Trial · NCT04762277
A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa
NCT04762277, Phase 2, Completed, Boehringer Ingelheim; results first posted 2024-10-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa. Trials, record NCT04762277. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04762277
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa
- NCT number
- NCT04762277
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 52 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Hidradenitis Suppurativa
- Interventions
- Spesolimab - solution for infusion, Placebo matching spesolimab - solution for infusion, Spesolimab- solution for injection, Placebo matching to spesolimab- solution for injection
- First posted
- 2021-02-21
- Last updated
- 2025-10-20
- Other registries' IDs
- eudract:2020-003672-40
- Results first posted
- 2024-10-09
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Total Abscess and Inflammatory Nodule Count at Week 12 | MMRM included measurements from baseline (Week 0) and at Weeks 1, 2, 4, 6, 8, 10, and 12 after first drug administration. MMRM estimates of percent change from baseline to Week 12 is reported. | Percent 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). Percent change from baseline in total abscess and inflammatory nodule count at Week 12 was modelled using mixed effects model for repeated measures (MMRM) accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to tumor necrosis factor inhibitor (TNFi)-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit (Weeks 1, 2, 4, 6, 8, 10, and 12). The Least Squares Mean (Standard Error) at Week 12 is reported. |
| Secondary | Percent Change From Baseline in Draining Fistula Count at Week 12 | MMRM included measurements from baseline (Week 0) and at Weeks 1, 2, 4, 6, 8, 10, and 12 after first drug administration. MMRM estimates of percent change in draining fistula from baseline to Week 12 is reported. | Percent 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). Percent change from baseline in draining fistula count at Week 12 was modelled using mixed effects model for repeated measures (MMRM) accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to tumor necrosis factor inhibitor (TNFi)-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit (Weeks 1, 2, 4, 6, 8, 10, and 12). The Least Squares Mean (Standard Error) at Week 12 is reported. |
| Secondary | Achievement of Hidradenitis Suppurativa Clinical Response (HiSCR) at 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. Proportion of patients with achievement of Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 is reported. Proportion of patients with achievement of HiSCR at Week 12 was calculated as: number of patients with achievement of HiSCR at Week 12/number of patients analyzed. Proportions were rounded up to three decimal places. |
| Secondary | Absolute Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Value at 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 fistula \* 4. A total score of 3 or less signifies mild, 4-10 signifies moderate and 11 or higher signifies severe disease. Absolute change from baseline in IHS4 value at Week 12 was modelled using mixed effects model for repeated measures (MMRM) accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to tumor necrosis factor inhibitor (TNFi)-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit (Weeks 1, 2, 4, 6, 8, 10, and 12). The Least Squares Mean (Standard Error) at Week 12 is reported. |
| Secondary | Absolute Change From Baseline in Hidradenitis Suppurativa Area and Severity Index (HASI) Score at 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 in the table below. | HASI includes four domains to assess the severity of HS disease activity, which are erythema, induration, open ulcer and draining fistula and scored on a Likert scale 0 (none) to 3 (severe/extensive) for each predetermined body region. For body surface area (BSA) assessment, the number of palms (one palm indicates 1% of the patient'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)) derive from MMRM. |
| Secondary | Achievement of Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) Score of 0 or 1 at Week 12 | At Week 12. | HS-PGA documents the physician's assessment of the patient's HS at a given timepoint. The HS-PGA score ranges from 0 to 5, where: 0=clear - no abscesses, draining fistula, inflammatory nodules or noninflammatory nodules); 1=minimal - no abscesses, draining fistula or inflammatory nodules and the presence of noninflammatory nodules); 2=mild - no abscesses or draining fistula and 1-4 inflammatory nodules, or 1 abscess or draining tunnel and no inflammatory nodules); 3=moderate - no abscesses or draining fistula and ≥5 inflammatory nodules, or 1 abscess or draining fistula and ≥1 inflammatory nodule, or 2-5 abscesses or draining fistula and \<10 inflammatory nodules); 4=severe - 2-5 abscesses or draining fistula and ≥10 inflammatory nodules); 5=very severe - \>5 abscesses or draining fistula). Proportion of patients with achievement of HS-PGA score of 0 or 1 at Week 12 was calculated as: number of patients with achievement of HS-PGA score of 0 or 1 at Week 12/number of patients analyzed. |
