Lunsayil 1: A Study to Test Whether Spesolimab Helps Peop... | NCT05819398 | Trialant
NCT05819398
Sponsor
Boehringer Ingelheim
Status
Completed
Last Update Posted
Nov 5, 2025Actual
Enrollment
209Actual
Phase
Phase 2Phase 3
Conditions
Hidradenitis Suppurativa
Interventions
Spesolimab i.v.
Spesolimab s.c.
Placebo matching Spesolimab i.v.
Placebo matching Spesolimab s.c.
Countries
United States
Argentina
Australia
Austria
Belgium
Bulgaria
Canada
Chile
China
Czechia
Denmark
Finland
France
Germany
Greece
Israel
Italy
Japan
Lithuania
Malaysia
Mexico
Netherlands
New Zealand
Philippines
Poland
Singapore
Slovakia
South Africa
South Korea
Spain
Switzerland
Taiwan
Turkey (Türkiye)
United Kingdom
Vietnam
Protocol Section
Identification Module
NCT ID
NCT05819398
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
1368-0098
Secondary IDs
ID
Type
Description
Link
2022-501074-19-00
Registry Identifier
CTIS (EU)
Brief Title
Lunsayil 1: A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa
Official Title
Randomised, Double-blind, Placebo-controlled, Phase IIb/Phase III Study to Evaluate the Efficacy and Safety of Spesolimab in Patients With Moderate to Severe Hidradenitis Suppurativa. Lunsayil 1.
Acronym
Not provided
Organization
Boehringer IngelheimINDUSTRY
Status Module
Record Verification Date
Oct 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 17, 2023Actual
Primary Completion Date
Aug 1, 2024Actual
Completion Date
Mar 31, 2025Actual
First Submitted Date
Apr 6, 2023
First Submission Date that Met QC Criteria
Apr 6, 2023
First Posted Date
Apr 19, 2023Actual
Results Waived
Not provided
Results First Submitted Date
Jul 31, 2025
Results First Submitted that Met QC Criteria
Oct 17, 2025
Results First Posted Date
Nov 5, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 17, 2025
Last Update Posted Date
Nov 5, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Boehringer IngelheimINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study is open to adults with moderate to severe hidradenitis suppurativa (HS). The purpose of this study is to find out whether a medicine called spesolimab helps people with HS. People who have previously taken specific medicines such as immunosuppressive biologics other than Tumor necrosis factor (TNF) inhibitors cannot take part.
This study has 2 parts. In Part 1, participants are divided into 4 groups of almost equal size. 3 groups get different doses of spesolimab, 1 group gets placebo. All participants get injections into a vein or under the skin. Placebo injections look like spesolimab injections, but do not contain any medicine. Every participant has an equal chance of being in each group. In the beginning, participants get the study medicine every week and later every 2 weeks. After 4 months, participants in the placebo group switch to spesolimab treatment.
In Part 2, participants are divided into 2 groups. One group gets a suitable dose of spesolimab that was found in Part 1 of the study. The other group gets placebo. After 4 months, participants in the placebo group switch to spesolimab treatment.
Participants join only one of the two parts. They are in the study for about 1 year. During this time, they visit the study site in the beginning every week and later every 2 weeks. Some of the visits can be done at the participant's home instead of the study site. The doctors regularly check participants' HS symptoms. The results are compared between the groups to see whether spesolimab works. The doctors also regularly check participants' general health and take note of any unwanted effects.
Detailed Description
Main endpoints for Part 2 will be supported by Part 1 results available at time of primary analysis.
Conditions Module
Conditions
Hidradenitis Suppurativa
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
209Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Spesolimab low dose group
Experimental
Patients with moderate to severe HS were administered an initial weekly low dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).
From Week 16, if patients had inadequate clinical response defined as 25% increase in the ANdT count compared to baseline, the dose could be increased every two weeks to a pre-determined concentration.
Drug: Spesolimab i.v.
Drug: Spesolimab s.c.
Spesolimab medium dose group
Experimental
Patients with moderate to severe HS were administered an initial weekly medium dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).
Drug: Spesolimab i.v.
Drug: Spesolimab s.c.
Spesolimab high dose group
Experimental
Patients with moderate to severe HS were administered an initial weekly high dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).
Drug: Spesolimab i.v.
Drug: Spesolimab s.c.
Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Spesolimab i.v.
Drug
Weekly dose of spesolimab via i.v. for 4 weeks.
Spesolimab high dose group
Spesolimab low dose group
Spesolimab medium dose group
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part 1 - Percent Change From Baseline in Draining Fistula/Tunnel (dT) Count at Week 8
Percent change from baseline in draining fistula/tunnel (dT) count at Week 8 is reported. Tunnel/fistula/sinus were counted as dT only if draining. Percent change was calculated as follows: (dT count at week 8 - dT count at baseline)/ dT at baseline.
Least square means and standard errors were estimated by Mixed effect model for repeated measurements (MMRM). The MMRM included fixed categorical effects of treatment at each visit, Tumor Necrosis Factor inhibitor (TNFi) status at baseline, and categorical baseline dT count at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-trial participant measurements.
The MMRM model incorporates dT count from baseline (Week 0), Week 2, Week 4, Week 6 and Week 8. The data represent the Least Squares Means at Week 8.
Secondary Outcomes
Measure
Description
Time Frame
Part 1 - Percent Change From Baseline in Draining Fistula/Tunnel (dT) Count at Week 16
Percent change from baseline in draining fistula/tunnel (dT) count at Week 16 is reported. Tunnel/fistula/sinus were counted as dT only if draining.
Least square means and standard errors were estimated by MMRM, which included fixed categorical effects of treatment at each visit, TNFi status at baseline, categorical baseline dT count and fixed continuous effect of baseline of outcome measures at each visit. Visit was treated as repeated measure with an unstructured covariance matrix for the within trial participant variability and all visits with planned measurements of the outcome variable as well as all dose groups were included in the model.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Of full age of consent at screening.
Signed and dated written informed consent in accordance with International Council on Harmonisation-Good clinical practice (ICH-GCP) and local legislation prior to admission to the trial.
Moderate to severe HS.
