Trial Outcomes & Findings for Initial Dosing of BI 655130 in Palmoplantar Pustulosis Patients (NCT NCT03135548)

Last Updated: 2025-10-16

Results Overview

Percentage of participants who achieved 50% reduction in ppPASI score was assessed by ppPASI50. ppPASI is modification of PASI score and an investigator assessment of the extent and severity of pustular and plaque lesions on the palms and soles presenting in PPP participants. This tool provides a numeric scoring for participants overall PPP disease state, ranging from 0 to maximum 72, where 0 corresponds to no signs of psoriasis. It is a linear combination of the percent of surface area of skin that is affected on the palms and soles and the severity of Erythema (E), Pustules (P) (total), and scaling (Desquamation (D)). Missing values for severity or area of involvement were not imputed. ppPASI was calculated as a weighted sum of the scores obtained for E, P, D and Area affected (in%) (where area assessed is glabrous skin on the palms/ soles) (A): \[(E+P+D) x A x 0.2 (right palm)\] + \[(E+P+D) x A x 0.2 (left palm)\] + \[(E+P+D) x A x 0.3 (right sole)\] + \[(E+P+D) x A x 0.3 (left sole)\].

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

59 participants

Primary outcome timeframe

Week 16

Results posted on

2025-10-16

Participant Flow

This was a randomised, double-blind, placebo-controlled, parallel-design trial to investigate the safety and efficacy of BI 655130 in patients with Palmoplantar Pustulosis (PPP) following multiple intravenous administrations of either low dose or high dose compared with placebo.

All participants were screened for eligibility to participate in the trial. Participants attended specialist sites which would then ensured that all participants met all inclusion/exclusion criteria. Participants were not to be randomised to trial treatment if any one of the specific entry criteria were not met.

Participant milestones

Participant milestones
Measure	BI 655130 Low Dose Participants were administered low dose of BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.	BI 655130 High Dose Participants were administered high dose of BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.	Placebo Matching to BI 655130 Participants were administered placebo matching to BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.
Overall Study STARTED	19	19	21
Overall Study COMPLETED	14	15	18
Overall Study NOT COMPLETED	5	4	3

Reasons for withdrawal

Reasons for withdrawal
Measure	BI 655130 Low Dose Participants were administered low dose of BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.	BI 655130 High Dose Participants were administered high dose of BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.	Placebo Matching to BI 655130 Participants were administered placebo matching to BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.
Overall Study Lost to Follow-up	3	0	0
Overall Study Withdrawal by Subject	2	2	1
Overall Study Other than listed	0	2	2

Baseline Characteristics

Initial Dosing of BI 655130 in Palmoplantar Pustulosis Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BI 655130 Low Dose n=19 Participants Participants were administered low dose of BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.	BI 655130 High Dose n=19 Participants Participants were administered high dose of BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.	Placebo Matching to BI 655130 n=21 Participants Participants were administered placebo matching to BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.	Total n=59 Participants Total of all reporting groups
Age, Continuous	54.6 Years STANDARD_DEVIATION 7.7 • n=5 Participants	49.4 Years STANDARD_DEVIATION 11.3 • n=7 Participants	46.3 Years STANDARD_DEVIATION 11.7 • n=5 Participants	50.0 Years STANDARD_DEVIATION 10.9 • n=4 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	16 Participants n=7 Participants	17 Participants n=5 Participants	49 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	10 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants	16 Participants n=7 Participants	20 Participants n=5 Participants	53 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	19 Participants n=7 Participants	19 Participants n=5 Participants	56 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 16

Population: Full analysis set (FAS): FAS included all patients in the Safety analysis set (SAF) (SAF included all randomised patients who received at least one dose of study drug) who had a baseline measurement available for the primary endpoint. Patients from FAS with no response imputation (NRI) were included for analysis of this endpoint. (FAS (NRI))

Outcome measures

Outcome measures
Measure	BI 655130 Low Dose n=19 Participants Participants were administered low dose of BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.	BI 655130 High Dose n=19 Participants Participants were administered high dose of BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.	Placebo Matching to BI 655130 n=21 Participants Participants were administered placebo matching to BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.
Percentage of Participants With Palmoplantar (pp) Pustular Psoriasis Area and Severity Index 50 (PASI) (ppPASI50) at Week 16	31.6 Percentage of participants (%)	31.6 Percentage of participants (%)	23.8 Percentage of participants (%)

PRIMARY outcome

Timeframe: From first drug administration until 16 weeks after the last drug administration, up to 32 weeks.

