Trial · NCT04876391
A Study Investigating Long-term Treatment With Spesolimab in People With a Skin Disease Called Hidradenitis Suppurativa Who Completed a Previous Clinical Trial
NCT04876391, Phase 2, Completed, Boehringer Ingelheim; results first posted 2025-06-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Investigating Long-term Treatment With Spesolimab in People With a Skin Disease Called Hidradenitis Suppurativa Who Completed a Previous Clinical Trial. Trials, record NCT04876391. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04876391
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Investigating Long-term Treatment With Spesolimab in People With a Skin Disease Called Hidradenitis Suppurativa Who Completed a Previous Clinical Trial
- NCT number
- NCT04876391
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 45 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Hidradenitis Suppurativa
- Interventions
- Spesolimab 1200 mg, Spesolimab 600 mg, Placebo matching 600 mg Spesolimab, Placebo matching 1200 mg Spesolimab
- First posted
- 2021-05-06
- Last updated
- 2025-11-14
- Other registries' IDs
- eudract:2020-005587-55
- Results first posted
- 2025-06-08
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 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. |
| Secondary | Percent Change in Total Abscess and Inflammatory Nodule (AN) Count From Baseline up to Week 12 | 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 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. |
| Secondary | Percentage Change in Total Draining Fistula (DF) Count From Baseline up to Week 12 | 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. | 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. |
| Secondary | Achievement of Hidradenitis Suppurativa Clinical Response (HiSCR) up to Week 12 | At baseline (Week 0) and at Week 12. | HiSCR is defined as at least a 50% reduction in the total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to baseline. Percentage of participants with achievement of Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 is reported. Percentage of participants with achievement of HiSCR at Week 12 was calculated as: number of participants with achievement of HiSCR at Week 12/number of participants analyzed \* 100. |
| Secondary | Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Value up to Week 12 | MMRM included measurements at baseline (Week 0) and at Weeks 1, 2, 4, 6, 8, 10, and 12 after first drug administration. MMRM estimates of absolute change in IHS4 from baseline to Week 12 is reported. | The IHS4 assesses the hidradenitis suppurativa (HS) severity and the resulting IHS4 score is arrived at by= number of nodules \* 1 + number of abscesses \* 2 + number of draining tunnels (fistulae or sinuses) \* 4. A total score of 3 or less signifies mild, 4-10 signifies moderate and 11 or higher signifies severe disease. The minimum score is 0 while the maximum score is variable and depends on the counts of nodules, abscesses, and draining tunnels (fistulae or sinuses). Absolute change from baseline in IHS4 value at Week 12 was modelled using a restricted maximum likelihood (REML)-based mixed effect model with repeated measures (MMRM) approach, accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, prior use of TNF inhibitor and the fixed continuous effects of baseline at each visit (Weeks 1, 2, 4, 6, 8, 10, and 12) as well as random effect of each visit. Baseline refers to the last measurement prior to the start of spesolimab. |
| Secondary | Percentage of Participants With Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) Score of 0 or 1 up to Week 12 | At 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. |
| Secondary | Absolute Change From Baseline in Hidradenitis Suppurativa Area and Severity Index (HASI) Score up to Week 12 | MMRM included measurements at baseline (Week 0) and at Weeks 1, 2, 4, 6, 8, 10, and 12 after first drug administration. MMRM estimates of absolute change from baseline in HASI score at Week 12 is reported. | The HASI assesses HS severity across four domains: erythema, induration, open ulcer, and draining fistula, scored on a 0 (none) to 3 (severe/extensive) Likert scale for each body region. For body surface area (BSA) assessment, the number of palms (one palm indicates 1% of the participant's BSA) involved for each body region (head, right axilla, left axilla, anterior chest, back, anterior bathing trunk, posterior bathing trunk, other) is assessed and converted to a percentage of that region. An area score was assigned to each region using the approach (0 = none, 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89%, 6 = 90- 100%). Scores for the four domains of HS are summed and adjusted for the area affected, and the score of each area are summed to calculate the total HASI score, which ranges from 0 (no disease) to 72 (severe disease). The Least Squares Mean (Standard Error (SE)) was derived from mixed effect model with repeated measures (MMRM). |