HS lesions in at least 2 distinct anatomic areas.
Biologic naive or Tumor Necrosis Factor inhibitor (TNFi)-exposed for HS.
For biologic naïve, inadequate response to an adequate course of appropriate oral antibiotics for treatment of HS in the last 1 year prior to the Baseline visit, as per investigator discretion. All participants must have previous exposure to antibiotics for HS.
Total AN count of greater than or equal to 5.
Total dT count of at least 1 at Baseline visit. Further inclusion criteria apply.
Exclusion Criteria:
Participants who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
Prior exposure to any immunosuppressive/immunomodulatory biologic other than TNFi for HS.
Prior exposure to Interleukin 36 receptor (IL-36R) inhibitors including spesolimab.
Treated with any investigational device or investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives of the drug, whichever is longer.
Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
Participants with history of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients.
Participants with a transplanted organ (with exception of a corneal transplant >12 weeks prior to screening) or who has ever received stem cell therapy (e.g., Remestemcel-L).
Participants with any documented active or suspected malignancy or history of malignancy within 5 years prior to the screening visit, except appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ carcinoma of uterine cervix.
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).
Subjects were screened for eligibility prior to participation and attended a specialist site which ensured that they 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. The trial was completed according to the protocol. However, part 2 was never initiated. The primary and interim analyses of part 1 (dose finding phase) didn't show signal to proceed with the confirmatory phase (part 2).
Recruitment Details
This was an international, Phase IIb/III multi-center, double-blind, placebo-controlled, randomised trial assessing the efficacy and safety of spesolimab versus placebo in patients with moderate to severe Hidradenitis suppurativa.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Patients with moderate to severe Hidradenitis suppurativa (HS) were administered an initial weekly dose of placebo via intravenous infusion (i.v.) (Week 0 to Week 3). Afterwards, patients were administered a subcutaneous injection (s.c.) dose of placebo once a week for 4 weeks (Week 4 to Week 7), and once every 2 weeks for the following 7 weeks (Week 8 to Week 14).
From Week 16 until the end of treatment (Week 48), patients were switched to the same s.c. dose of spesolimab administered to patients in the medium and high dose groups (starting with 3 loading s.c. doses of spesolimab every week and then maintenance s.c. dose of spesolimab every 2 weeks).
Patients with moderate to severe Hidradenitis suppurativa (HS) were administered an initial weekly dose of placebo via intravenous infusion (i.v.) (Week 0 to Week 3). Afterwards, patients were administered a subcutaneous injection (s.c.) dose of placebo once a week for 4 weeks (Week 4 to Week 7), and once every 2 weeks for the following 7 weeks (Week 8 to Week 14).
From Week 16 until the end of treatment (Week 48), patients were switched to the same s.c. dose of spesolimab administered to patients in the medium and high dose groups (starting with 3 loading s.c. doses of spesolimab every week and then maintenance s.c. dose of spesolimab every 2 weeks).
Drug: Spesolimab s.c.
Drug: Placebo matching Spesolimab i.v.
Drug: Placebo matching Spesolimab s.c.
Spevigo®
Spesolimab s.c.
Drug
Weekly s.c. dose of spesolimab for 4 weeks (3 weeks for Placebo), and maintenance s.c. dose of spesolimab every two weeks until the end of the treatment.
Placebo
Spesolimab high dose group
Spesolimab low dose group
Spesolimab medium dose group
Spevigo®
Placebo matching Spesolimab i.v.
Drug
Weekly dose of placebo via i.v. for 4 weeks.
Placebo
Placebo matching Spesolimab s.c.
Drug
Weekly s.c. dose of placebo for 4 weeks, and once every 2 weeks for the following 7 weeks.
Placebo
The MMRM model incorporates dT count from baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14 and Week 16. The data represent the Least Squares Means at Week 16.
Part 1 - Absolute Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Value at Week 8
IHS4 is a validated, clinical scoring system for dynamic assessment of HS severity. The score was calculated as: (number of nodules x1) + (number of abscesses x2) + (number of draining tunnels [fistulae/sinuses] x4). The minimum is 0, the maximum depends on the count of nodules, abscesses, and draining tunnels. Scores 0-3 indicate mild HS, 4-10 moderate HS, ≥11 severe HS. Absolute change from baseline was calculated as follows: (IHS4 value at visit timepoints) - (IHS4 value at baseline).
Least square means and standard errors were estimated by MMRM, which included fixed categorical effects of treatment at each visit, TNFi status at baseline, categorical baseline dT count and fixed continuous effect of baseline of outcome measures at each visit. Visit was treated as repeated measure with an unstructured covariance matrix for the within trial participant variability and all visits with planned measurements of the outcome variable as well as all dose groups were included in the model.
The MMRM model incorporates IHS4 value from baseline (Week 0), Week 2, Week 4, Week 6 and Week 8. The data represent the Least Squares Means at Week 8.
Part 1 - Absolute Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Value at Week 16
IHS4 is a validated, clinical scoring system for dynamic assessment of HS severity. The score was calculated as: (number of nodules x1) + (number of abscesses x2) + (number of draining tunnels [fistulae/sinuses] x4). The minimum is 0, the maximum depends on the count of nodules, abscesses, and draining tunnels. Scores 0-3 indicate mild HS, 4-10 moderate HS, ≥11 severe HS. Absolute change from baseline was calculated as follows: (IHS4 value at visit timepoints) - (IHS4 value at baseline).
Least square means and standard errors were estimated by MMRM, which included fixed categorical effects of treatment at each visit, TNFi status at baseline, categorical baseline dT count and fixed continuous effect of baseline of outcome measures at each visit. Visit was treated as repeated measure with an unstructured covariance matrix for the within trial participant variability and all visits with planned measurements of the outcome variable as well as all dose groups were included in the model.
The MMRM model incorporates IHS4 from baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14 and Week 16. The data represent the Least Squares Means at Week 16.
Part 1 - Occurrence of Treatment Emergent Adverse Events (TEAEs)
The occurrence of treatment emergent adverse events (TEAEs) is reported as the number of patients with TEAEs.
From first drug administration until end of exposure, plus residual effect period, up to approximately 68 weeks.
Los Angeles
California
90045
United States
Integrative Skin Science and Research-Sacramento-69402
Sacramento
California
95815
United States
Clinical Trials Research Institute
Thousand Oaks
California
91320
United States
Ziaderm Research
North Miami Beach
Florida
33162
United States
ForCare Clinical Research, Inc.
Tampa
Florida
33613
United States
Olympian Clinical Research-Tampa-69560
Tampa
Florida
33615
United States
Dawes Fretzin Clinical Research Group, LLC-Indianapolis -68995
Indianapolis
Indiana
46250
United States
Skin Sciences, PLLC
Louisville
Kentucky
40217
United States
University of Michigan Health System
Ann Arbor
Michigan
48109
United States
Oakland Hills Dermatology, PC
Auburn Hills
Michigan
48326
United States
Skin Specialists, P.C.
Omaha
Nebraska
68144
United States
AXIS Clinicals
Fargo
North Dakota
58103
United States
Unity Clinical Research
Oklahoma City
Oklahoma
73118
United States
University of Pennsylvania
Philadelphia
Pennsylvania
19104
United States
Medical University of South Carolina
Charleston
South Carolina
29425
United States
Palmetto Clinical Trial Services
Greenville
South Carolina
29615
United States
Center for Clinical Studies-Houston-58806
Houston
Texas
77004
United States
Progressive Clinical Research
San Antonio
Texas
78213
United States
STAT Research
CABA
C1023AAB
Argentina
Hospital Italiano de Buenos Aires
CABA
C1056AB
Argentina
Hospital Alemán
Capital Federal
C1118AAT
Argentina
Centro de Investigaciones Medicas Mar del Plata
Mar del Plata
7600
Argentina
Instituto de Especialidades de la Salud Rosario
Rosario
2000
Argentina
Sanatorio 9 de Julio S.A.
San Miguel de Tucumán
4000
Argentina
Holdsworth House Medical Practice
Sydney
New South Wales
2010
Australia
Westmead Hospital
Westmead
New South Wales
2145
Australia
Alfred Hospital
Melbourne
Victoria
3004
Australia
AKH - Medical University of Vienna
Vienna
1090
Austria
Cliniques Universitaires Saint-Luc
Brussels
1200
Belgium
Centre Hospitalier Universitaire de Liège
Liège
4000
Belgium
Medical Center "Kordis"
Pleven
5800
Bulgaria
ASMC-IPSMC-skin and Veneral Diseases
Sofia
1407
Bulgaria
Diagnostic Consultative Center Alexandrovska
Sofia
1431
Bulgaria
DCC "Fokus-5-LZIP" OOD
Sofia
1463
Bulgaria
Medical Military Academy MHAT Sofia
Sofia
1606
Bulgaria
MHAT Prof Stoyan Kirkovich AD
Stara Zagora
6000
Bulgaria
Alberta DermaSurgery Centre
Edmonton
Alberta
T6G 1C3
Canada
SimcoDerm Medical and Surgical Dermatology Centre
Barrie
Ontario
L4M 7G1
Canada
Guelph Dermatology Research
Guelph
Ontario
N1L 0B7
Canada
Dr. S. K. Siddha Medicine Professional Corporation
Newmarket
Ontario
L3Y 5G8
Canada
York Dermatology Clinic and Research Centre
Richmond Hill
Ontario
L4B 1L1
Canada
Centro Internacional de Estudios ClÃnicos (CIEC)
Comuna de Recoleta
8420383
Chile
ClÃnica Dermacross S.A.
Vitacura
7640881
Chile
Peking University First Hospital
Beijing
100034
China
The First Hospital of Jilin University
Changchun
130021
China
The Second Xiangya Hospital Of Central South University
Changsha
410011
China
West China Hospital of Sichuan University
Chengdu
610041
China
Southern Medical University Dermatology Hospital
Guangzhou
510091
China
The First Affiliated Hospital, Zhejiang University
Hangzhou
310003
China
Shanghai Skin Disease Hospital
Shanghai
200000
China
Xinjiang Uygur Autonomous Region People's Hospital
HCMC Hospital of Dermato-Venereology-Ho Chi Minh-66092
Ho Chi Minh City
70000
Vietnam
FG001
Spesolimab low dose group
Patients with moderate to severe HS were administered an initial weekly low dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).
From Week 16, if patients had inadequate clinical response defined as 25% increase in the ANdT count compared to baseline, the dose could be increased every two weeks to a pre-determined concentration.
FG002
Spesolimab medium dose group
Patients with moderate to severe HS were administered an initial weekly medium dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).
FG003
Spesolimab high dose group
Patients with moderate to severe HS were administered an initial weekly high dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).
FG00053 subjects
FG00153 subjects
FG00252 subjects
FG00351 subjects
COMPLETED
FG00021 subjects
FG00120 subjects
FG00220 subjects
FG00317 subjects
NOT COMPLETED
FG00032 subjects
FG00133 subjects
FG00232 subjects
FG00334 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG00011 subjects
FG0017 subjects
FG0026 subjects
FG0036 subjects
Lost to Follow-up
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0031 subjects
Adverse Event
FG0001 subjects
FG0013 subjects
FG0024 subjects
FG0035 subjects
Other than listed
FG0000 subjects
FG0012 subjects
FG0022 subjects
FG0030 subjects
Lack of Efficacy
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Study terminated by sponsor
FG00020 subjects
FG00118 subjects
FG00220 subjects
FG00322 subjects
Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Patients with moderate to severe Hidradenitis suppurativa (HS) were administered an initial weekly dose of placebo via intravenous infusion (i.v.) (Week 0 to Week 3). Afterwards, patients were administered a subcutaneous injection (s.c.) dose of placebo once a week for 4 weeks (Week 4 to Week 7), and once every 2 weeks for the following 7 weeks (Week 8 to Week 14).
From Week 16 until the end of treatment (Week 48), patients were switched to the same s.c. dose of spesolimab administered to patients in the medium and high dose groups (starting with 3 loading s.c. doses of spesolimab every week and then maintenance s.c. dose of spesolimab every 2 weeks).
