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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: COVA322
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COVA322<br>single i.v. infusion | Drug: COVA322<br> <br> |
| Placebo Comparator: Placebo<br>single i.v. infusion | Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Adverse Events as a Measure of Safety and Tolerability | 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. | Up to 12 weeks |