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

Plaque Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02243787
• Other study ID #: COVA322-SAD-Psoriasis-001
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: September 9, 2014
• Last updated: February 29, 2016
• Start date: April 2014

Study information

• Verified date: February 2016
• Source: Covagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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-a 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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• COVA322

Other:
• Placebo

Locations

Country	Name	City	State
Germany	Charité research organisation	Berlin
Germany	SCIderm and Clinical Trial Center North	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Covagen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No