This trial is not actively recruiting.
This trial has completed recruitment on this platform, and is no longer accepting new referrals.
A Clinical Trial to Learn More About an Investigational Drug as Treatment for Moderate to Severe Active Psoriatic Arthritis
About the Trial:
This trial will include adults with moderate to severe PsA who live in the US and Poland.
People who join the trial will be randomly assigned to get either the investigational drug or a placebo (a treatment that looks exactly like the investigational drug but has no active ingredients in it). Half of the participants will receive the investigational drug and half will receive a placebo. During the trial, none of the participants, trial doctors, or staff will know which study treatment each of the participant is getting.
The main goal of the trial is to learn whether more participants who take the investigational drug have improvement in their PsA symptoms than those who take a placebo. The other goal is to learn about any medical issues the participants might have during treatment in the trial.
Estimated Enrollment
70 Participants
Phase
2aEligibility Criteria
Participants must:
Inclusion Criteria
Participants must
- Be 18 to 75 years old
- Have moderate to severe PsA
- Have an active or history of plaque psoriasis (raised red patches covered with scales)
- Have been unresponsive to certain PsA medications after at least 3 months of treatment, or not be eligible for treatment with a type of PsA medication called “disease-modifying antirheumatic drugs” (DMARDs)
Participants must not:
Exclusion Criteria
Participants must not
- Have any type of arthritis before the age of 16 years
- Have any inflammatory joint condition other than PsA
- Have any immunological disease (a condition wherein the body’s immune system attacks its own healthy cells)
- Have “reactive arthritis” (arthritis triggered by an infection in another part of the body), “axial spondylarthritis” (arthritis in the spine and joints connecting the spine to the pelvis), or “fibromyalgia” (a condition causing muscle and joint pain and stiffness all over the body)
- Have a current diagnosis or history of certain medical conditions, including but not limited to, active tuberculosis (“active” is when there are symptoms), chronic liver problem, HIV, or stroke
- Have a current or recent history (within the last 12 months) of drug abuse, or any history of alcoholism
- Have participated in another trial for the investigational drug
Where You Can Join
You will need to travel to one of the study clinics taking part in this clinical trial. Sites are located in:
See if You are Eligible
About the Condition/ Disease Overview:
Psoriatic arthritis (PsA) is a type of arthritis that affects about 30% of people with psoriasis – a skin condition characterized by red patches and scaling1. PsA can cause pain, swelling, and stiffness in any joint in the body. It is a long-term (also called “chronic”) condition and worsens over time.
PsA affects people differently. Some can have mild symptoms in a few joints, while others can have severe ones affecting many joints in the body. If left untreated, it can lead to permanent joint damage or deformation.
Researchers are looking for other ways to treat PsA. In this trial, researchers want to study an oral medication (investigational drug) that was developed to target components in the body that trigger inflammation. They want to see whether the investigational drug can help improve symptoms in people with moderate to severe PsA.
1Mease PJ, Gladman DD, Papp KA, et al. Prevalence of rheumatologist-diagnosed psoriatic arthritis in patients with psoriasis in European/North American dermatology clinics. J Am Acad Dermatol. 2013;69(5):729-735.
What Will Happen in This Trial
If you are interested in joining this trial, you will need to visit a trial site. A trial doctor will explain the trial to you. If you agree to join, the doctors and other site staff will give you an examination and ask you questions about your PsA, your medical history, and the medications you were taking to make sure you are eligible to take part in the trial.
If you decide to join the trial, you will take your assigned study treatment twice a day for 12 weeks (about 3 months). You will visit a trial site 7 times during this period.
During trial site visits, the trial doctors will:
- Give you a physical examination
- Check your heart health using a test called “electrocardiogram”
- Collect blood and urine samples
- Refill your study medication supply
- Check your PsA symptoms, how you are feeling, any new medications you are taking, and any new or worsening medical problems you might be having.
During the trial, you will be allowed to continue taking your current PsA medication as long as it is one of the allowed medications (trial doctors will evaluate this before you join the trial).
At the end of the trial, you will have 1 more visit to the trial site about a month after you take the last dose of your assigned trial treatment.
In total, the participants will be asked to visit the trial site 9 times over a period of up to 21 weeks.
