Trial · NCT03598790
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
NCT03598790, Phase 3, Completed, UCB Biopharma SRL; results first posted 2024-12-06
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis. Trials, record NCT03598790. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03598790
On this page
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 Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
- NCT number
- NCT03598790
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,353 participants, actual
- Lead sponsor
- UCB Biopharma SRL
- Conditions
- Chronic Plaque Psoriasis, Moderate to Severe Chronic Plaque Psoriasis
- Interventions
- Bimekizumab
- First posted
- 2018-07-26
- Last updated
- 2026-04-15
- Other registries' IDs
- eudract:2016-003427-30
- Results first posted
- 2024-12-06
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Investigational Medicinal Product (IMP) | From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period | The number of TEAEs adjusted by duration of exposure to study treatment were scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to first occurrence of the AE being considered. If a participant had no events, the total time at risk was used. |
| Secondary | Number of Serious Adverse Events (SAEs) Adjusted by Duration of Subject Exposure to IMP | From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period | The number of SAEs adjusted by duration of exposure to study treatment were scaled such that it provides an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk is used. |
| Secondary | Number of TEAEs Leading to Withdrawal Adjusted by Duration of Subject Exposure to IMP | From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period | The number of TEAEs leading to withdrawal adjusted by duration of exposure to study treatment were scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used. |
| Secondary | Psoriasis Area Severity Index 90 (PASI90) Response at Week 144 (Non-responder Imputation) | Week 144 compared to Baseline of Feeder study for Cohort A and Baseline of PS0014 for Cohort B | The PASI90 response assessments were based on improvement (reduction) of at least 90% in the PASI score compared to Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI=average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. |
| Secondary | Psoriasis Area Severity Index 90 (PASI90) Response at Week 144 (Observed Case) | Week 144 compared to Baseline of PS0014 for Cohort B | PASI90 response assessments were based on improvement (reduction) of at least 90% in the PASI score compared to Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI=average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by involved psoriasis area score of respective section, and weighted by percentage of person's affected skin for respective section. Minimum score is 0= no disease, maximum score is 72= maximal disease. |
| Secondary | Investigator´s Global Assessment (IGA) 0/1 Response at Week 144 (Non-responder Imputation) | Week 144 compared to Baseline of Feeder study for Cohort A and Baseline of PS0014 for Cohort B | The Investigator assessed the overall severity of psoriasis using the following 5-point scale: 0 = Clear (no signs of psoriasis; post-inflammatory hyperpigmentation may be present); 1= Almost clear (no thickening; normal to pink coloration; no to minimal focal scaling); 2= Mild (just detectable to mild thickening; pink to light red coloration; predominately fine scaling); 3= Moderate (clearly distinguishable to moderate thickening; dull to bright red coloration; moderate scaling); 4= Severe (Severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions). IGA response -IGA score of clear \[0\] or almost clear \[1\] with at least two category improvement from Baseline at visit timepoint. |
| Secondary | Investigator´s Global Assessment (IGA) 0/1 Response at Week 144 (Observed Case) | Week 144 for Cohort B EP and GPP groups | The Investigator assessed the overall severity of psoriasis using the following 5-point scale: 0 = Clear (no signs of psoriasis; post-inflammatory hyperpigmentation may be present); 1= Almost clear (no thickening; normal to pink coloration; no to minimal focal scaling); 2= Mild (just detectable to mild thickening; pink to light red coloration; predominately fine scaling); 3= Moderate (clearly distinguishable to moderate thickening; dull to bright red coloration; moderate scaling); 4= Severe (Severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions). IGA response -IGA score of 0 or 1 at Week 144. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Investigational Medicinal Product (IMP) | From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period | CA-SS -All Cohort A participants who received at least 1 dose of the IMP in this study. Cohort A OLE2 Period Set (CA-OL2S)-All participants who received at least 1 dose of BKZ in the OLE2 Period. Cohort B PSO SS-All participants with a diagnosis of PSO disease at Baseline. Cohort B EP-SS-All participants with a diagnosis of EP disease at Baseline. Cohort B GPP-SS-All participants with a diagnosis of GPP disease at Baseline. | no. of new events per 100 subject-years | NUMBER |
