Trial · NCT05819398
Lunsayil 1: A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa
NCT05819398, Phase 2, Phase 3, Completed, Boehringer Ingelheim; results first posted 2025-11-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Lunsayil 1: A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa. Trials, record NCT05819398. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05819398
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lunsayil 1: A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa
- NCT number
- NCT05819398
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 209 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Hidradenitis Suppurativa
- Interventions
- Spesolimab i.v., Spesolimab s.c., Placebo matching Spesolimab i.v., Placebo matching Spesolimab s.c.
- First posted
- 2023-04-19
- Last updated
- 2025-11-05
- Results first posted
- 2025-11-05
- Limitations and caveats
The Part 2 was not initiated due to discontinuation of this trial according to protocol. The interim analysis in Part 1 was done after all patients reached Week 16 milestone, and following the analysis, the decision to discontinue was taken.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1 - Percent Change From Baseline in Draining Fistula/Tunnel (dT) Count at Week 8 | The MMRM model incorporates dT count from baseline (Week 0), Week 2, Week 4, Week 6 and Week 8. The data represent the Least Squares Means at Week 8. | Percent change from baseline in draining fistula/tunnel (dT) count at Week 8 is reported. Tunnel/fistula/sinus were counted as dT only if draining. Percent change was calculated as follows: (dT count at week 8 - dT count at baseline)/ dT at baseline. Least square means and standard errors were estimated by Mixed effect model for repeated measurements (MMRM). The MMRM included fixed categorical effects of treatment at each visit, Tumor Necrosis Factor inhibitor (TNFi) status at baseline, and categorical baseline dT count at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-trial participant measurements. |
| Secondary | Part 1 - Percent Change From Baseline in Draining Fistula/Tunnel (dT) Count at Week 16 | The MMRM model incorporates dT count from baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14 and Week 16. The data represent the Least Squares Means at Week 16. | Percent change from baseline in draining fistula/tunnel (dT) count at Week 16 is reported. Tunnel/fistula/sinus were counted as dT only if draining. Least square means and standard errors were estimated by MMRM, which included fixed categorical effects of treatment at each visit, TNFi status at baseline, categorical baseline dT count and fixed continuous effect of baseline of outcome measures at each visit. Visit was treated as repeated measure with an unstructured covariance matrix for the within trial participant variability and all visits with planned measurements of the outcome variable as well as all dose groups were included in the model. |
| Secondary | Part 1 - Absolute Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Value at Week 8 | The MMRM model incorporates IHS4 value from baseline (Week 0), Week 2, Week 4, Week 6 and Week 8. The data represent the Least Squares Means at Week 8. | IHS4 is a validated, clinical scoring system for dynamic assessment of HS severity. The score was calculated as: (number of nodules x1) + (number of abscesses x2) + (number of draining tunnels \[fistulae/sinuses\] x4). The minimum is 0, the maximum depends on the count of nodules, abscesses, and draining tunnels. Scores 0-3 indicate mild HS, 4-10 moderate HS, ≥11 severe HS. Absolute change from baseline was calculated as follows: (IHS4 value at visit timepoints) - (IHS4 value at baseline). Least square means and standard errors were estimated by MMRM, which included fixed categorical effects of treatment at each visit, TNFi status at baseline, categorical baseline dT count and fixed continuous effect of baseline of outcome measures at each visit. Visit was treated as repeated measure with an unstructured covariance matrix for the within trial participant variability and all visits with planned measurements of the outcome variable as well as all dose groups were included in the model. |
| Secondary | Part 1 - Absolute Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Value at Week 16 | The MMRM model incorporates IHS4 from baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14 and Week 16. The data represent the Least Squares Means at Week 16. | IHS4 is a validated, clinical scoring system for dynamic assessment of HS severity. The score was calculated as: (number of nodules x1) + (number of abscesses x2) + (number of draining tunnels \[fistulae/sinuses\] x4). The minimum is 0, the maximum depends on the count of nodules, abscesses, and draining tunnels. Scores 0-3 indicate mild HS, 4-10 moderate HS, ≥11 severe HS. Absolute change from baseline was calculated as follows: (IHS4 value at visit timepoints) - (IHS4 value at baseline). Least square means and standard errors were estimated by MMRM, which included fixed categorical effects of treatment at each visit, TNFi status at baseline, categorical baseline dT count and fixed continuous effect of baseline of outcome measures at each visit. Visit was treated as repeated measure with an unstructured covariance matrix for the within trial participant variability and all visits with planned measurements of the outcome variable as well as all dose groups were included in the model. |
