Safety and Tolerability Study of COVA322 in Patients With Stable Chronic Moderate-to-severe Plaque Psoriasis
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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
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Condition or disease | Intervention/treatment | Phase |
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Plaque Psoriasis | Drug: COVA322 Other: Placebo | Phase 1 Phase 2 |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: COVA322
single i.v. infusion
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Drug: COVA322 |
Placebo Comparator: Placebo
single i.v. infusion
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Other: Placebo |
- 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.

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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 |
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)

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
Germany | |
Charité research organisation | |
Berlin, Germany | |
SCIderm and Clinical Trial Center North | |
Hamburg, Germany |
Principal Investigator: | Kristian Reich, Prof. Dr. med | Sciderm GmbH |
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 |
Psoriasis Skin Diseases, Papulosquamous Skin Diseases |