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.
Number of Subjects With Treatment Emergent Adverse Events (TEAEs)Primary· From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
TEAEs were defined as all adverse events (AEs) occurring between start of treatment in this extension trial and the end of its residual effect period. Adverse events that started before first intake of trial medication in the extension trial and deteriorated under treatment during the extension trial were also considered as 'treatment-emergent'.
Group
Value
95% CI
Spesolimab (BI 655130)
96
Percent Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) From Baseline in Parent Trial (NCT04015518) at Weeks 48 and 96Secondary· Week 0 (baseline) and Week 48, Week 96
Percent change in PPP ASI from baseline in parent trial is reported. The adaptation from Psoriasis Area and Severity Index was used in this trial. The index is a linear combination of the percent of surface area of skin affected on the palms and soles of the body and the severity of erythema (E), pustules (P) and scaling / desquamation (D), providing a numeric score for the overall PPP disease state, ranging from 0 (best outcome) to 72 (worst outcome), calculated as: PPP ASI = \[(E+P+D) Area x 0.2 (right palm)\] + \[(E+P+D) Area x 0.2 (left palm)\] + \[(E+P+D) Area x 0.3 (right sole)\] + \[(E+
Week 48
Group
Value
95% CI
Spesolimab (BI 655130)
-76.85
± 22.63
Week 96
Group
Value
95% CI
Spesolimab (BI 655130)
-77.58
± 18.59
Proportion of Patients With PPP ASI50 Compared to Baseline in Parent Trial (NCT04015518) at Weeks 48, 96Secondary· Week 0 (baseline) and Week 48, Week 96
Proportion of patients achieving a 50% decrease in PPP ASI compared to baseline in the parent trial at Weeks 48 and 96 is reported. The calculated index is a linear combination of the percent of surface area of skin affected on the palms and soles of the body and the severity of erythema, pustules and scaling / desquamation, providing a numeric score for the overall PPP disease state, ranging from 0 (best outcome) to 72 (worst outcome), calculated as: PPP ASI = \[(E+P+D) Area x 0.2 (right palm)\] + \[(E+P+D) Area x 0.2 (left palm)\] + \[(E+P+D) Area x 0.3 (right sole)\] + \[(E+P+D) Area x 0.3
Week 48
Group
Value
95% CI
Spesolimab (BI 655130)
0.770
0.678 – 0.842
Week 96
Group
Value
95% CI
Spesolimab (BI 655130)
0.683
0.530 – 0.804
Proportion of Patients With PPP PGA of 0 (Clear) or 1 (Almost Clear) at Week 48, 96Secondary· Week 48 and Week 96
Proportion of patients with PPP PGA of 0 (clear) or 1 (almost clear) is reported. The Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) was used to assess the patient's skin presentation on the palms and soles. The investigator scored the individual components (erythema, pustules and scaling/crusting) from 0 to 4 as clear, almost clear, mild, moderate or severe. The PPP PGA was analyzed as PPP PGA total score including erythema, pustules and scaling, and as PPP PGA pustules score for pustules only. Number of patients with PPP PGA of 0/1 at Week X/number of evaluable patients at Wee
Week 48
Group
Value
95% CI
Spesolimab (BI 655130)
0.720
0.625 – 0.799
Week 96
Group
Value
95% CI
Spesolimab (BI 655130)
0.707
0.555 – 0.824
Adverse events — posted to ClinicalTrials.gov
Time frame: From first administration of study drug until last administration of study drug + 112 days, up to 869 days..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Spesolimab (BI 655130)
Serious: 19/108 (18%)
Deaths: 0/108
Serious adverse events (30 terms)
Reaction
System
Spesolimab (BI 655130)
Fall
Injury, poisoning and procedural complications
—
Cardiac failure chronic
Cardiac disorders
—
Tricuspid valve incompetence
Cardiac disorders
—
Hypertrophic cardiomyopathy
Congenital, familial and genetic disorders
—
Colitis
Gastrointestinal disorders
—
Large intestine polyp
Gastrointestinal disorders
—
Pancreatitis
Gastrointestinal disorders
—
Appendicitis
Infections and infestations
—
COVID-19
Infections and infestations
—
Gangrene
Infections and infestations
—
Osteomyelitis
Infections and infestations
—
Paraspinal abscess
Infections and infestations
—
Pulmonary sepsis
Infections and infestations
—
Staphylococcal bacteraemia
Infections and infestations
—
Toxic shock syndrome
Infections and infestations
—
Ankle fracture
Injury, poisoning and procedural complications
—
Lower limb fracture
Injury, poisoning and procedural complications
—
Meniscus injury
Injury, poisoning and procedural complications
—
Post procedural haemorrhage
Injury, poisoning and procedural complications
—
Spinal fracture
Injury, poisoning and procedural complications
—
Obesity
Metabolism and nutrition disorders
—
Chondropathy
Musculoskeletal and connective tissue disorders
—
Scleroderma
Musculoskeletal and connective tissue disorders
—
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This study is open to people with palmoplantar pustulosis who took part in previous clinical studies of a medicine called spesolimab. Participants who benefited from spesolimab treatment in the previous studies can join this study.
The purpose of this study is to find out how safe spesolimab is and whether it helps people with palmoplantar pustulosis in the long-term. Participants are in this study for up to 5 years. During this time they visit the study site every month to get spesolimab injections under the skin.
At study visits, doctors check the severity of participants' palmoplantar pustulosis and collect information on any health problems of the participants.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06624670 — A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum
· Phase 3
· recruiting
NCT06520514 — A Study to Test How Well Healthy People Tolerate Spesolimab When Given in 2 Different Ways
· Phase 1
· completed
NCT06241573 — A Study to Test Long-term Treatment With Spesolimab in People With a Skin Condition Disease Called Hidradenitis Suppurat
· Phase 2, PHASE3
· terminated
NCT06013969 — A Study to Test Whether Spesolimab Helps People With Generalized Pustular Psoriasis (GPP) Who Need Treatment for Repeate
· Phase 4
· active not 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
Other Boehringer Ingelheim trials
Trials by the same sponsor.
NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection
· not yet recruiting
NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a
· not yet recruiting
NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I
· Phase 3
· not yet recruiting
NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants
· Phase 1
· not yet recruiting
NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis
· Phase 3
· not yet 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 Boehringer Ingelheim
Last refreshed: 20 October 2025
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/NCT04493424.