Safety and Efficacy Study of MM-093 in Patients With Chronic Plaque Psoriasis
Merrimack is conducting a research study to see if an experimental drug, called MM-093, is safe and effective in the treatment of psoriasis. MM-093 is a genetically engineered version of a naturally occurring protein called alpha fetoprotein (AFP). Adults normally have very small amounts of AFP in their bloodstream. However, during pregnancy, AFP levels in both the mother and the fetus are much higher than normal. It has been observed that some women with psoriasis and other autoimmune diseases such as rheumatoid arthritis have fewer symptoms during pregnancy, particularly during the third trimester. At this time, the levels of AFP in the blood of the mother and fetus are the highest. This observation led Merrimack to begin examining MM-093 as a potential treatment for psoriasis. This study is designed to further test the safety and effectiveness of MM-093 in patients with psoriasis.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study To Evaluate the Tolerability, Pharmacokinetics, Pharmacodynamics, and Biologic Activity of MM-093 in Patients With Moderate to Severe Chronic Plaque Psoriasis|
- To evaluate safety and tolerability of MM-093 in psoriasis patients.
- To evaluate efficacy of MM-093 as measured by percent of patients achieving PASI 50.
|Study Start Date:||September 2005|
|Estimated Study Completion Date:||July 2006|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00147329
|United States, Texas|
|Texas Dermatology Research Institute|
|Dallas, Texas, United States, 75230|
|United States, Utah|
|U. of Utah School of Medicine- Department of Dermatology|
|Salt Lake City, Utah, United States, 84132|
|Principal Investigator:||Alan Mentor, MD|
|Principal Investigator:||Gerald Krueger|