18 and older, any sex, with Palmoplantar Pustulosis. 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.
Palmoplantar Pustulosis Psoriasis Area and Severity Index (PPPASI) at Week 20 Compared With BaselinePrimary· PPPASI Score at baseline and Week 20.
The PPPASI assess palms of hands and soles of feet for psoriasis involvement. The PPPASI score range from 0-72, with higher scores indicating more severe disease.
Visit 2 - Baseline
Group
Value
95% CI
Full Analysis Set (FAS)
16.50
14.00 – 19.50
Per Protocol Set (PPS)
15.85
13.95 – 19.85
Full Analysis Set - LOCF
16.50
14.00 – 19.50
Visit 5 - End of Study - Week 20
Group
Value
95% CI
Full Analysis Set (FAS)
7.65
4.45 – 10.6
Per Protocol Set (PPS)
7.65
4.45 – 10.60
Full Analysis Set - LOCF
8.10
4.50 – 11.20
Number of Participants With PPPASI 50 ResponseSecondary· At Visit 3 (Week 4), Visit 4 (Week 12) and Visit 5 (Week 20).
PPPASI 50 response defined as a 50% decrease in PPPASI from baseline.
Visit 3 - Week 4
Group
Value
95% CI
Full Analysis Set (FAS)
7
Per Protocol Set (PPS)
7
Visit 4 - Week 12
Group
Value
95% CI
Full Analysis Set (FAS)
12
Per Protocol Set (PPS)
12
Visit 5 - End of Study - Week 20
Group
Value
95% CI
Full Analysis Set (FAS)
13
Per Protocol Set (PPS)
13
Number of Participants With PPPASI 75 ResponseSecondary· At Visit 3 (Week 4), Visit 4 (Week 12) and Visit 5 (Week 20).
PPPASI 75 response defined as a 75% decrease in PPPASI from baseline.
Visit 3 - Week 4
Group
Value
95% CI
Full Analysis Set (FAS)
2
Per Protocol Set (PPS)
2
Visit 4 - Week 12
Group
Value
95% CI
Full Analysis Set (FAS)
6
Per Protocol Set (PPS)
6
Visit 5 - End of Study - Week 20
Group
Value
95% CI
Full Analysis Set (FAS)
3
Per Protocol Set (PPS)
3
Dermatology Life Quality Index (DLQI)Secondary· At Visit 2 (Baseline), Visit 4 (Week 12) and Visit 5 (Week 20).
The DLQI is a dermatology-specific quality of life instrument designed to assess the impact of a disease on the patient's daily life which is also validated for PPP. It is a 10-item questionnaire and can be used to assess 6 different aspects: symptoms and feelings, leisure, daily activities, work or school performance, personal relationship and treatment. The DLQI was calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life was impaired.
Meaning of DLQI scores:
* 0 to 1 = No effect at all on patient's lif
Visit 2 - Baseline
Group
Value
95% CI
Full Analysis Set (FAS)
8.50
5.00 – 15.50
Per Protocol Set (PPS)
8.00
5.00 – 16.00
Visit 4 - Week 12
Group
Value
95% CI
Full Analysis Set (FAS)
2.50
1.00 – 10.50
Per Protocol Set (PPS)
2.50
1.00 – 10.50
Visit 5 - End of Study - Week 20
Group
Value
95% CI
Full Analysis Set (FAS)
2.00
1.00 – 13.00
Per Protocol Set (PPS)
2.00
1.00 – 13.00
Hand and Feet Physician Global Assessment (H&F PGA)Secondary· At Visit 2 (Baseline), Visit 3 (Week 4) , Visit 4 (Week 12) and Visit 5 (Week 20).
The H\&F PGA describes the severity of psoriasis on the hands and/or feet using five categories ranging from 0 (clear) to 4 (severe).
Visit 2 - Baseline
Group
Value
95% CI
Full Analysis Set (FAS)
0
Per Protocol Set (PPS)
0
Full Analysis Set (FAS)
0
Per Protocol Set (PPS)
0
Full Analysis Set (FAS)
2
Per Protocol Set (PPS)
2
Full Analysis Set (FAS)
19
Per Protocol Set (PPS)
18
Visit 3 - Week 4
Group
Value
95% CI
Full Analysis Set (FAS)
0
Per Protocol Set (PPS)
0
Full Analysis Set (FAS)
1
Per Protocol Set (PPS)
1
Full Analysis Set (FAS)
10
Per Protocol Set (PPS)
10
Full Analysis Set (FAS)
9
Per Protocol Set (PPS)
9
Visit 4 - Week 12
Group
Value
95% CI
Full Analysis Set (FAS)
0
Per Protocol Set (PPS)
0
Full Analysis Set (FAS)
3
Per Protocol Set (PPS)
3
Full Analysis Set (FAS)
9
Per Protocol Set (PPS)
9
Full Analysis Set (FAS)
8
Per Protocol Set (PPS)
8
Visit 5 - End of Study - Week 20
Group
Value
95% CI
Full Analysis Set (FAS)
1
Per Protocol Set (PPS)
1
Full Analysis Set (FAS)
1
Per Protocol Set (PPS)
1
Full Analysis Set (FAS)
10
Per Protocol Set (PPS)
10
Full Analysis Set (FAS)
8
Per Protocol Set (PPS)
8
Pustules Count Percent Change From BaselineSecondary· At Visit 2 (Baseline) and Visit 5 (End of Study - Week 20)
Percentage change from baseline in Pustules count after 20 weeks of treatment with Apremilast
Group
Value
95% CI
Full Analysis Set - LOCF
-76.3
-100 – -53.4
Per Protocol Set (PPS)
-79.82
-100 – -57.33
Number of Participants With Pustules Count 50 and 75 ResponseSecondary· At Visit 3 (Week 4), Visit 4 (Week 12) and Visit 5 (End of Study-Week 20).
Patients experiencing a 50% and 75% decrease in Pustules count from baseline
Pustules count 50: Visit 3 - Week 4
Group
Value
95% CI
Full Analysis Set (FAS)
13
Per Protocol Set (PPS)
14
Pustules count 50: Visit 4 - Week 12
Group
Value
95% CI
Full Analysis Set (FAS)
18
Per Protocol Set (PPS)
17
Pustules count 50: Visit 5-End of Study- Week 20
Group
Value
95% CI
Full Analysis Set (FAS)
16
Per Protocol Set (PPS)
16
Pustules count 75: Visit 3 - Week 4
Group
Value
95% CI
Full Analysis Set (FAS)
8
Per Protocol Set (PPS)
9
Pustules count 75: Visit 4 - Week 12
Group
Value
95% CI
Full Analysis Set (FAS)
14
Per Protocol Set (PPS)
14
Pustules count 75: Visit 5-End of Study- Week 20
Group
Value
95% CI
Full Analysis Set (FAS)
12
Per Protocol Set (PPS)
12
Visual Analogue Scale (VAS) Discomfort/PainSecondary· At Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 12) and Visit 5 (End of Study - Week 20).
VAS was used to assess discomfort/pain. The patient was asked to place a vertical stroke on a 100 mm VAS on which the left-hand boundary represented no discomfort/pain (at 0 mm), and the right-hand boundary (at 100 mm) represented discomfort/pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded, with higher values indicating more discomfort/pain (worse conditions).
Visit 2 - Baseline
Group
Value
95% CI
Full Analysis Set (FAS)
44.0
11.0 – 67.0
Per Protocol Set (PPS)
37.5
9.0 – 61.0
Visit 3 - Week 4
Group
Value
95% CI
Full Analysis Set (FAS)
4.0
0.0 – 19.0
Per Protocol Set (PPS)
3.0
0.0 – 19.0
Visit 4 - Week 12
Group
Value
95% CI
Full Analysis Set (FAS)
2.0
0.0 – 27.0
Per Protocol Set (PPS)
1.5
0.0 – 21.0
Visit 5 - End of Study - Week 20
Group
Value
95% CI
Full Analysis Set (FAS)
9.0
3.0 – 61.0
Per Protocol Set (PPS)
7.5
2.5 – 29.5
Visual Analogue Scale (VAS) Pruritus/ItchSecondary· At Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 12) and Visit 5 (End of Study - Week 20).
VAS was used to assess pruritus/itch. The patient was asked to place a vertical stroke on a 100 mm VAS on which the left-hand boundary (at 0 mm) represented no pruritus/itch, and the right-hand boundary (at 100 mm) represented pruritus/itch as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded, with higher values indicating more pruritus/itch (worse outcomes).