Population: Safety analysis set (SAF): This set included all randomised patients who received at least one dose of study drug.

Number of participants with drug-related AEs are presented.

Outcome measures

Outcome measures
Measure	BI 655130 Low Dose n=19 Participants Participants were administered low dose of BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.	BI 655130 High Dose n=19 Participants Participants were administered high dose of BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.	Placebo Matching to BI 655130 n=21 Participants Participants were administered placebo matching to BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.
Number of Participants With Drug-related Adverse Events (AEs)	8 Participants	8 Participants	9 Participants

SECONDARY outcome

Timeframe: Week 16

Population: FAS (NRI)

Percentage of participants who achieved \>75% reduction in ppPASI score was assessed by ppPASI75. ppPASI is modification of PASI score and an investigator assessment of the extent and severity of pustular and plaque lesions on the palms and soles presenting in PPP participants. This tool provides a numeric scoring for participants overall PPP disease state, ranging from 0 to maximum 72, where 0 corresponds to no signs of psoriasis. It is a linear combination of the percent of surface area of skin that is affected on the palms and soles and the severity of Erythema (E), Pustules (P) (total), and scaling (Desquamation (D)). Missing values for severity or area of involvement were not imputed. ppPASI was calculated as a weighted sum of the scores obtained for E, P, D and Area affected (in%) (where area assessed is glabrous skin on the palms/ soles) (A): \[(E+P+D) x A x 0.2 (right palm)\] + \[(E+P+D) x A x 0.2 (left palm)\] + \[(E+P+D) x A x 0.3 (right sole)\] + \[(E+P+D) x A x 0.3 (left sole)\].

Outcome measures

Outcome measures
Measure	BI 655130 Low Dose n=19 Participants Participants were administered low dose of BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.	BI 655130 High Dose n=19 Participants Participants were administered high dose of BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.	Placebo Matching to BI 655130 n=21 Participants Participants were administered placebo matching to BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.
Percentage of Participants With Palmoplantar Pustular Psoriasis Area and Severity Index 75 (ppPASI75) at Week 16	0.0 Percentage of participnats (%)	21.1 Percentage of participnats (%)	9.5 Percentage of participnats (%)

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Patients from FAS with observed cases (OC) were included for analysis of this endpoint. (FAS (OC))

The percentage change in the ppPASI score from Baseline to Week 16 was measured. ppPASI is modification of PASI score and an investigator assessment of the extent and severity of pustular and plaque lesions on the palms and soles presenting in PPP participants. This tool provides a numeric scoring for participants overall PPP disease state, ranging from 0 to maximum 72, where 0 corresponds to no signs of psoriasis. It is a linear combination of the percent of surface area of skin that is affected on the palms and soles and the severity of Erythema (E), Pustules (P) (total), and scaling (Desquamation (D)). Missing values for severity or area of involvement were not imputed. ppPASI was calculated as a weighted sum of the scores obtained for E, P, D and Area affected (in%) (where area assessed is glabrous skin on the palms/ soles) (A): \[(E+P+D) x A x 0.2 (right palm)\] + \[(E+P+D) x A x 0.2 (left palm)\] + \[(E+P+D) x A x 0.3 (right sole)\] + \[(E+P+D) x A x 0.3 (left sole)\].

