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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02243787
Recruitment Status : Terminated (Based on the observed safety profile of COVA322, the sponsor decided to stop the clinical study.)
First Posted : September 18, 2014
Last Update Posted : March 1, 2016
Sponsor:
Information provided by (Responsible Party):
Covagen

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.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: COVA322 Other: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : April 2014
Actual Primary Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: COVA322
single i.v. infusion
Drug: COVA322
Placebo Comparator: Placebo
single i.v. infusion
Other: Placebo



Primary Outcome Measures :
  1. Occurrence of Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to 12 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02243787


Locations
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Germany
Charité research organisation
Berlin, Germany
SCIderm and Clinical Trial Center North
Hamburg, Germany
Sponsors and Collaborators
Covagen
Investigators
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Principal Investigator: Kristian Reich, Prof. Dr. med Sciderm GmbH

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Covagen
ClinicalTrials.gov Identifier: NCT02243787    
Other Study ID Numbers: COVA322-SAD-Psoriasis-001
First Posted: September 18, 2014    Key Record Dates
Last Update Posted: March 1, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases