CompletedNCT02400749Updated Nov 20, 2018Results posted

Apremilast in Palmo-Plantar Psoriasis

A Phase 4 interventional study of Apremilast and Placebo in Palmo-plantar Psoriasis, sponsored by Innovaderm Research Inc.. Completed at 11 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-20.

Sponsored by Innovaderm Research Inc. · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 100
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Palmo-plantar Psoriasis

Browse trials for

Psoriasis 1,899

Keywords

moderate to severe non-pustular palmo-plantar psoriasis

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 100 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Innovaderm Research Inc. is the lead sponsor of 34 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.
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.
Known hypersensitivity to apremilast or any excipients in formulation.
Patient has the following hereditary disease: galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
Use of strong cytochrome P450 enzyme inducers (e.g. rifampin, phenobarbital, carbamazepine, phenytoin)
Active substance abuse or a history of substance abuse within 6 months prior to Screening.
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.
Presence of uncontrolled depression.

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 100 participants (actual)

Study arms

Experimental
Apremilast
Patients will receive Apremilast until week 32.
Drug: Apremilast
Placebo comparator
Placebo followed by Apremilast
Patients will receive Placebo until week 16 and then receive Apremilast until week 32
Drug: Apremilast · Drug: Placebo

Interventions

DrugApremilast
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
DrugPlacebo
Placebo tablets will be provided to sites in blister cards.

What researchers measure

Primary outcomes

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 \[Very severe\]).
Time frame: 16 weeks

Secondary outcomes

Palmoplantar Psoriasis Physician Global Assessment (PPPGA)
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 \[Very severe\]).
Time frame: 16 weeks
Palmoplantar Psoriasis Area Severity Index (PPPASI)
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)
Time frame: 16 weeks
Palmoplantar Psoriasis Surface Area (PPPSA)
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).
Time frame: 16 weeks
Palmoplantar Psoriasis Area Severity Index (PPPASI)
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)
Time frame: 32 weeks
Palmoplantar Pustulosis Physician Global Assessment (PPPGA) of 0 or 1
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 \[Very severe\]).
Time frame: 32 weeks

Results

Posted Oct 24, 2018

Limitations and caveats

Clinical evaluations of psoriasis on palms and soles are not easy to perform. This is especially difficult for soles where frictional hyperkeratosis and physiological erythema is often difficult to differentiate form psoriasis.

Participant flow

Week 0 -16

Participant flow — Week 0 -16
Milestone	Apremilast	Placebo Followed by Apremilast
Started	50	50
Completed	39	44
Not completed	11	6
Withdrew: Withdrawal by subject	5	5
Withdrew: Adverse event	3	1
Withdrew: Lost to follow-up	2	0
Withdrew: Protocol violation	1	0

Week 17 - 32

Participant flow — Week 17 - 32
Milestone	Apremilast	Placebo Followed by Apremilast
Started	39	44
Completed	34	41
Not completed	5	3
Withdrew: Withdrawal by subject	3	2
Withdrew: Adverse event	2	1

Outcome measures

PrimaryPalmoplantar 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 \[Very severe\]).

Time frame:: 16 weeks
Reported as:: Count of participants · Participants

Palmoplantar Psoriasis Physician Global Assessment (PPPGA) of 0 or 1
Participants	Apremilast	Placebo Followed by Apremilast
Palmoplantar Psoriasis Physician Global Assessment (PPPGA) of 0 or 1	7	2

SecondaryPalmoplantar Psoriasis Physician Global Assessment (PPPGA)

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 \[Very severe\]).

Time frame:: 16 weeks
Reported as:: Mean · units on a scale

Palmoplantar Psoriasis Physician Global Assessment (PPPGA)
units on a scale	Apremilast	Placebo Followed by Apremilast
Palmoplantar Psoriasis Physician Global Assessment (PPPGA)	-0.8 ± 1.0	-0.4 ± 0.8

SecondaryPalmoplantar Psoriasis Area Severity Index (PPPASI)

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)

Time frame:: 16 weeks
Reported as:: Mean · units on a scale

Palmoplantar Psoriasis Area Severity Index (PPPASI)
units on a scale	Apremilast	Placebo Followed by Apremilast
Palmoplantar Psoriasis Area Severity Index (PPPASI)	-7.4 ± 7.1	-3.6 ± 5.9

SecondaryPalmoplantar Psoriasis Surface Area (PPPSA)

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).

Time frame:: 16 weeks
Reported as:: Mean · units on a scale

Palmoplantar Psoriasis Surface Area (PPPSA)
units on a scale	Apremilast	Placebo Followed by Apremilast
Palmoplantar Psoriasis Surface Area (PPPSA)	-0.1 ± 0.1	0.0 ± 0.2

SecondaryPalmoplantar Psoriasis Area Severity Index (PPPASI)

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)

Time frame:: 32 weeks
Reported as:: Mean · units on a scale

Palmoplantar Psoriasis Area Severity Index (PPPASI)
units on a scale	Apremilast
Palmoplantar Psoriasis Area Severity Index (PPPASI)	-11.3 (-14.1 to -8.5)

SecondaryPalmoplantar Pustulosis Physician Global Assessment (PPPGA) of 0 or 1

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 \[Very severe\]).

Time frame:: 32 weeks
Reported as:: Count of participants · Participants

Palmoplantar Pustulosis Physician Global Assessment (PPPGA) of 0 or 1
Participants	Apremilast
Palmoplantar Pustulosis Physician Global Assessment (PPPGA) of 0 or 1	12

Adverse events

Collected over After the first study drug administration and until the end of study at Week 32.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Apremilast	—	3/50 (6%)	27/50 (54%)
Placebo Followed by Apremilast	—	2/50 (4%)	29/50 (58%)

Most frequent serious events

Most frequent serious events
Event	Apremilast	Placebo Followed by Apremilast
myocardial infarctionCardiac disorders	2/50	0/50
breast cancer requiring hospitalization for bilateral mastectomyNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/50	1/50
E. coli bacteremia, C-difficile + hypokalemia requiring hospitalizationInfections and infestations	1/50	0/50
carbon monoxide poisoningInjury, poisoning and procedural complications	1/50	0/50
cholecystitis infectiveInfections and infestations	0/50	1/50

Most frequent other events

Most frequent other events
Event	Apremilast	Placebo Followed by Apremilast
DiarrhoeaGastrointestinal disorders	9/50	9/50
HeadacheNervous system disorders	8/50	7/50
NauseaGastrointestinal disorders	6/50	6/50
Upper respiratory tract infectionInfections and infestations	4/50	6/50
Decreased appetiteMetabolism and nutrition disorders	4/50	0/50
Back painMusculoskeletal and connective tissue disorders	3/50	4/50
Frequent bowel movementsGastrointestinal disorders	3/50	1/50
FatigueGeneral disorders	3/50	2/50
BronchitisInfections and infestations	3/50	0/50

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Apremilast	Placebo Followed by Apremilast	Total
Mean	56.6 ± 8.6	53.6 ± 13.5	55.1 ± 11.5

Sex: Female, Male
Sex: Female, Male(Participants)	Apremilast	Placebo Followed by Apremilast	Total
Female	30	29	59
Male	20	21	41

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Apremilast	Placebo Followed by Apremilast	Total
Asian	3	3	6
Black	1	0	1
Caucasian	45	47	92
Other	1	0	1

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Apremilast	Placebo Followed by Apremilast	Total
Not Hispanic or Latino	50	50	100

Smoking Status
Smoking Status(Participants)	Apremilast	Placebo Followed by Apremilast	Total
Never	12	19	31
Past	18	18	36
Present	20	13	33

Weight
Weight(kg)	Apremilast	Placebo Followed by Apremilast	Total
Mean	86.9 ± 17.1	88.3 ± 19.8	87.6 ± 18.4

BMI
BMI(kg/m^2)	Apremilast	Placebo Followed by Apremilast	Total
Mean	31.1 ± 5.5	31.0 ± 6.6	31.0 ± 6.0

Palmoplantar Psoriasis Physician Global Assessment (PPPGA)
Palmoplantar Psoriasis Physician Global Assessment (PPPGA)(Participants)	Apremilast	Placebo Followed by Apremilast	Total
Score 3	30	32	62
Score 4	19	16	35
Score 5	1	2	3

3 further baseline measures are reported on the registry.

Study locations

11 sites

Innovaderm Investigational Site
Arlington Heights, Illinois, United States
Innovaderm Investigational Site
Calgary, Alberta, Canada
Innovaderm Investigational Site
Saint John's, Newfoundland and Labrador, Canada
Innovaderm Investigational Site
Barrie, Ontario, Canada
Innovaderm Investigational Site
Markham, Ontario, Canada
Innovaderm Investigational Site
North Bay, Ontario, Canada
Innovaderm Investigational Site
Peterborough, Ontario, Canada
Innovaderm Investigational Site
Drummondville, Quebec, Canada
Innovaderm Investigational Site
Montreal, Quebec, Canada
Innovaderm Investigational Site
Saint-Jerome, Quebec, Canada
Innovaderm Investigational Site
Québec, Canada

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02400749
Lead sponsor: Innovaderm Research Inc.
Collaborators: Celgene
Responsible party: Sponsor
First posted: Mar 27, 2015
Start date: May 2015
Primary completion: Sep 2016
Completion: Nov 2016
Results posted: Oct 24, 2018
Last update: Nov 20, 2018

Study contacts

Robert Bissonnette, MD, FRCPC

principal investigator · Innovaderm Research Inc.

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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