| Secondary | Achievement of at Least 30% Reduction From Baseline in Numerical Rating Scale (NRS30) in Patient's Global Assessment of HS Pain at Week 12 | At baseline (Week 0) and at Week 12. | The HS Pain Numerical Rating Scale (NRS) is an endpoint for the assessment of HS-related pain severity. Recall period is 24 hours and response is given by an 11-point scale ranging from 0 (no pain) to 10 (worst possible pain). For the analysis of pain, weekly average of daily assessment was calculated for each visit based on values prior to the visit. Missing daily values within a week were ignored if there are at least 4 reported values. Proportion of patients with achievement of at least 30% reduction from baseline in NRS30 in Patient's Global Assessment of HS Pain at Week 12. Proportion of patients with achievement of at least 30% reduction from baseline in NRS30 in Patient's Global Assessment of HS Pain at Week 12 was calculated as: number of patients with achievement of at least 30% reduction from baseline in NRS30 in Patient's Global Assessment of HS Pain at Week 12/number of patients analyzed. Proportions were rounded up to three decimal places. |
| Secondary | Occurrence of Complete Elimination of Draining Fistulas at Week 12 | Baseline (Week 0) and at Week 12. | Proportion of patients with occurrence of complete elimination of draining fistulas at Week 12 is reported. Proportion of patients with occurrence of complete elimination of draining fistulas at Week 12 was calculated as: number of patients with occurrence of complete elimination of draining fistulas at Week 12/number of patients analyzed. Proportions were rounded up to three decimal places. |
| Secondary | Occurrence of at Least One Flare at Week 12 | At Week 12. | Proportion of patients 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. Proportion of patients with occurrence of at least one flare at Week 12 was calculated as: number of patients with occurrence of at least one flare at Week 12/number of patients analyzed. Proportions were rounded up to three decimal places. |
| Secondary | Absolute Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 12 | MMRM included measurements at baseline (Week 0) and at Weeks 1, 4, 8, and 12 after first drug administration. MMRM estimates of absolute change in DLQI from baseline to Week 12 is reported. | The DLQI is a patient-administered, ten-question, quality of life questionnaire that covers six domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. Response categories include "not relevant" (score of 0), "not at all" (score of 0), "a little" (score of 1), "a lot" (score of 2) and "very much" (score of 3). DLQI total score is calculated by summing the scores of each question resulting in a range of 0 to 30 with higher scores indicating greater health-related quality of life impairment. Absolute change from baseline in DLQI score at Week 12 was modelled using MMRM accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to tumor necrosis factor inhibitor (TNFi)-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit (Weeks 1, 4, 8, and 12). |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Total Abscess and Inflammatory Nodule Count at Week 12 | MMRM included measurements from baseline (Week 0) and at Weeks 1, 2, 4, 6, 8, 10, and 12 after first drug administration. MMRM estimates of percent change from baseline to Week 12 is reported. | Safety Analysis Set (SAF): This patient set included all patients who were randomized and 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 non-missing endpoint data were included. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Draining Fistula Count at Week 12 | MMRM included measurements from baseline (Week 0) and at Weeks 1, 2, 4, 6, 8, 10, and 12 after first drug administration. MMRM estimates of percent change in draining fistula from baseline to Week 12 is reported. | Safety Analysis Set (SAF): This patient set included all patients who were randomized and 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. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Achievement of Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 | At baseline (Week 0) and at Week 12. | Safety Analysis Set (SAF): This patient set included all patients who were randomized and 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. | proportion of patients | NUMBER |
| SECONDARY | Absolute Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Value at 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 patient set included all patients who were randomized and 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 non-missing endpoint data were included. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change From Baseline in Hidradenitis Suppurativa Area and Severity Index (HASI) Score at 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 in the table below. | Safety Analysis Set (SAF): This patient set included all patients who were randomized and 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 non-missing endpoint data were included. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Achievement of Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) Score of 0 or 1 at Week 12 | At Week 12. | Safety Analysis Set (SAF): This patient set included all patients who were randomized and 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. | proportion of patients | NUMBER |
