Trial Outcomes & Findings for A Study Investigating Long-term Treatment With Spesolimab in People With a Skin Disease Called Hidradenitis Suppurativa Who Completed a Previous Clinical Trial (NCT NCT04876391)

Last Updated: 2025-11-14

Results Overview

TEAEs were defined as all adverse events (AEs) occurring from the start of treatment in this extension trial to the end of its residual effect period. AEs that began during the on-treatment period of the parent Proof of Concept and Confirmatory (PoCC) trial (1368-0052) and were still ongoing in this extension trial will also be considered as treatment-emergent.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

45 participants

Primary outcome timeframe

From drug administration until the end of maintenance treatment period (120 weeks). This period includes the Residual effect period (REP) (i.e., 16 weeks after the last study treatment).

Results posted on

2025-11-14

Participant Flow

This was a multi-national, multi-centre, non-controlled, single-arm, open-label extension trial of the proof-of-clinical-concept (PoCC) trial 1368-0052, consisting of a 104-week treatment period and a 16-week safety follow-up. Patients from the PoCC trial (spesolimab or placebo group) rolled over into this trial. The primary objective was to assess the long-term safety of spesolimab in patients with hidradenitis suppurativa (HS), with additional objectives focusing on efficacy at a lower dose.

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

Participant milestones
Measure	Prior Placebo (PP) Participants in the placebo arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 1200 mg intravenous (i.v.) loading dose of spesolimab plus subcutaneous (s.c.) placebo at Visit 1, followed by 600 mg s.c. doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.	Prior Spesolimab (PS) Participants in the active arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 600 mg subcutaneous (s.c.) loading dose of spesolimab plus intravenous (i.v.) placebo at Visit 1, followed by 600 mg s.c. doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.
Overall Study STARTED	15	30
Overall Study COMPLETED	7	9
Overall Study NOT COMPLETED	8	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Prior Placebo (PP) Participants in the placebo arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 1200 mg intravenous (i.v.) loading dose of spesolimab plus subcutaneous (s.c.) placebo at Visit 1, followed by 600 mg s.c. doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.	Prior Spesolimab (PS) Participants in the active arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 600 mg subcutaneous (s.c.) loading dose of spesolimab plus intravenous (i.v.) placebo at Visit 1, followed by 600 mg s.c. doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.
Overall Study Withdrawal by Subject	1	10
Overall Study Lost to Follow-up	2	4
Overall Study Lack of Efficacy	0	2
Overall Study Adverse Event	3	1
Overall Study Patient non-compliance	0	1
Overall Study Personal reasons	0	1
Overall Study Withdrawn as per protocol	2	2

Baseline Characteristics

A Study Investigating Long-term Treatment With Spesolimab in People With a Skin Disease Called Hidradenitis Suppurativa Who Completed a Previous Clinical Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prior Placebo (PP) n=15 Participants Participants in the placebo arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 1200 mg intravenous (i.v.) loading dose of spesolimab plus subcutaneous (s.c.) placebo at Visit 1, followed by 600 mg s.c. doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.	Prior Spesolimab (PS) n=30 Participants Participants in the active arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 600 mg subcutaneous (s.c.) loading dose of spesolimab plus intravenous (i.v.) placebo at Visit 1, followed by 600 mg s.c. doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.	Total n=45 Participants Total of all reporting groups
Age, Continuous	35.7 Years STANDARD_DEVIATION 10.7 • n=10 Participants	35.5 Years STANDARD_DEVIATION 10.8 • n=10 Participants	35.6 Years STANDARD_DEVIATION 10.7 • n=20 Participants
Sex: Female, Male Female	8 Participants n=10 Participants	19 Participants n=10 Participants	27 Participants n=20 Participants
Sex: Female, Male Male	7 Participants n=10 Participants	11 Participants n=10 Participants	18 Participants n=20 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=10 Participants	1 Participants n=10 Participants	2 Participants n=20 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=10 Participants	25 Participants n=10 Participants	39 Participants n=20 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants	4 Participants n=10 Participants	4 Participants n=20 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) Asian	2 Participants n=10 Participants	4 Participants n=10 Participants	6 Participants n=20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants	1 Participants n=10 Participants	1 Participants n=20 Participants
Race (NIH/OMB) Black or African American	2 Participants n=10 Participants	2 Participants n=10 Participants	4 Participants n=20 Participants
Race (NIH/OMB) White	11 Participants n=10 Participants	19 Participants n=10 Participants	30 Participants n=20 Participants
Race (NIH/OMB) More than one race	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants	4 Participants n=10 Participants	4 Participants n=20 Participants

PRIMARY outcome

Timeframe: From drug administration until the end of maintenance treatment period (120 weeks). This period includes the Residual effect period (REP) (i.e., 16 weeks after the last study treatment).

