Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Apremilast in Palmo-Plantar Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02400749
Recruitment Status : Completed
First Posted : March 27, 2015
Results First Posted : October 24, 2018
Last Update Posted : November 20, 2018
Sponsor:
Collaborator:
Celgene
Information provided by (Responsible Party):
Innovaderm Research Inc.

Tracking Information
First Submitted Date  ICMJE March 24, 2015
First Posted Date  ICMJE March 27, 2015
Results First Submitted Date  ICMJE May 17, 2018
Results First Posted Date  ICMJE October 24, 2018
Last Update Posted Date November 20, 2018
Study Start Date  ICMJE May 2015
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2018)
Palmoplantar Psoriasis Physician Global Assessment (PPPGA) of 0 or 1 [ Time Frame: 16 weeks ]
Number of patients who achieve a PPPGA of 0 or 1 at Week 16 for patients randomized to apremilast as compared to patients randomized to placebo The PPPGA is a zero to five, 6-point scale that evaluates the severity of palmoplantar psoriasis (score 0 [Clear]; score 1 [Almost clear]; score 2 [Mild]; score 3 [Moderate]; score 4 [Severe]; score 5 [Very severe]).
Original Primary Outcome Measures  ICMJE
 (submitted: March 26, 2015)
PPPGA of 0 or 1 [ Time Frame: 16 weeks ]
Proportion of patients who achieve a PPPGA of 0 or 1 at week 16 for patients randomized to apremilast as compared to patients randomized to placebo
Change History Complete list of historical versions of study NCT02400749 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2018)
  • Palmoplantar Psoriasis Physician Global Assessment (PPPGA) [ Time Frame: 16 weeks ]
    Change from baseline in mean PPPGA at Week 16 for patients randomized to apremilast as compared to patients randomized to placebo The PPPGA is a zero to five, 6-point scale that evaluates the severity of palmoplantar psoriasis (score 0 [Clear]; score 1 [Almost clear]; score 2 [Mild]; score 3 [Moderate]; score 4 [Severe]; score 5 [Very severe]).
  • Palmoplantar Psoriasis Area Severity Index (PPPASI) [ Time Frame: 16 weeks ]
    Change from baseline in PPPASI at Week 16 for patients randomized to apremilast as compared to patients randomized to placebo Palmoplantar psoriasis area severity index (PPPASI) is a scale that can vary from 0 to 72. Erythema (E), induration (I), and desquamation (D) are evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The combined score of each of these features, for the right (R) and left (L) palms and soles, gives a PPPASI score from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible). PPPASI = (E + I + D)Area X 0.2 (R palm) + (E + I + D) Area X 0.2 (L palm) + (E + I + D) Area X 0.3 (R sole) + (E + I + D) Area X 0.3 (L sole)
  • Palmoplantar Psoriasis Surface Area (PPPSA) [ Time Frame: 16 weeks ]
    Change from baseline in PPPSA at Week 16 for patients randomized to apremilast as compared to patients randomized to placebo The surface affected by psoriasis on palms and soles is estimated as a percentage of the total surface of palms and soles. Each palm represents 20% and each sole 30%. PPPSA values range from 0% (no psoriasis on palms and soles) to 100% (all palms and soles covered by psoriasis).
  • Palmoplantar Psoriasis Area Severity Index (PPPASI) [ Time Frame: 32 weeks ]
    Change from baseline in PPPASI at Week 32 for patients randomized to apremilast Palmoplantar psoriasis area severity index (PPPASI) is a scale that can vary from 0 to 72. Erythema (E), induration (I), and desquamation (D) are evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The combined score of each of these features, for the right (R) and left (L) palms and soles, gives a PPPASI score from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible). PPPASI = (E + I + D)Area X 0.2 (R palm) + (E + I + D) Area X 0.2 (L palm) + (E + I + D) Area X 0.3 (R sole) + (E + I + D) Area X 0.3 (L sole)
  • Palmoplantar Pustulosis Physician Global Assessment (PPPGA) of 0 or 1 [ Time Frame: 32 weeks ]
    Number of patients who achieve a PPPGA of 0 or 1 at Week 32 for patients randomized to apremilast The PPPGA is a zero to five, 6-point scale that evaluates the severity of palmoplantar psoriasis (score 0 [Clear]; score 1 [Almost clear]; score 2 [Mild]; score 3 [Moderate]; score 4 [Severe]; score 5 [Very severe]).
Original Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2015)
  • PPPGA [ Time Frame: 16, 32 weeks ]
    Change from baseline in mean PPPGA at weeks 16 and 32 for patients randomized to apremilast as compared to patients randomized to placebo
  • PPPASI [ Time Frame: 16, 32 weeks ]
    Change from baseline in PPPASI at weeks 16 and 32 in patients randomized to apremilast as compared to patients randomized to placebo
  • PPPSA [ Time Frame: 16, 32 weeks ]
    Change from baseline in PPPSA at weeks 16 and 32 for patients randomized to apremilast as compared to patients randomized to placebo
  • Hand and Foot main measurement (VAS scale) [ Time Frame: 16 weeks ]
    Change from baseline in hand and feet pain as measured by Visual Analog Scale (VAS) at week 16 for patients randomized to apremilast as compared to patients randomized to placebo
  • PPPGA of 0 or 1 [ Time Frame: 32 weeks ]
    Proportion of patients who achieve a PPPGA of 0 or 1 at week 32 for patients randomized to apremilast
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: March 26, 2015)
  • SF-36 questionnaire [ Time Frame: 16. 32 weeks ]
    Change from baseline in SF-36 score at weeks 16 and 32 for patients randomized to apremilast as compared to patients randomized to placebo
  • DLQI questionnaire [ Time Frame: 16, 32 weeks ]
    Change from baseline in DLQI score at weeks 16 and 32 for patients randomized to apremilast as compared to patients randomized to placebo
  • WPAI-SHP [ Time Frame: 16, 32 weeks ]
    Change from baseline in WPAI-SHP at weeks 16 and 32 for patients randomized to apremilast as compared to patients randomized to placebo
  • PPPASI-50 [ Time Frame: 16 weeks ]
    Proportion of patients who achieve a PPPASI-50 at week 16 for patients randomized to apremilast as compared to patients randomized to placebo
  • PPPASI-75 [ Time Frame: 16 weeks ]
    Proportion of patients who achieve a PPPASI-75 at week 16 for patients randomized to apremilast as compared to patients randomized to placebo
  • Biomarkers [ Time Frame: 16 weeks ]
    Change from baseline in biomarkers in patients randomized to apremilast as compared to patients randomized to placebo
 
