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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-508377-82-00 | Registry Identifier | CTIS (EU) | |
| U1111-1300-2310 | Registry Identifier | WHO International Clinical Trials Registry Platform (ICTRP) |
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This study is open to people with hidradenitis suppurativa (HS) who have completed another study with spesolimab (study 1368-0098 (NCT05819398) or study 1368-0100).
The purpose of this study is to find out how well people tolerate spesolimab and whether it helps people with HS in the long-term. For about 1.5 years, participants get spesolimab injections under the skin every 2 weeks.
Participants are in the study for about 2 years. During this time, participants have 41 visits. 24 visits are done at the study site. 17 visits can be done by video call at the participant's home. At study visits, doctors check the severity of the participant's HS and collect information on any health problems of the participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spesolimab low dose | Experimental | Participants with hidradenitis suppurativa who completed their treatment with spesolimab in Part 1 of trial 1368-0098 and who met the eligibility criteria for this extension trial. Participants continued on the same dosing regimen that they had in the parent trial. Spesolimab was administered every 2 weeks with a subcutaneous injection. To keep the study blinded, participants were additionally administered placebo to match the volume administered to the participants in the high dose group. Patients were planned to be treated for 76 weeks, followed by a 16-week safety follow-up period. |
|
| Spesolimab high dose | Experimental | Participants with hidradenitis suppurativa who completed their treatment with spesolimab in Part 1 of trial 1368-0098 and who met the eligibility criteria for this extension trial. Participants continued on the same dosing regimen that they had in the parent trial. Spesolimab was administered every 2 weeks with a subcutaneous injection. Patients were planned to be treated for 76 weeks, followed by a 16-week safety follow-up period. |
|
| Spesolimab high dose with prior placebo | Experimental | Participants with hidradenitis suppurativa who completed their treatment with placebo in Part 1 of trial 1368-0098 and who met the eligibility criteria for this extension trial. Participants continued on the same dosing regimen that they had in the parent trial. Spesolimab was administered every 2 weeks with a subcutaneous injection. Patients were planned to be treated for 76 weeks, followed by a 16-week safety follow-up period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spesolimab | Drug | Administered every 2 weeks with a subcutaneous injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Treatment Emergent Adverse Events (TEAE) up to the End of Maintenance Treatment Period | The occurrence of treatment emergent adverse events (TEAEs) is reported as the number of patients with TEAEs. TEAEs were defined as all adverse events occurring between start of treatment in the extension trial and the end of its residual effect period. Adverse events that start before first drug intake in the extension trial and deteriorate under treatment during the extension trial were also considered as 'treatment-emergent'. | From first drug administration, up to 16 weeks after last administration, up to 39 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
Further exclusion criteria apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First OC Dermatology | Fountain Valley | California | 92708 | United States | ||
| Dermatology Research Associates |
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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).
https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
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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 randomised, placebo-controlled, double-blind, 92-week extension trial to investigate the long-term safety of spesolimab in participants with hidradenitis suppurativa who had completed their treatment in Part 1 of trial 1368-0098.
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| ID | Title | Description |
|---|---|---|
| FG000 | Spesolimab Low Dose | Participants with hidradenitis suppurativa who completed their treatment with spesolimab in Part 1 of trial 1368-0098 and who met the eligibility criteria for this extension trial. Participants continued on the same dosing regimen that they had in the parent trial. Spesolimab was administered every 2 weeks with a subcutaneous injection. To keep the study blinded, participants were additionally administered placebo to match the volume administered to the participants in the high dose group. Patients were planned to be treated for 76 weeks, followed by a 16-week safety follow-up period. |
| 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 | Nov 15, 2023 | Apr 7, 2026 |
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| Placebo | Drug | Administered every 2 weeks with a subcutaneous injection. |
|
| 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 |
| STAT Research | CABA | C1023AAB | Argentina |
| Hospital Italiano de Buenos Aires | CABA | C1199ABB | Argentina |
| Hospital Alemán | Capital Federal | C1118AAT | Argentina |
| Holdsworth House Medical Practice | Sydney | New South Wales | 2010 | Australia |
| Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Medical Center "Kordis" | Pleven | 5800 | Bulgaria |
| ASMC-IPSMC-skin and Veneral Diseases | Sofia | 1407 | Bulgaria |
| 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 |
| HOP Privé Antony | Antony | 92160 | France |
| Hôpital Edouard Herriot | Lyon | 69437 | France |
| Fachklinik Bad Bentheim | Bad Bentheim | 48455 | Germany |
| Hautmedizin Saar | Merzig | 66663 | Germany |
| Kurume University Hospital | Fukuoka, Kurume | 830-0011 | Japan |
| Ogaki Municipal Hospital | Gifu, Ogaki | 503-8502 | Japan |
| The University of Tokyo Hospital | Tokyo, Bunkyo-ku | 113-8655 | Japan |
| Nihon University Itabashi Hospital | Tokyo, Itabashi-ku | 173-8610 | Japan |
| Tokyo Medical University Hospital | Tokyo, Shinjuku-ku | 160-0023 | Japan |
| Hospital of Lithuanian University of Health Sciences Kauno Klinikos | Kaunas | 50161 | Lithuania |
| Vilnius University Hospital, Santariskiu | Vilnius | 08411 | Lithuania |
| Hospital Pulau Pinang-Pulau Pinang-21953 | Georgetown Pulau Pinang | 10990 | Malaysia |
| Hospital Sultan Ismail | Johor Bahru | 81100 | Malaysia |
| Hospital Kuala Lumpur | Kuala Lumpur | 50586 | Malaysia |
| Sarawak General Hospital | Kuching | 93586 | Malaysia |
| Sunway Medical Centre | Selangor Darul Ehsan | 47500 | Malaysia |
| Non-Public Health Care Facility LABDERM | Ossy | 42624 | Poland |
| Provita Clinic | Warsaw | 02-647 | Poland |
| Royalderm | Warsaw | 02-962 | Poland |
| National University Hospital-Singapore-42005 | Singapore | 119074 | Singapore |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Hospital Universitario Miguel Servet | Zaragoza | 50009 | Spain |