Visit 2 - Baseline
Group
Value
95% CI
Full Analysis Set (FAS)
31.0
16.0 – 55.0
Per Protocol Set (PPS)
29.5
12.5 – 49.0
Visit 3 - Week 4
Group
Value
95% CI
Full Analysis Set (FAS)
2.0
2.0 – 48.0
Per Protocol Set (PPS)
11.0
2.0 – 39.75
Visit 4 - Week 12
Group
Value
95% CI
Full Analysis Set (FAS)
25.0
4.0 – 44.0
Per Protocol Set (PPS)
24.0
3.5 – 37.25
Visit 5 - End of Study - Week 20
Group
Value
95% CI
Full Analysis Set (FAS)
12.0
6.0 – 49.0
Per Protocol Set (PPS)
11.5
5.25 – 30.25
Psoriasis Area and Severity Index (PASI)Secondary· At Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 12) and Visit 5 (End of Study - Week 20).
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. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).
Visit 2 - Baseline
Group
Value
95% CI
Per Protocol Set (PPS)
3.85
1.93 – 5.18
Visit 3 - Week 4
Group
Value
95% CI
Per Protocol Set (PPS)
2.27
0.3 – 3.65
Visit 4 - Week 12
Group
Value
95% CI
Per Protocol Set (PPS)
0.5
0.0 – 2.35
Visit 5-End of Study-Week 20
Group
Value
95% CI
Per Protocol Set (PPS)
0.95
0.0 – 2.28
Dynamic H&F PGASecondary· At Visit 3 (Week 4), Visit 4 (Week 12) and Visit 5 (End of Study - Week 20).
The dynamic H\&F PGA describes the global improvement compared with baseline. It relies on the physician's memory of the baseline severity to evaluate the level of alteration. The categories vary between 0 (cleared) and 6 (worse).
Visit 3 - Week 4
Group
Value
95% CI
Per Protocol Set (PPS)
0
Per Protocol Set (PPS)
2
Per Protocol Set (PPS)
4
Per Protocol Set (PPS)
3
Visit 4 - Week 12
Group
Value
95% CI
Per Protocol Set (PPS)
0
Per Protocol Set (PPS)
5
Per Protocol Set (PPS)
5
Per Protocol Set (PPS)
2
Visit 5 - End of Study - Week 20
Group
Value
95% CI
Per Protocol Set (PPS)
0
Per Protocol Set (PPS)
5
Per Protocol Set (PPS)
7
Per Protocol Set (PPS)
2
Adverse events — posted to ClinicalTrials.gov
Time frame: All AEs were monitored/assessed from baseline (Visit 2, onset of treatment) until the patient's last study visit (i.e., up to 20 weeks). All SAEs were monitored/assessed upon ICF signature (Visit 1) until 30 days after the patient had stopped study participation (i.e., up to 24 weeks plus 30 days)..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Multicenter, open-label, single-arm, phase II, pilot study. The screening period was up to 4 weeks and treatment took place over 20 weeks per patient. Five visits per patient were performed including: Visit 1 at week -4 to -1 (screening), Visit 2 at week 0 (baseline), Visit 3 at week 4, Visit 4 at week 12, and Visit 5 at week 20 (end of study). There was no follow-up period.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07398651 — Apremilast and Adalimumab in Psoriatic Arthritis Patients
· NA
· not yet recruiting
NCT07325266 — Human Laboratory Study of Apremilast for Alcohol Use Disorder
· Phase 2
· recruiting
NCT07432386 — Methotrexate Versus Apremilast for Pruritus in Psoriasis
· Phase 4
· not yet recruiting
NCT07352566 — Utilization of a Microdevice for Psoriasis and Atopic Dermatitis
· Phase 4
· not yet recruiting
NCT07337434 — To Check Comparison of Apremilast and Methotrexate Efficacy in Patients With Moderate to Severe Plaque Psoriasis Present
· EARLY_PHASE1
· recruiting
Other recruiting trials for Palmoplantar Pustulosis
Currently open trials in the same condition.
NCT07219420 — A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Palmoplantar Pustulosis
· Phase 3
· recruiting
NCT07013201 — A 16-week Trial to Investigate the Efficacy and Safety of Delgocitinib Cream 20 mg/g in Adult Participants With Mild to
· Phase 2
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Kristian Reich
Last refreshed: 24 September 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04572997.