BG001
Spesolimab low dose group
Patients with moderate to severe HS were administered an initial weekly low dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).
From Week 16, if patients had inadequate clinical response defined as 25% increase in the ANdT count compared to baseline, the dose could be increased every two weeks to a pre-determined concentration.
BG002
Spesolimab medium dose group
Patients with moderate to severe HS were administered an initial weekly medium dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).
BG003
Spesolimab high dose group
Patients with moderate to severe HS were administered an initial weekly high dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00053
BG00153
BG00252
BG00351
BG004209
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00033.8± 8.8
BG00137.0± 12.1
BG00239.5± 13.9
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00019
BG00122
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0006
BG0017
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0001
BG0011
BG002
Number of draining fistulas/tunnels (dT)
Tunnel/fistula/sinus should be counted as dT only if draining. Baseline values were recorded prior to first drug administration at Week 0.
Mean
Standard Deviation
Draining fistulas/tunnels
Title
Denominators
Categories
Title
Measurements
BG0005.2± 5.8
BG001
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
Primary
Part 1 - Percent Change From Baseline in Draining Fistula/Tunnel (dT) Count at Week 8
Percent change from baseline in draining fistula/tunnel (dT) count at Week 8 is reported. Tunnel/fistula/sinus were counted as dT only if draining. Percent change was calculated as follows: (dT count at week 8 - dT count at baseline)/ dT at baseline.
Least square means and standard errors were estimated by Mixed effect model for repeated measurements (MMRM). The MMRM included fixed categorical effects of treatment at each visit, Tumor Necrosis Factor inhibitor (TNFi) status at baseline, and categorical baseline dT count at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-trial participant measurements.
Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug. The use of "treatment policy" approach disregards the intercurrent event and uses the value of the variable regardless of the occurrence of the intercurrent event.
Posted
Least Squares Mean
Standard Error
Percentage change
The MMRM model incorporates dT count from baseline (Week 0), Week 2, Week 4, Week 6 and Week 8. The data represent the Least Squares Means at Week 8.
ID
Title
Description
OG000
Placebo
Patients with moderate to severe Hidradenitis suppurativa (HS) were administered an initial weekly dose of placebo via intravenous infusion (i.v.) (Week 0 to Week 3). Afterwards, patients were administered a subcutaneous injection (s.c.) dose of placebo once a week for 4 weeks (Week 4 to Week 7), and once every 2 weeks for the following 7 weeks (Week 8 to Week 14).
From Week 16 until the end of treatment (Week 48), patients were switched to the same s.c. dose of spesolimab administered to patients in the medium and high dose groups (starting with 3 loading s.c. doses of spesolimab every week and then maintenance s.c. dose of spesolimab every 2 weeks).
OG001
Spesolimab low dose group
Patients with moderate to severe HS were administered an initial weekly low dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).
From Week 16, if patients had inadequate clinical response defined as 25% increase in the ANdT count compared to baseline, the dose could be increased every two weeks to a pre-determined concentration.
OG002
Spesolimab medium dose group
Patients with moderate to severe HS were administered an initial weekly medium dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).
OG003
Spesolimab high dose group
Patients with moderate to severe HS were administered an initial weekly high dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).
Units
Counts
Participants
OG00053
OG00153
OG00252
OG003
Title
Denominators
Categories
Title
Measurements
OG000-21.5± 7.7
OG001-41.9± 7.8
OG002-39.3± 7.9
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
The MMRM included fixed categorical effects of treatment at each visit, Tumor Necrosis Factor inhibitor (TNFi) status at baseline, and categorical baseline dT count at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-trial participant measurements.
Difference of least square means
-20.4
Standard Error of the Mean
10.9
2-Sided
95
-41.9
1.1
Difference = (least square mean Spesolimab low dose) - (least square mean Placebo)
Other
Secondary
Part 1 - Percent Change From Baseline in Draining Fistula/Tunnel (dT) Count at Week 16
Percent change from baseline in draining fistula/tunnel (dT) count at Week 16 is reported. Tunnel/fistula/sinus were counted as dT only if draining.
Least square means and standard errors were estimated by MMRM, which included fixed categorical effects of treatment at each visit, TNFi status at baseline, categorical baseline dT count and fixed continuous effect of baseline of outcome measures at each visit. Visit was treated as repeated measure with an unstructured covariance matrix for the within trial participant variability and all visits with planned measurements of the outcome variable as well as all dose groups were included in the model.
Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug. The use of "treatment policy" approach disregards the intercurrent event and uses the value of the variable regardless of the occurrence of the intercurrent event.
Posted
Least Squares Mean
Standard Error
Percentage change
The MMRM model incorporates dT count from baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14 and Week 16. The data represent the Least Squares Means at Week 16.
ID
Title
Description
OG000
Placebo
Patients with moderate to severe Hidradenitis suppurativa (HS) were administered an initial weekly dose of placebo via intravenous infusion (i.v.) (Week 0 to Week 3). Afterwards, patients were administered a subcutaneous injection (s.c.) dose of placebo once a week for 4 weeks (Week 4 to Week 7), and once every 2 weeks for the following 7 weeks (Week 8 to Week 14).
From Week 16 until the end of treatment (Week 48), patients were switched to the same s.c. dose of spesolimab administered to patients in the medium and high dose groups (starting with 3 loading s.c. doses of spesolimab every week and then maintenance s.c. dose of spesolimab every 2 weeks).
Secondary
Part 1 - Absolute Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Value at Week 8
IHS4 is a validated, clinical scoring system for dynamic assessment of HS severity. The score was calculated as: (number of nodules x1) + (number of abscesses x2) + (number of draining tunnels [fistulae/sinuses] x4). The minimum is 0, the maximum depends on the count of nodules, abscesses, and draining tunnels. Scores 0-3 indicate mild HS, 4-10 moderate HS, ≥11 severe HS. Absolute change from baseline was calculated as follows: (IHS4 value at visit timepoints) - (IHS4 value at baseline).
