Plaque Psoriasis
Conditions
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 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.
Interventions
DRUGCOVA322
OTHERPlacebo
Sponsors
Covagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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 * Physicians 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Adverse Events as a Measure of Safety and Tolerability | Up to 12 weeks | The safety and tolerability of COVA322 will be assessed by monitoring the occurrence of local and systemic adverse events or abnormalities as identified by physical examinations, safety lab, vital parameters, ECG and immune response/antibodies to COVA322. |
Countries
Germany
Outcome results
None listed