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

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

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.

Study Overview

• Status: Terminated
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Other: Placebo; Drug: COVA322

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Charité Research Organisation
  • Hamburg, Germany
    • SCIderm and Clinical Trial Center North

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COVA322; single i.v. infusion	Drug: COVA322
Placebo Comparator: Placebo; single i.v. infusion	Other: Placebo

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Covagen
• Investigators: Principal Investigator: Kristian Reich, Prof. Dr. med, SCIderm GmbH

Publications and helpful links

General Publications

• Silacci M, Lembke W, Woods R, Attinger-Toller I, Baenziger-Tobler N, Batey S, Santimaria R, von der Bey U, Koenig-Friedrich S, Zha W, Schlereth B, Locher M, Bertschinger J, Grabulovski D. Discovery and characterization of COVA322, a clinical-stage bispecific TNF/IL-17A inhibitor for the treatment of inflammatory diseases. MAbs. 2016;8(1):141-9. doi: 10.1080/19420862.2015.1093266. Epub 2015 Sep 22.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: September 9, 2014
• First Submitted That Met QC Criteria: September 16, 2014
• First Posted (Estimate): September 18, 2014

Study Record Updates

• Last Update Posted (Estimate): March 1, 2016
• Last Update Submitted That Met QC Criteria: February 29, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: COVA322-SAD-Psoriasis-001