A Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety of Bimekizumab in Patients With Chronic Plaque Psoriasis

NCT03025542 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: PS00162016-002368-15
• Study Type: interventional
• Target: 49
• Locations: 4 countries
• Sites: 8

Brief Summary

This is a Phase 2a, multicenter, randomized, subject-blind, investigator-blind, study to investigate the pharmacokinetics (PK), pharmacodynamics (PD), and safety of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis

Conditions

Chronic Plaque Psoriasis

Keywords

Psoriasis; Chronic Plaque Psoriasis; Bimekizumab

Outcome Measures

Primary Outcomes (14)

• Change From Baseline in Psoriasis Area and Severity Index (PASI) at Week 28

  The PASI is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies. The PASI quantifies the severity and extent of the disease and weighs these with the percentage of body surface area (BSA) involvement. The percent area of involvement (BSA%) is estimated across 4 body areas; head (10%), upper limbs (20%), trunk (30%), and lower limbs (40%) and then transferred into a grade. The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5 point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.

  From Baseline to Week 28

• Plasma Concentration of Bimekizumab at Baseline

  Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.

  at Baseline

• Plasma Concentration of Bimekizumab at Week 2

  Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.

  at Week 2

• Plasma Concentration of Bimekizumab at Week 4

  Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.

  at Week 4

• Plasma Concentration of Bimekizumab at Week 8

  Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.

  at Week 8

• Plasma Concentration of Bimekizumab at Week 12

  Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.

  at Week 12

• Plasma Concentration of Bimekizumab at Week 16

  Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (µg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.

  at Week 16

• Plasma Concentration of Bimekizumab at Week 20

  Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.

  at Week 20

• Plasma Concentration of Bimekizumab at Week 24

  Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.

  at Week 24

• Plasma Concentration of Bimekizumab at Week 28

  Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.

  at Week 28

• Plasma Concentration of Bimekizumab at Week 36

  Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.

  at Week 36

• Percentage of Participants Reporting Positive Anti-Drug-Antibodies (ADA) Titre Prior to Study Treatment With Bimekizumab at Baseline

  An ADA status of positive was concluded for any participant with an ADA level that was above cut point (ACP) and 'confirmed positive' (CP) at any time point. A participant was classified as having treatment-induced ADA positivity when meeting one of the following criteria: -The Baseline result was either below cut point (BCP) or ACP and 'not confirmed positive' (NCP), and at least 1 post Baseline time point was ACP and CP. -The Baseline result was positive (ACP and CP) and at least one post-Baseline measurement showed a pre-defined fold increase in titre from the Baseline value. Note: The overall status of a participant is 'Positive' if at any post-Baseline visit the result was ACP and confirmed positive.

  at Baseline

• Percentage of Participants Reporting an Overall Positive Anti-Drug-Antibodies (ADA) Titre Following Study Treatment With Bimekizumab

  An ADA status of positive was concluded for any participant with an ADA level that was above cut point (ACP) and 'confirmed positive' (CP) at any time point. A participant was classified as having treatment-induced ADA positivity when meeting one of the following criteria: -The Baseline result was either below cut point (BCP) or ACP and 'not confirmed positive' (NCP), and at least 1 post Baseline time point was ACP and CP. -The Baseline result was positive (ACP and CP) and at least one post-Baseline measurement showed a pre-defined fold increase in titre from the Baseline value. Note: The overall status of a participant is 'Positive' if at any post-Baseline visit the result was ACP and confirmed positive.

  From Baseline to Safety Follow-Up Visit (Week 36)

• Percentage of Participants Who Experienced at Least One Adverse Events (AEs)

  An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. Within the Safety Set, this trial reported a total of 164 occurences of adverse events, of which 7 were pre-treatment adverse events and 157 were treatment-emergent adverse events (TEAEs).

  From Screening to Safety Follow-Up Visit (Week 36)

Secondary Outcomes (4)

• Percentage of Participants Achieving a 75% or Higher Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16

  From Baseline to Week 16

• Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16

  From Baseline to Week 16

• Percentage of Participants Achieving a 100% Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16

  From Baseline to Week 16

• Percentage of Participants With IGA (Investigator´s Global Assessment) Response at Week 16

  at Week 16

Study Arms (2)

Treatment Arm 1

EXPERIMENTAL

Subjects randomized in this arm will receive a combination of Bimekizumab and Placebo injections.

Drug: Bimekizumab; Other: Placebo

Treatment Arm 2

EXPERIMENTAL

Subjects randomized in this arm will receive Bimekizumab injections.

Drug: Bimekizumab

Interventions

Bimekizumab DRUG

Based on their randomization subjects will receive a combination of several injections of Bimekizumab.

Also known as: UCB4940

Treatment Arm 1; Treatment Arm 2

Placebo OTHER

Subjects will receive injections of Placebo.

