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Apremilast in Palmo-Plantar Psoriasis

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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.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Palmo-plantar Psoriasis
Interventions Drug: Apremilast
Drug: Placebo
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Apremilast Placebo Followed by Apremilast
Hide Arm/Group Description

Patients will receive apremilast until Week 32.

Apremilast: Apremilast tablets provided to sites in blister cards.

Patients will be provided a titration blister pack containing apremilast 10 mg, 20 mg and 30 mg at Day 0 and Week 16 visits. Following a 6-day titration period (for Day 0 and Week 16), patients will use blister packs containing apremilast 30 mg bid.

Patients will receive Placebo until Week 16 and then receive apremilast until Week 32

Placebo/Apremilast: Placebo and apremilast tablets provided to sites in blister cards.

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

Period Title: Week 0 -16
Started 50 50
Completed 39 44
Not Completed 11 6
Reason Not Completed
Withdrawal by Subject             5             5
Adverse Event             3             1
Lost to Follow-up             2             0
Protocol Violation             1             0
Period Title: Week 17 - 32
Started 39 44
Completed 34 41
Not Completed 5 3
Reason Not Completed
Withdrawal by Subject             3             2
Adverse Event             2             1
Arm/Group Title Apremilast Placebo Followed by Apremilast Total
Hide Arm/Group Description

Patients will receive apremilast until Week 32.

Apremilast: Apremilast tablets provided to sites in blister cards.

Patients will be provided a titration blister pack containing apremilast 10 mg, 20 mg and 30 mg at Day 0 and Week 16 visits. Following a 6-day titration period (for Day 0 and Week 16), patients will use blister packs containing apremilast 30 mg bid.

Patients will receive Placebo until Week 16 and then receive apremilast until Week 32

Placebo/Apremilast: Placebo and apremilast tablets provided to sites in blister cards.

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

Total of all reporting groups
Overall Number of Baseline Participants 50 50 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 50 participants 100 participants
56.6  (8.6) 53.6  (13.5) 55.1  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Female
30
  60.0%
29
  58.0%
59
  59.0%
Male
20
  40.0%
21
  42.0%
41
  41.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Asian
3
   6.0%
3
   6.0%
6
   6.0%
Black
1
   2.0%
0
   0.0%
1
   1.0%
Caucasian
45
  90.0%
47
  94.0%
92
  92.0%
Other
1
   2.0%
0
   0.0%
1
   1.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Not Hispanic or Latino Number Analyzed 50 participants 50 participants 100 participants
50
 100.0%
50
 100.0%
100
 100.0%
Smoking Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Never
12
  24.0%
19
  38.0%
31
  31.0%
Past
18
  36.0%
18
  36.0%
36
  36.0%
Present
20
  40.0%
13
  26.0%
33
  33.0%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 50 participants 50 participants 100 participants
86.9  (17.1) 88.3  (19.8) 87.6  (18.4)
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 50 participants 50 participants 100 participants
31.1  (5.5) 31.0  (6.6) 31.0  (6.0)
Palmoplantar Psoriasis Physician Global Assessment (PPPGA)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Score 3
30
  60.0%
32
  64.0%
62
  62.0%
Score 4
19
  38.0%
16
  32.0%
35
  35.0%
Score 5
1
   2.0%
2
   4.0%
3
   3.0%
[1]
Measure Description: 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 Physician Global Assessment (PPPGA)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 50 participants 50 participants 100 participants
3.4  (0.5) 3.4  (0.6) 3.4  (0.6)
[1]
Measure Description: 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)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 50 participants 50 participants 100 participants
18.7  (11.3) 15.6  (8.5) 17.1  (10.1)
[1]
Measure Description:

The 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)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 50 participants 50 participants 100 participants
38.1  (23.4) 30.5  (18.3) 34.3  (0.2)
[1]
Measure Description: 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).
1.Primary Outcome
Title Palmoplantar Psoriasis Physician Global Assessment (PPPGA) of 0 or 1
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Apremilast Placebo Followed by Apremilast
Hide Arm/Group Description:

Patients will receive apremilast until Week 32.

Apremilast: Apremilast tablets provided to sites in blister cards.

Patients will be provided a titration blister pack containing apremilast 10 mg, 20 mg and 30 mg at Day 0 and Week 16 visits. Following a 6-day titration period (for Day 0 and Week 16), patients will use blister packs containing apremilast 30 mg bid.

Patients will receive placebo until Week 16 and then receive apremilast until Week 32

Placebo/Apremilast: Placebo and apremilast tablets provided to sites in blister cards.

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

Overall Number of Participants Analyzed 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
7
  14.0%
2
   4.0%
2.Secondary Outcome
Title Palmoplantar Psoriasis Physician Global Assessment (PPPGA)
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Apremilast Placebo Followed by Apremilast
Hide Arm/Group Description:

Patients will receive apremilast until Week 32.

Apremilast: Apremilast tablets provided to sites in blister cards.

Patients will be provided a titration blister pack containing apremilast 10 mg, 20 mg and 30 mg at Day 0 and Week 16 visits. Following a 6-day titration period (for Day 0 and Week 16), patients will use blister packs containing apremilast 30 mg bid.

Patients will receive placebo until Week 16 and then receive apremilast until Week 32

Placebo/Apremilast: Placebo and apremilast tablets provided to sites in blister cards.

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

Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.8  (1.0) -0.4  (0.8)
3.Secondary Outcome
Title Palmoplantar Psoriasis Area Severity Index (PPPASI)
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Apremilast Placebo Followed by Apremilast
Hide Arm/Group Description:

Patients will receive apremilast until Week 32.

Apremilast: Apremilast tablets provided to sites in blister cards.

