Trial Outcomes & Findings for A Study to Test Long-term Treatment With Spesolimab in People With Palmoplantar Pustulosis (PPP) Who Took Part in Previous Studies With Spesolimab (NCT NCT04493424)
NCT ID: NCT04493424
Last Updated: 2025-10-17
Results Overview
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'.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
108 participants
Primary outcome timeframe
From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Results posted on
2025-10-17
Participant Flow
This study was a phase II, open-label, single arm, to test the safety and efficacy of long-term treatment with Spesolimab in patients with Palmoplantar Pustulosis (PPP) who took part in previous studies with Spesolimab
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
Spesolimab (BI 655130)
The patients were administered 600 milligram (mg) Spesolimab (BI 655130) prefilled syringes subcutaneously in thighs or abdomen every 4 weeks for up to 5 years (260 weeks). Patients were to continue the treatment until no longer benefited under the patient opinion or investigator assessment, or withdrawal of consent, whichever occurred first.
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|---|---|
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Overall Study
STARTED
|
108
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
108
|
Reasons for withdrawal
| Measure |
Spesolimab (BI 655130)
The patients were administered 600 milligram (mg) Spesolimab (BI 655130) prefilled syringes subcutaneously in thighs or abdomen every 4 weeks for up to 5 years (260 weeks). Patients were to continue the treatment until no longer benefited under the patient opinion or investigator assessment, or withdrawal of consent, whichever occurred first.
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|---|---|
|
Overall Study
Termination of the trial by the sponsor
|
89
|
|
Overall Study
Withdrawal by Subject
|
9
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Lack of Efficacy
|
3
|
|
Overall Study
Adverse Event
|
5
|
Baseline Characteristics
A Study to Test Long-term Treatment With Spesolimab in People With Palmoplantar Pustulosis (PPP) Who Took Part in Previous Studies With Spesolimab
Baseline characteristics by cohort
| Measure |
Spesolimab (BI 655130)
n=108 Participants
The patients were administered 600 milligram (mg) Spesolimab (BI 655130) prefilled syringes subcutaneously in thighs or abdomen every 4 weeks for up to 5 years (260 weeks). Patients were to continue the treatment until no longer benefited under the patient opinion or investigator assessment, or withdrawal of consent, whichever occurred first.
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|---|---|
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Age, Continuous
|
55.2 Years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
108 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
69 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Palmoplantar Pustulosis Area and Severity Index (PPP ASI)
|
24.97 Score in a scale
STANDARD_DEVIATION 10.93 • n=5 Participants
|
PRIMARY outcome
Timeframe: From first administration of study drug until last administration of study drug + 112 days, up to 869 days.Population: Treated Set for Maintenance Treatment (TS-MT): This patient set included all patients who received at least one dose of the maintenance treatment 600 mg s.c. every 4 weeks.
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'.
Outcome measures
| Measure |
Spesolimab (BI 655130)
n=108 Participants
The patients were administered 600 milligram (mg) Spesolimab (BI 655130) prefilled syringes subcutaneously in thighs or abdomen every 4 weeks for up to 5 years (260 weeks). Patients were to continue the treatment until no longer benefited under the patient opinion or investigator assessment, or withdrawal of consent, whichever occurred first.
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|---|---|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
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96 Participants
|
SECONDARY outcome
Timeframe: Week 0 (baseline) and Week 48, Week 96Population: Safety analysis set for maintenance treatment (SAF-MT) This patient set included all patients who received at least one dose of the maintenance treatment.
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 = \[(E+P+D) Area x 0.2 (right palm)\] + \[(E+P+D) Area x 0.2 (left palm)\] + \[(E+P+D) Area x 0.3 (right sole)\] + \[(E+P+D) Area x 0.3 (left sole)\]. The weighted sum of the scores obtained for Erythema (E), Pustules (P), desquamation (D) (scaling) were based on a score range from 0: None to 4: Very severe, and the area affected on a score range from 0 (0%) to 6 (90-100%). Percent change was calculated as: (PPP ASI at Week X - PPP ASI at baseline in parent trial)/PPP ASI at baseline in parent trial \* 100%.
Outcome measures
| Measure |
Spesolimab (BI 655130)
n=108 Participants
The patients were administered 600 milligram (mg) Spesolimab (BI 655130) prefilled syringes subcutaneously in thighs or abdomen every 4 weeks for up to 5 years (260 weeks). Patients were to continue the treatment until no longer benefited under the patient opinion or investigator assessment, or withdrawal of consent, whichever occurred first.
|
|---|---|
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Percent Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) From Baseline in Parent Trial (NCT04015518) at Weeks 48 and 96
Week 48
|
-76.85 Percent change
Standard Deviation 22.63
|
|
Percent Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) From Baseline in Parent Trial (NCT04015518) at Weeks 48 and 96
Week 96
|
-77.58 Percent change
Standard Deviation 18.59
|
SECONDARY outcome
Timeframe: Week 0 (baseline) and Week 48, Week 96Population: Safety analysis set for maintenance treatment (SAF-MT) This patient set included all patients who received at least one dose of the maintenance treatment.
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 = \[(E+P+D) Area x 0.2 (right palm)\] + \[(E+P+D) Area x 0.2 (left palm)\] + \[(E+P+D) Area x 0.3 (right sole)\] + \[(E+P+D) Area x 0.3 (left sole)\]. The weighted sum of the scores obtained for Erythema (E), Pustules (P), desquamation (D) (scaling) were based on a score range from 0: None to 4: Very severe, and the area affected from 0 (0%) to 6 (90-100%). Proportion was calculated as: Patients with PPP ASI50 at Week X/number of evaluable patients at Week X. Non-response imputation (NRI) was used for missing data imputation.
