A Phase 2, randomized, double-blind, placebo-controlled, dose-finding study to evaluate the safety, tolerability, and efficacy of KD025 in adult subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy
September 29, 2016
Natasha Mesinkovska, MD, PhD
At the UC Irvine campus:
Dermatology Clinical Research Center
843 Health Science Road
Hewitt Hall, Room 1001
Irvine, CA 92697
The purpose of this study is to find out if KD025, an oral investigational new drug, is safe as a possible treatment for moderate to severe chronic plaque psoriasis as well as to determine how the human body will tolerate different doses of the drug versus placebo for 4 months.
Please note this is not a complete list of the eligibility criteria for the study. We have included a few examples of study criteria to help you better understand how your eligibility in the study will be determined. Your study team will go through all the study eligibility criteria with you to verify if you qualify for participation in this study.
You can participate in this study if you are:
1. 18 to 65 years of age
2. Diagnosed with moderate to severe chronic plaque psoriasis
3. A candidate for phototherapy or systemic therapy
You cannot participate in this study if you:
1. Have non-plaque or drug-induced (e.g., anti-malarial, lithium) psoriasis
2. Use certain prohibited medications (e.g., use of high-dose corticosteroid within 12 weeks prior or during the study, methotrexate or cyclosporine within 4 weeks prior to study entry)
3. Are a pregnant or nursing (lactating) woman, or planning to get pregnant during the entire study or longer
4. Are in another research study or if you have been in any other research study in the last 30 days
5. Have had exposure to KD025 within the last 6 months or have a known allergy/sensitivity to any of the KD025 ingredients
The study will last about 24 weeks (4 months of treatment and a 30-day follow-up visit) and involve 11 to 13 study visits to the facility. At the end of the initial study period, there will be an option for you to continue on the study for an additional 24 weeks. Visits will last 1 to 6 hours each.
Taking part in this study may or may not make your health better. While researchers hope KD025 will be more effective and have fewer side effects than the standard (usual) treatment, there is no proof of this yet.
You may have side effects while on the study. Everyone taking part in the study will be watched carefully for any side effects. Because KD025 is an investigational drug, all of its side effects may not be known. Side effects may be mild or very serious.
You will be paid by check at specified time points over the course of the study. There are 11 or 13 regularly scheduled visits, depending on if you were on active drug or placebo during the main part of the study. You will receive $125 per visit for screening visit, week 1 (baseline visit), weeks 12, 16, 24, 36 and 48. You will receive $75 per visit for weeks 4, 8 and the follow-up visit. You will receive $50 per visit for weeks 18, 30 and 42. If you need an early termination visit, you will receive $70. Total compensation for participation in the entire study is $1225, or $1325 if you are in the placebo during the main part of the study. If you decide to withdraw from the study, or are withdrawn by the research team, you will receive compensation for the visits that you have completed.
Patty Summerville, clinical research coordinator, Department of Dermatology