| Secondary | Part 1 - Occurrence of Treatment Emergent Adverse Events (TEAEs) | From first drug administration until end of exposure, plus residual effect period, up to approximately 68 weeks. | The occurrence of treatment emergent adverse events (TEAEs) is reported as the number of patients with TEAEs. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1 - Percent Change From Baseline in Draining Fistula/Tunnel (dT) Count at Week 8 | The MMRM model incorporates dT count from baseline (Week 0), Week 2, Week 4, Week 6 and Week 8. The data represent the Least Squares Means at Week 8. | Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug. The use of treatment policy approach disregards the intercurrent event and uses the value of the variable regardless of the occurrence of the intercurrent event. | Percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | Part 1 - Percent Change From Baseline in Draining Fistula/Tunnel (dT) Count at Week 16 | The MMRM model incorporates dT count from baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14 and Week 16. The data represent the Least Squares Means at Week 16. | Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug. The use of treatment policy approach disregards the intercurrent event and uses the value of the variable regardless of the occurrence of the intercurrent event. | Percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | Part 1 - Absolute Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Value at Week 8 | The MMRM model incorporates IHS4 value from baseline (Week 0), Week 2, Week 4, Week 6 and Week 8. The data represent the Least Squares Means at Week 8. | Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug. The use of treatment policy approach disregards the intercurrent event and uses the value of the variable regardless of the occurrence of the intercurrent event. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Part 1 - Absolute Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Value at Week 16 | The MMRM model incorporates IHS4 from baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14 and Week 16. The data represent the Least Squares Means at Week 16. | Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug. The use of treatment policy approach disregards the intercurrent event and uses the value of the variable regardless of the occurrence of the intercurrent event. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Part 1 - Occurrence of Treatment Emergent Adverse Events (TEAEs) | From first drug administration until end of exposure, plus residual effect period, up to approximately 68 weeks. | Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part 1 - Percent Change From Baseline in Draining Fistula/Tunnel (dT) Count at Week 8 | Placebo | -21.5 | Standard Error 7.7 | Percentage change | |
| Part 1 - Percent Change From Baseline in Draining Fistula/Tunnel (dT) Count at Week 8 | Spesolimab low dose group | -41.9 | Standard Error 7.8 | Percentage change | |
| Part 1 - Percent Change From Baseline in Draining Fistula/Tunnel (dT) Count at Week 8 | Spesolimab medium dose group | -39.3 | Standard Error 7.9 | Percentage change | |
| Part 1 - Percent Change From Baseline in Draining Fistula/Tunnel (dT) Count at Week 8 | Spesolimab high dose group | -25.8 | Standard Error 7.9 | Percentage change | |
| Part 1 - Percent Change From Baseline in Draining Fistula/Tunnel (dT) Count at Week 16 | Placebo | -14.0 | Standard Error 10.6 | Percentage change | |
| Part 1 - Percent Change From Baseline in Draining Fistula/Tunnel (dT) Count at Week 16 | Spesolimab low dose group | -23.5 | Standard Error 10.7 | Percentage change | |
| Part 1 - Percent Change From Baseline in Draining Fistula/Tunnel (dT) Count at Week 16 | Spesolimab medium dose group | -36.2 | Standard Error 10.8 | Percentage change | |
| Part 1 - Percent Change From Baseline in Draining Fistula/Tunnel (dT) Count at Week 16 | Spesolimab high dose group | -22.7 | Standard Error 11.2 | Percentage change | |
| Part 1 - Absolute Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Value at Week 8 | Placebo | -13.5 | Standard Error 2.5 | Units on a scale | |
| Part 1 - Absolute Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Value at Week 8 | Spesolimab low dose group | -11.1 | Standard Error 2.5 | Units on a scale |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 53 | |
| Overall Study | STARTED | Spesolimab low dose group | 53 | |
| Overall Study | STARTED | Spesolimab medium dose group | 52 | |
| Overall Study | STARTED | Spesolimab high dose group | 51 | |
| Overall Study | COMPLETED | Placebo | 21 | |
| Overall Study | COMPLETED | Spesolimab low dose group | 20 | |
| Overall Study | COMPLETED | Spesolimab medium dose group | 20 | |
| Overall Study | COMPLETED | Spesolimab high dose group | 17 | |
| Overall Study | NOT COMPLETED | Placebo | 32 | |
| Overall Study | NOT COMPLETED | Spesolimab low dose group | 33 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events320
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 | Diarrhoea | Gastrointestinal disorders | Placebo | 3 | 53 | |
| other | Diarrhoea | Gastrointestinal disorders | Spesolimab following placebo | 1 | 50 | |
| other | Diarrhoea | Gastrointestinal disorders | Spesolimab low dose group | 3 | 53 | |
| other | Diarrhoea | Gastrointestinal disorders | Spesolimab medium dose group | 1 | 52 | |
| other | Diarrhoea | Gastrointestinal disorders | Spesolimab high dose group | 4 | 51 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 4 | 53 | |
| other | Nausea | Gastrointestinal disorders | Spesolimab following placebo | 2 | 50 | |
| other | Nausea | Gastrointestinal disorders | Spesolimab low dose group | 3 | 53 | |
| other | Nausea | Gastrointestinal disorders | Spesolimab medium dose group | 2 | 52 | |
| other | Nausea | Gastrointestinal disorders | Spesolimab high dose group | 0 | 51 |
1 to 10 of 320Source ClinicalTrials.gov
See all 320 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 53 |
| Total, all-cause mortality | Spesolimab following placebo | 0 | 50 |
| Total, all-cause mortality | Spesolimab low dose group | 0 | 53 |
| Total, all-cause mortality | Spesolimab medium dose group | 0 | 52 |
| Total, all-cause mortality | Spesolimab high dose group | 0 | 51 |
| Total, other adverse events | Placebo | 29 | 53 |
| Total, other adverse events | Spesolimab following placebo | 32 | 50 |
| Total, other adverse events | Spesolimab low dose group | 39 | 53 |
| Total, other adverse events | Spesolimab medium dose group | 38 | 52 |
| Total, other adverse events | Spesolimab high dose group | 41 | 51 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT05819398
GET https://conductscience.org/api/trials/v1/NCT05819398/events?page=2