NCT03930186

A Phase 3B, Open-label, Single-arm Study of the Efficacy and Safety of Apremilast, in Subjects With Plaque Psoriasis That is Not Adequately Controlled by Topical Therapy

Completed Phase 3 Results posted Last updated 20 January 2022

What this trial tests

Phase 3 trial testing Apremilast in Plaque Psoriasis in 152 participants. Completed in 25 September 2020.

Timeline

17 June 2019

Primary endpoint
8 May 2020

25 September 2020

Quick facts

Lead sponsor	Amgen
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	152
Start date	17 June 2019
Primary completion	8 May 2020
Estimated completion	25 September 2020
Sites	56 locations across Japan, Germany

Drugs / interventions tested

• Apremilast (APREMILAST) — full drug profile →
• Topical Therapy — full drug profile →

Conditions studied

• Plaque Psoriasis — all drugs for Plaque Psoriasis →

Sponsor

Amgen — full company profile →

Who can join

20 and older, any sex, with Plaque Psoriasis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Who Achieved an sPGA Score of Clear (0) or Almost Clear (1) at Week 16 Primary · Week 16

The sPGA is an assessment by the Investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale, ranging from 0 (clear) to 4 (severe). The National Psoriasis Foundation Psoriasis Score version of a static PGA is calculated by averaging the total body erythema, induration, and desquamation scores. The overall scores are as follows: 0 = Clear; 1. = Almost Clear; 2. = Mild; 3. = Moderate; 4. = Severe. The percentage of participants with a sPGA response was estimated using a multiple imputation method fro

Group	Value	95% CI
Apremilast	43.7	35.72 – 51.66

Percentage of Participants Who Achieved an sPGA Score of Clear (0) or Almost Clear (1) at Week 32 Secondary · Week 32

The sPGA is an assessment by the Investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale, ranging from 0 (clear) to 4 (severe). The National Psoriasis Foundation Psoriasis Score version of a static PGA is calculated by averaging the total body erythema, induration, and desquamation scores. The overall scores are as follows: 0 = Clear; 1. = Almost Clear; 2. = Mild; 3. = Moderate; 4. = Severe.

Group	Value	95% CI
Apremilast	40.8	32.98 – 48.60

Percentage of Participants Who Achieved a Scalp Physicians Global Assessment (ScPGA) Score of Clear (0) or Almost Clear (1) at Weeks 16 and 32 Secondary · Weeks 16 and 32

The ScPGA assesses scalp involvement of psoriasis based on scalp plaque elevation, scaling, and erythema. The 5-point ScPGA scale ranges from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe).

Week 16

Group	Value	95% CI
Apremilast	52.3	43.69 – 61.00

Week 32

Group	Value	95% CI
Apremilast	50.8	42.12 – 59.44

Change From Baseline in Percentage of BSA Affected by Psoriasis at Weeks 16 and 32 Secondary · Baseline and weeks 16 and 32

The overall body surface area affected by psoriasis was estimated based on the palm area of the participant's hand, which equates to approximately 1% of total body surface area. BSA affected by psoriasis is expressed as a percentage of total body surface area. A negative change from baseline indicates improvement.

Week 16

Group	Value	95% CI
Apremilast	-7.86	± 8.755

Week 32

Group	Value	95% CI
Apremilast	-8.32	± 9.478

Percent Change From Baseline in Pruritus Visual Analog Scale (VAS) at Weeks 2, 16, and 32 Secondary · Baseline and weeks 2, 16, and 32

Participants were asked to indicate how much itch they have had due to psoriasis in the past week by placing a vertical stroke on a 100 mm line on which the left-hand boundary (0 mm) represented no itch, and the right-hand boundary (100 mm) represented worst itch imaginable. The distance from the mark to the left-hand boundary was recorded. A negative change from baseline indicates improvement.

