesity. If you are overweight, your body will produce more uric acid.
Medical conditions. Certain conditions can increase your risk of gout. These include high blood pressure, diabetes, metabolic syndrome, and heart and kidney diseases.
Certain medications. There is a link between hypertension treatments and high uric acid levels.
Family history and age/sex. It primarily occurs in males between the ages of 30 and 50, while women develop signs and symptoms after menopause.
The DISSOLVE I Study is testing an investigational drug, called SEL-212, to see whether it could help people with refractory (or hard-to-treat) gout.