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

Primary Purpose

Plaque Psoriasis

Status

Terminated

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

COVA322

Placebo

About this trial

This is an interventional treatment trial for Plaque Psoriasis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Charité research organisation
SCIderm and Clinical Trial Center North

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

COVA322

Placebo

Arm Description

single i.v. infusion

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02243787

First Posted

September 9, 2014

Last Updated

February 29, 2016

Sponsor

Covagen

1. Study Identification

Unique Protocol Identification Number

NCT02243787

Brief Title

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

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Terminated

Why Stopped

Based on the observed safety profile of COVA322, the sponsor decided to stop the clinical study.

Study Start Date

April 2014 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Covagen

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Plaque Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

COVA322

Arm Type

Experimental

Arm Description

single i.v. infusion

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

single i.v. infusion

Intervention Type

Drug

Intervention Name(s)

COVA322

Intervention Type

Other

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Occurrence of Adverse Events as a Measure of Safety and Tolerability

Description

Time Frame

Up to 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kristian Reich, Prof. Dr. med

Organizational Affiliation

Sciderm GmbH

Official's Role

Principal Investigator

Facility Information:

Facility Name

Charité research organisation

City

Berlin

Country

Germany

Facility Name

SCIderm and Clinical Trial Center North

City

Hamburg

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

26390837

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.

Results Reference

derived

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

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