Trial · NCT03536884
A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
NCT03536884, Phase 3, Completed, UCB Biopharma SRL; results first posted 2022-10-10
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 Compared to an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis. Trials, record NCT03536884. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03536884
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 Compared to an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
- NCT number
- NCT03536884
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 743 participants, actual
- Lead sponsor
- UCB Biopharma SRL
- Conditions
- Chronic Plaque Psoriasis, Moderate to Severe Chronic Plaque Psoriasis
- Interventions
- Bimekizumab, Secukinumab, Placebo
- First posted
- 2018-05-25
- Last updated
- 2026-04-15
- Other registries' IDs
- eudract:2017-003784-35
- Results first posted
- 2022-10-10
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI100) Response at Week 16 | Week 16 | The PASI100 response assessments are based on 100% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of 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 the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. |
| Secondary | Percentage of Participants With a PASI75 Response at Week 4 | Week 4 | The PASI75 response assessments are based on at least 75% improvement in PASI score from 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 body areas and converting to 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 the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. |
| Secondary | Percentage of Participants With a PASI90 Response at Week 16 | Week 16 | The PASI90 response assessments are based on at least 90% improvement in PASI score from 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 | Percentage of Participants With a PASI100 Response at Week 48 | Week 48 | The PASI100 response assessments are based on 100% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of 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 the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. |
| Secondary | Percentage of Participants With a Investigator´s Global Assessment (IGA) Response (0/1) at Week 16 | Week 16 | The IGA measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as Clear (0) or Almost Clear (1) with at least a two-category improvement from Baseline at Week 16. |
| Secondary | Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Investigational Medicinal Product (IMP) From Baseline up to Week 225 | From Baseline up to Week 225 | The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that 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 | Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 225 | From Baseline up to Week 225 | The number of SAEs adjusted by duration of exposure to study treatment was 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 | Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 225 | From Baseline up to Week 225 | The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI100) Response at Week 16 | Week 16 | The Randomized Set (RS) consisted of all randomized study participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a PASI75 Response at Week 4 | Week 4 | The Randomized Set (RS) consisted of all randomized study participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a PASI90 Response at Week 16 | Week 16 | The Randomized Set (RS) consisted of all randomized study participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a PASI100 Response at Week 48 | Week 48 | The Randomized Set (RS) consisted of all randomized study participants. The Maintenance Set (MS) consisted of all study participants that received at least 1 dose of IMP at Week 16 or later in the Double-Blind Treatment Period (including the Week 16 dose). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Investigator´s Global Assessment (IGA) Response (0/1) at Week 16 | Week 16 | The Randomized Set (RS) consisted of all randomized study participants. | percentage of participants | NUMBER |
| SECONDARY | Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Investigational Medicinal Product (IMP) From Baseline up to Week 225 | From Baseline up to Week 225 | The Safety Set (SS) consisted of all study participants that received at least 1 dose of IMP. The Open-Label Set (OLS) consisted of all study participants who received at least 1 dose of BKZ at Week 48 or later in the OLE Period (including the Week 48 dose). The Open-Label Set 2 (OLS2) consisted of all study participants who received at least 1 dose of BKZ at the Week 144/OLE2 Baseline Visit or later in the OLE2 Period (including the Week 144/OLE2 Baseline dose). | no. of new events per 100 subject-years | NUMBER |
| SECONDARY | Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 225 | From Baseline up to Week 225 | The SS consisted of all study participants that received at least 1 dose of IMP. The OLS consisted of all study participants who received at least 1 dose of BKZ at Week 48 or later in the OLE Period (including the Week 48 dose). The OLS2 consisted of all study participants who received at least 1 dose of BKZ at the Week 144/OLE2 Baseline Visit or later in the OLE2 Period (including the Week 144/OLE2 Baseline dose). | no. of new events per 100 subject-years | NUMBER |
