Title
Safety and Tolerability Study of COVA322 in Patients With Stable Chronic Moderate-to-severe Plaque Psoriasis
A Randomised, Double-blind, Sequential, Ascending Single-dose Study to Evaluate Safety, Tolerability, Biological Activity, and Systemic Exposure of COVA322, a Bispecific TNF-α / IL-17A Antibody Fusion Protein, in Patients With Stable Chronic Moderate-to-severe Plaque Psoriasis
Phase
Phase 1/Phase 2Lead Sponsor
CovagenStudy Type
InterventionalStatus
TerminatedIndication/Condition
Plaque PsoriasisIntervention/Treatment
jnj-61178104 ...Study Participants
24This 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.
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)
