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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-005587-55 | EudraCT Number |
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This study is open to adults with hidradenitis suppurativa who took part in a previous clinical study of a medicine called spesolimab. Participants who completed treatment can join this study.
The purpose of this study is to find out how safe spesolimab is and whether it helps people with hidradenitis suppurativa in the long-term. Participants are in this study for about 2 years and 4 months. For 2 years, participants visit the study site every 2 weeks to get spesolimab injections under the skin. At study visits, doctors check the severity of participants' hidradenitis suppurativa and collect information on any health problems of the participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prior Placebo (PP) | Experimental | 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. |
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| Prior Spesolimab (PS) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spesolimab 1200 mg | Drug | Participants in the 1368-0052 PoCC trial's placebo arm received a 1200 mg intravenous (i.v.) loading dose at Visit 1, then 600 mg s.c. every two weeks for 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 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. | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Total Abscess and Inflammatory Nodule (AN) Count From Baseline up to Week 12 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Research Associates | Los Angeles | California | 90045 | United States | ||
| Dawes Fretzin Clinical Research Group, LLC-Indianapolis-58713 |
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| Label | URL |
|---|---|
| Related Info | View source |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to: https://www.mystudywindow.com/msw/datatransparency
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 4, 2022 | Apr 4, 2025 |
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All medication kit assignments will occur in an open label fashion except for medications provided for visit 1. Only administration of study medication at visit 1 is blinded.
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| Spesolimab 600 mg | Drug | Participants in the 1368-0052 PoCC trial's active arm received a 600 mg subcutaneous (s.c.) loading dose of spesolimab at Visit 1, followed by 600 mg s.c. every two weeks for 12 weeks. |
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| Placebo matching 600 mg Spesolimab | Drug | Participants from the placebo arm of the 1368-0052 PoCC trial will receive a subcutaneous (s.c.) administration of placebo matching 600 mg spesolimab at Visit 1. |
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| Placebo matching 1200 mg Spesolimab | Drug | Participants from the active arm of the 1368-0052 PoCC trial will receive an intravenous (i.v.) infusion of placebo matching 1200 mg spesolimab at Visit 1 |
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| 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. |
| Percentage Change in Total Draining Fistula (DF) Count From Baseline up to Week 12 | 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. | 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. |
| Achievement of Hidradenitis Suppurativa Clinical Response (HiSCR) up to 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. | At baseline (Week 0) and at Week 12. |
| Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Value up to Week 12 | 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. | 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. |
| Percentage of Participants With Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) Score of 0 or 1 up to Week 12 | 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. | At Week 12. |
| Absolute Change From Baseline in Hidradenitis Suppurativa Area and Severity Index (HASI) Score up to Week 12 | 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). | 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. |
| 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 | 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. | Samples were taken at baseline (Week 0) and at Weeks 2, 4, 6, 8, 10, and 12 after first drug administration. |
| 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 | 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. | At baseline (Week 0) and at Week 12. |
| Indianapolis |
| Indiana |
| 46250 |
| United States |
| Mayo Clinic, Rochester | Rochester | Minnesota | 55905 | United States |
| Unity Clinical Research | Oklahoma City | Oklahoma | 73118 | United States |
| Holdsworth House Medical Practice | Sydney | New South Wales | 2010 | Australia |
| Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| Cliniques Universitaires Saint-Luc | Brussels | 1200 | Belgium |
| Dr. S. K. Siddha Medicine Professional Corporation | Newmarket | Ontario | L3Y 5G8 | Canada |
| University Hospital Ostrava | Ostrava | 708 52 | Czechia |
| CLI Reims Bezannes | Bezannes | 51430 | France |
| HOP Edouard Herriot | Lyon | 69437 | France |
| HOP Larrey | Toulouse | 31059 | France |
| Katholisches Klinikum Bochum gGmbH | Bochum | 44791 | Germany |
| Städtisches Klinikum Dessau | Dessau | 06847 | Germany |
| Universitätsklinikum Frankfurt | Frankfurt am Main | 60596 | Germany |
| Ospedali Riuniti di Ancona | Ancona | 60123 | Italy |
| Azienda Ospedaliera Universitaria Pisana | Pisa | 56126 | Italy |
| Erasmus Medisch Centrum-ROTTERDAM-50697 | Rotterdam | 3015 GD | Netherlands |
| Haukeland Universitetssykehus | Bergen | N-5021 | Norway |
| Nordlandssykehuset HF, Bodø | Bodø | N-8092 | Norway |
| Oslo Universitetssykehus HF, Rikshospitalet | Oslo | N-0372 | Norway |
| Non-Public Health Care Facility LABDERM | Ossy | 42624 | Poland |
| Cityclinic Medical and Psychological Clinic Matusiak Partnership | Wroclaw | 50-566 | Poland |
| Hospital Santa Creu i Sant Pau | Barcelona | 08026 | Spain |
| Hospital La Princesa | Madrid | 28006 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| FG001 | 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. |
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| COMPLETED | Trial medication |
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| NOT COMPLETED |
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Safety Analysis Set (SAF): The safety analysis set includes all participants who received at least one dose of the trial drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
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| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 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. | Safety Analysis Set (SAF): This participant set included all participants who were enrolled and received at least one dose of study drug. | Posted | Count of Participants | Participants | 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). |
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| Secondary | Percent Change in Total Abscess and Inflammatory Nodule (AN) Count From Baseline up to Week 12 | 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. | 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. | Posted | Least Squares Mean | Standard Error | Percentage change | 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. |
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| Secondary | Percentage Change in Total Draining Fistula (DF) Count From Baseline up to Week 12 | 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. | 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. | Posted | Least Squares Mean | Standard Error | Percentage change | 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. |
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| Secondary | Achievement of Hidradenitis Suppurativa Clinical Response (HiSCR) up to 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | At baseline (Week 0) and at Week 12. |
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| Secondary | Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Value up to Week 12 | 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. | 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. | Posted | Least Squares Mean | Standard Error | Score on a scale | 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. |
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| Secondary | Percentage of Participants With Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) Score of 0 or 1 up to Week 12 | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Week 12. |
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| Secondary | Absolute Change From Baseline in Hidradenitis Suppurativa Area and Severity Index (HASI) Score up to Week 12 | 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). | 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. | Posted | Least Squares Mean | Standard Error | Score on a scale | 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. |
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| Secondary | 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 | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Samples were taken at baseline (Week 0) and at Weeks 2, 4, 6, 8, 10, and 12 after first drug administration. |
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| Secondary | 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 | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | At baseline (Week 0) and at Week 12. |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 15 | 4 | 15 | 15 | 15 |
| EG001 | 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. | 0 | 30 | 6 | 30 | 27 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Acute hepatitis C | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Latent tuberculosis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Vulval abscess | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Guillain-Barre syndrome | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Acute psychosis | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hidradenitis | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Injection site haematoma | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Swelling face | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abscess sweat gland | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Erythrasma | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Nail infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pilonidal disease | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Tinea cruris | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Sunburn | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Bacterial test positive | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood fibrinogen increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Heart rate irregular | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Mycobacterium test positive | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Sacral pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Leukocyturia | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Heavy menstrual bleeding | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hidradenitis | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Intertrigo | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Skin haemorrhage | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 018002430127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 4, 2024 | Apr 4, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000712973 | spesolimab |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | 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. |
|
|
| OG001 | 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. |
|
|
|
|
| OG001 | 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. |
|
|
| OG001 | 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. |
|
|
| OG001 | 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. |
|
|
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. |
|
|
| OG001 | 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. |
|
|