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About
The objective of this Phase 2 trial is to determine the efficacy and safety of LYC-30937-EC in patients with moderate plaque-type psoriasis.
Full description
Approximately 30 subjects will be enrolled in this double-blind, placebo-controlled study. The randomization will be stratified 2:1 into the LYC-30937-EC cohort (2) or the placebo cohort (1). The active cohort will receive LYC-30937-EC 25 mg once daily, which demonstrated safety and tolerability in Phase I trials.
The study is designed for patients with previously diagnosed moderate chronic plaque-type psoriasis and consists of the following:
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Non-plaque-type psoriasis (eg, pustular, erythrodermic, and guttate psoriasis).
Drug-induced psoriasis (ie, new onset or current exacerbation from beta-blockers, calcium channel blockers, or lithium).
Spontaneously improving or rapidly deteriorating plaque psoriasis.
Comorbid psoriatic arthritis that is not amenable to treatment with NSAIDs.
Treatment with a biologic agent for psoriasis.
Failed 2 or more systemic treatments for plaque psoriasis.
Received phototherapy or prolonged sun exposure or use of tanning booth or other ultraviolet light source within 4 weeks of initiating screening procedures.
Received systemic drug therapy (non-biologic) for plaque psoriasis or any systemic medication that could affect psoriasis or its evaluation (PASI or IGA), including but not limited to oral or injectable corticosteroids, retinoids, sulfasalazine, within 4 weeks of initiating screening procedures.
Received topical medication that could affect psoriasis or its evaluation (PASI or IGA), including but not limited to corticosteroids, retinoids, topical vitamin D derivatives, pimecrolimus, tacrolimus, calcipotriene, within 2 weeks of initiating screening procedures.
Received immunosuppressant agents (eg, cyclosporine, azathioprine, methotrexate) within 8 weeks of initiating screening procedures.
Any of the following laboratory abnormalities:
Clinically relevant hepatic, neurological, pulmonary, dermatological, ophthalmological, gastrointestinal, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the subject at risk by participating in the study.
History of or currently active primary or secondary immunodeficiency.
Treatment with an investigational agent within 30 days prior to initiating screening procedures.
Primary purpose
Allocation
Interventional model
Masking
33 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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