Trial · NCT03895203
A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
NCT03895203, Phase 3, Completed, UCB Biopharma SRL; results first posted 2024-10-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis. Trials, record NCT03895203. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03895203
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
- NCT number
- NCT03895203
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 852 participants, actual
- Lead sponsor
- UCB Biopharma SRL
- Conditions
- Psoriatic Arthritis
- Interventions
- Bimekizumab, Adalimumab, Placebo
- First posted
- 2019-03-29
- Last updated
- 2026-09-28
- Other registries' IDs
- eudract:2017-002322-20
- Results first posted
- 2024-10-23
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 16 | Week 16 | ACR50 response rate: 50% or greater improvement of arthritis relative to Baseline. Those who met following 3 conditions for improvement from Baseline were classified as meeting ACR50 response criteria: greater than or equal (≥) 50% improvement in 68-tender joint count; ≥ 50% improvement in 66-swollen joint count; ≥ 50% improvement in at least 3 of 5 following parameters: Physician global assessment of disease activity (0-100 millimeter \[mm\] visual analog scale \[VAS\] \[0 = no symptoms;100 = severe symptoms\]), Patient global assessment of disease activity (100 mm VAS \[0 = no limitation of normal activities; 100 = very poor\]), Patient assessment of pain (100 mm VAS \[0 = no pain; 100 = most severe pain\]), Health Assessment Questionnaire-Disability Index (HAQ-DI) assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, lower scores indicated less disability and high-sensitivity C-reactive protein (hsCRP). |
| Secondary | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16 for Placebo and BKZ | Baseline, Week 16 | The HAQ-DI contains 20 items that measured the degree of difficulty experienced in the following 8 categories of the daily living activities: dressing and grooming (2 items), arising (2 items), eating (3 items), walking (2 items), hygiene (3 items), reach (2 items), grip (3 items), and common daily activities (3 items). Each question was scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). The overall HAQ-DI total score was calculated by dividing the sum of the highest category scores (0 to 24) by the number of categories with at least 1 question answered. The HAQ-DI total score ranges from 0 (no difficulty) to 3 (maximum difficulty). A lower HAQ-DI score indicated an improvement in function. Change from baseline was computed as the value at Week 16 minus the baseline value. A negative value in change from baseline indicated an improvement. |
| Secondary | Percentage of Participants With a Psoriasis Area Severity Index (PASI) 90 Response at Week 4 in the Subgroup of Participants With Psoriasis (PSO) Involving at Least 3% Body Surface Area (BSA) at Baseline | Baseline, Week 4 | 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 a 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 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 PASI90 Response at Week 16 in the Subgroup of Participants With PSO Involving at Least 3% BSA at Baseline | Baseline, 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 a 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 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 | Change From Baseline in the Short Form 36-item Health Survey (SF-36) Physical Component Summary (PCS) at Week 16 for Placebo and BKZ | Baseline, Week 16 | SF-36 (version 2, standard recall):36-item generic health-related Quality of Life instrument that uses recall period of 4 weeks. Questionnaire has 36 questions composing scale that represent 8 domains:physical functioning; role physical; bodily pain;general health;vitality; social functioning;role emotional; and mental health. Scores for 8 domains were combined into two summary scores: physical component summary (PCS) score and mental component summary (MCS) score. Scores for 2 components summary (PCS and MCS) and 8 domains have been calculated and computed as raw/observed score to norm-based T-score metric(mean=50, standard deviation=10), raw score min=0(worst), max=100(best). Individual respondent's score falls outside T-score range of 45 to 55 was considered outside average range and when considering group-level data, score below 47 was considered indicative of impaired functioning within that health domain or dimension. Positive value in change from Baseline indicated improvement. |
