Safety and Tolerability Study of COVA322 in Patients With Stable Chronic Moderate-to-severe Plaque Psoriasis

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 COVA322 (tumor necrosis factor alpha (TNF-α) / interleukin 17 A (IL-17A) antibody fusion protein) in patients with stable chronic moderate-to-severe plaque psoriasis. Patients will receive ascending single-doses of COVA322 or placebo as a constant-rate i.v. infusion, followed by 12 weeks of evaluation.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Covagen

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)