Clinical trial NCT02400749: Apremilast in Palmo-Plantar Psoriasis
Official title: A Double-blind, Placebo-controlled, Randomized Study on the Safety and Efficacy of Apremilast in Patients With Moderate to Severe Plaque Psoriasis Involving Palms and/or Soles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Palmo-plantar Psoriasis
Keywords: moderate to severe non-pustular palmo-plantar psoriasis
Lead sponsor: Innovaderm Research Inc.
Sponsor class: OTHER
Collaborators: name: Celgene
First posted: 2015-03-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare the safety and efficacy of Apremilast 30mg to placebo in subjects with moderate to severe plaque psoriasis involving palms and/or soles.

Apremilast will be administered orally twice daily for 16 to 32 weeks, and will be compared against placebo (dummy drug with no active ingredient).

This study will enroll approximately 100 adult subjects with moderate to severe plaque psoriasis involving palms and/or soles in approximately 20 centers in US and Canada. To be eligible, subjects must have moderate to severe plaque psoriasis involving palms or soles, with lesions covering at least 10% of the surface of palms and soles at the baseline visit. Study treatments will be assigned randomly (like flipping a coin) at a 1:1 ratio, meaning that there will be a 1 in 2 chance of either receiving Apremilast or placebo during the first 16 weeks. Subjects will not know which of the two treatments they receive. The study doctor, the study staff will not know which treatment they receive either. All subjects will receive Apremilast from Week 16 to Week 32.

Subjects will be asked to complete questionnaires about their hand and feet pain, their quality of life, their general health and the impact of psoriasis on their work.

Medical photographs of palms and soles will be taken for subjects at selected study sites only.

At Baseline and Week 16 visits, for willing subjects at certain study sites, skin biopsies can be taken. The biopsies will be analyzed for the presence of antibodies, antigens or certain cellular messengers that can be quantified. It is also possible to study the skin cellular structure and organization.

A total of 3 biopsies will be taken: At Baseline visit, one biopsy from psoriasis on palms or soles and one biopsy from normal skin of palms or soles will be collected. At Week 16 visit, only one biopsy from psoriasis on palms or soles will be collected.


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.

Primary outcomes:
measure: Palmoplantar Psoriasis Physician Global Assessment (PPPGA) of 0 or 1
timeFrame: 16 weeks
Secondary outcomes:
measure: Palmoplantar Psoriasis Physician Global Assessment (PPPGA)
timeFrame: 16 weeks
measure: Palmoplantar Psoriasis Area Severity Index (PPPASI)
timeFrame: 16 weeks
measure: Palmoplantar Psoriasis Surface Area (PPPSA)
timeFrame: 16 weeks
measure: Palmoplantar Psoriasis Area Severity Index (PPPASI)
timeFrame: 32 weeks
measure: Palmoplantar Pustulosis Physician Global Assessment (PPPGA) of 0 or 1
timeFrame: 32 weeks
Other outcomes:
Locations:
city: Arlington Heights
country: United States
facility: Innovaderm Investigational Site
state: Illinois
city: Calgary
country: Canada
facility: Innovaderm Investigational Site
state: Alberta
city: Saint John's
country: Canada
facility: Innovaderm Investigational Site
state: Newfoundland and Labrador
city: Barrie
country: Canada
facility: Innovaderm Investigational Site
state: Ontario
city: Markham
country: Canada
facility: Innovaderm Investigational Site
state: Ontario
city: North Bay
country: Canada
facility: Innovaderm Investigational Site
state: Ontario
city: Peterborough
country: Canada
facility: Innovaderm Investigational Site
state: Ontario
city: Drummondville
country: Canada
facility: Innovaderm Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Innovaderm Investigational Site
state: Quebec
city: Saint-Jerome
country: Canada
facility: Innovaderm Investigational Site
state: Quebec
city: Québec
country: Canada
facility: Innovaderm Investigational Site
Study officials:
affiliation: Innovaderm Research Inc.
name: Robert Bissonnette, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: