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

Covagen

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Plaque Psoriasis

Treatments

Other: Placebo

Drug: COVA322

Study type

Interventional

Funder types

Industry

Identifiers

NCT02243787

COVA322-SAD-Psoriasis-001

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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)