Palmo-plantar PsoriasisPhase 4NCT02400749

Apremilast in Palmo-Plantar Psoriasis

A Phase 4 study testing Apremilast in people with Palmo-plantar Psoriasis, run by Innovaderm Research Inc. at 11 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Palmo-plantar Psoriasis
What is being tested?: Apremilast
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: 11 sitesin 2 countries
Study dates: May 2015to Nov 2016
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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).

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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.

Trial locations and contacts

11 sites in 2 countries.

Country

City, postcode or hospital

11 sites in 2 countries

Canada10 sites

Innovaderm Investigational Site
Barrie, Ontario
Innovaderm Investigational Site
Calgary, Alberta
Innovaderm Investigational Site
Drummondville, Quebec
Innovaderm Investigational Site
Markham, Ontario
Innovaderm Investigational Site
Montreal, Quebec
Innovaderm Investigational Site
North Bay, Ontario
Innovaderm Investigational Site
Peterborough, Ontario
Innovaderm Investigational Site
Québec
Innovaderm Investigational Site
Saint-Jérôme, Quebec
Innovaderm Investigational Site
St. John's, Newfoundland and Labrador

Other trials in Canada

United States1 site

Innovaderm Investigational Site
Arlington Heights, Illinois

Other trials in United States

About this study

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

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: Palmo-plantar Psoriasis
Being tested: Apremilast, Placebo
Keywords: moderate to severe non-pustular palmo-plantar psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ApremilastDrug
Also called OTEZLA
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.
PlaceboDrug
Placebo tablets will be provided to sites in blister cards.

Study groups in NCT02400749
Study group	Role	What they receive
Apremilast	Experimental	Patients will receive Apremilast until week 32. Receives: Drug: Apremilast
Placebo followed by Apremilast	Placebo comparator	Patients will receive Placebo until week 16 and then receive Apremilast until week 32 Receives: Drug: Apremilast; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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]).
Measured: 16 weeks

Secondary outcomes (5)

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]).
Measured: 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)
Measured: 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).
Measured: 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)
Measured: 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]).
Measured: 32 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2015Nov 2016

First posted27 Mar 2015 (estimated)
Study startMay 2015
Primary completionSep 2016
Study completionNov 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Palmo-plantar PsoriasisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02400749
Sponsor's protocol ID: Inno-6040
Other IDs: AP-CL-PSOR-CARE-005313
Status last verified: Oct 2018
First submitted: 24 Mar 2015
Last updated: 20 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02400749
Acronym / sponsor ID: Inno-6040
Conditions: Palmo-plantar Psoriasis
Keywords: moderate to severe non-pustular palmo-plantar psoriasis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Innovaderm Research Inc.University, hospital or other
Collaborators: Celgene
Study start: May 2015
Primary completion: Sep 2016 (actual)
Study completion: Nov 2016 (actual)
First posted: 27 Mar 2015 (estimated)
Results: Posted 24 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Apremilast	Experimental	Drug: ApremilastPatients will receive Apremilast until week 32.
Placebo followed by Apremilast	Placebo comparator	Drug: Apremilast, Drug: PlaceboPatients will receive Placebo until week 16 and then receive Apremilast until week 32

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (24 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ApremilastAlso: OTEZLAApremilast 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.	Drug	Apremilast, Placebo followed by Apremilast
PlaceboPlacebo tablets will be provided to sites in blister cards.	Drug	Placebo followed by Apremilast

Primary outcome

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]).

5 secondary outcomes

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

Results and safety

Results posted to the registry on 24 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Apremilast	50	39
Placebo Followed by Apremilast	50	44

Primary outcome: Palmoplantar Psoriasis Physician Global Assessment (PPPGA) of 0 or 1

Time frame: 16 weeks. Count of participants. Unit: Participants

Measure	Apremilast n = 50	Placebo Followed by Apremilast n = 50
Value	7	2

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: After the first study drug administration and until the end of study at Week 32.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Apremilast	3 of 50 (6%)	27 of 50 (54%)	Not reported
Placebo Followed by Apremilast	2 of 50 (4%)	29 of 50 (58%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert Bissonnette, MD, FRCPC principal investigator

Innovaderm Research Inc.

11 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Apremilast in people with Palmo-plantar Psoriasis, run by Innovaderm Research Inc. at 11 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Palmoplantar Psoriasis Physician Global Assessment (PPPGA) of 0 or 1 (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02400749.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2018.