| SECONDARY | Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 225 | From Baseline up to Week 225 | The SS consisted of all study participants that received at least 1 dose of IMP. The OLS consisted of all study participants who received at least 1 dose of BKZ at Week 48 or later in the OLE Period (including the Week 48 dose). The OLS2 consisted of all study participants who received at least 1 dose of BKZ at the Week 144/OLE2 Baseline Visit or later in the OLE2 Period (including the Week 144/OLE2 Baseline dose). | no. of new events per 100 subject-years | NUMBER |
Source ClinicalTrials.gov
Results by group37
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI100) Response at Week 16 | ITP: Bimekizumab (BKZ) 320 mg Q4W | 61.7 | percentage of participants | ||
| Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI100) Response at Week 16 | ITP: Secukinumab 300 mg Q4W | 48.9 | percentage of participants | ||
| Percentage of Participants With a PASI75 Response at Week 4 | ITP: Bimekizumab (BKZ) 320 mg Q4W | 71.0 | percentage of participants | ||
| Percentage of Participants With a PASI75 Response at Week 4 | ITP: Secukinumab 300 mg Q4W | 47.3 | percentage of participants | ||
| Percentage of Participants With a PASI90 Response at Week 16 | ITP: Bimekizumab (BKZ) 320 mg Q4W | 85.5 | percentage of participants | ||
| Percentage of Participants With a PASI90 Response at Week 16 | ITP: Secukinumab 300 mg Q4W | 74.3 | percentage of participants | ||
| Percentage of Participants With a PASI100 Response at Week 48 | ITP+MTP: BKZ Q4W/Q4W +BKZ Q4W/Q8W | 67.3 | percentage of participants | ||
| Percentage of Participants With a PASI100 Response at Week 48 | ITP+MTP: Secukinumab 300 mg Q4W/Q4W | 46.2 | percentage of participants | ||
| Percentage of Participants With a PASI100 Response at Week 48 | MTP: BKZ 320 mg Q4W/Q8W | 66.5 | percentage of participants | ||
| Percentage of Participants With a PASI100 Response at Week 48 | MTP: BKZ 320 mg Q4W/Q4W | 73.5 | percentage of participants |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 results by groupParticipant flow144
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind (DB) Period: ITP Wk 0-16 | STARTED | ITP: Bimekizumab (BKZ) 320 Milligrams (mg) Q4W | 373 | |
| Double-Blind (DB) Period: ITP Wk 0-16 | STARTED | ITP: Secukinumab 300 mg Q4W | 370 | |
| Double-Blind (DB) Period: ITP Wk 0-16 | STARTED | MTP: BKZ 320 mg Q4W/Q8W | 0 | |
| Double-Blind (DB) Period: ITP Wk 0-16 | STARTED | MTP: BKZ 320 mg Q4W/Q4W | 0 | |
| Double-Blind (DB) Period: ITP Wk 0-16 | STARTED | MTP: Secukinumab 300 mg Q4W/Q4W | 0 | |
| Double-Blind (DB) Period: ITP Wk 0-16 | STARTED | OLE Period: BKZ Week 0-48/BKZ Q8W 320 mg | 0 | |
| Double-Blind (DB) Period: ITP Wk 0-16 | STARTED | OLE Period: BKZ Week 0-48/ BKZ Q4W 320 mg | 0 | |
| Double-Blind (DB) Period: ITP Wk 0-16 | STARTED | OLE Period: Secukinumab Week 0-48/ BKZ Q8W 320 mg | 0 | |
| Double-Blind (DB) Period: ITP Wk 0-16 | STARTED | OLE Period: Secukinumab Week 0-48/ BKZ Q4W 320 mg | 0 | |
| Double-Blind (DB) Period: ITP Wk 0-16 | STARTED | OLE2 Period - Group A: BKZ 320 mg Q8W | 0 |
1 to 10 of 144Source ClinicalTrials.gov
See all 144 participant flowAdverse events1,380
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 | Macrocytosis | Blood and lymphatic system disorders | ITP: BKZ 320 mg Q4W (up to Week 16) | 0 | 373 | 0 |
| other | Macrocytosis | Blood and lymphatic system disorders | ITP: Secukinumab 300 mg Q4W (up to Week 16) | 0 | 370 | 0 |
| other | Macrocytosis | Blood and lymphatic system disorders | MTP: BKZ 320 mg Q8W (Week 16 to Week 48) | 0 | 215 | 0 |
| other | Macrocytosis | Blood and lymphatic system disorders | ITP+MTP: BKZ 320 mg Q4W (up to Week 48) | 0 | 373 | 0 |
| other | Macrocytosis | Blood and lymphatic system disorders | ITP+MTP: Secukinumab 300 mg Q4W (up to Week 48) | 0 | 370 | 0 |
| other | Macrocytosis | Blood and lymphatic system disorders | OLE Period: BKZ 320 mg Q8W (Week 48 to Week 144) | 0 | 626 | 0 |
| other | Macrocytosis | Blood and lymphatic system disorders | OLE Period: BKZ 320 mg Q4W (Week 48 to Week 144) | 0 | 294 | 0 |
| other | Macrocytosis | Blood and lymphatic system disorders | OLE2 Period - Group A: BKZ 320 mg Q8W | 1 | 9 | 1 |
| other | Macrocytosis | Blood and lymphatic system disorders | OLE2 Period - Group B: BKZ 320 mg Q8W | 0 | 66 | 0 |
| other | Macrocytosis | Blood and lymphatic system disorders | OLE2 Period -Group B: BKZ 320 mg Q4W/Q8W | 0 | 59 | 0 |
1 to 10 of 1,380Source ClinicalTrials.gov
See all 1,380 adverse eventsAdverse event totals30
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ITP: BKZ 320 mg Q4W (up to Week 16) | 0 | 373 |
| Total, all-cause mortality | ITP: Secukinumab 300 mg Q4W (up to Week 16) | 0 | 370 |
| Total, all-cause mortality | MTP: BKZ 320 mg Q8W (Week 16 to Week 48) | 1 | 215 |
| Total, all-cause mortality | ITP+MTP: BKZ 320 mg Q4W (up to Week 48) | 0 | 373 |
| Total, all-cause mortality | ITP+MTP: Secukinumab 300 mg Q4W (up to Week 48) | 2 | 370 |
| Total, all-cause mortality | OLE Period: BKZ 320 mg Q8W (Week 48 to Week 144) | 3 | 626 |
| Total, all-cause mortality | OLE Period: BKZ 320 mg Q4W (Week 48 to Week 144) | 1 | 294 |
| Total, all-cause mortality | OLE2 Period - Group A: BKZ 320 mg Q8W | 0 | 9 |
| Total, all-cause mortality | OLE2 Period - Group B: BKZ 320 mg Q8W | 0 | 66 |
| Total, all-cause mortality | OLE2 Period -Group B: BKZ 320 mg Q4W/Q8W | 1 | 59 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 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/NCT03536884
GET https://conductscience.org/api/trials/v1/NCT03536884/results?page=2