| Secondary | Patients With Occurrence of at Least One Flare (Defined as at Least 25 % Increase in AN Count With a Minimum Increase of 2 Relative to Baseline) up to Week 12 | Samples were taken at baseline (Week 0) and at Weeks 2, 4, 6, 8, 10, and 12 after first drug administration. | Percentage of participants with occurrence of at least one flare at Week 12. Flare was defined as at least 25 % increase in abscess and inflammatory nodule count with a minimum increase of 2 relative to baseline. Percentage of participants with occurrence of at least one flare at Week 12 was calculated as: number of participants with occurrence of at least one flare at Week 12/number of participants analyzed \* 100. |
| Secondary | Achievement of at Least 30% Reduction From Baseline in Numerical Rating Scale (NRS30) in Patient's Global Assessment of HS Pain up to Week 12 | At baseline (Week 0) and at Week 12. | The analysis assessed the percentage of participants who achieved at least a 30% reduction from baseline in the Numerical Rating Scale (NRS30) for the Participant's Global Assessment of HS Pain by Week 12. The HS Pain Numerical Rating Scale (NRS) measures HS-related pain severity, with a recall period of 24 hours and responses on an 11-point scale from 0 (no pain) to 10 (worst possible pain). For pain analysis, a weekly average of daily assessments was calculated at each visit, based on recorded values before the visit. Weeks with at least four reported daily values were included, ignoring any missing daily values. The percentage of participants achieving at least a 30% reduction from baseline in NRS30 by Week 12 was calculated as the number of participants meeting this criterion divided by the total number of participants analyzed \* 100. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From drug administration until the end of maintenance treatment period (120 weeks). This period includes the Residual effect period (REP) (i.e., 16 weeks after the last study treatment). | Safety Analysis Set (SAF): This participant set included all participants who were enrolled and received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent Change in Total Abscess and Inflammatory Nodule (AN) Count From Baseline up to Week 12 | 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. | Safety Analysis Set (SAF): This participant set included all participants who received at least one dose of the study drug. Data up to the use of rescue therapy were included for analysis, and data post-use were censored. Only participants with non-missing endpoint data were included. | Percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Change in Total Draining Fistula (DF) Count From Baseline up to Week 12 | 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. | Safety Analysis Set (SAF): This patient set included all patients who received at least one dose of study drug. Data up to use of rescue therapy were included for analysis, and data post the use were censored. Only patients with baseline draining fistulas \>=1 and non-missing endpoint data were included. | Percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | Achievement of Hidradenitis Suppurativa Clinical Response (HiSCR) up to Week 12 | At baseline (Week 0) and at Week 12. | Safety Analysis Set (SAF): This participant set included all participants who received at least one dose of the study drug. Data up to the use of rescue therapy were included for analysis, and data post-use were censored. Only participants with non-missing endpoint data were included. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Value up to Week 12 | 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. | Safety Analysis Set (SAF): This participant set included all participants who received at least one dose of the study drug. Data up to the use of rescue therapy were included for analysis, and data post-use were censored. Only participants with non-missing endpoint data were included. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) Score of 0 or 1 up to Week 12 | At Week 12. | Safety Analysis Set (SAF): This participant set included all participants who received at least one dose of study drug. Any binary data collected after use of any rescue therapy was censored and then imputed using the no response imputation (NRI) method as described in the statistical analysis plan. | Percentage of participants | NUMBER |
