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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 (BE READY)

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ClinicalTrials.gov Identifier: NCT03410992
Recruitment Status : Active, not recruiting
First Posted : January 25, 2018
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

Brief Summary:
Phase 3 study to compare the efficacy of bimekizumab versus placebo in the treatment of subjects with moderate to severe chronic plaque psoriasis.

Condition or disease Intervention/treatment Phase
Chronic Plaque Psoriasis Moderate to Severe Chronic Plaque Psoriasis Psoriatic Arthritis Drug: Bimekizumab Other: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 435 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 5, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Bimekizumab cohort
Subjects will receive bimekizumab for 16 Weeks. Subjects who achieve certain predefined response criteria will be re-randomized to either receive bimekizumab or placebo until Week 56. Subjects who do not achieve predefined response criteria will enter the bimekizumab escape arm.
Drug: Bimekizumab
Bimekizumab will be provided at pre-specified time intervals.
Other Name: UCB4940

Other: Placebo
Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.
Other Name: PBO

Placebo Comparator: Placebo
Subjects will receive placebo for 16 Weeks. Subjects who achieve certain predefined response criteria will proceed with placebo until Week 56. Subjects who do not achieve certain predefined response criteria will enter the bimekizumab escape arm.
Other: Placebo
Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.
Other Name: PBO




Primary Outcome Measures :
  1. Psoriasis Area and Severity Index 90 (PASI90) response at Week 16 [ Time Frame: Week 16 ]
    A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.

  2. Investigator's Global Assessment (IGA) response at Week 16 [ Time Frame: Week 16 ]
    IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.


Secondary Outcome Measures :
  1. PASI100 response at Week 16 [ Time Frame: Week 16 ]
    A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score.

  2. PASI75 response at Week 4 [ Time Frame: Week 4 ]
    A PASI75 responder is defined as a subject that achieves 75% reduction from Baseline in the PASI score.

  3. Change from Baseline in the Patient Symptom Diary responses for itch at Week 16 [ Time Frame: Week 16 ]
    A Patient-Reported outcome (PRO) measure will be used to assess key symptoms relevant to patients with moderate to severe chronic plaque PSO. Site staff will train the participating subjects on the use of the electronic PRO (ePRO) diary at the Screening Visit, following which the device will be dispensed to the subject for home use until the Week 16 Visit. The ePRO diary will be administered on a daily basis from Screening to the Week 16 Visit.

  4. Change from Baseline in the Patient Symptom Diary responses for pain at Week 16 [ Time Frame: Week 16 ]
    A PRO measure will be used to assess key symptoms relevant to patients with moderate to severe chronic plaque PSO. Site staff will train the participating subjects on the use of the electronic PRO (ePRO) diary at the Screening Visit, following which the device will be dispensed to the subject for home use until the Week 16 Visit. The ePRO diary will be administered on a daily basis from Screening to the Week 16 Visit.

  5. Change from Baseline in the Patient Symptom Diary responses for scaling at Week 16 [ Time Frame: Week 16 ]
    A PRO measure will be used to assess key symptoms relevant to patients with moderate to severe chronic plaque PSO. Site staff will train the participating subjects on the use of the electronic PRO (ePRO) diary at the Screening Visit, following which the device will be dispensed to the subject for home use until the Week 16 Visit. The ePRO diary will be administered on a daily basis from Screening to the Week 16 Visit.

  6. IGA response (Clear or Almost Clear) at Week 16 for subjects with scalp psoriasis (PSO) at Baseline [ Time Frame: Week 16 ]
    Only subjects with scalp involvement at Baseline will complete the scalp IGA. Subjects with scalp involvement at Baseline are defined as those with a scalp IGA score >0 at Baseline. Scalp lesions will be assessed in terms of clinical signs of redness, thickness, and scaliness using a 5-point scale (0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4= Severe).

  7. PASI90 response at Week 56 among Week 16 PASI90 responders [ Time Frame: Week 56 ]
    A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.

  8. Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment [ Time Frame: From Baseline to Safety Follow Up (up to Week 76) ]
    The number of TEAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the Adverse Event (AE) being considered. If a subject has no events, the total time at risk is used.

  9. Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment [ Time Frame: From Baseline to Safety Follow Up (up to Week 76) ]
    The number of SAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.

  10. Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to study treatment [ Time Frame: From Baseline to Safety Follow Up (up to Week 76) ]
    The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03410992


  Show 83 Study Locations
Sponsors and Collaborators
UCB Biopharma S.P.R.L.
Investigators
Study Director: UCB Cares +1 844 599 2273 (UCB)

Responsible Party: UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier: NCT03410992     History of Changes
Other Study ID Numbers: PS0013
2016-003426-16 ( EudraCT Number )
First Posted: January 25, 2018    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):
Bimekizumab
PSO
Psoriasis

Additional relevant MeSH terms:
Psoriasis
Arthritis, Psoriatic
Skin Diseases, Papulosquamous
Skin Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases