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

NCT ID: NCT02243787

Last Updated: 2016-03-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30

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.

Conditions

Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

COVA322

single i.v. infusion

Group Type: EXPERIMENTAL

COVA322

Intervention Type: DRUG

Placebo

single i.v. infusion

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Interventions

COVA322

Intervention Type: DRUG

Placebo

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Covagen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristian Reich, Prof. Dr. med

Role: PRINCIPAL_INVESTIGATOR

Sciderm GmbH

Locations

Charité research organisation

Berlin, , Germany

SCIderm and Clinical Trial Center North

Hamburg, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 26390837 (View on PubMed)

Other Identifiers

COVA322-SAD-Psoriasis-001

Identifier Type: -

Identifier Source: org_study_id