Outcome measures
| Measure |
Spesolimab (BI 655130)
n=108 Participants
The patients were administered 600 milligram (mg) Spesolimab (BI 655130) prefilled syringes subcutaneously in thighs or abdomen every 4 weeks for up to 5 years (260 weeks). Patients were to continue the treatment until no longer benefited under the patient opinion or investigator assessment, or withdrawal of consent, whichever occurred first.
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|---|---|
|
Proportion of Patients With PPP ASI50 Compared to Baseline in Parent Trial (NCT04015518) at Weeks 48, 96
Week 48
|
0.770 Proportion of participants
Interval 0.678 to 0.842
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|
Proportion of Patients With PPP ASI50 Compared to Baseline in Parent Trial (NCT04015518) at Weeks 48, 96
Week 96
|
0.683 Proportion of participants
Interval 0.53 to 0.804
|
SECONDARY outcome
Timeframe: Week 48 and Week 96Population: Safety analysis set for maintenance treatment (SAF-MT) This patient set included all patients who received at least one dose of the maintenance treatment.
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 Week X was calculated. NRI approach was used for missing data imputation. The PPP PGA total score was derived as the mean of all individual components: 0 = If mean=0, for all three components: 1. = If 0 \< mean \<1.5 2. = If 1.5 \<= mean \<2.5 3. = If 2.5 \<= mean \<3.5 4. = If mean \>=3.5
Outcome measures
| Measure |
Spesolimab (BI 655130)
n=108 Participants
The patients were administered 600 milligram (mg) Spesolimab (BI 655130) prefilled syringes subcutaneously in thighs or abdomen every 4 weeks for up to 5 years (260 weeks). Patients were to continue the treatment until no longer benefited under the patient opinion or investigator assessment, or withdrawal of consent, whichever occurred first.
|
|---|---|
|
Proportion of Patients With PPP PGA of 0 (Clear) or 1 (Almost Clear) at Week 48, 96
Week 48
|
0.720 Proportion of participants
Interval 0.625 to 0.799
|
|
Proportion of Patients With PPP PGA of 0 (Clear) or 1 (Almost Clear) at Week 48, 96
Week 96
|
0.707 Proportion of participants
Interval 0.555 to 0.824
|
Adverse Events
Spesolimab (BI 655130)
Serious events: 19 serious events
Other events: 77 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Spesolimab (BI 655130)
n=108 participants at risk
The patients were administered 600 milligram (mg) Spesolimab (BI 655130) prefilled syringes subcutaneously in thighs or abdomen every 4 weeks for up to 5 years (260 weeks). Patients were to continue the treatment until no longer benefited under the patient opinion or investigator assessment, or withdrawal of consent, whichever occurred first.
|
|---|---|
|
Cardiac disorders
Cardiac failure chronic
|
0.93%
1/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.93%
1/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
|
0.93%
1/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.93%
1/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.93%
1/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.93%
1/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
Infections and infestations
Appendicitis
|
0.93%
1/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
Infections and infestations
COVID-19
|
0.93%
1/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
Infections and infestations
Gangrene
|
0.93%
1/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
Infections and infestations
Osteomyelitis
|
0.93%
1/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
Infections and infestations
Paraspinal abscess
|
0.93%
1/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
Infections and infestations
Pulmonary sepsis
|
0.93%
1/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.93%
1/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
Infections and infestations
Toxic shock syndrome
|
0.93%
1/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.93%
1/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
1.9%
2/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.93%
1/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.93%
1/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.93%
1/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.93%
1/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
Metabolism and nutrition disorders
Obesity
|
0.93%
1/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.93%
1/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
Musculoskeletal and connective tissue disorders
Scleroderma
|
0.93%
1/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.93%
1/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
Nervous system disorders
Epilepsy
|
0.93%
1/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.93%
1/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.93%
1/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
Renal and urinary disorders
Renal colic
|
0.93%
1/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.93%
1/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.93%
1/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
Other adverse events
| Measure |
Spesolimab (BI 655130)
n=108 participants at risk
The patients were administered 600 milligram (mg) Spesolimab (BI 655130) prefilled syringes subcutaneously in thighs or abdomen every 4 weeks for up to 5 years (260 weeks). Patients were to continue the treatment until no longer benefited under the patient opinion or investigator assessment, or withdrawal of consent, whichever occurred first.
|
|---|---|
|
General disorders
Injection site erythema
|
18.5%
20/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
General disorders
Injection site induration
|
5.6%
6/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
General disorders
Injection site pain
|
8.3%
9/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
General disorders
Injection site pruritus
|
5.6%
6/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
General disorders
Injection site swelling
|
11.1%
12/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
General disorders
Injection site warmth
|
5.6%
6/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
General disorders
Pyrexia
|
13.0%
14/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
Infections and infestations
COVID-19
|
27.8%
30/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
Infections and infestations
Nasopharyngitis
|
14.8%
16/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
6/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
12/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.2%
11/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
Nervous system disorders
Headache
|
7.4%
8/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
6.5%
7/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
8.3%
9/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
|
Skin and subcutaneous tissue disorders
Palmoplantar pustulosis
|
7.4%
8/108 • From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER