Trial · NCT03896581

A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

NCT03896581, Phase 3, Completed, UCB Biopharma SRL; results first posted 2024-10-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis. Trials, record NCT03896581. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03896581

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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 the Treatment of Subjects With Active Psoriatic Arthritis
NCT number: NCT03896581
Status: Completed
Phases: Phase 3
Enrollment: 400 participants, actual
Lead sponsor: UCB Biopharma SRL
Conditions: Psoriatic Arthritis
Interventions: Bimekizumab, Placebo
First posted: 2019-04-01
Last updated: 2026-09-25
Other registries' IDs: eudract:2017-002804-29
Results first posted: 2024-10-16

Source ClinicalTrials.gov

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Participants With American College of Rheumatology 50 (ACR50) Response	From Baseline to Week 16	The ACR50 response rate was based on a 50% or greater improvement of arthritis relative to Baseline. Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria: 1.≥ 50% improvement in 68-tender joint count; 2.≥ 50% improvement in 66-swollen joint count; and 3.≥ 50% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity \[100 mm visual analog scale (VAS) (0=no symptoms;100=severe symptoms)\], 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), its 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) Total Score at Week 16	Baseline and 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 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	Psoriasis Area Severity Index 90 Response (PASI90) at Week 4 in the Subgroup of Participants With Psoriasis (PSO) Involving at Least 3% Body Surface Area (BSA) at Baseline	From Baseline to 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	Psoriasis Area Severity Index 90 (PASI90) Response at Week 16 in the Subgroup of Participants With Psoriasis (PSO) Involving at Least 3% Body Surface Area at Baseline	From Baseline to 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) Score at Week 16	Baseline and Week 16	The SF-36 (version 2, standard recall) is a 36-item generic HRQoL instrument that uses a recall period of 4 weeks. The questionnaire has 36 questions composing the scale that represent 8 domains: 1) physical functioning, 2) role physical, 3) bodily pain, 4) general health, 5) vitality, 6) social functioning, 7) role emotional, and 8) mental health. The scores for the 8 domains were combined into two summary scores: the physical component summary (PCS) score and the mental component summary (MCS) score. Domains 1 to 4 primarily contribute to the PCS score of the SF-36. Domains 5-8 primarily contribute to the MCS score of the SF-36. Each of the 8 domain scores and the component summary score range from 0=worst to 100=best. Higher scores represent better health status. A positive change in value indicated improvement from baseline.
Secondary	Minimal Disease Activity (MDA) at Week 16	Week 16	MDA is a measure to indicate disease remission, and is based on a composite score of 7 domains. A participant is considered as having achieved the MDA if the participant fulfills at least 5 of the following 7 criteria: Tender joint count (0-68 joints) \<=1; Swollen joint count (0-66 joints) \<=1; PASI \<=1 for participants with psoriasis covering BSA \<=3% \[PASI evaluates the severity and extent of psoriasis. In PASI, body is divided into four parts, head and neck, upper limb, trunk and lower limbs. Each area is assessed for erythema, induration and scaling, each rated on a scale of 0 to 4. The total score ranges from 0 (no disease) to 72 (maximal disease)\]; Patient's Assessment of Arthritis Pain \<=15 \[using VAS on a scale of 0 (no pain) to 100 (serious pain)\]; 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; Leeds Enthesitis Index score \<=1 for participants with enthesitis at baseline.
Secondary	Percentage of Participants With American College of Rheumatology 20 (ACR20) Response	From Baseline to 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.
Secondary	Percentage of Participants With American College of Rheumatology 70 (ACR70) Response	From Baseline to Week 16	The ACR70 response rate was based on a 70% 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.≥ 70% improvement in 68-tender joint count; 2.≥ 70% improvement in 66-swollen joint count; and 3.≥ 70% 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.
Secondary	Investigator Global Assessment (IGA) Response Defined as Score of 0 (Clear) or 1 (Almost Clear) and at Least a 2-grade Reduction From Baseline at Week 4 in the Subset of Participants With Psoriatic Skin Lesions at Baseline	Baseline and Week 4	IGA measured the overall severity of PSO using the following 5-point scale and score was rated as 0=clear (No signs of PSO; 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, moderate scaling), and 4=severe (Severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions). The IGA response is defined as score of 0 (clear) or 1 (almost clear) with at least a 2-category improvement relative to Baseline.
Secondary	Investigator Global Assessment (IGA) Response Defined as Score of 0 (Clear) or 1 (Almost Clear) and at Least a 2-grade Reduction From Baseline at Week 16 in the Subset of Participants With Psoriatic Skin Lesions at Baseline	Baseline and Week 16	IGA measured the overall severity of PSO using the following 5-point scale and score was rated as 0=clear (No signs of PSO; 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, moderate scaling), and 4=severe (Severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions). The IGA response is defined as score of 0 (clear) or 1 (almost clear) with at least a 2-category improvement relative to Baseline.

