Apremilast in Palmo-Plantar Psoriasis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02400749
• Date of registration: 24/03/2015
• Prospective Registration: Yes
• Primary sponsor: Innovaderm Research Inc.
• Public title: Apremilast in Palmo-Plantar Psoriasis
• Scientific 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
• Date of first enrolment: May 2015
• Target sample size: 100
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02400749
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Canada, United States

Contacts

• Name: Robert Bissonnette, MD, FRCPC
• Affiliation: Innovaderm Research Inc.

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Palmo-plantar Psoriasis

Intervention(s)

Drug: Apremilast

Drug: Placebo

Primary Outcome(s)

Palmoplantar Psoriasis Physician Global Assessment (PPPGA) of 0 or 1 [Time Frame: 16 weeks]

Secondary Outcome(s)

Palmoplantar Psoriasis Area Severity Index (PPPASI) [Time Frame: 16 weeks]

Palmoplantar Psoriasis Area Severity Index (PPPASI) [Time Frame: 32 weeks]

Palmoplantar Psoriasis Surface Area (PPPSA) [Time Frame: 16 weeks]

Palmoplantar Pustulosis Physician Global Assessment (PPPGA) of 0 or 1 [Time Frame: 32 weeks]

Palmoplantar Psoriasis Physician Global Assessment (PPPGA) [Time Frame: 16 weeks]

Secondary ID(s)

AP-CL-PSOR-CARE-005313

Inno-6040

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Celgene

Results

• Results available: Yes
• Date Posted: 24/10/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02400749