Trial Outcomes & Findings for Apremilast in Palmo-Plantar Psoriasis (NCT NCT02400749)

Last Updated: 2018-11-20

Results Overview

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 \[Very severe\]).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

100 participants

Primary outcome timeframe

16 weeks

Results posted on

2018-11-20

Participant Flow

Participant milestones

Participant milestones
Measure	Apremilast 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.	Placebo Followed by Apremilast 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.
Week 0 -16 STARTED	50	50
Week 0 -16 COMPLETED	39	44
Week 0 -16 NOT COMPLETED	11	6
Week 17 - 32 STARTED	39	44
Week 17 - 32 COMPLETED	34	41
Week 17 - 32 NOT COMPLETED	5	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Apremilast 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.	Placebo Followed by Apremilast 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.
Week 0 -16 Withdrawal by Subject	5	5
Week 0 -16 Adverse Event	3	1
Week 0 -16 Lost to Follow-up	2	0
Week 0 -16 Protocol Violation	1	0
Week 17 - 32 Withdrawal by Subject	3	2
Week 17 - 32 Adverse Event	2	1

Baseline Characteristics

Apremilast in Palmo-Plantar Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Apremilast n=50 Participants 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.	Placebo Followed by Apremilast n=50 Participants 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 n=100 Participants Total of all reporting groups
Race/Ethnicity, Customized Not Hispanic or Latino	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants
Smoking Status Never	12 Participants n=5 Participants	19 Participants n=7 Participants	31 Participants n=5 Participants
Smoking Status Past	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants
Smoking Status Present	20 Participants n=5 Participants	13 Participants n=7 Participants	33 Participants n=5 Participants
Weight	86.9 kg STANDARD_DEVIATION 17.1 • n=5 Participants	88.3 kg STANDARD_DEVIATION 19.8 • n=7 Participants	87.6 kg STANDARD_DEVIATION 18.4 • n=5 Participants
BMI	31.1 kg/m^2 STANDARD_DEVIATION 5.5 • n=5 Participants	31.0 kg/m^2 STANDARD_DEVIATION 6.6 • n=7 Participants	31.0 kg/m^2 STANDARD_DEVIATION 6.0 • n=5 Participants
Palmoplantar Psoriasis Physician Global Assessment (PPPGA) Score 3	30 Participants n=5 Participants	32 Participants n=7 Participants	62 Participants n=5 Participants
Palmoplantar Psoriasis Physician Global Assessment (PPPGA) Score 4	19 Participants n=5 Participants	16 Participants n=7 Participants	35 Participants n=5 Participants
Palmoplantar Psoriasis Physician Global Assessment (PPPGA) Score 5	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Palmoplantar Psoriasis Physician Global Assessment (PPPGA)	3.4 units on a scale STANDARD_DEVIATION 0.5 • n=5 Participants	3.4 units on a scale STANDARD_DEVIATION 0.6 • n=7 Participants	3.4 units on a scale STANDARD_DEVIATION 0.6 • n=5 Participants
Palmoplantar Psoriasis Area Severity Index (PPPASI)	18.7 units on a scale STANDARD_DEVIATION 11.3 • n=5 Participants	15.6 units on a scale STANDARD_DEVIATION 8.5 • n=7 Participants	17.1 units on a scale STANDARD_DEVIATION 10.1 • n=5 Participants
Age, Continuous	56.6 years STANDARD_DEVIATION 8.6 • n=5 Participants	53.6 years STANDARD_DEVIATION 13.5 • n=7 Participants	55.1 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	29 Participants n=7 Participants	59 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	21 Participants n=7 Participants	41 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	45 Participants n=5 Participants	47 Participants n=7 Participants	92 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Palmoplantar Psoriasis Surface Area (PPPSA)	38.1 units on a scale STANDARD_DEVIATION 23.4 • n=5 Participants	30.5 units on a scale STANDARD_DEVIATION 18.3 • n=7 Participants	34.3 units on a scale STANDARD_DEVIATION 0.2 • n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks

Outcome measures

Outcome measures
Measure	Apremilast n=50 Participants 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.	Placebo Followed by Apremilast n=50 Participants 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.
Palmoplantar Psoriasis Physician Global Assessment (PPPGA) of 0 or 1	7 Participants	2 Participants

SECONDARY outcome

Timeframe: 16 weeks

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 \[Very severe\]).

Outcome measures

Outcome measures
Measure	Apremilast n=50 Participants 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.	Placebo Followed by Apremilast n=50 Participants 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.
Palmoplantar Psoriasis Physician Global Assessment (PPPGA)	-0.8 units on a scale Standard Deviation 1.0	-0.4 units on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: 16 weeks

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)

Outcome measures

Outcome measures
Measure	Apremilast n=50 Participants 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.	Placebo Followed by Apremilast n=50 Participants 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.
Palmoplantar Psoriasis Area Severity Index (PPPASI)	-7.4 units on a scale Standard Deviation 7.1	-3.6 units on a scale Standard Deviation 5.9

SECONDARY outcome

Timeframe: 16 weeks

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).

