Trial · NCT04242498
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa
NCT04242498, Phase 3, Completed, UCB Biopharma SRL; results first posted 2024-12-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa. Trials, record NCT04242498. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04242498
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa
- NCT number
- NCT04242498
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 509 participants, actual
- Lead sponsor
- UCB Biopharma SRL
- Conditions
- Hidradenitis Suppurativa
- Interventions
- Bimekizumab, Placebo
- First posted
- 2020-01-27
- Last updated
- 2026-10-26
- Other registries' IDs
- eudract:2019-002551-42
- Results first posted
- 2024-12-05
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16 | Week 16 | HiSCR50 was defined as at least a 50 percent (%) reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase from Baseline in abscess or draining tunnel count. Intermittent missing data are imputed using multiple imputation with Markov Chain Monte Carlo (MCMC) method followed by monotone regression for monotone missing data. Lesion counts were imputed and then dichotomized to obtain the response status. Participants who experienced an intercurrent event were treated as nonresponders following the intercurrent event. An intercurrent event was defined as receipt of systemic antibiotic rescue medication or discontinuation of study treatment due to an adverse event (AE) or lack of efficacy. Percentages of participants shown do not account for model effects using the logistic regression model. |
| Secondary | Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 16 | Week 16 | HiSCR75 was defined as at least a 75% reduction from Baseline in the total AN count, with no increase from Baseline in abscess or draining tunnel count. Intermittent missing data were imputed using multiple imputation with MCMC method followed by monotone regression for monotone missing data. Lesion counts were imputed and then dichotomized to obtain the response status. Participants who experienced an intercurrent event were treated as nonresponders following the intercurrent event. An intercurrent event was defined as receipt of systemic antibiotic rescue medication or discontinuation of study treatment due to an AE or lack of efficacy. Percentages of participants shown do not account for model effects using the logistic regression model. |
| Secondary | Percentage of Participants With Flare by Week 16 | From Baseline to Week 16 | Flare was defined as a greater than or equal to (\>=) 25% increase in AN count with an absolute increase in AN count of \>= 2 relative to Baseline. Intermittent missing data were imputed using multiple imputation with MCMC method followed by monotone regression for monotone missing data. Lesion counts were imputed and then dichotomized to obtain the response status. Participants who experienced an intercurrent event prior to experiencing a flare were treated as having experienced a flare at all flare assessments on and after the intercurrent event date. An intercurrent event was defined as receipt of systemic antibiotic rescue medication or discontinuation of study treatment due to an AE or lack of efficacy. Percentages of participants shown do not account for model effects using the logistic regression model. |
| Secondary | Absolute Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16 | Baseline, Week 16 | The DLQI is a patient-reported questionnaire designed for use in adult participants with skin diseases and Hidradenitis Suppurativa (HS). The DLQI is a skin disease-specific questionnaire aimed at the evaluation of how symptoms and treatment affect patients' health related quality of life (HRQoL), with a recall period of 7 days. This instrument asks participants 10 questions about symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The scoring of each answer for the DLQI is on a scale range of 0 (not at all) to 3 (very much). The DLQI total score was calculated by adding the score of each question. The maximum score is 30, and the minimum score is 0. The higher the score, the more quality of life is impaired. Participants who experienced an intercurrent event were treated as missing following the intercurrent event and imputed using the multiple imputation method for missing data. |
| Secondary | Absolute Change From Baseline in Worst Skin Pain Score at Week 16 | Baseline, Week 16 | Absolute change from Baseline in worst Skin Pain score at Week 16 was assessed using the worst skin pain item in the Hidradenitis Suppurativa Symptom Daily Diary (HSSDD). Worst skin pain during the past 24 hours was assessed daily using an 11-point numeric rating scale (NRS) which ranges from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The worst skin pain score was derived from the weekly average of daily scores, defined as the sum of the scored item over the course of the study week divided by the number of days in which the item was completed, relative to each respective visit date. Intermittent missing data are imputed using multiple imputation with MCMC method followed by monotone regression for monotone missing data. Participants who experienced an intercurrent event were treated as missing following the intercurrent event and imputed using the multiple imputation method for missing data. Mean values shown do not account for model effects using the ANCOVA model. |
