Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

1 to 12 of 12

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
SECONDARY	Absolute Change From Baseline in Hidradenitis Suppurativa Quality of Life (HiS-QoL) Total 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 HiS-QoL 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	The Occurrence of Treatment Emergent Adverse Events (TEAEs)	Up to 12 weeks for patients who did roll-over to the open-label extension (OLE) trial (trial number 1368-0067 (NCT04876391)) and up to 28 weeks who did not roll-over to the OLE trial. For details please see description.	Safety Analysis Set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug. One patient randomised to receive placebo took spesolimab during the study, therefore was considered in spesolimab arm instead for safety reporting.	percentage of patients	NUMBER

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

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