A study with a initial treatment period followed by a randomized-withdrawal period to evaluate the efficacy and safety of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis

A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study with an Initial Treatment Period Followed by a Randomized-Withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects with Moderate to Severe Chronic Plaque Psoriasis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003426-16-GB

Enrollment

400

Registered

2017-12-19

Start date

2018-07-12

Completion date

Unknown

Last updated

2020-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to severe chronic plaque psoriasis MedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858

Interventions

Product Name: Bimekizumab Product Code: UCB4940 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: BIMEKIZUMAB CAS Number: 1418205-77-2 Current Sponsor code: UCB494

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Must be at least 18 years of age - Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit - Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator’s Global Assessment (IGA) score >=3 on a 5-point scale - Subject is a candidate for systemic PSO therapy and/ or phototherapy - Female subject of child bearing potential must be willing to use highly effective method of contraception and/or phototherapy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 320 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80

Exclusion criteria

Exclusion criteria: - Subject has an active infection (except common cold), a recent serious infection, or a history of opportunistic, recurrent, or chronic infections - Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection - Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection - Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study - Presence of active suicidal ideation or positive suicide behavior - Presence of moderately severe major depression or severe major depression - Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer

Design outcomes

Primary

Measure	Time frame
Main Objective: Compare the efficacy of bimekizumab versus placebo in the treatment of subjects with moderate to severe chronic plaque psoriasis (PSO). ;Secondary Objective: - Evaluate efficacy of bimekizumab compared to placebo at achieving complete clearance (PASI100) after 16 weeks of treatment - Evaluate efficacy of bimekizumab compared to placebo after 4 weeks of treatment - Evaluate the change in itch, pain, and scaling of bimekizumab compared to placebo after 16 weeks of treatment as reported by subjects using the Patient Symptom Diary - Evaluate the change in psoriatic scalp disease of bimekizumab compared to placebo after 16 weeks of treatment in subjects with scalp psoriasis at Baseline - Evaluate the efficacy of continuous treatment with bimekizumab versus treatment withdrawal (placebo) as defined by PASI90 at Week 56 for subjects who responded to bimekizumab treatment at Week 16 - Assess the maintenance of efficacy of bimekizumab dosing 1 versus dosing 2 at Week 56 - Assess Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs leading to withdrawal adjusted by duration of subject exposure to study treatment ;Primary end point(s): 1. Psoriasis Area and Severity Index 90 (PASI90) response at Week 16 2. Investigator’s Global Assessment (IGA) response at Week 16 ;Timepoint(s) of evaluation of this end point: 1-2: Week 16	—

Measure

Time frame

Main Objective: Compare the efficacy of bimekizumab versus placebo in the treatment of subjects with moderate to severe chronic plaque psoriasis (PSO). ;Secondary Objective: - Evaluate efficacy of bimekizumab compared to placebo at achieving complete clearance (PASI100) after 16 weeks of treatment - Evaluate efficacy of bimekizumab compared to placebo after 4 weeks of treatment - Evaluate the change in itch, pain, and scaling of bimekizumab compared to placebo after 16 weeks of treatment as reported by subjects using the Patient Symptom Diary - Evaluate the change in psoriatic scalp disease of bimekizumab compared to placebo after 16 weeks of treatment in subjects with scalp psoriasis at Baseline - Evaluate the efficacy of continuous treatment with bimekizumab versus treatment withdrawal (placebo) as defined by PASI90 at Week 56 for subjects who responded to bimekizumab treatment at Week 16 - Assess the maintenance of efficacy of bimekizumab dosing 1 versus dosing 2 at Week 56 - Assess Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs leading to withdrawal adjusted by duration of subject exposure to study treatment ;Primary end point(s): 1. Psoriasis Area and Severity Index 90 (PASI90) response at Week 16 2. Investigator’s Global Assessment (IGA) response at Week 16 ;Timepoint(s) of evaluation of this end point: 1-2: Week 16

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Secondary

Measure	Time frame
Secondary end point(s): 1. PASI100 response at Week 16 2. PASI75 response at Week 4 3. Patient Symptom Diary response for itch at Week 16 4. Patient Symptom Diary response for pain at Week 16 5. Patient Symptom Diary response for scaling at Week 16 6. Scalp IGA response (Clear or Almost Clear with at least a 2-category improvement from Baseline) at Week 16 for subjects with scalp psoriasis (PSO) at Baseline 7. PASI90 response at Week 56 among Week 16 PASI90 responders 8. Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment 9. Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment 10. Number of Treatment Emergent Adverse Events (TEAEs) leading to withdrawal adjusted by duration of subject exposure to study treatment ;Timepoint(s) of evaluation of this end point: 1, 3, 4, 5, 6, 7: Week 16 2: Week 4 8-10: From Baseline to Safety Follow Up (up to Week 76)	—

Measure

Time frame

Secondary end point(s): 1. PASI100 response at Week 16 2. PASI75 response at Week 4 3. Patient Symptom Diary response for itch at Week 16 4. Patient Symptom Diary response for pain at Week 16 5. Patient Symptom Diary response for scaling at Week 16 6. Scalp IGA response (Clear or Almost Clear with at least a 2-category improvement from Baseline) at Week 16 for subjects with scalp psoriasis (PSO) at Baseline 7. PASI90 response at Week 56 among Week 16 PASI90 responders 8. Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment 9. Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment 10. Number of Treatment Emergent Adverse Events (TEAEs) leading to withdrawal adjusted by duration of subject exposure to study treatment ;Timepoint(s) of evaluation of this end point: 1, 3, 4, 5, 6, 7: Week 16 2: Week 4 8-10: From Baseline to Safety Follow Up (up to Week 76)

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Countries

Australia, Canada, Czech Republic, Germany, Hungary, Korea, Republic of, Poland, Russian Federation, Taiwan, United Kingdom, United States

Contacts

Public ContactClin Trial Reg & Results Disclosure

UCB BIOSCIENCES GmbH

clinicaltrials@ucb.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026