| Secondary | Percentage of Participants Achieving Skin Pain Response at Week 16 | Week 16 | Skin pain response at Week 16, as assessed by "worst skin pain" item in HSSDD, was defined as an improvement in weekly worst skin pain score of at least 3 points versus Baseline. Worst skin pain during the past 24 hours was assessed daily using an 11-point numeric rating scale (NRS) which ranges from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). Worst skin pain score was derived from weekly average of daily scores (sum of scored item over study week/number of days in which item completed, relative to each respective visit). Intermittent missing data were imputed using multiple imputation with MCMC method followed by monotone regression for monotone missing data. Weekly pain scores were imputed and then dichotomized to obtain response status. Participants who experienced an intercurrent event were treated as non-responders following the intercurrent event. Percentages of participants shown do not account for model effects using logistic regression model. |
| Secondary | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study | From Baseline (Day 1) until Safety Follow-Up (up to Week 71) | An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] period). |
| Secondary | Percentage of Participants With Serious Treatment-emergent Adverse Events During the Study | From Baseline (Day 1) until Safety Follow-Up (up to Week 71) | A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: Results in death; Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent disability/incapacity; Is a congenital anomaly/birth defect; Important medical events. Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). |
| Secondary | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From the Study | From Baseline (Day 1) until Safety Follow-Up (up to Week 71) | An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week SFU period). TEAEs leading to discontinuation of the study are reported. |
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 | Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16 | Week 16 | The RS consisted of all study participants randomized into the study. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 16 | Week 16 | The RS consisted of all study participants randomized into the study. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Flare by Week 16 | From Baseline to Week 16 | The RS consisted of all study participants randomized into the study. | percentage of participants | NUMBER |
| SECONDARY | Absolute Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16 | Baseline, Week 16 | The RS consisted of all study participants randomized into the study. Mean values shown do not account for model effects using the analysis of covariance (ANCOVA) model. Intercurrent event defined as receipt of systemic antibiotic rescue medication or discontinuation of study treatment due to AE or lack of efficacy. | score on a scale | MEAN |
| SECONDARY | Absolute Change From Baseline in Worst Skin Pain Score at Week 16 | Baseline, Week 16 | The RS consisted of all study participants randomized into the study. Intercurrent event defined as receipt of systemic antibiotic rescue medication or discontinuation of study treatment due to AE or lack of efficacy. | score on a scale | MEAN |
| SECONDARY | Percentage of Participants Achieving Skin Pain Response at Week 16 | Week 16 | The RS consisted of all study participants randomized into the study. Here, number of participants analyzed included RS with HSSDD worst skin pain score \>=3 at Baseline. Intercurrent event defined as receipt of systemic antibiotic rescue medication or discontinuation of study treatment due to AE or lack of efficacy. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study | From Baseline (Day 1) until Safety Follow-Up (up to Week 71) | The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. The MS consisted of all study participants who received at least 1 dose (full or partial) of BKZ in the Maintenance Treatment Period. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Serious Treatment-emergent Adverse Events During the Study | From Baseline (Day 1) until Safety Follow-Up (up to Week 71) | The SS consisted of all study participants who received at least 1 dose (full or partial) of IMP. The MS consisted of all study participants who received at least 1 dose (full or partial) of BKZ in the Maintenance Treatment Period. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From the Study | From Baseline (Day 1) until Safety Follow-Up (up to Week 71) | The SS consisted of all study participants who received at least 1 dose (full or partial) of IMP. The MS consisted of all study participants who received at least 1 dose (full or partial) of BKZ in the Maintenance Treatment Period. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group39
