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

Phase 1

Terminated

• Conditions: Plaque Psoriasis
• Interventions: Other: Placebo; Drug: COVA322

• Registration Number: NCT02243787
• Lead Sponsor: Covagen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-09-09
• Study First Submitted QC: 2014-09-16
• Study First Posted: 2014-09-18
• Primary Completion: 2015-09
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-29
• Last Update Posted: 2016-03-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	single i.v. infusion
COVA322	COVA322	single i.v. infusion

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

SCIderm and Clinical Trial Center North; 🇩🇪 Hamburg, Germany

Charité research organisation; 🇩🇪 Berlin, Germany