| SECONDARY | Absolute Change From Baseline in Hidradenitis Suppurativa Area and Severity Index (HASI) Score up to Week 12 | 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. | Safety Analysis Set (SAF): This participant set included all participants who received at least one dose of the study drug. Data up to the use of rescue therapy were included for analysis, and data post-use were censored. Only participants with non-missing endpoint data were included. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Patients With Occurrence of at Least One Flare (Defined as at Least 25 % Increase in AN Count With a Minimum Increase of 2 Relative to Baseline) up to Week 12 | Samples were taken at baseline (Week 0) and at Weeks 2, 4, 6, 8, 10, and 12 after first drug administration. | Safety Analysis Set (SAF): This participant set included all participants who received at least one dose of study drug. Any binary data collected after use of any rescue therapy was censored and then imputed using the no response imputation (NRI) method as described in the statistical analysis plan. | Percentage of participants | NUMBER |
| SECONDARY | Achievement of at Least 30% Reduction From Baseline in Numerical Rating Scale (NRS30) in Patient's Global Assessment of HS Pain up to Week 12 | At baseline (Week 0) and at Week 12. | Safety Analysis Set (SAF): This participant set included all participants who received at least one dose of study drug. Any binary data collected after use of any rescue therapy was censored and then imputed using the no response imputation (NRI) method as described in the statistical analysis plan. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Prior Placebo (PP) | 15 | Participants | ||
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Prior Spesolimab (PS) | 28 | Participants | ||
| Percent Change in Total Abscess and Inflammatory Nodule (AN) Count From Baseline up to Week 12 | Prior Placebo (PP) | -18.3 | Standard Error 19.2 | Percentage change | |
| Percent Change in Total Abscess and Inflammatory Nodule (AN) Count From Baseline up to Week 12 | Prior Spesolimab (PS) | -35.0 | Standard Error 12.7 | Percentage change | |
| Percentage Change in Total Draining Fistula (DF) Count From Baseline up to Week 12 | Prior Placebo (PP) | 25.4 | Standard Error 25.5 | Percentage change | |
| Percentage Change in Total Draining Fistula (DF) Count From Baseline up to Week 12 | Prior Spesolimab (PS) | -44.6 | Standard Error 18.1 | Percentage change | |
| Achievement of Hidradenitis Suppurativa Clinical Response (HiSCR) up to Week 12 | Prior Placebo (PP) | 33.3 | 95% Confidence Interval 13.8 to 60.9 | Percentage of participants | |
| Achievement of Hidradenitis Suppurativa Clinical Response (HiSCR) up to Week 12 | Prior Spesolimab (PS) | 40.7 | 95% Confidence Interval 24.5 to 59.3 | Percentage of participants | |
| Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Value up to Week 12 | Prior Placebo (PP) | -3.1 | Standard Error 4.8 | Score on a scale | |
| Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Value up to Week 12 | Prior Spesolimab (PS) | -10.5 | Standard Error 3.3 | Score on a scale |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Prior Placebo (PP) | 15 | |
| Overall Study | STARTED | Prior Spesolimab (PS) | 30 | |
| Overall Study | COMPLETED | Prior Placebo (PP) | 7 | |
| Overall Study | COMPLETED | Prior Spesolimab (PS) | 9 | |
| Overall Study | NOT COMPLETED | Prior Placebo (PP) | 8 | |
| Overall Study | NOT COMPLETED | Prior Spesolimab (PS) | 21 |
Source ClinicalTrials.gov
Adverse events182
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Lymphadenopathy | Blood and lymphatic system disorders | Prior Placebo (PP) | 1 | 15 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Prior Spesolimab (PS) | 0 | 30 | |
| other | Sinus tachycardia | Cardiac disorders | Prior Placebo (PP) | 1 | 15 | |
| other | Sinus tachycardia | Cardiac disorders | Prior Spesolimab (PS) | 0 | 30 | |
| other | Ventricular extrasystoles | Cardiac disorders | Prior Placebo (PP) | 1 | 15 | |
| other | Ventricular extrasystoles | Cardiac disorders | Prior Spesolimab (PS) | 0 | 30 | |
| other | Vision blurred | Eye disorders | Prior Placebo (PP) | 1 | 15 | |
| other | Vision blurred | Eye disorders | Prior Spesolimab (PS) | 0 | 30 | |
| other | Abdominal pain | Gastrointestinal disorders | Prior Placebo (PP) | 1 | 15 | |
| other | Abdominal pain | Gastrointestinal disorders | Prior Spesolimab (PS) | 2 | 30 |
1 to 10 of 182Source ClinicalTrials.gov
See all 182 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Prior Placebo (PP) | 0 | 15 |
| Total, all-cause mortality | Prior Spesolimab (PS) | 0 | 30 |
| Total, other adverse events | Prior Placebo (PP) | 15 | 15 |
| Total, other adverse events | Prior Spesolimab (PS) | 27 | 30 |
| Total, serious adverse events | Prior Placebo (PP) | 4 | 15 |
| Total, serious adverse events | Prior Spesolimab (PS) | 6 | 30 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Prior Spesolimab (PS) vs Prior Placebo (PP): Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Trial comparisons |
| Prior Spesolimab (PS) vs Prior Placebo (PP): deaths from any cause | Trial comparisons |
| Prior Spesolimab (PS) vs Prior Placebo (PP): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04876391
GET https://conductscience.org/api/trials/v1/NCT04876391/events?page=2