What Is the K-808-2.01 Study?
The K-808-2.01 Study is evaluating the safety and effectiveness of the study medication, K-808, in those who are living with primary biliary cholangitis (PBC). The trial will evaluate two different doses of K-808 with a placebo, which looks just like K-808 but contains no active drug.
In placebo-controlled trials, one group is given the inactive treatment while another group or groups is/are given the active treatment. This is the best way to find out if the treatment being tested works better than receiving no treatment at all.
Who Can Be in the K-808-2.01 Study?
- You are at least 18 years old
- You have been diagnosed with PBC
- You have a significantly elevated level of a liver enzyme called alkaline phosphatase (ALP)
- Your condition has not improved enough after taking ursodeoxycholic acid (UDCA) and/or OCA (obeticholic acid; Ocaliva®), OR you cannot take UDCA and/or OCA due to side effects
The trial team will be looking at additional criteria to confirm your eligibility for the trial.
Eligible participants who are currently taking fenofibrate or other fibrate medications must stop taking the medication for 8 weeks before screening.
What Happens During the K-808-2.01 Study?
The K-808-2.01 Study includes:
• Screening: up to 6 weeks
• Study Treatment Period: 12 weeks (3 months)
• Extension Period (for those not taking OCA): 52 weeks (1 year)
• Follow-up: Phone call 4 weeks after the last dose of the study medication (or placebo)
During the Screening Period, to determine whether you are eligible to participate in the trial, you will answer questions about yourself and your medical history and have some procedures (for example, a physical exam, blood and urine samples, etc.) to check your health. If you then choose to participate in the trial, you will enter the 12-week Treatment Period and be randomly chosen to receive one of two different doses of the study medication or a placebo. The efficacy and safety of two different doses will be tested to identify the minimum dose required to observe a potential benefit in participants. The placebo looks just like K-808 but contains no active drug. Both the study medication and placebo come in tablet form and will be taken once daily. You will have 4 trial visits and 1 telephone visit during the Treatment Period. A 52-week Extension Period follows the Treatment Period only for participants not taking OCA. During the Extension Period all eligible participants will receive one of two doses of K-808. If eligible, you will have at least 5 trial visits during the Extension Period.
All participants will receive a follow-up phone call 4 weeks after their last dose of the study medication (or placebo).
To learn more please email: kianakhbari@arizona.edu