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes15

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 American College of Rheumatology 50 (ACR50) Response	From Baseline to Week 16	Randomized Set 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 are considered as non-responders.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score at Week 16	Baseline and Week 16	Randomized Set consisted of all enrolled participants who had been randomized. Missing data and non-missing data preceded by a study treatment discontinuation were imputed using multiple imputation.	score on a scale	MEAN
SECONDARY	Psoriasis Area Severity Index 90 Response (PASI90) at Week 4 in the Subgroup of Participants With Psoriasis (PSO) Involving at Least 3% Body Surface Area (BSA) at Baseline	From Baseline to Week 4	Subset of study participants in Randomized Set with psoriasis involving at least 3% BSA at Baseline. Participants who had missing PASI90 data at Week 4 or who discontinued study treatment before or at Week 4 regardless whether they had data or not are considered as non-responders.	percentage of participants	NUMBER
SECONDARY	Psoriasis Area Severity Index 90 (PASI90) Response at Week 16 in the Subgroup of Participants With Psoriasis (PSO) Involving at Least 3% Body Surface Area at Baseline	From Baseline to Week 16	Subset of study participants in Randomized Set with psoriasis involving at least 3% BSA at Baseline. Participants who had missing PASI90 data at Week 16 or who discontinued study treatment before or at Week 16 regardless whether they had data or not are considered as non-responders.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in the Short Form 36-item Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 16	Baseline and Week 16	Randomized Set consisted of all enrolled participants who had been randomized.	score on a scale	MEAN
SECONDARY	Minimal Disease Activity (MDA) at Week 16	Week 16	Randomized Set consisted of all enrolled participants who had been randomized.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With American College of Rheumatology 20 (ACR20) Response	From Baseline to Week 16	Randomized Set consisted of all enrolled participants who had been randomized. Participants who had missing ACR20 data at Week 16 or who discontinued study treatment before Week 16 regardless of whether they had data or not are considered as non-responders.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With American College of Rheumatology 70 (ACR70) Response	From Baseline to Week 16	Randomized Set consisted of all enrolled participants who had been randomized. Participants who had missing ACR70 data at Week 16 or who discontinued study treatment before Week 16 regardless of whether they had data or not are considered as non-responders.	percentage of participants	NUMBER
SECONDARY	Investigator Global Assessment (IGA) Response Defined as Score of 0 (Clear) or 1 (Almost Clear) and at Least a 2-grade Reduction From Baseline at Week 4 in the Subset of Participants With Psoriatic Skin Lesions at Baseline	Baseline and Week 4	Subset of study participants in Randomized Set with psoriatic skin lesions at Baseline. Participants who had missing data at the Week 4 or who discontinued study treatment before or at the Week 4 regardless whether they had data or not are considered as non-responders.	percentage of participants	NUMBER
SECONDARY	Investigator Global Assessment (IGA) Response Defined as Score of 0 (Clear) or 1 (Almost Clear) and at Least a 2-grade Reduction From Baseline at Week 16 in the Subset of Participants With Psoriatic Skin Lesions at Baseline	Baseline and Week 16	Subset of study participants in Randomized Set with psoriatic skin lesions at Baseline. Participants who had missing data at the Week 16 or who discontinued study treatment before or at the Week 16 regardless whether they had data or not are considered as non-responders.	percentage of participants	NUMBER