Population: Safety Analysis Set (SAF): This participant set included all participants who were enrolled and received at least one dose of study drug.

Outcome measures

Outcome measures
Measure	Prior Placebo (PP) n=15 Participants Participants in the placebo arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 1200 mg intravenous (i.v.) loading dose of spesolimab plus subcutaneous (s.c.) placebo at Visit 1, followed by 600 mg subcutaneous (s.c.) doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.	Prior Spesolimab (PS) n=30 Participants Participants in the active arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 600 mg subcutaneous (s.c.) loading dose of spesolimab plus intravenous (i.v.) placebo at Visit 1, followed by 600 mg s.c. doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	15 Participants	28 Participants

SECONDARY outcome

Timeframe: MMRM included measurements from baseline (Week 12 of 1368-0052) and at Weeks 1, 2, 4, 6, 8, 10, and 12 after first drug administration.

Population: Safety Analysis Set (SAF): This participant set included all participants who received at least one dose of the study drug. Data up to the use of rescue therapy were included for analysis, and data post-use were censored. Only participants with non-missing endpoint data were included.

Percentage change from baseline in total abscess and inflammatory nodule count at Week 12= \[(Total Abscess at Week 12 + Total Inflammatory Nodule at Week 12) - (Total Abscess at baseline + Total Inflammatory Nodule at baseline)\] \*100/ (Total Abscess at baseline + Total Inflammatory Nodule at baseline). Percentage change from baseline in total abscess and inflammatory nodule count at Week 12 was modelled using a restricted maximum likelihood (REML)-based mixed effect model with repeated measures (MMRM) approach, accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, prior use of TNF inhibitor and the fixed continuous effects of baseline at each visit (Weeks 1, 2, 4, 6, 8, 10, and 12) as well as random effect of each visit. Baseline refers to the last measurement prior to the start of spesolimab. The Least Squares Mean (Standard Error) of percentage change at Week 12 is reported.

Outcome measures

Outcome measures
Measure	Prior Placebo (PP) n=12 Participants Participants in the placebo arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 1200 mg intravenous (i.v.) loading dose of spesolimab plus subcutaneous (s.c.) placebo at Visit 1, followed by 600 mg subcutaneous (s.c.) doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.	Prior Spesolimab (PS) n=26 Participants Participants in the active arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 600 mg subcutaneous (s.c.) loading dose of spesolimab plus intravenous (i.v.) placebo at Visit 1, followed by 600 mg s.c. doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.
Percent Change in Total Abscess and Inflammatory Nodule (AN) Count From Baseline up to Week 12	-18.3 Percentage change Standard Error 19.2	-35.0 Percentage change Standard Error 12.7

SECONDARY outcome

Timeframe: MMRM included measurements from baseline (Week 12 of 1368-0052) and at Weeks 1, 2, 4, 6, 8, 10, and 12 after first drug administration. MMRM estimates of percentage change in draining fistula from baseline to Week 12 is reported.

Population: Safety Analysis Set (SAF): This patient set included all patients who received at least one dose of study drug. Data up to use of rescue therapy were included for analysis, and data post the use were censored. Only patients with baseline draining fistulas \>=1 and non-missing endpoint data were included.

Percentage change from baseline in draining fistula at Week 12 was calculated as: \[(total draining fistula at Week 12) - (total draining fistula at baseline)\] \* 100 %/ (total draining fistula at baseline). Percentage change from baseline in in draining fistula count at Week 12 was modelled using a restricted maximum likelihood (REML)-based mixed effect model with repeated measures (MMRM) approach, accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, prior use of TNF inhibitor and the fixed continuous effects of baseline at each visit (Weeks 1, 2, 4, 6, 8, 10, and 12) as well as random effect of each visit. Baseline refers to the last measurement prior to the start of spesolimab. Unstructured covariance matrix was used.

