Hidradenitis SuppurativaPhase 2NCT04876391
A Study Investigating Long-term Treatment With Spesolimab in People With a Skin Disease Called Hidradenitis Suppurativa Who Completed a Previous Clinical Trial
A Phase 2 study testing Spesolimab 1200 mg and Spesolimab 600 mg in people with Hidradenitis Suppurativa, run by Boehringer Ingelheim at 26 sites in 12 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Spesolimab 1200 mg and Spesolimab 600 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 26 sitesin 12 countries
- Study dates
- 24 Aug 2021to 26 Apr 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have completed treatment in the parent Hidradenitis suppurativa (HS) spesolimab trial (1368-0052) without premature discontinuation
- Signed and dated written informed consent in accordance with ICH Harmonized Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
- Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information and consent form.
Who cannot join
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial
- Patients who experienced study treatment-limiting adverse events during the 1368-0052 parent trial
- Severe, progressive, or uncontrolled condition such as renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof
- Any new documented active or suspected malignancy except appropriately treated basal cell carcinoma, squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix
- Use of any restricted medication or any drug considered by the investigator likely to interfere with the safe conduct of the study since the last visit of the 1368-0052 parent trial
- History of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients
- Major surgery (major according to the investigator's assessment) planned during this extension trial (e.g. hip replacement, aneurysm removal, stomach ligation), as assessed by the investigator
- Any condition which in the opinion of the investigator affects the safety of the patient, the patient's ability to participate in this trial or could compromise the quality of data Further exclusion criteria apply
Trial locations and contacts
26 sites in 12 countries.
26 sites in 12 countries
United States4 sites
Dawes Fretzin Clinical Research Group, LLC-Indianapolis-58713
Indianapolis, Indiana, 46250
Dermatology Research Associates
Los Angeles, California, 90045
Unity Clinical Research
Oklahoma City, Oklahoma, 73118
Mayo Clinic, Rochester
Rochester, Minnesota, 55905
France3 sites
CLI Reims Bezannes
Bezannes, 51430
HOP Edouard Herriot
Lyon, 69437
HOP Larrey
Toulouse, 31059
Germany3 sites
Katholisches Klinikum Bochum gGmbH
Bochum, 44791
Städtisches Klinikum Dessau
Dessau, 06847
Universitätsklinikum Frankfurt
Frankfurt am Main, 60596
Norway3 sites
Haukeland Universitetssykehus
Bergen, N-5021
Nordlandssykehuset HF, Bodø
Bodø, N-8092
Oslo Universitetssykehus HF, Rikshospitalet
Oslo, N-0372
Spain3 sites
Hospital Santa Creu i Sant Pau
Barcelona, 08026
Hospital La Princesa
Madrid, 28006
Hospital Universitario 12 de Octubre
Madrid, 28041
Australia2 sites
Royal Melbourne Hospital
Parkville, Victoria, 3050
Holdsworth House Medical Practice
Sydney, New South Wales, 2010
Italy2 sites
Ospedali Riuniti di Ancona
Ancona, 60123
Azienda Ospedaliera Universitaria Pisana
Pisa, 56126
Poland2 sites
Non-Public Health Care Facility LABDERM
Ossy, 42624
Cityclinic Medical and Psychological Clinic Matusiak Partnership
Wroclaw, 50-566
Canada1 site
Dr. S. K. Siddha Medicine Professional Corporation
Newmarket, Ontario, L3Y 5G8
Netherlands1 site
Erasmus Medisch Centrum-ROTTERDAM-50697
Rotterdam, 3015 GD
About this study
Official title: An Open-label, Long-term Extension Trial of Spesolimab Treatment in Adult Patients With Hidradenitis Suppurativa (HS)
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.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Spesolimab 1200 mg, Spesolimab 600 mg, Placebo matching 600 mg Spesolimab, Placebo matching 1200 mg Spesolimab
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spesolimab 1200 mgDrug
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.
Spesolimab 600 mgDrug
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.
Placebo matching 600 mg SpesolimabDrug
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.
Placebo matching 1200 mg SpesolimabDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Spesolimab 1200 mg; Drug: Spesolimab 600 mg; Drug: Placebo matching 600 mg Spesolimab |
| 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. Receives: Drug: Spesolimab 600 mg; Drug: Placebo matching 1200 mg Spesolimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: At baseline (Week 0) and at Week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start24 Aug 2021
- Primary completion26 Apr 2024
- Study completion26 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876391
- Sponsor's protocol ID
- 1368-0067
- Other IDs
- 2020-005587-55
- Status last verified
- Nov 2025
- First submitted
- 4 May 2021
- Last updated
- 14 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Long-term Extension Trial of Spesolimab Treatment in Adult Patients With Hidradenitis Suppurativa (HS)
- ClinicalTrials.gov ID
- NCT04876391
- Acronym / sponsor ID
- 1368-0067
- Conditions
- Hidradenitis Suppurativa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 24 Aug 2021 (actual)
- Primary completion
- 26 Apr 2024 (actual)
- Study completion
- 26 Apr 2024 (actual)
- First posted
- 6 May 2021 (actual)
- Results
- Posted 8 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prior Placebo (PP) | Experimental | Drug: Spesolimab 1200 mg, Drug: Spesolimab 600 mg, Drug: Placebo matching 600 mg SpesolimabParticipants in the placebo arm of the 1368-0052 Proof of Concept Clinical (PoCC) trial received an initial 1200 mg intravenous (i.v.) loading dose of spesolimab plus subcutaneous (s.c.) placebo at Visit 1, followed by 600 mg s.c. doses of spesolimab every two weeks for the next 12 weeks. Further dosing was based on changes in HS-PGA grade assessment from baseline to week 12. |
| Prior Spesolimab (PS) | Experimental | Drug: Spesolimab 600 mg, Drug: Placebo matching 1200 mg SpesolimabParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who have completed treatment in the parent Hidradenitis suppurativa (HS) spesolimab trial (1368-0052) without premature discontinuation
- Signed and dated written informed consent in accordance with ICH Harmonized Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
- Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information and consent form.
Key exclusion criteria (8 listed)
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial
- Patients who experienced study treatment-limiting adverse events during the 1368-0052 parent trial
- Severe, progressive, or uncontrolled condition such as renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof
- Any new documented active or suspected malignancy except appropriately treated basal cell carcinoma, squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix
- Use of any restricted medication or any drug considered by the investigator likely to interfere with the safe conduct of the study since the last visit of the 1368-0052 parent trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spesolimab 1200 mgParticipants 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. | Drug | Prior Placebo (PP) |
| Spesolimab 600 mgParticipants 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. | Drug | Prior Placebo (PP), Prior Spesolimab (PS) |
| Placebo matching 600 mg SpesolimabParticipants 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. | Drug | Prior Placebo (PP) |
| Placebo matching 1200 mg SpesolimabParticipants 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 | Drug | Prior Spesolimab (PS) |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: 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).
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.
8 secondary outcomes
Percent Change in Total Abscess and Inflammatory Nodule (AN) Count From Baseline up to Week 12
Time frame: 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
Time frame: 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
Time frame: At baseline (Week 0) and at Week 12.
Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Value up to Week 12
Time frame: 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
Time frame: At Week 12.
Absolute Change From Baseline in Hidradenitis Suppurativa Area and Severity Index (HASI) Score up to Week 12
Time frame: 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
Time frame: 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
Time frame: At baseline (Week 0) and at Week 12.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
26 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Spesolimab 1200 mg and Spesolimab 600 mg in people with Hidradenitis Suppurativa, run by Boehringer Ingelheim at 26 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, France, Germany, Norway, Spain and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.