Least square means and standard errors were estimated by MMRM, which included fixed categorical effects of treatment at each visit, TNFi status at baseline, categorical baseline dT count and fixed continuous effect of baseline of outcome measures at each visit. Visit was treated as repeated measure with an unstructured covariance matrix for the within trial participant variability and all visits with planned measurements of the outcome variable as well as all dose groups were included in the model.
Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug. The use of "treatment policy" approach disregards the intercurrent event and uses the value of the variable regardless of the occurrence of the intercurrent event.
Posted
Least Squares Mean
Standard Error
Units on a scale
The MMRM model incorporates IHS4 value from baseline (Week 0), Week 2, Week 4, Week 6 and Week 8. The data represent the Least Squares Means at Week 8.
ID
Title
Description
OG000
Placebo
Patients with moderate to severe Hidradenitis suppurativa (HS) were administered an initial weekly dose of placebo via intravenous infusion (i.v.) (Week 0 to Week 3). Afterwards, patients were administered a subcutaneous injection (s.c.) dose of placebo once a week for 4 weeks (Week 4 to Week 7), and once every 2 weeks for the following 7 weeks (Week 8 to Week 14).
From Week 16 until the end of treatment (Week 48), patients were switched to the same s.c. dose of spesolimab administered to patients in the medium and high dose groups (starting with 3 loading s.c. doses of spesolimab every week and then maintenance s.c. dose of spesolimab every 2 weeks).
Secondary
Part 1 - Absolute Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Value at Week 16
IHS4 is a validated, clinical scoring system for dynamic assessment of HS severity. The score was calculated as: (number of nodules x1) + (number of abscesses x2) + (number of draining tunnels [fistulae/sinuses] x4). The minimum is 0, the maximum depends on the count of nodules, abscesses, and draining tunnels. Scores 0-3 indicate mild HS, 4-10 moderate HS, ≥11 severe HS. Absolute change from baseline was calculated as follows: (IHS4 value at visit timepoints) - (IHS4 value at baseline).
Least square means and standard errors were estimated by MMRM, which included fixed categorical effects of treatment at each visit, TNFi status at baseline, categorical baseline dT count and fixed continuous effect of baseline of outcome measures at each visit. Visit was treated as repeated measure with an unstructured covariance matrix for the within trial participant variability and all visits with planned measurements of the outcome variable as well as all dose groups were included in the model.
Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug. The use of "treatment policy" approach disregards the intercurrent event and uses the value of the variable regardless of the occurrence of the intercurrent event.
Posted
Least Squares Mean
Standard Error
Units on a scale
The MMRM model incorporates IHS4 from baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14 and Week 16. The data represent the Least Squares Means at Week 16.
ID
Title
Description
OG000
Placebo
Patients with moderate to severe Hidradenitis suppurativa (HS) were administered an initial weekly dose of placebo via intravenous infusion (i.v.) (Week 0 to Week 3). Afterwards, patients were administered a subcutaneous injection (s.c.) dose of placebo once a week for 4 weeks (Week 4 to Week 7), and once every 2 weeks for the following 7 weeks (Week 8 to Week 14).
From Week 16 until the end of treatment (Week 48), patients were switched to the same s.c. dose of spesolimab administered to patients in the medium and high dose groups (starting with 3 loading s.c. doses of spesolimab every week and then maintenance s.c. dose of spesolimab every 2 weeks).
Secondary
Part 1 - Occurrence of Treatment Emergent Adverse Events (TEAEs)
The occurrence of treatment emergent adverse events (TEAEs) is reported as the number of patients with TEAEs.
Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Posted
Count of Participants
Participants
From first drug administration until end of exposure, plus residual effect period, up to approximately 68 weeks.
ID
Title
Description
OG000
Placebo
Patients with moderate to severe Hidradenitis suppurativa (HS) were administered an initial weekly dose of placebo via intravenous infusion (i.v.) (Week 0 to Week 3). Afterwards, patients were administered a subcutaneous injection (s.c.) dose of placebo once a week for 4 weeks (Week 4 to Week 7), and once every 2 weeks for the following 7 weeks (Week 8 to Week 14).
From Week 16 until the end of treatment (Week 48), patients were switched to the same s.c. dose of spesolimab administered to patients in the medium and high dose groups (starting with 3 loading s.c. doses of spesolimab every week and then maintenance s.c. dose of spesolimab every 2 weeks).
OG001
Spesolimab low dose group
Patients with moderate to severe HS were administered an initial weekly low dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).
From Week 16, if patients had inadequate clinical response defined as 25% increase in the ANdT count compared to baseline, the dose could be increased every two weeks to a pre-determined concentration.
Time Frame
From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks.
Description
Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo
Patients with moderate to severe Hidradenitis suppurativa (HS) were administered an initial weekly dose of placebo via intravenous infusion (i.v.) (Week 0 to Week 3). Afterwards, patients were administered a subcutaneous injection (s.c.) dose of placebo once a week for 4 weeks (Week 4 to Week 7), and once every 2 weeks for the following 7 weeks (Week 8 to Week 14).
From Week 16 until the end of treatment (Week 48), patients were switched to the same s.c. dose of spesolimab administered to patients in the medium and high dose groups (starting with 3 loading s.c. doses of spesolimab every week and then maintenance s.c. dose of spesolimab every 2 weeks).
0
53
3
53
29
53
EG001
Spesolimab following placebo
Patients in the placebo group switched from Week 16 until the end of treatment (Week 48) to the same subcutaneous injection (s.c.) dose of spesolimab administered to patients in the medium and high dose groups (starting with 3 loading s.c. doses of spesolimab every week and then maintenance s.c. dose of spesolimab every 2 weeks).
0
50
7
50
32
50
EG002
Spesolimab low dose group
Patients with moderate to severe HS were administered an initial weekly low dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).
From Week 16, if patients had inadequate clinical response defined as 25% increase in the ANdT count compared to baseline, the dose could be increased every two weeks to a pre-determined concentration.
0
53
3
53
39
53
EG003
Spesolimab medium dose group
Patients with moderate to severe HS were administered an initial weekly medium dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).
0
52
8
52
38
52
EG004
Spesolimab high dose group
Patients with moderate to severe HS were administered an initial weekly high dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).
0
51
6
51
41
51
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected53 at risk
EG0011 affected50 at risk
EG0020 affected53 at risk
EG0030 affected52 at risk
EG0040 affected51 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected50 at risk
EG0020 affected53 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected50 at risk
EG0020 affected53 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected50 at risk
EG0021 affected53 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected50 at risk
EG0020 affected53 at risk
EG003
Severe fever with thrombocytopenia syndrome
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected50 at risk
EG0020 affected53 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected50 at risk
EG0020 affected53 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected50 at risk
EG0020 affected53 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected50 at risk
EG0020 affected53 at risk
EG003
Polycythaemia vera
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected50 at risk
EG0020 affected53 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected50 at risk
EG0020 affected53 at risk
EG003
Sinoatrial block
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected50 at risk
EG0020 affected53 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected53 at risk
EG0011 affected50 at risk
EG0020 affected53 at risk
EG003
Abscess limb
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected50 at risk
EG0021 affected53 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected53 at risk
EG0011 affected50 at risk
EG0020 affected53 at risk
EG003
Sepsis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected53 at risk
EG0011 affected50 at risk
EG0020 affected53 at risk
EG003
Skin infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected53 at risk
EG0011 affected50 at risk
EG0020 affected53 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected53 at risk
EG0011 affected50 at risk
EG0020 affected53 at risk
EG003
Animal scratch
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 affected53 at risk
EG0011 affected50 at risk
EG0020 affected53 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected53 at risk
EG0011 affected50 at risk
EG0020 affected53 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected50 at risk
EG0020 affected53 at risk
EG003
Hidradenitis
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected53 at risk
EG0012 affected50 at risk
EG0020 affected53 at risk
EG003
Atrial tachycardia
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected50 at risk
EG0021 affected53 at risk
EG003
Heart failure with preserved ejection fraction
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected50 at risk
EG0020 affected53 at risk
EG003
Biliary colic
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected50 at risk
EG0020 affected53 at risk
EG003
Portal vein thrombosis
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected50 at risk
EG0020 affected53 at risk
EG003
Latent tuberculosis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected50 at risk
EG0020 affected53 at risk
EG003
Scrotal abscess
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected50 at risk
EG0020 affected53 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 affected53 at risk
EG0011 affected50 at risk
EG0020 affected53 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected50 at risk
EG0020 affected53 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected50 at risk
EG0020 affected53 at risk
EG003
Obesity
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected50 at risk
EG0020 affected53 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected50 at risk
EG0021 affected53 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0003 affected53 at risk
EG0011 affected50 at risk
EG0023 affected53 at risk
EG0031 affected52 at risk
EG0044 affected51 at risk
Nausea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0004 affected53 at risk
EG0012 affected50 at risk
EG0023 affected53 at risk
EG003
Chest pain
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected50 at risk
EG0023 affected53 at risk
EG003
Fatigue
General disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected53 at risk
EG0010 affected50 at risk
EG0022 affected53 at risk
EG003
Injection site pain
General disorders
MedDRA 27.1
Systematic Assessment
EG0003 affected53 at risk
EG0012 affected50 at risk
EG0023 affected53 at risk
EG003
Injection site pruritus
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected53 at risk
EG0012 affected50 at risk
EG0022 affected53 at risk
EG003
Injection site reaction
General disorders
MedDRA 27.1
Systematic Assessment
EG0003 affected53 at risk
EG0015 affected50 at risk
EG0025 affected53 at risk
EG003
Pyrexia
General disorders
MedDRA 27.1
Systematic Assessment
EG0003 affected53 at risk
EG0015 affected50 at risk
EG0023 affected53 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0004 affected53 at risk
EG0010 affected50 at risk
EG0022 affected53 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0002 affected53 at risk
EG0015 affected50 at risk
EG0029 affected53 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0003 affected53 at risk
EG0011 affected50 at risk
EG0020 affected53 at risk
EG003
Headache
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0009 affected53 at risk
EG0014 affected50 at risk
EG0026 affected53 at risk
EG003
Hidradenitis
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0009 affected53 at risk
EG00113 affected50 at risk
EG00219 affected53 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0003 affected53 at risk
EG0010 affected50 at risk
EG0025 affected53 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected53 at risk
EG0011 affected50 at risk
EG0020 affected53 at risk
EG003
Influenza like illness
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected53 at risk
EG0011 affected50 at risk
EG0023 affected53 at risk
EG003
Injection site bruising
General disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected53 at risk
EG0011 affected50 at risk
EG0021 affected53 at risk
EG003
Injection site erythema
General disorders
MedDRA 27.1
Systematic Assessment
EG0003 affected53 at risk
EG0013 affected50 at risk
EG0021 affected53 at risk
EG003
Injection site swelling
General disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected53 at risk
EG0013 affected50 at risk
EG0020 affected53 at risk
EG003
Pain
General disorders
MedDRA 27.1
Systematic Assessment
EG0004 affected53 at risk
EG0011 affected50 at risk
EG0021 affected53 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0002 affected53 at risk
EG0014 affected50 at risk
EG0024 affected53 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected53 at risk
EG0012 affected50 at risk
EG0023 affected53 at risk
EG003
Influenza
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected50 at risk
EG0024 affected53 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected50 at risk
EG0020 affected53 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 affected53 at risk
EG0010 affected50 at risk
EG0023 affected53 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0003 affected53 at risk
EG0012 affected50 at risk
EG0021 affected53 at risk
EG003
Hypertension
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected53 at risk
EG0011 affected50 at risk
EG0023 affected53 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected53 at risk
EG0011 affected50 at risk
EG0021 affected53 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected53 at risk
EG0013 affected50 at risk
EG0021 affected53 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 affected53 at risk
EG0011 affected50 at risk
EG0023 affected53 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected53 at risk
EG0010 affected50 at risk
EG0021 affected53 at risk
EG003
The Part 2 was not initiated due to discontinuation of this trial according to protocol. The interim analysis in Part 1 was done after all patients reached Week 16 milestone, and following the analysis, the decision to discontinue was taken.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
The MMRM included fixed categorical effects of treatment at each visit, Tumor Necrosis Factor inhibitor (TNFi) status at baseline, and categorical baseline dT count at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-trial participant measurements.