| SECONDARY | Achievement of at Least 30% Reduction From Baseline in Numerical Rating Scale (NRS30) in Patient's Global Assessment of HS Pain at Week 12 | At baseline (Week 0) and at Week 12. | Safety Analysis Set (SAF): This patient set included all patients who were randomized and 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. | proportion of patients | NUMBER |
| SECONDARY | Occurrence of Complete Elimination of Draining Fistulas at Week 12 | Baseline (Week 0) and at Week 12. | Safety Analysis Set (SAF): This patient set included all patients who were randomized and 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. Only patients with baseline draining fistulas \>= 1 and non-missing endpoint data were included. | proportion of patients | NUMBER |
| SECONDARY | Occurrence of at Least One Flare at Week 12 | At Week 12. | Safety Analysis Set (SAF): This patient set included all patients who were randomized and 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. | proportion of patients | NUMBER |
| SECONDARY | Absolute Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 12 | MMRM included measurements at baseline (Week 0) and at Weeks 1, 4, 8, and 12 after first drug administration. MMRM estimates of absolute change in DLQI from baseline to Week 12 is reported. | Safety Analysis Set (SAF): This patient set included all patients who were randomized and 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 non-missing endpoint data were included. | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Total Abscess and Inflammatory Nodule Count at Week 12 | Placebo | -34.7 | Standard Error 11.1 | percent change | |
| Percent Change From Baseline in Total Abscess and Inflammatory Nodule Count at Week 12 | Spesolimab | -38.8 | Standard Error 7.5 | percent change | |
| Percent Change From Baseline in Draining Fistula Count at Week 12 | Placebo | 56.6 | Standard Deviation 23.0 | percent change | |
| Percent Change From Baseline in Draining Fistula Count at Week 12 | Spesolimab | -40.1 | Standard Deviation 16.8 | percent change | |
| Achievement of Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 | Placebo | 0.176 | proportion of patients | ||
| Achievement of Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 | Spesolimab | 0.314 | proportion of patients | ||
| Absolute Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Value at Week 12 | Placebo | 4.9 | Standard Error 4.7 | units on a scale | |
| Absolute Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Value at Week 12 | Spesolimab | -9.0 | Standard Error 3.2 | units on a scale | |
| Absolute Change From Baseline in Hidradenitis Suppurativa Area and Severity Index (HASI) Score at Week 12 | Placebo | -3.8 | Standard Error 6.9 | units on a scale | |
| Absolute Change From Baseline in Hidradenitis Suppurativa Area and Severity Index (HASI) Score at Week 12 | Spesolimab | -23.6 | Standard Error 4.7 | units on a scale |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 17 | |
| Overall Study | STARTED | Spesolimab | 35 | |
| Overall Study | COMPLETED | Placebo | 16 | |
| Overall Study | COMPLETED | Spesolimab | 32 | |
| Overall Study | NOT COMPLETED | Placebo | 1 | |
| Overall Study | NOT COMPLETED | Spesolimab | 3 |
Source ClinicalTrials.gov
Adverse events94
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 | Arrhythmia | Cardiac disorders | Placebo | 1 | 16 | |
| other | Arrhythmia | Cardiac disorders | Spesolimab | 0 | 36 | |
| other | Tachycardia | Cardiac disorders | Placebo | 1 | 16 | |
| other | Tachycardia | Cardiac disorders | Spesolimab | 0 | 36 | |
| other | Vertigo | Ear and labyrinth disorders | Placebo | 1 | 16 | |
| other | Vertigo | Ear and labyrinth disorders | Spesolimab | 0 | 36 | |
| other | Keratitis | Eye disorders | Placebo | 1 | 16 | |
| other | Keratitis | Eye disorders | Spesolimab | 0 | 36 | |
| other | Angular cheilitis | Gastrointestinal disorders | Placebo | 1 | 16 | |
| other | Angular cheilitis | Gastrointestinal disorders | Spesolimab | 0 | 36 |
1 to 10 of 94Source ClinicalTrials.gov
See all 94 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 16 |
| Total, all-cause mortality | Spesolimab | 0 | 36 |
| Total, other adverse events | Placebo | 14 | 16 |
| Total, other adverse events | Spesolimab | 26 | 36 |
| Total, serious adverse events | Placebo | 1 | 16 |
| Total, serious adverse events | Spesolimab | 0 | 36 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Spesolimab vs Placebo: deaths from any cause | Trial comparisons |
| Spesolimab vs Placebo: 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.
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GET https://conductscience.org/api/trials/v1/NCT04762277/results?page=2