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16 | Placebo | 32.2 | 95% Confidence Interval 21.4 to 42.9 | percentage of participants | |
| Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16 | BKZ Dosing Regimen 1 | 53.8 | 95% Confidence Interval 45.4 to 62.1 | percentage of participants | |
| Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16 | BKZ Dosing Regimen 2 | 52.0 | 95% Confidence Interval 46.1 to 57.8 | percentage of participants | |
| Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 16 | Placebo | 15.6 | 95% Confidence Interval 7.2 to 24.0 | percentage of participants | |
| Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 16 | BKZ Dosing Regimen 1 | 33.7 | 95% Confidence Interval 25.7 to 41.7 | percentage of participants | |
| Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 16 | BKZ Dosing Regimen 2 | 35.7 | 95% Confidence Interval 30.1 to 41.3 | percentage of participants | |
| Percentage of Participants With Flare by Week 16 | Placebo | 28.0 | 95% Confidence Interval 17.6 to 38.4 | percentage of participants | |
| Percentage of Participants With Flare by Week 16 | BKZ Dosing Regimen 1 | 23.6 | 95% Confidence Interval 16.5 to 30.7 | percentage of participants | |
| Percentage of Participants With Flare by Week 16 | BKZ Dosing Regimen 2 | 28.8 | 95% Confidence Interval 23.5 to 34.1 | percentage of participants | |
| Absolute Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16 | Placebo | -3.2 | Standard Error 0.6 | score on a scale |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 results by groupParticipant flow42
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Initial Treatment Period: Week 0-16 | STARTED | Placebo | 74 | |
| Initial Treatment Period: Week 0-16 | STARTED | BKZ Dosing Regimen 1 | 144 | |
| Initial Treatment Period: Week 0-16 | STARTED | BKZ Dosing Regimen 2 | 291 | |
| Initial Treatment Period: Week 0-16 | STARTED | Placebo/BKZ Dosing Regimen 2 | 0 | |
| Initial Treatment Period: Week 0-16 | STARTED | BKZ Dosing Regimen 1/BKZ Dosing Regimen 1 | 0 | |
| Initial Treatment Period: Week 0-16 | STARTED | BKZ Dosing Regimen 2/BKZ Dosing Regimen 1 | 0 | |
| Initial Treatment Period: Week 0-16 | STARTED | BKZ Dosing Regimen 2/BKZ Dosing Regimen 2 | 0 | |
| Initial Treatment Period: Week 0-16 | COMPLETED | Placebo | 69 | |
| Initial Treatment Period: Week 0-16 | COMPLETED | BKZ Dosing Regimen 1 | 133 | |
| Initial Treatment Period: Week 0-16 | COMPLETED | BKZ Dosing Regimen 2 | 262 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 participant flowAdverse events252
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 | 6 | 74 | 7 |
| other | Diarrhoea | Gastrointestinal disorders | BKZ Dosing Regimen 1 | 5 | 142 | 6 |
| other | Diarrhoea | Gastrointestinal disorders | BKZ Dosing Regimen 2 | 18 | 290 | 21 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo/BKZ Dosing Regimen 2 | 2 | 69 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | BKZ Dosing Regimen 1/BKZ Dosing Regimen 1 | 6 | 133 | 8 |
| other | Diarrhoea | Gastrointestinal disorders | BKZ Dosing Regimen 2/BKZ Dosing Regimen 1 | 4 | 130 | 5 |
| other | Diarrhoea | Gastrointestinal disorders | BKZ Dosing Regimen 2/BKZ Dosing Regimen 2 | 3 | 131 | 3 |
| other | Oral candidiasis | Infections and infestations | Placebo | 0 | 74 | 0 |
| other | Oral candidiasis | Infections and infestations | BKZ Dosing Regimen 1 | 5 | 142 | 5 |
| other | Oral candidiasis | Infections and infestations | BKZ Dosing Regimen 2 | 24 | 290 | 26 |
1 to 10 of 252Source ClinicalTrials.gov
See all 252 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 74 |
| Total, all-cause mortality | BKZ Dosing Regimen 1 | 0 | 142 |
| Total, all-cause mortality | BKZ Dosing Regimen 2 | 0 | 290 |
| Total, all-cause mortality | Placebo/BKZ Dosing Regimen 2 | 0 | 69 |
| Total, all-cause mortality | BKZ Dosing Regimen 1/BKZ Dosing Regimen 1 | 0 | 133 |
| Total, all-cause mortality | BKZ Dosing Regimen 2/BKZ Dosing Regimen 1 | 0 | 130 |
| Total, all-cause mortality | BKZ Dosing Regimen 2/BKZ Dosing Regimen 2 | 0 | 131 |
| Total, other adverse events | Placebo | 18 | 74 |
| Total, other adverse events | BKZ Dosing Regimen 1 | 40 | 142 |
| Total, other adverse events | BKZ Dosing Regimen 2 | 101 | 290 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers10
The papers the trial lists on ClinicalTrials.gov.
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/NCT04242498
GET https://conductscience.org/api/trials/v1/NCT04242498/results?page=2