Outcome measures

Outcome measures
Measure	BI 655130 Low Dose n=15 Participants Participants were administered low dose of BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.	BI 655130 High Dose n=14 Participants Participants were administered high dose of BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.	Placebo Matching to BI 655130 n=15 Participants Participants were administered placebo matching to BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.
Percent Change From Baseline in the ppPASI at Week 16	-32.74 Unit on scale Standard Deviation 38.52	-45.80 Unit on scale Standard Deviation 27.00	-39.97 Unit on scale Standard Deviation 32.94

SECONDARY outcome

Timeframe: Week 16

Population: FAS (NRI)

pppPGA was relied on the participant's overall skin lesions status on the lesions of the most severely affected palmoplantar surface of the palms and sole was assessed by investigator as clear (0), almost clear (1), mild (2), moderate (3) and severe (4) at week 16. Score Wording were: 0 = Clear = No signs of PPP; no scaling or crusts or pustule remains. 1. = Almost clear = Slight scaling and/or erythema and / or slight crusts; very few new (yellow) and / or old (brown) pustules. 2. = Mild = Scaling and/or erythema and/or crusts; visible new (yellow) and/or old (brown) pustules of limited number and extent. 3. =Moderate = Prominent scaling and/or erythema and / or crusting; prominent new (yellow) and / or old (brown) pustules covering most of the area involved. 4. =Severe = Severe scaling and/or erythema and / or crusting; numerous new (yellow) or old (brown) pustules with and/or without major conflence covering the entire area of at least 2 palmoplantar surfaces.

Outcome measures

Outcome measures
Measure	BI 655130 Low Dose n=19 Participants Participants were administered low dose of BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.	BI 655130 High Dose n=19 Participants Participants were administered high dose of BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.	Placebo Matching to BI 655130 n=21 Participants Participants were administered placebo matching to BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.
Percentage of Participants Achieving Treatment Success (Treatment Success Defined as Achieving a Clinical Response of 0 or 1=Clear/Almost Clear) Via Palmoplantar Pustulosis Physicians Global Assessment (pppPGA) at Week 16	0.0 Percentage of participants (%)	15.8 Percentage of participants (%)	14.3 Percentage of participants (%)

Adverse Events

BI 655130 Low Dose

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

BI 655130 High Dose

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Placebo Matching to BI 655130

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	BI 655130 Low Dose n=19 participants at risk Participants were administered low dose of BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.	BI 655130 High Dose n=19 participants at risk Participants were administered high dose of BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.	Placebo Matching to BI 655130 n=21 participants at risk Participants were administered placebo matching to BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.
Nervous system disorders VIth nerve paralysis	5.3% 1/19 • From first drug administration until 16 weeks after the last drug administration, up to 32 weeks. Analysis set for safety presentation was Safety analysis set (SAF). SAF included all randomised patients who received at least one dose of study drug.	0.00% 0/19 • From first drug administration until 16 weeks after the last drug administration, up to 32 weeks. Analysis set for safety presentation was Safety analysis set (SAF). SAF included all randomised patients who received at least one dose of study drug.	0.00% 0/21 • From first drug administration until 16 weeks after the last drug administration, up to 32 weeks. Analysis set for safety presentation was Safety analysis set (SAF). SAF included all randomised patients who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Palmoplantar pustulosis	0.00% 0/19 • From first drug administration until 16 weeks after the last drug administration, up to 32 weeks. Analysis set for safety presentation was Safety analysis set (SAF). SAF included all randomised patients who received at least one dose of study drug.	0.00% 0/19 • From first drug administration until 16 weeks after the last drug administration, up to 32 weeks. Analysis set for safety presentation was Safety analysis set (SAF). SAF included all randomised patients who received at least one dose of study drug.	4.8% 1/21 • From first drug administration until 16 weeks after the last drug administration, up to 32 weeks. Analysis set for safety presentation was Safety analysis set (SAF). SAF included all randomised patients who received at least one dose of study drug.

Other adverse events

Additional Information

Boehringer Ingelheim, Call Centre

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.
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Restriction type: OTHER