Apremilast in Palmo-Plantar Psoriasis

Launched by INNOVADERM RESEARCH INC. · Mar 26, 2015

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient, male or female, is aged 18 years or older at the screening visit.
• • 2. Patient has a history of plaque psoriasis involving the palm(s) and/or sole(s) for at least 6 month(s).
• • 3. Patient has moderate to severe psoriasis with a PPPGA of at least 3 and with at least 10% of the total surface of palms and soles (PPPSA) affected by psoriatic plaques at baseline.
• Exclusion Criteria:
• • 1. Female patient is pregnant or breastfeeding
• • 2. Patient has the presence of pustules on palms or soles at screening or baseline
• • 3. Patient who has used any topical treatment for psoriasis (except non-medicated emollients) in the last 14 days before Day 0 with the exception of hydrocortisone and desonide for the face, groin (including genitals) and inframammary areas as well as shampoos containing tar, salicylic acid or zinc pyrithione if they are applied with gloves.
• • 4. Patient who has used ultraviolet B (UVB) phototherapy or excessive sun exposure less than 28 days before Day 0.
• • 5. Patient has used any non-biological systemic therapy for the treatment of psoriasis (including psoralens ultraviolet A (PUVA)) therapy, methotrexate, acitretin and cyclosporin), systemic steroids or systemic immunosuppressants less than 28 days before Day 0.
• • 6. Use of any investigational agents within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
• • 7. Prior treatment with apremilast
• • 8. Patient is currently participating in a clinical trial with an experimental agent or device.
• • 9. Patient is using or has used any biological therapy for the treatment of psoriasis. Exceptions to this criterion are: patients who used no more than one biologic in the past and stopped for reasons other than lack of efficacy are eligible.
• • 10. Patient is taking or requires oral or injectable corticosteroids during the study. Inhaled corticosteroids for stable medical conditions are allowed. Patients who have used oral or injectable corticosteroids less than 28 days before Day 0 are excluded.
• • 11. Patient is known to have immune deficiency or is immunocompromised or currently uses or plans to use anti-retroviral therapy at any time during the study.
• • 12. Active tuberculosis or history of inadequately treated tuberculosis
• • 13. Other than psoriasis, patient has any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is currently uncontrolled.
• • 14. Other than psoriasis, patient has any other dermatological condition that could, in the opinion of the investigator, interfere with the study assessments.
• • 15. Any condition, including the presence of laboratory abnormalities (including estimated creatinine clearance of less than 30 mL per minute), which would place the patient at unacceptable risk if he/she were to participate in the study.
• 16. Malignancy or history of malignancy, except for:
• • treated \[ie, cured\] basal cell or squamous cell in situ skin carcinomas;
• • treated \[ie, cured\] malignancy with no evidence of recurrence within the previous 5 years.
• • 17. Known hypersensitivity to apremilast or any excipients in formulation.
• • 18. Patient has the following hereditary disease: galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
• • 19. Use of strong cytochrome P450 enzyme inducers (e.g. rifampin, phenobarbital, carbamazepine, phenytoin)
• • 20. Active substance abuse or a history of substance abuse within 6 months prior to Screening.
• • 21. Prior history of suicide attempt at any time in the patient's life time prior to screening or randomization, or major psychiatric illness requiring hospitalization within the last 3 years.
• • 22. Presence of uncontrolled depression.