Outcome measures

Outcome measures
Measure	Prior Placebo (PP) n=11 Participants Participants in the placebo arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 1200 mg intravenous (i.v.) loading dose of spesolimab plus subcutaneous (s.c.) placebo at Visit 1, followed by 600 mg subcutaneous (s.c.) doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.	Prior Spesolimab (PS) n=21 Participants Participants in the active arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 600 mg subcutaneous (s.c.) loading dose of spesolimab plus intravenous (i.v.) placebo at Visit 1, followed by 600 mg s.c. doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.
Percentage Change in Total Draining Fistula (DF) Count From Baseline up to Week 12	25.4 Percentage change Standard Error 25.5	-44.6 Percentage change Standard Error 18.1

SECONDARY outcome

Timeframe: At baseline (Week 0) and at Week 12.

HiSCR is defined as at least a 50% reduction in the total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to baseline. Percentage of participants with achievement of Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 is reported. Percentage of participants with achievement of HiSCR at Week 12 was calculated as: number of participants with achievement of HiSCR at Week 12/number of participants analyzed \* 100.

Outcome measures

Outcome measures
Measure	Prior Placebo (PP) n=12 Participants Participants in the placebo arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 1200 mg intravenous (i.v.) loading dose of spesolimab plus subcutaneous (s.c.) placebo at Visit 1, followed by 600 mg subcutaneous (s.c.) doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.	Prior Spesolimab (PS) n=27 Participants Participants in the active arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 600 mg subcutaneous (s.c.) loading dose of spesolimab plus intravenous (i.v.) placebo at Visit 1, followed by 600 mg s.c. doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.
Achievement of Hidradenitis Suppurativa Clinical Response (HiSCR) up to Week 12	33.3 Percentage of participants Interval 13.8 to 60.9	40.7 Percentage of participants Interval 24.5 to 59.3

SECONDARY outcome

Timeframe: MMRM included measurements at baseline (Week 0) and at Weeks 1, 2, 4, 6, 8, 10, and 12 after first drug administration. MMRM estimates of absolute change in IHS4 from baseline to Week 12 is reported.

The IHS4 assesses the hidradenitis suppurativa (HS) severity and the resulting IHS4 score is arrived at by= number of nodules \* 1 + number of abscesses \* 2 + number of draining tunnels (fistulae or sinuses) \* 4. A total score of 3 or less signifies mild, 4-10 signifies moderate and 11 or higher signifies severe disease. The minimum score is 0 while the maximum score is variable and depends on the counts of nodules, abscesses, and draining tunnels (fistulae or sinuses). Absolute change from baseline in IHS4 value at Week 12 was modelled using a restricted maximum likelihood (REML)-based mixed effect model with repeated measures (MMRM) approach, accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, prior use of TNF inhibitor and the fixed continuous effects of baseline at each visit (Weeks 1, 2, 4, 6, 8, 10, and 12) as well as random effect of each visit. Baseline refers to the last measurement prior to the start of spesolimab.

Outcome measures

Outcome measures
Measure	Prior Placebo (PP) n=13 Participants Participants in the placebo arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 1200 mg intravenous (i.v.) loading dose of spesolimab plus subcutaneous (s.c.) placebo at Visit 1, followed by 600 mg subcutaneous (s.c.) doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.	Prior Spesolimab (PS) n=26 Participants Participants in the active arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 600 mg subcutaneous (s.c.) loading dose of spesolimab plus intravenous (i.v.) placebo at Visit 1, followed by 600 mg s.c. doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.
Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Value up to Week 12	-3.1 Score on a scale Standard Error 4.8	-10.5 Score on a scale Standard Error 3.3

SECONDARY outcome

Timeframe: At Week 12.

Population: Safety Analysis Set (SAF): This participant set included all participants who received at least one dose of study drug. Any binary data collected after use of any rescue therapy was censored and then imputed using the no response imputation (NRI) method as described in the statistical analysis plan.

