An Efficacy and Safety Study of LYC-30937-EC in Subjects With Moderate Chronic Plaque-type Psoriasis

A Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of LYC-30937-EC in Subjects With Moderate Chronic Plaque-Type Psoriasis

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.

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:

• Screening period (initials assessment and eligibility scoring)
• Day 1: confirm eligibility, baseline efficacy assessments (PASI, IGA), randomize and initiate dosing
• Week 2: safety assessments including vital signs, body temperature, physical exam, clinical labs will be performed
• Week 4: efficacy (PASI, IGA) and safety assessments including vital signs, body temperature, physical exam, and clinical labs will be performed
• Week 8: efficacy (PASI, IGA) and safety assessments including vital signs, body temperature, physical exam, and clinical labs will be performed
• Week 12: final efficacy assessments (PASI, IGA), safety assessments including vital signs, body temperature, physical exam, ECG, and clinical labs will be performed
• Week 14: final safety assessments including vital signs, body temperature, and clinical labs

Inclusion Criteria:

• Have a diagnosis of plaque-type psoriasis for at least 6 months prior to screening.
• Must have chronic moderate plaque-type psoriasis confirmed at both screening and baseline visits. Moderate plaque-type psoriasis is defined as a PASI > 7, with body surface area (BSA) involvement 5-15% inclusive and overall lesion severity of "moderate" or "marked, " where "moderate" = plaque elevation (0.75mm), moderate red coloration, coarse scale predominates; "marked" = moderate plaque elevation (1.0mm), bright red coloration, and thick, non-tenacious scale predominates.
• Female subjects of childbearing potential must agree to use two highly effective forms of contraception during study participation and for 30 days after their last dose of treatment of study drug treatment.
• Male subjects with partners of childbearing potential must take appropriate precautions to avoid fathering a child while participating in the study and use appropriate barrier contraception or abstinence during the study and for 30 days after their last dose of study drug.
• Agree to avoid prolonged sun exposure and avoid tanning booths or ultraviolet (UV) light sources during the study.
• Ability to provide written informed consent and to be compliant with the schedule of events.

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:

  1. liver function tests > 1.5 x the upper limit of normal (ULN) or direct bilirubin > 1.5 x ULN
  2. hemoglobin < 8.5 g/dl (international system units [SI]: < 85 g/L)
  3. neutrophils < 1500/mm3 (SI: < 1.5 x 109/L)
  4. white blood cell (WBC) count < 3,000/mm3 (SI: < 3.0 x 109/L)
  5. platelets < 80,000 mm3 (SI: 80 x 109/L)
  6. international normalized ratio (INR) > 1.5
  7. serum creatinine > 1.4 mg/dL for women or > 1.6 mg/dL for men

• 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.