Difference of least square means
-17.8
Standard Error of the Mean
11.0
2-Sided
95
-39.5
3.9
Difference = (least square mean Spesolimab medium dose) - (least square mean Placebo)
Other
OG000
OG003
The MMRM included fixed categorical effects of treatment at each visit, Tumor Necrosis Factor inhibitor (TNFi) status at baseline, and categorical baseline dT count at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-trial participant measurements.
Difference of least square means
-4.3
Standard Error of the Mean
11.0
2-Sided
95
-26.0
17.5
Difference = (least square mean Spesolimab high dose) - (least square mean Placebo)
Other
OG000
OG001
OG002
OG003
Multiple comparison and modelling techniques (MCPMod) was used to evaluate several possible dose response models (patterns: Linear, Exponential, Emax, SigEmax, BetaMod), and to identify the best-fitting model or subset of models.
MCPMod Linear model
No assumptions.
0.697
Adjusted p-value from multiple contrast test.
Other
OG000
OG001
OG002
OG003
Multiple comparison and modelling techniques (MCPMod) was used to evaluate several possible dose response models (patterns: Linear, Exponential, Emax, SigEmax, BetaMod), and to identify the best-fitting model or subset of models.
MCPMod Exponential: model
Assumption: 30% of the maximum effect is achieved at the medium dose.
0.844
Adjusted p-value from multiple contrast test.
Other
OG000
OG001
OG002
OG003
Multiple comparison and modelling techniques (MCPMod) was used to evaluate several possible dose response models (patterns: Linear, Exponential, Emax, SigEmax, BetaMod), and to identify the best-fitting model or subset of models.
MCPMod Emax model
Assumption: 70% of the maximum effect is achieved at the medium dose.
0.256
Adjusted p-value from multiple contrast test.
Other
OG000
OG001
OG002
OG003
Multiple comparison and modelling techniques (MCPMod) was used to evaluate several possible dose response models (patterns: Linear, Exponential, Emax, SigEmax, BetaMod), and to identify the best-fitting model or subset of models.
MCPMod SigEmax model
Assumption: 70% of the maximum effect is achieved at the medium dose and 25% of the maximum effect is achieved at the low dose.
0.571
Adjusted p-value from multiple contrast test.
Other
OG000
OG001
OG002
OG003
Multiple comparison and modelling techniques (MCPMod) was used to evaluate several possible dose response models (patterns: Linear, Exponential, Emax, SigEmax, BetaMod), and to identify the best-fitting model or subset of models.
MCPMod BetaMod model
Assumption: 80% of the maximum effect is achieved at the medium dose and the maximum effect is achieved at the 70% of the high dose.
0.232
Adjusted p-value from multiple contrast test.
Other
OG001
Spesolimab low dose group
Patients with moderate to severe HS were administered an initial weekly low dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).
From Week 16, if patients had inadequate clinical response defined as 25% increase in the ANdT count compared to baseline, the dose could be increased every two weeks to a pre-determined concentration.
OG002
Spesolimab medium dose group
Patients with moderate to severe HS were administered an initial weekly medium dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).
OG003
Spesolimab high dose group
Patients with moderate to severe HS were administered an initial weekly high dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).
Units
Counts
Participants
OG00053
OG00153
OG00252
OG00351
Title
Denominators
Categories
Title
Measurements
OG000-14.0± 10.6
OG001-23.5± 10.7
OG002-36.2± 10.8
OG003-22.7± 11.2
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
The MMRM included fixed categorical effects of treatment at each visit, TNFi status at baseline, categorical baseline dT count and fixed continuous effect of baseline of outcome measures at each visit. Visit was treated as repeated measure with an unstructured covariance matrix for the within trial participant variability and all visits with planned measurements of the outcome variable as well as all dose groups were included in the model.
Difference of least square means
-9.6
Standard Error of the Mean
15.0
2-Sided
95
-39.2
20.1
Difference = (least square mean Spesolimab low dose) - (least square mean Placebo)
Other
OG000
OG002
The MMRM included fixed categorical effects of treatment at each visit, TNFi status at baseline, categorical baseline dT count and fixed continuous effect of baseline of outcome measures at each visit. Visit was treated as repeated measure with an unstructured covariance matrix for the within trial participant variability and all visits with planned measurements of the outcome variable as well as all dose groups were included in the model.
Difference of least square means
-22.2
Standard Error of the Mean
15.1
2-Sided
95
-52.0
7.6
Difference = (least square mean Spesolimab medium dose) - (least square mean Placebo)
Other
OG000
OG003
The MMRM included fixed categorical effects of treatment at each visit, TNFi status at baseline, categorical baseline dT count and fixed continuous effect of baseline of outcome measures at each visit. Visit was treated as repeated measure with an unstructured covariance matrix for the within trial participant variability and all visits with planned measurements of the outcome variable as well as all dose groups were included in the model.
Difference of least square means
-8.8
Standard Error of the Mean
15.4
2-Sided
95
-39.1
21.6
Difference = (least square mean Spesolimab high dose) - (least square mean Placebo)
Other
OG001
Spesolimab low dose group
Patients with moderate to severe HS were administered an initial weekly low dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).
From Week 16, if patients had inadequate clinical response defined as 25% increase in the ANdT count compared to baseline, the dose could be increased every two weeks to a pre-determined concentration.
OG002
Spesolimab medium dose group
Patients with moderate to severe HS were administered an initial weekly medium dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).
OG003
Spesolimab high dose group
Patients with moderate to severe HS were administered an initial weekly high dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).
Units
Counts
Participants
OG00053
OG00153
OG00252
OG00351
Title
Denominators
Categories
Title
Measurements
OG000-13.5± 2.5
OG001-11.1± 2.5
OG002-14.1± 2.5
OG003-10.5± 2.5
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
The MMRM included fixed categorical effects of treatment at each visit, TNFi status at baseline, categorical baseline dT count and fixed continuous effect of baseline of outcome measures at each visit. Visit was treated as repeated measure with an unstructured covariance matrix for the within trial participant variability and all visits with planned measurements of the outcome variable as well as all dose groups were included in the model.