| Secondary | Percentage of Participants With a Minimal Disease Activity (MDA) at Week 16 | Week 16 | MDA is measure to indicate disease remission, and is based on composite score of 7 domains. Participant is considered having achieved MDA if participant fulfills at least 5 of following 7 criteria: Tender joint count (0-68 joints) less than or equal to (≤1); Swollen joint count (0-66 joints) ≤ 1; PASI ≤ 1 or BSA ≤ 3: In PASI, body divided into four parts, head and neck, upper limb, trunk and lower limbs. Each area assessed for erythema, induration and scaling, each rated on a scale of 0 to 4. Total score ranges from 0(no disease) to 72 (maximal disease)\]; Patient's Assessment of Arthritis Pain ≤ 15 \[using VAS on a scale of 0 (no pain) to 100 (severe pain)\]; Patient's Global Assessment of Disease Activity ≤ 20 \[using VAS on a scale of 0 (very well) to 100 (very poor)\]; HAQ-DI score ≤ 0.5, HAQ-DI score ranges from 0 (no difficulty) to 3 (maximum difficulty); Leeds Enthesitis Index score ≤ 1 for participants with enthesitis at baseline. |
| Secondary | Change From Baseline in Van Der Heijde Modified Total Sharp Score (vdHmTSS) in Participants With Elevated Hs-CRP and/or at Least 1 Bone Erosion at Baseline at Week 16 for Placebo and BKZ | Baseline, Week 16 | The degree of joint damage was assessed using the vdHmTSS by quantifying the extent of bone erosions and joint space narrowing for 64 and 52 joints, respectively. The vdHmTSS ranges from 0 to 528, with higher scores representing greater damage. Descriptive statistics for ADA 40 mg reference arm was not calculated and reported since reference based imputation analysis method is used with Placebo as reference. As pre-specified in the SAP, this analysis was performed only for the participants randomized to Placebo and BKZ. |
| Secondary | Percentage of Participants With an Enthesitis-free State in the Leeds Enthesitis Index (LEI) at Week 16 in the Subgroup of Participants With Enthesitis at Baseline in the Pooled Population of PA0010 and PA0011 | Baseline of PA0010 for Participants of PA0010 and Baseline of PA0011 for Participants of PA0011, Week 16 | Presence of enthesitis was assessed in the subgroup of participants with enthesitis by palpation on the lateral epicondyles of the humerus (elbows), medial femoral epicondyles (knees), and Achilles tendons (heels) bilaterally and scored as 0 (no tenderness) and 1 (tenderness) at Baseline. The LEI consists of 6 items, 3 for the right part and 3 for the left part of the body. LEI is derived as the sum of the enthesitis score over the 6 sites mentioned above. The total score ranges from 0 to 6, higher scores indicates greater degree of enthesitis. Descriptive/Inferential statistics for ADA 40 mg reference arm was not calculated and reported since pooled data with PA0011 study is used which did not have ADA 40 mg arm. |
| Secondary | Percentage of Participants With a Dactylitis-free State Based on the Leeds Dactylitis Index (LDI) at Week 16 in the Subgroup of Participants With Dactylitis at Baseline in the Pooled Population of PA0010 and PA0011 | Baseline of PA0010 for Participants of PA0010 and Baseline of PA0011 for Participants of PA0011, Week 16 | The LDI quantitatively measures dactylitis using the circumference of involved digits and control digits and tenderness of involved digits. Digits affected by dactylitis are defined as those with a 10% difference in the ratio of circumference of the affected digit to the contralateral digit. The control digit is either the contralateral digit (digit on opposite hand or foot). The ratio of circumference between an affected digit and the control digit is multiplied by the tenderness score for the affected digit. The results from each involved digit are summed to provide the final LDI score. A higher LDI indicates worse dactylitis. Tenderness score (0 = no tenderness, 1 = tender). Descriptive/Inferential statistics for ADA 40 mg reference arm was not calculated and reported since pooled data with PA0011 study was used which did not have ADA 40 mg arm. |
| Secondary | Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 16 | Week 16 | The ACR20 response rate was based on a 20% or greater improvement of arthritis relative to Baseline. Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: 1. ≥ 20% improvement in 68-tender joint count; 2. ≥ 20% improvement in 66-swollen joint count; and 3. ≥ 20% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity (100 mm VAS \[0 = no symptoms; 100 = severe symptoms\]), Patient global assessment of disease activity (100 mm VAS \[0 = no limitation of normal activities; 100 = very poor\]), Patient assessment of pain (100 mm VAS \[0 = no pain; 100 = most severe pain\]), HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, lower scores indicated less disability, hsCRP. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
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 an American College of Rheumatology (ACR) 50 Response at Week 16 | Week 16 | RS consisted of all enrolled participants who had been randomized. Participants who had missing ACR50 data at Week 16 or who discontinued study treatment before Week 16 regardless of whether they had data or not were considered as non-responders. Inferential Statistics for ADA 40 mg reference arm was not calculated and reported as no formal comparison was planned. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16 for Placebo and BKZ | Baseline, Week 16 | RS consisted of all enrolled participants who had been randomized. Missing data and non-missing data preceded by a study treatment discontinuation were imputed using reference based multiple imputation. Descriptive statistics for ADA 40 mg reference arm was not calculated and reported since reference based imputation analysis method is used with Placebo as reference. As pre-specified in the SAP, this analysis was performed only for the participants randomized to Placebo and BKZ. | score on a scale | MEAN |