Patients will be provided a titration blister pack containing apremilast 10 mg, 20 mg and 30 mg at Day 0 and Week 16 visits. Following a 6-day titration period (for Day 0 and Week 16), patients will use blister packs containing apremilast 30 mg bid.

Patients will receive placebo until Week 16 and then receive apremilast until Week 32

Placebo/Apremilast: Placebo and apremilast tablets provided to sites in blister cards.

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

Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
-7.4  (7.1) -3.6  (5.9)
4.Secondary Outcome
Title Palmoplantar Psoriasis Surface Area (PPPSA)
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Apremilast Placebo Followed by Apremilast
Hide Arm/Group Description:

Patients will receive apremilast until Week 32.

Apremilast: Apremilast tablets provided to sites in blister cards.

Patients will be provided a titration blister pack containing apremilast 10 mg, 20 mg and 30 mg at Day 0 and Week 16 visits. Following a 6-day titration period (for Day 0 and Week 16), patients will use blister packs containing apremilast 30 mg bid.

Patients will receive placebo until Week 16 and then receive apremilast until Week 32

Placebo/Apremilast: Placebo and apremilast tablets provided to sites in blister cards.

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

Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.1  (0.1) 0.0  (0.2)
5.Secondary Outcome
Title Palmoplantar Psoriasis Area Severity Index (PPPASI)
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Apremilast
Hide Arm/Group Description:

Patients will receive apremilast until Week 32.

Apremilast: Apremilast tablets provided to sites in blister cards.

Patients will be provided a titration blister pack containing apremilast 10 mg, 20 mg and 30 mg at Day 0 and Week 16 visits. Following a 6-day titration period (for Day 0 and Week 16), patients will use blister packs containing apremilast 30 mg bid.

Overall Number of Participants Analyzed 50
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-11.3
(-14.1 to -8.5)
6.Secondary Outcome
Title Palmoplantar Pustulosis Physician Global Assessment (PPPGA) of 0 or 1
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Apremilast
Hide Arm/Group Description:

Patients will receive apremilast until Week 32.

Apremilast: Apremilast tablets provided to sites in blister cards.

Patients will be provided a titration blister pack containing apremilast 10 mg, 20 mg and 30 mg at Day 0 and Week 16 visits. Following a 6-day titration period (for Day 0 and Week 16), patients will use blister packs containing apremilast 30 mg bid.

Overall Number of Participants Analyzed 50
Measure Type: Count of Participants
Unit of Measure: Participants
12
  24.0%
Time Frame After the first study drug administration and until the end of study at Week 32.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Apremilast Placebo Followed by Apremilast
Hide Arm/Group Description

Patients will receive apremilast until Week 32.

Apremilast: Apremilast tablets provided to sites in blister cards.

Patients will be provided a titration blister pack containing apremilast 10 mg, 20 mg and 30 mg at Day 0 and Week 16 visits. Following a 6-day titration period (for Day 0 and Week 16), patients will use blister packs containing apremilast 30 mg bid.

Patients will receive placebo until Week 16 and then receive apremilast until Week 32

Placebo/Apremilast: Placebo and apremilast tablets provided to sites in blister cards.

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

All-Cause Mortality
Apremilast Placebo Followed by Apremilast
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Apremilast Placebo Followed by Apremilast
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/50 (6.00%)      2/50 (4.00%)    
Cardiac disorders     
myocardial infarction *  2/50 (4.00%)  2 0/50 (0.00%)  0
Infections and infestations     
E. coli bacteremia, C-difficile + hypokalemia requiring hospitalization *  1/50 (2.00%)  1 0/50 (0.00%)  0
cholecystitis infective *  0/50 (0.00%)  0 1/50 (2.00%)  1
Injury, poisoning and procedural complications     
carbon monoxide poisoning *  1/50 (2.00%)  1 0/50 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
breast cancer requiring hospitalization for bilateral mastectomy *  0/50 (0.00%)  0 1/50 (2.00%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Apremilast Placebo Followed by Apremilast
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   27/50 (54.00%)      29/50 (58.00%)    
Gastrointestinal disorders     
Diarrhoea *  9/50 (18.00%)  13 9/50 (18.00%)  15
Frequent bowel movements *  3/50 (6.00%)  3 1/50 (2.00%)  1
Nausea *  6/50 (12.00%)  6 6/50 (12.00%)  6
General disorders     
Fatigue *  3/50 (6.00%)  3 2/50 (4.00%)  2
Infections and infestations     
Bronchitis *  3/50 (6.00%)  3 0/50 (0.00%)  0
Upper respiratory tract infection *  4/50 (8.00%)  6 6/50 (12.00%)  6
Metabolism and nutrition disorders     
Decreased appetite *  4/50 (8.00%)  4 0/50 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back pain *  3/50 (6.00%)  4 4/50 (8.00%)  8
Nervous system disorders     
Headache *  8/50 (16.00%)  10 7/50 (14.00%)  8
*
Indicates events were collected by non-systematic assessment
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Investigator have an obligation to present or publish the results in accordance with GCP, ICH, and the declaration of Helsinki, provided that confidential information and/or proprietary information of the sponsor, not publicly known is not disclosed without prior, written permission from the sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Robert Bissonnette
Organization: Innovaderm Research Inc.
Phone: 514-521-4285
EMail: rbissonnette@innovaderm.ca
Layout table for additonal information
Responsible Party: Innovaderm Research Inc.
ClinicalTrials.gov Identifier: NCT02400749     History of Changes
Other Study ID Numbers: Inno-6040
AP-CL-PSOR-CARE-005313 ( Other Identifier: Celgene )
First Submitted: March 24, 2015
First Posted: March 27, 2015
Results First Submitted: May 17, 2018
Results First Posted: October 24, 2018
Last Update Posted: November 20, 2018