Week 2

Group	Value	95% CI
Apremilast	-36.96	± 46.474

Week 16

Group	Value	95% CI
Apremilast	-28.05	± 118.300

Week 32

Group	Value	95% CI
Apremilast	-25.29	± 122.113

Mean Change From Baseline in Shiratori's Pruritus Severity Score at Weeks 2, 16, and 32 Secondary · Baseline and weeks 2, 16, and 32

Shiratori's Pruritus Severity Score is a pruritus (itchiness) severity assessment tool used in Japan. Daytime and nighttime pruritus were evaluated and scored separately. Daytime pruritus was rated on a five-grade scale: 0 (absent), 1 (endurable without scratching; minimal), 2 (subsides with slight scratching; mild), 3 (subsides with considerable scratching; moderate), or 4 (not subsiding with scratching, which prompts repeated scratching; severe). Nighttime pruritus was rated on a five-grade scale: 0 (absent), 1 (slight itching at bedtime but not causing intentional scratching; no difficulty

Daytime: Week 2

Group	Value	95% CI
Apremilast	-0.5	± 0.77

Daytime: Week 16

Group	Value	95% CI
Apremilast	-0.7	± 0.95

Daytime: Week 32

Group	Value	95% CI
Apremilast	-0.7	± 0.95

Nighttime: Week 2

Group	Value	95% CI
Apremilast	-0.4	± 0.85

Nighttime: Week 16

Group	Value	95% CI
Apremilast	-0.7	± 0.86

Nighttime: Week 32

Group	Value	95% CI
Apremilast	-0.7	± 0.91

Percentage of Participants Who Achieved a ≥ 50% Reduction From Baseline in NAPSI Score (NAPSI-50) at Weeks 16 and 32 Among Participants With NAPSI ≥ 1 at Baseline Secondary · Weeks 16 and 32

One target thumb nail or fingernail representing the worst nail psoriasis involvement was selected for assessment at Baseline. The nail matrix was assessed for presence of any of the nail matrix features (pitting, leukonychia red spots in the lunula, crumbling) graded on a scale of 0 (none) to 4 (present in all 4 quadrants). The nail bed was assessed for the presence of any nail bed features (onycholysis, splinter hemorrhages, subungual hyperkeratosis, "oil drop" (salmon patch dyschroma) on a scale from 0 (none) to 4 (present in all quadrants). The sum of the nail matrix and nail bed scores

Week 16

Group	Value	95% CI
Apremilast	44.7	33.56 – 55.92

Week 32

Group	Value	95% CI
Apremilast	57.9	46.79 – 68.99

Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 16 and 32 Secondary · Baseline and weeks 16 and 32

The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much), except for Question 7, which first asks whether the participant's skin prevented them from working or studying (Yes (score = 3) or No (score = 0), then If "No", the participant is asked how much their ski

Week 16

Group	Value	95% CI
Apremilast	-2.2	± 2.96

Week 32

Group	Value	95% CI
Apremilast	-2.3	± 2.97

Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Weeks 16 and 32 Secondary · Baseline and weeks 16 and 32

The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. The PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. A negative change from baseline indicates improvement.

Week 16

Group	Value	95% CI
Apremilast	-69.61	± 22.896

Week 32

Group	Value	95% CI
Apremilast	-69.48	± 25.421

Percentage of Participants Who Achieved ≥ 75% Reduction From Baseline in PASI Score (PASI-75) Secondary · Weeks 16 and 32

The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. The PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.

Week 16

Group	Value	95% CI
Apremilast	43.4	35.54 – 51.30

Week 32

Group	Value	95% CI
Apremilast	46.7	38.78 – 54.64

Percentage of Participants Who Achieved ≥ 50% Reduction From Baseline in PASI Score (PASI-50) Secondary · Weeks 16 and 32

The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. The PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.

