Clinical trial NCT02243787: Safety and Tolerability Study of COVA322 in Patients With Stable Chronic Moderate-to-severe Plaque Psoriasis
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Plaque Psoriasis
Lead sponsor: Covagen
Sponsor class: INDUSTRY
First posted: 2014-09-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Occurrence of Adverse Events as a Measure of Safety and Tolerability
timeFrame: Up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité research organisation
city: Hamburg
country: Germany
facility: SCIderm and Clinical Trial Center North
Study officials:
affiliation: Sciderm GmbH
name: Kristian Reich, Prof. Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.