HS-PGA documents the physician's assessment of the participant's HS at a given timepoint. The HS-PGA score ranges from 0 to 5: 0=clear (no abscesses, draining fistula, inflammatory or noninflammatory nodules); 1=minimal (no abscesses, draining fistula, inflammatory nodules; noninflammatory nodules present); 2=mild (no abscesses, draining fistula, 1-4 inflammatory nodules; or 1 abscess or draining tunnel, no inflammatory nodules); 3=moderate (no abscesses, draining fistula, ≥5 inflammatory nodules; or 1 abscess/draining fistula, ≥1 inflammatory nodule; or 2-5 abscesses/draining fistula, \<10 inflammatory nodules); 4=severe (2-5 abscesses/draining fistula, ≥10 inflammatory nodules); 5=very severe (\>5 abscesses/draining fistula). The percentage of participants with HS-PGA 0 or 1 at Week 12 was calculated as: (number with HS-PGA 0/1 at Week 12 ÷ number analyzed) × 100.

Outcome measures

Outcome measures
Measure	Prior Placebo (PP) n=13 Participants Participants in the placebo arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 1200 mg intravenous (i.v.) loading dose of spesolimab plus subcutaneous (s.c.) placebo at Visit 1, followed by 600 mg subcutaneous (s.c.) doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.	Prior Spesolimab (PS) n=27 Participants Participants in the active arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 600 mg subcutaneous (s.c.) loading dose of spesolimab plus intravenous (i.v.) placebo at Visit 1, followed by 600 mg s.c. doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.
Percentage of Participants With Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) Score of 0 or 1 up to Week 12	0 Percentage of participants Interval 0.0 to 22.8	3.7 Percentage of participants Interval 0.7 to 18.3

SECONDARY outcome

Timeframe: MMRM included measurements at baseline (Week 0) and at Weeks 1, 2, 4, 6, 8, 10, and 12 after first drug administration. MMRM estimates of absolute change from baseline in HASI score at Week 12 is reported.

The HASI assesses HS severity across four domains: erythema, induration, open ulcer, and draining fistula, scored on a 0 (none) to 3 (severe/extensive) Likert scale for each body region. For body surface area (BSA) assessment, the number of palms (one palm indicates 1% of the participant's BSA) involved for each body region (head, right axilla, left axilla, anterior chest, back, anterior bathing trunk, posterior bathing trunk, other) is assessed and converted to a percentage of that region. An area score was assigned to each region using the approach (0 = none, 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89%, 6 = 90- 100%). Scores for the four domains of HS are summed and adjusted for the area affected, and the score of each area are summed to calculate the total HASI score, which ranges from 0 (no disease) to 72 (severe disease). The Least Squares Mean (Standard Error (SE)) was derived from mixed effect model with repeated measures (MMRM).

Outcome measures

Outcome measures
Measure	Prior Placebo (PP) n=13 Participants Participants in the placebo arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 1200 mg intravenous (i.v.) loading dose of spesolimab plus subcutaneous (s.c.) placebo at Visit 1, followed by 600 mg subcutaneous (s.c.) doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.	Prior Spesolimab (PS) n=26 Participants Participants in the active arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 600 mg subcutaneous (s.c.) loading dose of spesolimab plus intravenous (i.v.) placebo at Visit 1, followed by 600 mg s.c. doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.
Absolute Change From Baseline in Hidradenitis Suppurativa Area and Severity Index (HASI) Score up to Week 12	5.0 Score on a scale Standard Error 8.9	-22.8 Score on a scale Standard Error 6.1

SECONDARY outcome

Timeframe: Samples were taken at baseline (Week 0) and at Weeks 2, 4, 6, 8, 10, and 12 after first drug administration.

Percentage of participants with occurrence of at least one flare at Week 12. Flare was defined as at least 25 % increase in abscess and inflammatory nodule count with a minimum increase of 2 relative to baseline. Percentage of participants with occurrence of at least one flare at Week 12 was calculated as: number of participants with occurrence of at least one flare at Week 12/number of participants analyzed \* 100.

Outcome measures

Outcome measures
Measure	Prior Placebo (PP) n=12 Participants Participants in the placebo arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 1200 mg intravenous (i.v.) loading dose of spesolimab plus subcutaneous (s.c.) placebo at Visit 1, followed by 600 mg subcutaneous (s.c.) doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.	Prior Spesolimab (PS) n=27 Participants Participants in the active arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 600 mg subcutaneous (s.c.) loading dose of spesolimab plus intravenous (i.v.) placebo at Visit 1, followed by 600 mg s.c. doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.
Patients With Occurrence of at Least One Flare (Defined as at Least 25 % Increase in AN Count With a Minimum Increase of 2 Relative to Baseline) up to Week 12	8.3 Percentage of participants Interval 1.5 to 35.4	14.8 Percentage of participants Interval 5.9 to 32.5

SECONDARY outcome

Timeframe: At baseline (Week 0) and at Week 12.

