An Efficacy and Safety Study of LYC-30937-EC in Subjects With Moderate Chronic Plaque-type Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Drug: LYC-30937-EC; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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.