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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

100

participants targeted

Target at P50-P75 for phase_4

Timeline

Completed

Started May 2015

Geographic Reach

2 countries

11 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.5 years study duration

First Submitted

Initial submission to the registry

March 24, 2015

Completed

3 days until next milestone

First Posted

Study publicly available on registry

March 27, 2015

Completed

1 month until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed

2 years until next milestone

Results Posted

Study results publicly available

October 24, 2018

Completed

Last Updated

November 20, 2018

Status Verified

October 1, 2018

Enrollment Period

1.3 years

First QC Date

March 24, 2015

Results QC Date

May 17, 2018

Last Update Submit

October 23, 2018

Conditions

Palmo-plantar Psoriasis

Keywords

moderate to severe non-pustular palmo-plantar psoriasis

Outcome Measures

Primary Outcomes (1)

Palmoplantar Psoriasis Physician Global Assessment (PPPGA) of 0 or 1
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 \[Very severe\]).
16 weeks

Secondary Outcomes (5)

Palmoplantar Psoriasis Physician Global Assessment (PPPGA)
16 weeks
Palmoplantar Psoriasis Area Severity Index (PPPASI)
16 weeks
Palmoplantar Psoriasis Surface Area (PPPSA)
16 weeks
Palmoplantar Psoriasis Area Severity Index (PPPASI)
32 weeks
Palmoplantar Pustulosis Physician Global Assessment (PPPGA) of 0 or 1
32 weeks

Study Arms (2)

Apremilast

EXPERIMENTAL

Patients will receive Apremilast until week 32.

Drug: Apremilast

Placebo followed by Apremilast

PLACEBO COMPARATOR

Patients will receive Placebo until week 16 and then receive Apremilast until week 32

Drug: ApremilastDrug: Placebo

Interventions

ApremilastDRUG

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.

Also known as: OTEZLA

ApremilastPlacebo followed by Apremilast

PlaceboDRUG

Placebo tablets will be provided to sites in blister cards.

Placebo followed by Apremilast

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patient, male or female, is aged 18 years or older at the screening visit.
Patient has a history of plaque psoriasis involving the palm(s) and/or sole(s) for at least 6 month(s).
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.

You may not qualify if:

Female patient is pregnant or breastfeeding
Patient has the presence of pustules on palms or soles at screening or baseline
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.
Patient who has used ultraviolet B (UVB) phototherapy or excessive sun exposure less than 28 days before Day 0.
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.
Use of any investigational agents within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
Prior treatment with apremilast
Patient is currently participating in a clinical trial with an experimental agent or device.
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.
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.
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.
Active tuberculosis or history of inadequately treated tuberculosis
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.
Other than psoriasis, patient has any other dermatological condition that could, in the opinion of the investigator, interfere with the study assessments.
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.
+9 more criteria

Contact the study team to confirm eligibility.