The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03410992




Registration number
NCT03410992
Ethics application status
Date submitted
19/01/2018
Date registered
25/01/2018
Date last updated
27/01/2020

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
2016-003426-16
Secondary ID [2] 0 0
PS0013
Universal Trial Number (UTN)
Trial acronym
BE READY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Plaque Psoriasis 0 0
Moderate to Severe Chronic Plaque Psoriasis 0 0
Psoriatic Arthritis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Bimekizumab
Other interventions - Placebo

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.

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.


Treatment: Drugs: Bimekizumab
Bimekizumab will be provided at pre-specified time intervals.

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

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Psoriasis Area and Severity Index 90 (PASI90) response at Week 16 - A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.
Timepoint [1] 0 0
Week 16
Primary outcome [2] 0 0
Investigator's Global Assessment (IGA) response at Week 16 - IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.
Timepoint [2] 0 0
Week 16
Secondary outcome [1] 0 0
PASI100 response at Week 16 - A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score.
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
PASI75 response at Week 4 - A PASI75 responder is defined as a subject that achieves 75% reduction from Baseline in the PASI score.
Timepoint [2] 0 0
Week 4
Secondary outcome [3] 0 0
Change from Baseline in the Patient Symptom Diary responses for itch at 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.
Timepoint [3] 0 0
Week 16
Secondary outcome [4] 0 0
Change from Baseline in the Patient Symptom Diary responses for pain at 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.
Timepoint [4] 0 0
Week 16
Secondary outcome [5] 0 0
Change from Baseline in the Patient Symptom Diary responses for scaling at 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.
Timepoint [5] 0 0
Week 16
Secondary outcome [6] 0 0
IGA response (Clear or Almost Clear) at Week 16 for subjects with scalp psoriasis (PSO) at Baseline - 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).
Timepoint [6] 0 0
Week 16
Secondary outcome [7] 0 0
PASI90 response at Week 56 among Week 16 PASI90 responders - A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.
Timepoint [7] 0 0
Week 56
Secondary outcome [8] 0 0
Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment - 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.
Timepoint [8] 0 0
From Baseline to Safety Follow Up (up to Week 76)
Secondary outcome [9] 0 0
Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment - 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.
Timepoint [9] 0 0
From Baseline to Safety Follow Up (up to Week 76)
Secondary outcome [10] 0 0
Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to study treatment - 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.
Timepoint [10] 0 0
From Baseline to Safety Follow Up (up to Week 76)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Ps0013 003 - Carlton
Recruitment hospital [2] 0 0
Ps0013 008 - East Melbourne
Recruitment hospital [3] 0 0
Ps0013 006 - Kogarah
Recruitment postcode(s) [1] 0 0
- Carlton
Recruitment postcode(s) [2] 0 0
- East Melbourne
Recruitment postcode(s) [3] 0 0
- Kogarah
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
New Hampshire
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
United States of America
State/province [13] 0 0
Rhode Island
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Utah
Country [16] 0 0
Canada
State/province [16] 0 0
Ajax
Country [17] 0 0
Canada
State/province [17] 0 0
Edmonton
Country [18] 0 0
Canada
State/province [18] 0 0
Hamilton
Country [19] 0 0
Canada
State/province [19] 0 0
Markham
Country [20] 0 0
Canada
State/province [20] 0 0
Mississauga
Country [21] 0 0
Canada
State/province [21] 0 0
Montréal
Country [22] 0 0
Canada
State/province [22] 0 0
North Bay
Country [23] 0 0
Canada
State/province [23] 0 0
Ottawa
Country [24] 0 0
Canada
State/province [24] 0 0
Québec
Country [25] 0 0
Canada
State/province [25] 0 0
Surrey
Country [26] 0 0
Canada
State/province [26] 0 0
Waterloo
Country [27] 0 0
Germany
State/province [27] 0 0
Hamburg
Country [28] 0 0
Germany
State/province [28] 0 0
Münster
Country [29] 0 0
Germany
State/province [29] 0 0
Schwerin
Country [30] 0 0
Germany
State/province [30] 0 0
Witten
Country [31] 0 0
Hungary
State/province [31] 0 0
Budapest
Country [32] 0 0
Hungary
State/province [32] 0 0
Miskolc
Country [33] 0 0
Hungary
State/province [33] 0 0
Orosháza
Country [34] 0 0
Hungary
State/province [34] 0 0
Szeged
Country [35] 0 0
Hungary
State/province [35] 0 0
Szolnok
Country [36] 0 0
Hungary
State/province [36] 0 0
Veszprém
Country [37] 0 0
Korea, Republic of
State/province [37] 0 0
Busan
Country [38] 0 0
Korea, Republic of
State/province [38] 0 0
Seongnam-si
Country [39] 0 0
Korea, Republic of
State/province [39] 0 0
Seoul
Country [40] 0 0
Poland
State/province [40] 0 0
Bialystok
Country [41] 0 0
Poland
State/province [41] 0 0
Gdansk
Country [42] 0 0
Poland
State/province [42] 0 0
Katowice
Country [43] 0 0
Poland
State/province [43] 0 0
Kielce
Country [44] 0 0
Poland
State/province [44] 0 0
Kraków
Country [45] 0 0
Poland
State/province [45] 0 0
Lublin
Country [46] 0 0
Poland
State/province [46] 0 0
Poznan
Country [47] 0 0
Poland
State/province [47] 0 0
Szczecin
Country [48] 0 0
Poland
State/province [48] 0 0
Warsaw
Country [49] 0 0
Poland
State/province [49] 0 0
Warszawa
Country [50] 0 0
Poland
State/province [50] 0 0
Wroclaw
Country [51] 0 0
Poland
State/province [51] 0 0
Lódz
Country [52] 0 0
Russian Federation
State/province [52] 0 0
Moscow
Country [53] 0 0
Russian Federation
State/province [53] 0 0
Saint Petersburg
Country [54] 0 0
Russian Federation
State/province [54] 0 0
Saratov
Country [55] 0 0
Russian Federation
State/province [55] 0 0
Yaroslavl
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Manchester
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Reading
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Salford

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
UCB Biopharma S.P.R.L.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03410992
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
UCB Cares
Address 0 0
+1 844 599 2273 (UCB)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications