Status:
TERMINATED
Safety and Tolerability Study of COVA322 in Patients With Stable Chronic Moderate-to-severe Plaque Psoriasis
Lead Sponsor:
Covagen
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
This study is a randomised, double-blind, placebo-controlled, sequential, ascending single-dose, parallel group study to evaluate safety, tolerability, biological activity, and systemic exposure of CO...
Eligibility Criteria
Inclusion
- Male or female subjects of any ethnic origin; women must be of non-childbearing potential
- Aged between 18 to 65 yrs inclusive
- Body weight of ≥ 40 kg and body mass index between 19 - 32 kg/m2 inclusive
- Established diagnosis of moderate to severe plaque psoriasis for at least 6 months prior to screening. The patients must meet all of the following criteria:
- Psoriasis involving ≥ 10% of body surface area
- Requirement of phototherapy or systemic therapy
- Psoriasis Area and Severity Index (PASI) score of ≥ 10
- Physician"s Global Assessment (PGA) score of ≥ 3
- stable disease
Exclusion
- History of clinically relevant allergies or idiosyncrasies to COVA322
- Any history of clinically significant drug hypersensitivity following any therapy with a therapeutical biologic, or asthma, urticaria, or other allergic diathesis
- Clinically significant flare of psoriasis during the 12 weeks before randomization
- Current evidence of non-plaque forms of psoriasis
- Currently evidence of drug-induced psoriasis
- Evidence of any serious systemic or local infection within 3 months before screening
- Evidence of subclinical/latent tuberculosis infection
- History or any signs of lymphoproliferative disease, or a known malignancy or a history of malignancy within the previous 5 years
- History or current evidence of autoimmune diseases other than psoriasis
- Women of child-bearing potential
- Recent previous exposure to systemic psoriasis treatments, including anti-TNF-α therapies, immunosuppressive agents such as cyclosporine, mycophenolate, or tacrolimus, and other medications affecting the immune function
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥ 2.5 times the upper limit of normal (ULN) at screening
- Serum creatinine level ≥ 1.5 times the ULN at screening
- Positive results in any of the virology tests for HIV-Ab, hepatitis C-virus antibody (HCV-Ab) and hepatitis B-virus surface antigen (HBsAg) or hepatitis B core antibody (HBc-Ab)
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02243787
Start Date
April 1 2014
Last Update
March 1 2016
Active Locations (2)
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1
Charité research organisation
Berlin, Germany
2
SCIderm and Clinical Trial Center North
Hamburg, Germany