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group30

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percentage of Participants With American College of Rheumatology 50 (ACR50) Response	Placebo	6.8		percentage of participants
Percentage of Participants With American College of Rheumatology 50 (ACR50) Response	Bimekizumab 160mg	43.4		percentage of participants
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score at Week 16	Placebo	-0.0701	Standard Error 0.0432	score on a scale
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score at Week 16	Bimekizumab 160mg	-0.3751	Standard Error 0.0286	score on a scale
Psoriasis Area Severity Index 90 Response (PASI90) at Week 4 in the Subgroup of Participants With Psoriasis (PSO) Involving at Least 3% Body Surface Area (BSA) at Baseline	Placebo	0		percentage of participants
Psoriasis Area Severity Index 90 Response (PASI90) at Week 4 in the Subgroup of Participants With Psoriasis (PSO) Involving at Least 3% Body Surface Area (BSA) at Baseline	Bimekizumab 160mg	26.7		percentage of participants
Psoriasis Area Severity Index 90 (PASI90) Response at Week 16 in the Subgroup of Participants With Psoriasis (PSO) Involving at Least 3% Body Surface Area at Baseline	Placebo	6.8		percentage of participants
Psoriasis Area Severity Index 90 (PASI90) Response at Week 16 in the Subgroup of Participants With Psoriasis (PSO) Involving at Least 3% Body Surface Area at Baseline	Bimekizumab 160mg	68.8		percentage of participants
Change From Baseline in the Short Form 36-item Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 16	Placebo	1.413	Standard Error 0.714	score on a scale
Change From Baseline in the Short Form 36-item Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 16	Bimekizumab 160mg	7.258	Standard Error 0.531	score on a scale

1 to 10 of 30Source ClinicalTrials.gov

See all 30 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	133
Overall Study	STARTED	Bimekizumab 160mg	267
Overall Study	COMPLETED	Placebo	125
Overall Study	COMPLETED	Bimekizumab 160mg	263
Overall Study	NOT COMPLETED	Placebo	8
Overall Study	NOT COMPLETED	Bimekizumab 160mg	4

Source ClinicalTrials.gov

Adverse events22

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	Corona virus infection	Infections and infestations	Placebo	6	132	6
other	Corona virus infection	Infections and infestations	Bimekizumab 160mg	5	267	5
other	Nasopharyngitis	Infections and infestations	Placebo	1	132	1
other	Nasopharyngitis	Infections and infestations	Bimekizumab 160mg	10	267	11
other	Oral candidiasis	Infections and infestations	Placebo	0	132	0
other	Oral candidiasis	Infections and infestations	Bimekizumab 160mg	7	267	9
other	Upper respiratory tract infection	Infections and infestations	Placebo	2	132	2
other	Upper respiratory tract infection	Infections and infestations	Bimekizumab 160mg	6	267	6
other	Urinary tract infection	Infections and infestations	Placebo	3	132	3
other	Urinary tract infection	Infections and infestations	Bimekizumab 160mg	5	267	6

1 to 10 of 22Source ClinicalTrials.gov

See all 22 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	132
Total, all-cause mortality	Bimekizumab 160mg	0	267
Total, other adverse events	Placebo	15	132
Total, other adverse events	Bimekizumab 160mg	34	267
Total, serious adverse events	Placebo	0	132
Total, serious adverse events	Bimekizumab 160mg	5	267

Source ClinicalTrials.gov

Papers19

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
36495881	DERIVED	PubMed
38073049	DERIVED	PubMed
38446397	RESULT	PubMed
38488975	RESULT	PubMed
38754125	DERIVED	PubMed
39120848	DERIVED	PubMed
39120849	RESULT	PubMed
39215949	DERIVED	PubMed
39313302	DERIVED	PubMed
39534481	RESULT	PubMed

1 to 10 of 19

See all 19 papers

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 comparisons5

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Bimekizumab 160mg vs Placebo: Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study	Trial comparisons
Bimekizumab 160mg vs Placebo: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From Investigational Medicinal Product (IMP) During the Study	Trial comparisons
Bimekizumab 160mg vs Placebo: Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Study	Trial comparisons
Bimekizumab 160mg vs Placebo: deaths from any cause	Trial comparisons
Bimekizumab 160mg vs Placebo: serious adverse events	Trial comparisons

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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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