Safety and Tolerability Study of COVA322 in Patients With Stable Chronic Moderate-to-severe Plaqu… (NCT02243787) | Clinical Trial Compass
TerminatedPhase 1/2
Safety and Tolerability Study of COVA322 in Patients With Stable Chronic Moderate-to-severe Plaque Psoriasis
Stopped: Based on the observed safety profile of COVA322, the sponsor decided to stop the clinical study.
Germany24 participantsStarted 2014-04
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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, i…
What they're measuring
1
Occurrence of Adverse Events as a Measure of Safety and Tolerability