The analysis assessed the percentage of participants who achieved at least a 30% reduction from baseline in the Numerical Rating Scale (NRS30) for the Participant's Global Assessment of HS Pain by Week 12. The HS Pain Numerical Rating Scale (NRS) measures HS-related pain severity, with a recall period of 24 hours and responses on an 11-point scale from 0 (no pain) to 10 (worst possible pain). For pain analysis, a weekly average of daily assessments was calculated at each visit, based on recorded values before the visit. Weeks with at least four reported daily values were included, ignoring any missing daily values. The percentage of participants achieving at least a 30% reduction from baseline in NRS30 by Week 12 was calculated as the number of participants meeting this criterion divided by the total number of participants analyzed \* 100.

Outcome measures

Outcome measures
Measure	Prior Placebo (PP) n=12 Participants Participants in the placebo arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 1200 mg intravenous (i.v.) loading dose of spesolimab plus subcutaneous (s.c.) placebo at Visit 1, followed by 600 mg subcutaneous (s.c.) doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.	Prior Spesolimab (PS) n=27 Participants Participants in the active arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 600 mg subcutaneous (s.c.) loading dose of spesolimab plus intravenous (i.v.) placebo at Visit 1, followed by 600 mg s.c. doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.
Achievement of at Least 30% Reduction From Baseline in Numerical Rating Scale (NRS30) in Patient's Global Assessment of HS Pain up to Week 12	25.0 Percentage of participants Interval 8.9 to 53.2	33.3 Percentage of participants Interval 20.2 to 55.5

Adverse Events

Prior Placebo (PP)

Serious events: 4 serious events

Other events: 15 other events

Deaths: 0 deaths

Prior Spesolimab (PS)