Outcome measures

Outcome measures
Measure	Apremilast n=50 Participants 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.	Placebo Followed by Apremilast n=50 Participants 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.
Palmoplantar Psoriasis Surface Area (PPPSA)	-0.1 units on a scale Standard Deviation 0.1	0.0 units on a scale Standard Deviation 0.2

SECONDARY outcome

Timeframe: 32 weeks

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)

Outcome measures

Outcome measures
Measure	Apremilast n=50 Participants 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.	Placebo Followed by Apremilast 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.
Palmoplantar Psoriasis Area Severity Index (PPPASI)	-11.3 units on a scale Interval -14.1 to -8.5	—

SECONDARY outcome

Timeframe: 32 weeks

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 \[Very severe\]).

Outcome measures

Outcome measures
Measure	Apremilast n=50 Participants 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.	Placebo Followed by Apremilast 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.
Palmoplantar Pustulosis Physician Global Assessment (PPPGA) of 0 or 1	12 Participants	—

Adverse Events

Apremilast

Serious events: 3 serious events

Other events: 27 other events

Deaths: 0 deaths

Placebo Followed by Apremilast

Serious events: 2 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Apremilast n=50 participants at risk 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.	Placebo Followed by Apremilast n=50 participants at risk 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.
Cardiac disorders myocardial infarction	4.0% 2/50 • Number of events 2 • After the first study drug administration and until the end of study at Week 32.	0.00% 0/50 • After the first study drug administration and until the end of study at Week 32.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) breast cancer requiring hospitalization for bilateral mastectomy	0.00% 0/50 • After the first study drug administration and until the end of study at Week 32.	2.0% 1/50 • Number of events 1 • After the first study drug administration and until the end of study at Week 32.
Infections and infestations E. coli bacteremia, C-difficile + hypokalemia requiring hospitalization	2.0% 1/50 • Number of events 1 • After the first study drug administration and until the end of study at Week 32.	0.00% 0/50 • After the first study drug administration and until the end of study at Week 32.
Injury, poisoning and procedural complications carbon monoxide poisoning	2.0% 1/50 • Number of events 1 • After the first study drug administration and until the end of study at Week 32.	0.00% 0/50 • After the first study drug administration and until the end of study at Week 32.
Infections and infestations cholecystitis infective	0.00% 0/50 • After the first study drug administration and until the end of study at Week 32.	2.0% 1/50 • Number of events 1 • After the first study drug administration and until the end of study at Week 32.

Other adverse events

Other adverse events
Measure	Apremilast n=50 participants at risk 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.	Placebo Followed by Apremilast n=50 participants at risk 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.
Gastrointestinal disorders Diarrhoea	18.0% 9/50 • Number of events 13 • After the first study drug administration and until the end of study at Week 32.	18.0% 9/50 • Number of events 15 • After the first study drug administration and until the end of study at Week 32.
Gastrointestinal disorders Frequent bowel movements	6.0% 3/50 • Number of events 3 • After the first study drug administration and until the end of study at Week 32.	2.0% 1/50 • Number of events 1 • After the first study drug administration and until the end of study at Week 32.
Gastrointestinal disorders Nausea	12.0% 6/50 • Number of events 6 • After the first study drug administration and until the end of study at Week 32.	12.0% 6/50 • Number of events 6 • After the first study drug administration and until the end of study at Week 32.
General disorders Fatigue	6.0% 3/50 • Number of events 3 • After the first study drug administration and until the end of study at Week 32.	4.0% 2/50 • Number of events 2 • After the first study drug administration and until the end of study at Week 32.
Infections and infestations Bronchitis	6.0% 3/50 • Number of events 3 • After the first study drug administration and until the end of study at Week 32.	0.00% 0/50 • After the first study drug administration and until the end of study at Week 32.
Infections and infestations Upper respiratory tract infection	8.0% 4/50 • Number of events 6 • After the first study drug administration and until the end of study at Week 32.	12.0% 6/50 • Number of events 6 • After the first study drug administration and until the end of study at Week 32.
Metabolism and nutrition disorders Decreased appetite	8.0% 4/50 • Number of events 4 • After the first study drug administration and until the end of study at Week 32.	0.00% 0/50 • After the first study drug administration and until the end of study at Week 32.
Musculoskeletal and connective tissue disorders Back pain	6.0% 3/50 • Number of events 4 • After the first study drug administration and until the end of study at Week 32.	8.0% 4/50 • Number of events 8 • After the first study drug administration and until the end of study at Week 32.
Nervous system disorders Headache	16.0% 8/50 • Number of events 10 • After the first study drug administration and until the end of study at Week 32.	14.0% 7/50 • Number of events 8 • After the first study drug administration and until the end of study at Week 32.

Additional Information

Dr Robert Bissonnette

Innovaderm Research Inc.

Phone: 514-521-4285

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER