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Clinical Trials/NCT00147329
NCT00147329CompletedPhase 2

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

Merrimack Pharmaceuticals4 sites in 1 country30 target enrollmentStarted: September 2005Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
30
Locations
4
Primary Endpoint
To evaluate safety and tolerability of MM-093 in psoriasis patients.

Study Overview

Brief Summary

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.

Detailed Description

TBA

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry

Study Sites (4)

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