Serious events: 6 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Prior Placebo (PP) n=15 participants at risk Participants in the placebo arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 1200 mg intravenous (i.v.) loading dose of spesolimab plus subcutaneous (s.c.) placebo at Visit 1, followed by 600 mg s.c. doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.	Prior Spesolimab (PS) n=30 participants at risk Participants in the active arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 600 mg subcutaneous (s.c.) loading dose of spesolimab plus intravenous (i.v.) placebo at Visit 1, followed by 600 mg s.c. doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12.
Gastrointestinal disorders Pancreatitis	0.00% 0/15 • All-cause mortality, AEs and SAEs: From drug administration until the end of maintenance treatment period (120 weeks). This period includes the Residual effect period (REP) (i.e., 16 weeks after the last study treatment). Safety Analysis Set (SAF): The safety analysis set includes all participants who received at least one dose of the trial drug.	3.3% 1/30 • All-cause mortality, AEs and SAEs: From drug administration until the end of maintenance treatment period (120 weeks). This period includes the Residual effect period (REP) (i.e., 16 weeks after the last study treatment). Safety Analysis Set (SAF): The safety analysis set includes all participants who received at least one dose of the trial drug.
Infections and infestations Abdominal abscess	0.00% 0/15 • All-cause mortality, AEs and SAEs: From drug administration until the end of maintenance treatment period (120 weeks). This period includes the Residual effect period (REP) (i.e., 16 weeks after the last study treatment). Safety Analysis Set (SAF): The safety analysis set includes all participants who received at least one dose of the trial drug.	3.3% 1/30 • All-cause mortality, AEs and SAEs: From drug administration until the end of maintenance treatment period (120 weeks). This period includes the Residual effect period (REP) (i.e., 16 weeks after the last study treatment). Safety Analysis Set (SAF): The safety analysis set includes all participants who received at least one dose of the trial drug.
Infections and infestations Acute hepatitis C	6.7% 1/15 • All-cause mortality, AEs and SAEs: From drug administration until the end of maintenance treatment period (120 weeks). This period includes the Residual effect period (REP) (i.e., 16 weeks after the last study treatment). Safety Analysis Set (SAF): The safety analysis set includes all participants who received at least one dose of the trial drug.	0.00% 0/30 • All-cause mortality, AEs and SAEs: From drug administration until the end of maintenance treatment period (120 weeks). This period includes the Residual effect period (REP) (i.e., 16 weeks after the last study treatment). Safety Analysis Set (SAF): The safety analysis set includes all participants who received at least one dose of the trial drug.
Infections and infestations Latent tuberculosis	6.7% 1/15 • All-cause mortality, AEs and SAEs: From drug administration until the end of maintenance treatment period (120 weeks). This period includes the Residual effect period (REP) (i.e., 16 weeks after the last study treatment). Safety Analysis Set (SAF): The safety analysis set includes all participants who received at least one dose of the trial drug.	0.00% 0/30 • All-cause mortality, AEs and SAEs: From drug administration until the end of maintenance treatment period (120 weeks). This period includes the Residual effect period (REP) (i.e., 16 weeks after the last study treatment). Safety Analysis Set (SAF): The safety analysis set includes all participants who received at least one dose of the trial drug.
Infections and infestations Vulval abscess	6.7% 1/15 • All-cause mortality, AEs and SAEs: From drug administration until the end of maintenance treatment period (120 weeks). This period includes the Residual effect period (REP) (i.e., 16 weeks after the last study treatment). Safety Analysis Set (SAF): The safety analysis set includes all participants who received at least one dose of the trial drug.	0.00% 0/30 • All-cause mortality, AEs and SAEs: From drug administration until the end of maintenance treatment period (120 weeks). This period includes the Residual effect period (REP) (i.e., 16 weeks after the last study treatment). Safety Analysis Set (SAF): The safety analysis set includes all participants who received at least one dose of the trial drug.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/15 • All-cause mortality, AEs and SAEs: From drug administration until the end of maintenance treatment period (120 weeks). This period includes the Residual effect period (REP) (i.e., 16 weeks after the last study treatment). Safety Analysis Set (SAF): The safety analysis set includes all participants who received at least one dose of the trial drug.	3.3% 1/30 • All-cause mortality, AEs and SAEs: From drug administration until the end of maintenance treatment period (120 weeks). This period includes the Residual effect period (REP) (i.e., 16 weeks after the last study treatment). Safety Analysis Set (SAF): The safety analysis set includes all participants who received at least one dose of the trial drug.
Nervous system disorders Guillain-Barre syndrome	0.00% 0/15 • All-cause mortality, AEs and SAEs: From drug administration until the end of maintenance treatment period (120 weeks). This period includes the Residual effect period (REP) (i.e., 16 weeks after the last study treatment). Safety Analysis Set (SAF): The safety analysis set includes all participants who received at least one dose of the trial drug.	3.3% 1/30 • All-cause mortality, AEs and SAEs: From drug administration until the end of maintenance treatment period (120 weeks). This period includes the Residual effect period (REP) (i.e., 16 weeks after the last study treatment). Safety Analysis Set (SAF): The safety analysis set includes all participants who received at least one dose of the trial drug.
Psychiatric disorders Acute psychosis	0.00% 0/15 • All-cause mortality, AEs and SAEs: From drug administration until the end of maintenance treatment period (120 weeks). This period includes the Residual effect period (REP) (i.e., 16 weeks after the last study treatment). Safety Analysis Set (SAF): The safety analysis set includes all participants who received at least one dose of the trial drug.	3.3% 1/30 • All-cause mortality, AEs and SAEs: From drug administration until the end of maintenance treatment period (120 weeks). This period includes the Residual effect period (REP) (i.e., 16 weeks after the last study treatment). Safety Analysis Set (SAF): The safety analysis set includes all participants who received at least one dose of the trial drug.
Skin and subcutaneous tissue disorders Hidradenitis	6.7% 1/15 • All-cause mortality, AEs and SAEs: From drug administration until the end of maintenance treatment period (120 weeks). This period includes the Residual effect period (REP) (i.e., 16 weeks after the last study treatment). Safety Analysis Set (SAF): The safety analysis set includes all participants who received at least one dose of the trial drug.	6.7% 2/30 • All-cause mortality, AEs and SAEs: From drug administration until the end of maintenance treatment period (120 weeks). This period includes the Residual effect period (REP) (i.e., 16 weeks after the last study treatment). Safety Analysis Set (SAF): The safety analysis set includes all participants who received at least one dose of the trial drug.

Other adverse events

Additional Information

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