Difference of least square means
2.4
Standard Error of the Mean
3.5
2-Sided
95
-4.5
9.4
Difference = (least square mean Spesolimab low dose) - (least square mean Placebo)
Other
OG000
OG002
The MMRM included fixed categorical effects of treatment at each visit, TNFi status at baseline, categorical baseline dT count and fixed continuous effect of baseline of outcome measures at each visit. Visit was treated as repeated measure with an unstructured covariance matrix for the within trial participant variability and all visits with planned measurements of the outcome variable as well as all dose groups were included in the model.
Difference of least square means
-0.6
Standard Error of the Mean
3.5
2-Sided
95
-7.5
6.3
Difference = (least square mean Spesolimab medium dose) - (least square mean Placebo)
Other
OG000
OG003
The MMRM included fixed categorical effects of treatment at each visit, TNFi status at baseline, categorical baseline dT count and fixed continuous effect of baseline of outcome measures at each visit. Visit was treated as repeated measure with an unstructured covariance matrix for the within trial participant variability and all visits with planned measurements of the outcome variable as well as all dose groups were included in the model.
Difference of least square means
3.0
Standard Error of the Mean
3.5
2-Sided
95
-3.9
10.0
Difference = (least square mean Spesolimab high dose) - (least square mean Placebo)
Other
OG000
OG001
OG002
OG003
Multiple comparison and modelling techniques (MCPMod) was used to evaluate several possible dose response models (patterns: Linear, Exponential, Emax, SigEmax, BetaMod), and to identify the best-fitting model or subset of models.
MCPMod Linear model
No assumptions.
0.887
Adjusted p-value from multiple contrast test.
Other
OG000
OG001
OG002
OG003
Multiple comparison and modelling techniques (MCPMod) was used to evaluate several possible dose response models (patterns: Linear, Exponential, Emax, SigEmax, BetaMod), and to identify the best-fitting model or subset of models.
MCPMod Exponential: model
Assumption: 30% of the maximum effect is achieved at the medium dose.
0.902
Adjusted p-value from multiple contrast test.
Other
OG000
OG001
OG002
OG003
Multiple comparison and modelling techniques (MCPMod) was used to evaluate several possible dose response models (patterns: Linear, Exponential, Emax, SigEmax, BetaMod), and to identify the best-fitting model or subset of models.
MCPMod Emax model
Assumption: 70% of the maximum effect is achieved at the medium dose.
0.866
Adjusted p-value from multiple contrast test.
Other
OG000
OG001
OG002
OG003
Multiple comparison and modelling techniques (MCPMod) was used to evaluate several possible dose response models (patterns: Linear, Exponential, Emax, SigEmax, BetaMod), and to identify the best-fitting model or subset of models.
MCPMod SigEmax model
Assumption: 70% of the maximum effect is achieved at the medium dose and 25% of the maximum effect is achieved at the low dose.
0.825
Adjusted p-value from multiple contrast test.
Other
OG000
OG001
OG002
OG003
Multiple comparison and modelling techniques (MCPMod) was used to evaluate several possible dose response models (patterns: Linear, Exponential, Emax, SigEmax, BetaMod), and to identify the best-fitting model or subset of models.
MCPMod BetaMod model
Assumption: 80% of the maximum effect is achieved at the medium dose and the maximum effect is achieved at the 70% of the high dose.
0.634
Adjusted p-value from multiple contrast test.
Other
OG001
Spesolimab low dose group
Patients with moderate to severe HS were administered an initial weekly low dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).
From Week 16, if patients had inadequate clinical response defined as 25% increase in the ANdT count compared to baseline, the dose could be increased every two weeks to a pre-determined concentration.
OG002
Spesolimab medium dose group
Patients with moderate to severe HS were administered an initial weekly medium dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).
OG003
Spesolimab high dose group
Patients with moderate to severe HS were administered an initial weekly high dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).
Units
Counts
Participants
OG00053
OG00153
OG00252
OG00351
Title
Denominators
Categories
Title
Measurements
OG000-11.8± 3.8
OG001-7.2± 3.9
OG002-17.0± 3.9
OG003-4.2± 4.0
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
The MMRM included fixed categorical effects of treatment at each visit, TNFi status at baseline, categorical baseline dT count and fixed continuous effect of baseline of outcome measures at each visit. Visit was treated as repeated measure with an unstructured covariance matrix for the within trial participant variability and all visits with planned measurements of the outcome variable as well as all dose groups were included in the model.
Difference of least square means
4.6
Standard Error of the Mean
5.4
2-Sided
95
-6.1
15.3
Difference = (least square mean Spesolimab low dose) - (least square mean Placebo)
Other
OG000
OG002
The MMRM included fixed categorical effects of treatment at each visit, TNFi status at baseline, categorical baseline dT count and fixed continuous effect of baseline of outcome measures at each visit. Visit was treated as repeated measure with an unstructured covariance matrix for the within trial participant variability and all visits with planned measurements of the outcome variable as well as all dose groups were included in the model.
Difference of least square means
-5.2
Standard Error of the Mean
5.4
2-Sided
95
-15.9
5.5
Difference = (least square mean Spesolimab medium dose) - (least square mean Placebo)
Other
OG000
OG003
The MMRM included fixed categorical effects of treatment at each visit, TNFi status at baseline, categorical baseline dT count and fixed continuous effect of baseline of outcome measures at each visit. Visit was treated as repeated measure with an unstructured covariance matrix for the within trial participant variability and all visits with planned measurements of the outcome variable as well as all dose groups were included in the model.
Difference of least square means
7.6
Standard Error of the Mean
5.5
2-Sided
95
-3.3
18.5
Difference = (least square mean Spesolimab high dose) - (least square mean Placebo)
Other
OG002
Spesolimab medium dose group
Patients with moderate to severe HS were administered an initial weekly medium dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).
OG003
Spesolimab high dose group
Patients with moderate to severe HS were administered an initial weekly high dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).