| FG001 | Spesolimab High Dose | Participants with hidradenitis suppurativa who completed their treatment with spesolimab in Part 1 of trial 1368-0098 and who met the eligibility criteria for this extension trial. Participants continued on the same dosing regimen that they had in the parent trial. Spesolimab was administered every 2 weeks with a subcutaneous injection. Patients were planned to be treated for 76 weeks, followed by a 16-week safety follow-up period. |
| FG002 | Spesolimab High Dose With Prior Placebo | Participants with hidradenitis suppurativa who completed their treatment with placebo in Part 1 of trial 1368-0098 and who met the eligibility criteria for this extension trial. Participants continued on the same dosing regimen that they had in the parent trial. Spesolimab was administered every 2 weeks with a subcutaneous injection. Patients were planned to be treated for 76 weeks, followed by a 16-week safety follow-up period. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Treated Set (TS): all participants who have received at least 1 dose of trial treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Spesolimab Low Dose | Participants with hidradenitis suppurativa who completed their treatment with spesolimab in Part 1 of trial 1368-0098 and who met the eligibility criteria for this extension trial. Participants continued on the same dosing regimen that they had in the parent trial. Spesolimab was administered every 2 weeks with a subcutaneous injection. To keep the study blinded, participants were additionally administered placebo to match the volume administered to the participants in the high dose group. Patients were planned to be treated for 76 weeks, followed by a 16-week safety follow-up period. |
| BG001 | Spesolimab High Dose | Participants with hidradenitis suppurativa who completed their treatment with spesolimab in Part 1 of trial 1368-0098 and who met the eligibility criteria for this extension trial. Participants continued on the same dosing regimen that they had in the parent trial. Spesolimab was administered every 2 weeks with a subcutaneous injection. Patients were planned to be treated for 76 weeks, followed by a 16-week safety follow-up period. |
| BG002 | Spesolimab High Dose With Prior Placebo | Participants with hidradenitis suppurativa who completed their treatment with placebo in Part 1 of trial 1368-0098 and who met the eligibility criteria for this extension trial. Participants continued on the same dosing regimen that they had in the parent trial. Spesolimab was administered every 2 weeks with a subcutaneous injection. Patients were planned to be treated for 76 weeks, followed by a 16-week safety follow-up period. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Occurrence of Treatment Emergent Adverse Events (TEAE) up to the End of Maintenance Treatment Period | The occurrence of treatment emergent adverse events (TEAEs) is reported as the number of patients with TEAEs. TEAEs were defined as all adverse events occurring between start of treatment in the extension trial and the end of its residual effect period. Adverse events that start before first drug intake in the extension trial and deteriorate under treatment during the extension trial were also considered as 'treatment-emergent'. | Treated Set (TS): all participants who have received at least 1 dose of trial treatment. | Posted | Count of Participants | Participants | From first drug administration, up to 16 weeks after last administration, up to 39 weeks. |
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|
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Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks.
Treated Set (TS): all participants who have received at least 1 dose of trial treatment.
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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 | Spesolimab Low Dose | Participants with hidradenitis suppurativa who completed their treatment with spesolimab in Part 1 of trial 1368-0098 and who met the eligibility criteria for this extension trial. Participants continued on the same dosing regimen that they had in the parent trial. Spesolimab was administered every 2 weeks with a subcutaneous injection. To keep the study blinded, participants were additionally administered placebo to match the volume administered to the participants in the high dose group. Patients were planned to be treated for 76 weeks, followed by a 16-week safety follow-up period. | 0 | 5 | 0 | 5 | 3 | 5 |
| EG001 | Spesolimab High Dose | Participants with hidradenitis suppurativa who completed their treatment with spesolimab in Part 1 of trial 1368-0098 and who met the eligibility criteria for this extension trial. Participants continued on the same dosing regimen that they had in the parent trial. Spesolimab was administered every 2 weeks with a subcutaneous injection. Patients were planned to be treated for 76 weeks, followed by a 16-week safety follow-up period. | 0 | 21 | 0 | 21 | 1 | 21 |
| EG002 | Spesolimab High Dose With Prior Placebo | Participants with hidradenitis suppurativa who completed their treatment with placebo in Part 1 of trial 1368-0098 and who met the eligibility criteria for this extension trial. Participants continued on the same dosing regimen that they had in the parent trial. Spesolimab was administered every 2 weeks with a subcutaneous injection. Patients were planned to be treated for 76 weeks, followed by a 16-week safety follow-up period. | 0 | 13 | 1 | 13 | 5 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sweat gland infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Inflammation | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Tinea cruris | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Interferon gamma release assay positive | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Microalbuminuria | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dyshidrotic eczema | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hidradenitis | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
|
According to the protocol, participants from trial 1368-0098 Part 1, 1368-0098 Part 2, and trial 1368-0100 were planned to be enrolled in this trial. However, 1368-0098 Part 2 and trial 1368-0100 were not initiated because of the termination of the Hidradenitis Suppurativa program development. Therefore, only some patients from 1368-0098 Part 1 have been enrolled in this trial.
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 | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 8, 2025 | Apr 7, 2026 | SAP_001.pdf |
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| 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 |
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| ID | Term |
|---|---|
| C000712973 | spesolimab |
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| 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 |
|