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

NCT02243787 | Terminated Phase 1 DMC

• 1 other identifier: COVA322-SAD-Psoriasis-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

COVA322

EXPERIMENTAL

single i.v. infusion

Drug: COVA322

Placebo

PLACEBO COMPARATOR

single i.v. infusion

Other: Placebo

Interventions

COVA322 DRUG

COVA322

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Covagen: lead

Study Sites (2)

Charité research organisation

Berlin, Germany

Location

SCIderm and Clinical Trial Center North

Hamburg, Germany

Location

Related Publications (1)

• 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.

  PMID: 26390837 DERIVED

Study Officials

• Kristian Reich, Prof. Dr. med

  Sciderm GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2014
• First Posted: September 18, 2014
• Study Start: April 1, 2014
• Primary Completion: September 1, 2015
• Last Updated: March 1, 2016

Record last verified: 2016-02

Locations

DE (2)