| SECONDARY | Percentage of Participants With a Psoriasis Area Severity Index (PASI) 90 Response at Week 4 in the Subgroup of Participants With Psoriasis (PSO) Involving at Least 3% Body Surface Area (BSA) at Baseline | Baseline, Week 4 | Subset of study participants in RS with psoriasis involving at least 3% BSA at Baseline. Participants who have missing PASI90 data at Week 4 or who discontinued study treatment before Week 4 regardless of whether they had data or not are considered as non-responders. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a PASI90 Response at Week 16 in the Subgroup of Participants With PSO Involving at Least 3% BSA at Baseline | Baseline, Week 16 | Subset of study participants in RS with psoriasis involving at least 3% BSA at Baseline. Participants who have missing PASI90 data at Week 16 or who discontinued study treatment before Week 16 regardless of whether they have data or not are considered as non-responders. Inferential Statistics for ADA 40 mg reference arm was not calculated and reported as no formal comparison was planned. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in the Short Form 36-item Health Survey (SF-36) Physical Component Summary (PCS) at Week 16 for Placebo and BKZ | Baseline, Week 16 | RS consisted of all enrolled participants who had been randomized. Missing data and non-missing data preceded by a study treatment discontinuation were imputed using reference based multiple imputation. Descriptive statistics for ADA 40 mg reference arm was not calculated and reported since imputation analysis method was used with Placebo as reference. As pre-specified in the SAP, this analysis was performed only for the participants randomized to Placebo and BKZ. | score on a scale | MEAN |
| SECONDARY | Percentage of Participants With a Minimal Disease Activity (MDA) at Week 16 | Week 16 | RS consisted of all enrolled participants who had been randomized. Participants who have missing MDA at Week 16 or who discontinued study treatment before Week 16 regardless of whether they have data or not are considered as non-responders. Inferential Statistics for ADA 40 mg reference arm was not calculated and reported as no formal comparison was planned. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Van Der Heijde Modified Total Sharp Score (vdHmTSS) in Participants With Elevated Hs-CRP and/or at Least 1 Bone Erosion at Baseline at Week 16 for Placebo and BKZ | Baseline, Week 16 | Radiographic Set (RAS): all participants in RS who received at least 1 dose of investigational medicinal product (IMP) and have valid radiographic image of hands and feet (with assessment performed by at least 2 reviewers) at Screening. Missing data and non-missing data preceded by treatment discontinuation were imputed using reference based multiple imputation. Here, number of participants analyzed included RAS with elevated hs-CRP and/or with at least one bone erosion at Baseline. | score on a scale | MEAN |
| SECONDARY | Percentage of Participants With an Enthesitis-free State in the Leeds Enthesitis Index (LEI) at Week 16 in the Subgroup of Participants With Enthesitis at Baseline in the Pooled Population of PA0010 and PA0011 | Baseline of PA0010 for Participants of PA0010 and Baseline of PA0011 for Participants of PA0011, Week 16 | As pre-specified in the SAP, the subgroup of participants with enthesitis at Baseline in the pooled population of PA0010 and PA0011 (NCT03896581) were included for the analysis of outcome measure. Participants who have missing LEI at Week 16 or who discontinued study treatment before Week 16 regardless of whether they had data or not are considered as non achieving entheistis free-state. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Dactylitis-free State Based on the Leeds Dactylitis Index (LDI) at Week 16 in the Subgroup of Participants With Dactylitis at Baseline in the Pooled Population of PA0010 and PA0011 | Baseline of PA0010 for Participants of PA0010 and Baseline of PA0011 for Participants of PA0011, Week 16 | As pre-specified in the SAP, the subgroup of participants with dactylitis at Baseline in the pooled population of PA0010 and PA0011 (NCT03896581) were included for the analysis of outcome measure. Participants who have missing LDI at Week 16 or who discontinued study treatment before Week 16 regardless of whether they have data or not are considered as non achieving dactylitis free-state. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 16 | Week 16 | RS consisted of all enrolled participants who had been randomized. Participants who have missing ACR20 data at Week 16 or who discontinued study treatment before Week 16 regardless of whether they have data or not are considered as non-responders. | percentage of participants | NUMBER |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group63