Week 16

Group	Value	95% CI
Apremilast	79.6	73.20 – 86.01

Week 32

Group	Value	95% CI
Apremilast	75.0	68.12 – 81.88

Treatment Satisfaction Questionnaire for Medication (TSQM) Sub-domain Scores Secondary · Baseline and weeks 16 and 32

The Treatment Satisfaction Questionnaire for Medication (TSQM) version II is a self-administered instrument to understand a participant's satisfaction on current therapy. The TSQM comprises 11 items across 4 domains focusing on effectiveness (Item 1 and 2), side effects (Item 4 to 6), convenience (Item 7 to 9), and global satisfaction (Item 10 and 11). With the exception of Item 3 (experience any side effects; yes or no), all items have five or seven responses. Item scores are summed to give four domain scores, which are in turn transformed to a scale from 0 (extremely dissatisfied) to 100 (ex

Effectiveness: Baseline

Group	Value	95% CI
Apremilast	52.25	± 17.553

Effectiveness: Week 16

Group	Value	95% CI
Apremilast	67.41	± 21.176

Effectiveness: Week 32

Group	Value	95% CI
Apremilast	68.93	± 19.067

Side Effects: Baseline

Group	Value	95% CI
Apremilast	97.37	± 10.078

Side Effects: Week 16

Group	Value	95% CI
Apremilast	90.40	± 17.714

Side Effects: Week 32

Group	Value	95% CI
Apremilast	93.21	± 14.947

Convenience: Baseline

Group	Value	95% CI
Apremilast	56.43	± 16.735

Convenience: Week 16

Group	Value	95% CI
Apremilast	70.34	± 17.201

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose of study drug until at least 28 days after last dose; up to 36 weeks.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Apremilast 30 mg

Serious: 4/152 (3%)

Deaths: 0/152

Serious adverse events (5 terms)

Reaction	System	Apremilast 30 mg
Deafness unilateral	Ear and labyrinth disorders	—
Gastroenteritis	Infections and infestations	—
Thoracic vertebral fracture	Injury, poisoning and procedural complications	—
Blood creatine phosphokinase increased	Investigations	—
Depression	Psychiatric disorders	—

Other adverse events (5 terms — click to expand)

Reaction	System	Apremilast 30 mg
Diarrhoea	Gastrointestinal disorders	—
Nausea	Gastrointestinal disorders	—
Nasopharyngitis	Infections and infestations	—
Faeces soft	Gastrointestinal disorders	—
Headache	Nervous system disorders	—

Most-reported serious reactions: Deafness unilateral, Gastroenteritis, Thoracic vertebral fracture, Blood creatine phosphokinase increased, Depression.

Data from ClinicalTrials.gov NCT03930186 adverse events section.

Sponsor's own description

The primary objective of the study is to assess the efficacy and safety of the combination of apremilast plus topical therapies for the treatment of adults with plaque psoriasis who have not achieved an adequate response with topicals alone.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. An Overview of PDE4 Inhibitors in Clinical Trials: 2010 to Early 2022.
   Crocetti L, Floresta G, Cilibrizzi A, Giovannoni MP. · · 2022 · cited 85× · PMID 35956914 · DOI 10.3390/molecules27154964
2. Phosphodiesterase-4 Inhibition in the Management of Psoriasis.
   Crowley EL, Gooderham MJ. · · 2023 · cited 24× · PMID 38258034 · DOI 10.3390/pharmaceutics16010023
3. Efficacy and Safety of Apremilast in the Treatment of Patients with Mild-to-Moderate Psoriasis in Japan: Results from PROMINENT, A Phase 3b, Open-Label, Single-Arm Study.
   Okubo Y, Takahashi H, Hino R, Endo K, et al · · 2022 · cited 10× · PMID 35689737 · DOI 10.1007/s13555-022-00747-5
4. Consistent Efficacy of Apremilast in Patients with Psoriasis Regardless of Baseline Disease Severity or Special Area Involvement: Subgroup Analysis from PROMINENT.
   Abe M, Okubo Y, Takahashi H, Endo K, et al · · 2024 · PMID 38801606 · DOI 10.1007/s13555-024-01179-z