Treatment Arm 1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female at least 18 years of age and less than or equal to 70
• Chronic plaque psoriasis for at least 6 months prior to Screening
• Psoriasis Area and Severity Index (PASI) \>=12 and body surface area (BSA) \>=10% and Investigator's Global Assessment (IGA) score \>=3 on a 5-point scale
• Candidates for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy
• Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception up till 20 weeks after last administration of study drug, and have a negative pregnancy test at Visit 1 (Screening) and immediately prior to first dose
• Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active, up till 20 weeks after the last administration of study medication (anticipated 5 half-lives)

You may not qualify if:

• Subjects previously participating in a bimekizumab study
• Subjects with erythrodermic, guttate, pustular form of psoriasis, or drug-induced psoriasis
• History of chronic or recurrent infections, or a serious or life-threatening infection within the 6 months prior to the Baseline Visit (including herpes zoster)
• High risk of infection in the Investigator's opinion
• Current sign or symptom that may indicate an active infection
• Concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
• Live (includes attenuated) vaccination within the 8 weeks prior to Baseline
• Subjects with concurrent malignancy or history of malignancy during the past 5 years (except for specific malignant condition as defined in the protocol)
• Primary immunosuppressive conditions
• TB infection, high risk of acquiring TB infection, latent TB infection (LTBI), or current or history of NTMB infection
• Laboratory abnormalities, as defined in the study protocol
• Exposure to more than 1 biological response modifier (limited to anti-TNF or IL-12/-23) or any biologic response modifier during the three months prior to the Baseline Visit
• Subjects have received previous treatment with any anti-IL-17 therapy for the treatment of psoriasis or psoriatic arthritis
• Subjects with a diagnosis of inflammatory conditions other than psoriasis or psoriatic arthritis, including but not limited to rheumatoid arthritis, sarcoidosis, or systemic lupus erythematosus. Subjects with a diagnosis of Crohn's disease or ulcerative colitis are allowed as long as they have no active symptomatic disease at Screening or Baseline
• Subjects taking psoriatic arthritis medications other than nonsteroidal anti-inflammatory drugs (NSAIDs) or analgesics

Sponsors & Collaborators

• UCB Biopharma SRL: lead
• Parexel: collaborator

Study Sites (8)

Ps0016 704

Bexley, Ohio, United States

Location

Ps0016 102

Kogarah, Australia

Location

Ps0016 101

Melbourne, Australia

Location

Ps0016 104

Woolloongabba, Australia

Location

Ps0016 201

Ajax, Canada

Location

Ps0016 203

London, Canada

Location

Ps0016 202

Windsor, Canada

Location

Ps0016 501

Chisinau, Moldova

Location

Related Publications (3)

• Oliver R, Krueger JG, Glatt S, Vajjah P, Mistry C, Page M, Edwards H, Garcet S, Li X, Dizier B, Maroof A, Watling M, El Baghdady A, Baeten D, Ionescu L, Shaw S. Bimekizumab for the treatment of moderate-to-severe plaque psoriasis: efficacy, safety, pharmacokinetics, pharmacodynamics and transcriptomics from a phase IIa, randomized, double-blind multicentre study. Br J Dermatol. 2022 Apr;186(4):652-663. doi: 10.1111/bjd.20827. Epub 2021 Dec 27.

  PMID: 34687214 RESULT

• Gordon KB, Langley RG, Warren RB, Okubo Y, Stein Gold L, Merola JF, Peterson L, Wixted K, Cross N, Deherder D, Thaci D. Bimekizumab Safety in Patients With Moderate to Severe Plaque Psoriasis: Pooled Results From Phase 2 and Phase 3 Randomized Clinical Trials. JAMA Dermatol. 2022 Jul 1;158(7):735-744. doi: 10.1001/jamadermatol.2022.1185.

  PMID: 35544084 RESULT

• Krueger JG, Cutcutache I, Lebwohl M, Gudjonsson JE, Pinter A, Langley RG, Merola J, Tada Y, Skelton A, Rastrick J, Ferecsko AS, Page M, Davies O, Lopez Pinto JM, Warham R, Shaw S, Warren RB. Bimekizumab long-term response in psoriasis: Mechanistic insights into efficacy level and durability. J Allergy Clin Immunol. 2026 Jan 22:S0091-6749(26)00012-6. doi: 10.1016/j.jaci.2025.12.1013. Online ahead of print.

  PMID: 41580158 RESULT

Related Links

• Product Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Psoriasis

Interventions

bimekizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

001 844 599 2273

Study Officials

• UCB Cares

  001 844 599 2273(UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is an Investigator- and Subject-blind study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 19, 2017
• Study Start: December 27, 2016
• Primary Completion: December 11, 2017
• Study Completion: December 11, 2017
• Last Updated: March 24, 2026
• Results First Posted: January 6, 2021

Record last verified: 2026-03

Locations

CA (3); US (1); AU (3); MO (1)