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 an American College of Rheumatology (ACR) 50 Response at Week 16 | Placebo | 10.0 | percentage of participants | ||
| Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 16 | BKZ 160 mg Q4W | 43.9 | percentage of participants | ||
| Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 16 | ADA 40 mg Q2W | 45.7 | percentage of participants | ||
| Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16 for Placebo and BKZ | Placebo | -0.0881 | Standard Error 0.0273 | score on a scale | |
| Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16 for Placebo and BKZ | BKZ 160 mg Q4W | -0.2567 | Standard Error 0.0208 | score on a scale | |
Percentage of Participants With a Psoriasis Area Severity Index (PASI) 90 Response at Week 4 in the Subgroup of Participants With Psoriasis (PSO) Involving at Least 3% Body Surface Area (BSA) at Baseline | Placebo | 4.3 | percentage of participants | ||
Percentage of Participants With a Psoriasis Area Severity Index (PASI) 90 Response at Week 4 in the Subgroup of Participants With Psoriasis (PSO) Involving at Least 3% Body Surface Area (BSA) at Baseline | BKZ 160 mg Q4W | 19.8 | percentage of participants | ||
Percentage of Participants With a Psoriasis Area Severity Index (PASI) 90 Response at Week 4 in the Subgroup of Participants With Psoriasis (PSO) Involving at Least 3% Body Surface Area (BSA) at Baseline | ADA 40 mg Q2W | 7.4 | percentage of participants | ||
| Percentage of Participants With a PASI90 Response at Week 16 in the Subgroup of Participants With PSO Involving at Least 3% BSA at Baseline | Placebo | 2.9 | percentage of participants | ||
| Percentage of Participants With a PASI90 Response at Week 16 in the Subgroup of Participants With PSO Involving at Least 3% BSA at Baseline | BKZ 160 mg Q4W | 61.3 | percentage of participants |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind Treatment Period: 16 Weeks | STARTED | Placebo | 281 | |
| Double-Blind Treatment Period: 16 Weeks | STARTED | BKZ 160 mg Q4W | 431 | |
| Double-Blind Treatment Period: 16 Weeks | STARTED | ADA 40 mg Q2W | 140 | |
| Double-Blind Treatment Period: 16 Weeks | STARTED | Placebo/BKZ 160 mg Q4W | 0 | |
| Double-Blind Treatment Period: 16 Weeks | STARTED | BKZ 160 mg Q4W/BKZ 160 mg Q4W | 0 | |
| Double-Blind Treatment Period: 16 Weeks | STARTED | ADA 40 mg Q2W/ADA 40 mg Q2W | 0 | |
| Double-Blind Treatment Period: 16 Weeks | Enthesitis at Baseline: PA0010/PA0011 Pooled Population | Placebo | 106 | |
| Double-Blind Treatment Period: 16 Weeks | Enthesitis at Baseline: PA0010/PA0011 Pooled Population | BKZ 160 mg Q4W | 249 | |
| Double-Blind Treatment Period: 16 Weeks | Enthesitis at Baseline: PA0010/PA0011 Pooled Population | ADA 40 mg Q2W | 0 | |
| Double-Blind Treatment Period: 16 Weeks | Enthesitis at Baseline: PA0010/PA0011 Pooled Population | Placebo/BKZ 160 mg Q4W | 0 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events432
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 | Nasopharyngitis | Infections and infestations | Placebo | 13 | 281 | 14 |
| other | Nasopharyngitis | Infections and infestations | BKZ 160 mg Q4W | 40 | 431 | 44 |
| other | Nasopharyngitis | Infections and infestations | ADA 40 mg Q2W | 7 | 140 | 8 |
| other | Nasopharyngitis | Infections and infestations | Placebo/BKZ 160 mg Q4W | 23 | 271 | 28 |
| other | Nasopharyngitis | Infections and infestations | BKZ 160 mg Q4W/BKZ 160 mg Q4W | 29 | 414 | 31 |
| other | Nasopharyngitis | Infections and infestations | ADA 40 mg Q2W/ADA 40 mg Q2W | 6 | 136 | 7 |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 18 | 281 | 18 |
| other | Upper respiratory tract infection | Infections and infestations | BKZ 160 mg Q4W | 22 | 431 | 25 |
| other | Upper respiratory tract infection | Infections and infestations | ADA 40 mg Q2W | 3 | 140 | 3 |
| other | Upper respiratory tract infection | Infections and infestations | Placebo/BKZ 160 mg Q4W | 12 | 271 | 15 |
1 to 10 of 432Source ClinicalTrials.gov
See all 432 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 281 |
| Total, all-cause mortality | BKZ 160 mg Q4W | 0 | 431 |
| Total, all-cause mortality | ADA 40 mg Q2W | 0 | 140 |
| Total, all-cause mortality | Placebo/BKZ 160 mg Q4W | 1 | 271 |
| Total, all-cause mortality | BKZ 160 mg Q4W/BKZ 160 mg Q4W | 0 | 414 |
| Total, all-cause mortality | ADA 40 mg Q2W/ADA 40 mg Q2W | 0 | 136 |
| Total, other adverse events | Placebo | 34 | 281 |
| Total, other adverse events | BKZ 160 mg Q4W | 77 | 431 |
| Total, other adverse events | ADA 40 mg Q2W | 13 | 140 |
| Total, other adverse events | Placebo/BKZ 160 mg Q4W | 54 | 271 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers20
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.
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