| SECONDARY | Number of Serious Adverse Events (SAEs) Adjusted by Duration of Subject Exposure to IMP | From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period | CA-SS -All Cohort A participants who received at least 1 dose of the IMP in this study. CA-OL2S-All participants who received at least 1 dose of BKZ in the OLE2 Period. Cohort B PSO SS-All participants with a diagnosis of PSO disease at Baseline. Cohort B EP-SS-All participants with a diagnosis of EP disease at Baseline. Cohort B GPP-SS-All participants with a diagnosis of GPP disease at Baseline. | no. of new events per 100 subject-years | NUMBER |
| SECONDARY | Number of TEAEs Leading to Withdrawal Adjusted by Duration of Subject Exposure to IMP | From Baseline up to 165 weeks for each study participant not entering the OLE2 Period and up to 212 weeks for participants entering OLE2 Period | CA-SS -All Cohort A participants who received at least 1 dose of the IMP in this study. CA-OL2S-All participants who received at least 1 dose of BKZ in the OLE2 Period. Cohort B PSO SS-All participants with a diagnosis of PSO disease at Baseline. Cohort B EP-SS-All participants with a diagnosis of EP disease at Baseline. Cohort B GPP-SS-All participants with a diagnosis of GPP disease at Baseline. | no. of new events per 100 subject-years | NUMBER |
| SECONDARY | Psoriasis Area Severity Index 90 (PASI90) Response at Week 144 (Non-responder Imputation) | Week 144 compared to Baseline of Feeder study for Cohort A and Baseline of PS0014 for Cohort B | Cohort A FAS included all Cohort A enrolled study participants who received at least 1 dose of IMP and had a valid efficacy measurement for PASI at Baseline of the feeder study and at Baseline of this study. Cohort B Psoriasis FAS included study participants with chronic plaque PSO at Baseline. Study participants who had missing data at the Week 144 were treated as though they did not respond to the treatment using Non-responder imputation (NRI) method. | percentage of participants | NUMBER |
| SECONDARY | Psoriasis Area Severity Index 90 (PASI90) Response at Week 144 (Observed Case) | Week 144 compared to Baseline of PS0014 for Cohort B | Cohort B GPP FAS included study participants with GPP at Baseline. Cohort B EP FAS included study participants with EP at Baseline. Only study participants with available data who had not discontinued study treatment at Week 144 were considered for the analysis. | percentage of participants | NUMBER |
| SECONDARY | Investigator´s Global Assessment (IGA) 0/1 Response at Week 144 (Non-responder Imputation) | Week 144 compared to Baseline of Feeder study for Cohort A and Baseline of PS0014 for Cohort B | Cohort A FAS included all Cohort A enrolled study participants who received at least 1 dose of IMP and had a valid efficacy measurement for PASI at Baseline of the feeder study and at Baseline of this study. Cohort B Psoriasis FAS included study participants with chronic plaque PSO at Baseline. Study participants who had missing data at the Week 144 were treated as though they did not respond to the treatment using NRI. | percentage of participants | NUMBER |
| SECONDARY | Investigator´s Global Assessment (IGA) 0/1 Response at Week 144 (Observed Case) | Week 144 for Cohort B EP and GPP groups | Cohort B GPP FAS included study participants with GPP at Baseline. Cohort B EP FAS included study participants with EP at Baseline. Only study participants with available data who had not discontinued study treatment at Week 144 were considered for the analysis. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Investigational Medicinal Product (IMP) | Cohort A: BKZ 320 mg Q8W | 97.83 | 95% Confidence Interval 91.73 to 104.22 | no. of new events per 100 subject-years | |
| Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Investigational Medicinal Product (IMP) | Cohort A: BKZ 320 mg Q4W | 179.68 | 95% Confidence Interval 166.62 to 193.49 | no. of new events per 100 subject-years | |
| Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Investigational Medicinal Product (IMP) | Cohort A: Group A BKZ 320 mg Q8W | 79.02 | 95% Confidence Interval 65.97 to 93.89 | no. of new events per 100 subject-years | |
| Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Investigational Medicinal Product (IMP) | Cohort A: Group B BKZ 320 mg Q8W | 77.11 | 95% Confidence Interval 51.64 to 110.74 | no. of new events per 100 subject-years | |
| Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Investigational Medicinal Product (IMP) | Cohort A: Group B BKZ 320 mg Q4W/Q8W | 73.78 | 95% Confidence Interval 47.75 to 108.92 | no. of new events per 100 subject-years | |
| Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Investigational Medicinal Product (IMP) | Cohort B: PSO BKZ Total | 244.08 | 95% Confidence Interval 178.03 to 326.60 | no. of new events per 100 subject-years | |
| Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Investigational Medicinal Product (IMP) | Cohort B: EP BKZ Total | 328.25 | 95% Confidence Interval 163.86 to 587.33 | no. of new events per 100 subject-years | |
| Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Investigational Medicinal Product (IMP) | Cohort B: GPP BKZ Total | 188.71 | 95% Confidence Interval 86.29 to 358.22 | no. of new events per 100 subject-years | |
| Number of Serious Adverse Events (SAEs) Adjusted by Duration of Subject Exposure to IMP | Cohort A: BKZ 320 mg Q8W | 5.24 | 95% Confidence Interval 4.36 to 6.25 | no. of new events per 100 subject-years | |
| Number of Serious Adverse Events (SAEs) Adjusted by Duration of Subject Exposure to IMP | Cohort A: BKZ 320 mg Q4W | 6.72 | 95% Confidence Interval 5.19 to 8.56 | no. of new events per 100 subject-years |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow54
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period (TP): Wk0-Wk144 | STARTED | Cohort A: BKZ 320 mg Q8W | 384 | |
| Treatment Period (TP): Wk0-Wk144 | STARTED | Cohort A: BKZ 320 mg Q4W/Q8W | 833 | |
| Treatment Period (TP): Wk0-Wk144 | STARTED | Cohort A: BKZ 320 mg Q4W | 70 | |
| Treatment Period (TP): Wk0-Wk144 | STARTED | Cohort A: Group A BKZ 320 mg Q8W | 0 | |
| Treatment Period (TP): Wk0-Wk144 | STARTED | Cohort A: Group B BKZ 320 mg Q8W | 0 | |
| Treatment Period (TP): Wk0-Wk144 | STARTED | Cohort A: Group B BKZ 320 mg Q4W/Q8W | 0 | |
| Treatment Period (TP): Wk0-Wk144 | STARTED | Cohort B: PSO BKZ Total | 45 | |
| Treatment Period (TP): Wk0-Wk144 | STARTED | Cohort B: EP BKZ Total | 11 | |
| Treatment Period (TP): Wk0-Wk144 | STARTED | Cohort B: GPP BKZ Total | 10 | |
| Treatment Period (TP): Wk0-Wk144 | COMPLETED | Cohort A: BKZ 320 mg Q8W | 326 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 participant flowAdverse events2,592
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 | Leukopenia | Blood and lymphatic system disorders | Cohort A: BKZ 320 mg Q8W | 1 | 1,217 | 1 |
| other | Leukopenia | Blood and lymphatic system disorders | Cohort A: BKZ 320 mg Q4W | 2 | 903 | 2 |
| other | Leukopenia | Blood and lymphatic system disorders | Cohort A: Group A BKZ 320 mg Q8W | 0 | 226 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Cohort A: Group B BKZ 320 mg Q8W | 0 | 51 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Cohort A: Group B BKZ 320 mg Q4W/Q8W | 0 | 41 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Cohort B: PSO BKZ Total | 2 | 45 | 3 |
| other | Leukopenia | Blood and lymphatic system disorders | Cohort B: EP BKZ Total | 0 | 11 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Cohort B: GPP BKZ Total | 1 | 10 | 1 |
| other | Cardiac failure chronic | Cardiac disorders | Cohort A: BKZ 320 mg Q8W | 1 | 1,217 | 1 |
| other | Cardiac failure chronic | Cardiac disorders | Cohort A: BKZ 320 mg Q4W | 0 | 903 | 0 |
1 to 10 of 2,592Source ClinicalTrials.gov
See all 2,592 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A: BKZ 320 mg Q8W | 9 | 1,217 |
| Total, all-cause mortality | Cohort A: BKZ 320 mg Q4W | 6 | 903 |
| Total, all-cause mortality | Cohort A: Group A BKZ 320 mg Q8W | 0 | 226 |
| Total, all-cause mortality | Cohort A: Group B BKZ 320 mg Q8W | 0 | 51 |
| Total, all-cause mortality | Cohort A: Group B BKZ 320 mg Q4W/Q8W | 0 | 41 |
| Total, all-cause mortality | Cohort B: PSO BKZ Total | 0 | 45 |
| Total, all-cause mortality | Cohort B: EP BKZ Total | 0 | 11 |
| Total, all-cause mortality | Cohort B: GPP BKZ Total | 0 | 10 |
| Total, other adverse events | Cohort A: BKZ 320 mg Q8W | 771 | 1,217 |
| Total, other adverse events | Cohort A: BKZ 320 mg Q4W | 566 | 903 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers13
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/NCT03598790
GET https://conductscience.org/api/trials/v1/NCT03598790/results?page=2