Descriptive Information
Brief Title  ICMJE Apremilast in Palmo-Plantar Psoriasis
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Palmo-plantar Psoriasis
Intervention  ICMJE
  • Drug: Apremilast

    Apremilast tablets will be provided to sites in blister cards.

    Patients will be provided a titration blister pack containing apremilast 10 mg, 20 mg and 30 mg at the Day 0 and week 16 visits (refer to section 6.1). Following the 6 day titration period (for Day 0 and week 16) blister packs will contain apremilast 30 mg bid or placebo bid.

    Other Name: OTEZLA
  • Drug: Placebo
    Placebo tablets will be provided to sites in blister cards.
Study Arms  ICMJE
  • Experimental: Apremilast
    Patients will receive Apremilast until week 32.
    Intervention: Drug: Apremilast
  • Placebo Comparator: Placebo followed by Apremilast
    Patients will receive Placebo until week 16 and then receive Apremilast until week 32
    Interventions:
    • Drug: Apremilast
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 26, 2015)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02400749
Other Study ID Numbers  ICMJE Inno-6040
AP-CL-PSOR-CARE-005313 ( Other Identifier: Celgene )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Innovaderm Research Inc.
Study Sponsor  ICMJE Innovaderm Research Inc.
Collaborators  ICMJE Celgene
Investigators  ICMJE
Principal Investigator: Robert Bissonnette, MD, FRCPC Innovaderm Research Inc.
PRS Account Innovaderm Research Inc.
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP