Chronic Plaque PsoriasisPhase 2BE ABLE 2NCT03010527

A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Patients With Chronic Plaque Psoriasis

A Phase 2 study testing Bimekizumab in people with Chronic Plaque Psoriasis, run by UCB Biopharma SRL at 36 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a multicenter extension study to assess the long-term safety, tolerability and efficacy of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Plaque Psoriasis
What is being tested?: Bimekizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 217 participants
Where: 36 sitesin 6 countries
Study dates: 14 Dec 2016to 25 Sep 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject has provided informed consent
Subject completes all dosing requirements in feeder study and completes PS0010 study without meeting any withdrawal criteria
Female subjects of childbearing potential and male subjects with a partner of childbearing potential must continue to use an acceptable method of contraception (as detailed in PS0010) for up to 20 weeks after the last dose of study treatment in PS0011

Who cannot join

Subject has previously participated in this study.
Female subjects who plan to become pregnant during the study or within 20 weeks following last dose of study medication. Male subjects who are planning a partner pregnancy during the study or within 20 weeks following the last dose
Subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study.
Subject must have a negative interferon gamma release assay (IGRA) as measured at Week 8 of PS0010

Trial locations and contacts

36 sites in 6 countries.

Country

City, postcode or hospital

36 sites in 6 countries

Poland11 sites

Ps0011 600
Bialystok
Ps0011 603
Bialystok
Ps0011 611
Bialystok
Ps0011 610
Gdynia
Ps0011 604
Kielce
Ps0011 608
Krakow
Ps0011 605
Lublin
Ps0011 606
Lublin
Ps0011 607
Warsaw
Ps0011 601
Wroclaw
Ps0011 609
Wroclaw

Other trials in Poland

United States8 sites

Ps0011 733
Dallas, Texas, 75231
Ps0011 709
Houston, Texas, 77004
Ps0011 702
Houston, Texas, 77598
Ps0011 708
Los Angeles, California, 90045
Ps0011 712
Portland, Oregon, 97223
Ps0011 706
Washington D.C., District of Columbia, 20037
Ps0011 704
West Des Moines, Iowa, 50265
Ps0011 738
Wilmington, North Carolina, 28405

Other trials in United States

Canada6 sites

Ps0011 209
Edmonton
Ps0011 201
North Bay
Ps0011 206
Peterborough
Ps0011 214
Québec
Ps0011 203
Surrey
Ps0011 205
Waterloo

Other trials in Canada

Czechia4 sites

Ps0011 300
Ostrava
Ps0011 303
Pardubice
Ps0011 301
Prague
Ps0011 304
Prague

Other trials in Czechia

Japan4 sites

Ps0011 504
Chiyoda-ku
Ps0011 503
Minatoku
Ps0011 502
Nagoya
Ps0011 501
Shinagawa-ku

Other trials in Japan

Hungary3 sites

Ps0011 404
Kecskemét
Ps0011 400
Orosháza
Ps0011 405
Szekszárd

Other trials in Hungary

About this study

Official title: A Multicenter, 48-Week, Double-Blind, Placebo-Controlled, Parallel-Group Extension Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

This is a multicenter extension study to assess the long-term safety, tolerability and efficacy of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis

Conditions: Chronic Plaque Psoriasis
Being tested: Bimekizumab, Placebo
Keywords: Chronic plaque psoriasis, Psoriasis, Bimekizumab
Medical subject headings: Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BimekizumabDrug
Also called UCB4940
Subjects will receive bimekizumab injections every four weeks (Q4W)
PlaceboOther
Subjects will receive Placebo injections every four weeks (Q4W)

Study groups in NCT03010527
Study group	Role	What they receive
Placebo	Placebo comparator	Subjects with a PASI90 response at Week 12 and receiving Placebo in PS0010 entering PS0011 will receive Placebo. Receives: Other: Placebo
Bimekizumab dosing regimen 1	Experimental	Subjects with a PASI90 response at Week 12 receiving dosing regimen 1 in PS0010 entering PS0011 will receive the same dosing regimen. Subjects who do not achieve PASI90 response at Week 12 receiving dosing regimen 1 in PS0010 will be assigned to a higher dosing regimen. Receives: Drug: Bimekizumab
Bimekizumab dosing regimen 2	Experimental	Subjects with a PASI90 response at Week 12 receiving dosing regimen 2 in PS0010 entering PS0011 will receive the same dosing regimen. Subjects who do not achieve PASI90 response at Week 12 receiving dosing regimen 2 in PS0010 will be assigned to a higher dosing regimen. Receives: Drug: Bimekizumab
Bimekizumab dosing regimen 3	Experimental	Subjects that were initially randomized to bimekizumab dosage regimen 3, 4 and 5 in PS0010 will receive bimekizumab dosing regimen 3. Receives: Drug: Bimekizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Treatment
Treatment-emergent Adverse Events (TEAEs) were defined as those events which started on or after the date of first dose of PS0011 investigational medicinal product (IMP), or events in which severity worsened on or after the date of first dose of PS0011 study medication. The exposure adjusted incidence rate (EAIR) is defined as the number of subjects (n) with a specific AE adjusted for the exposure and was scaled to 100 subject-years: where the numerator is the total number of subjects experiencing the AE and the denominator is the total time at risk scaled to 100 subject-years; that is, the total summation of individual subject-years at risk up to the first occurrence of the AE for subjects with that AE, and the total subject-years at risk for those subjects not experiencing that AE, divided by 100.
Measured: From Baseline until Safety Follow-Up Visit (up to Week 64)

Secondary outcomes (2)

Percentage of Participants With Psoriasis Area Severity Index (PASI90) Response Over Time
The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. It averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale) and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity. PASI90 response is defined to be equal to 1 if the percentage improvement from Baseline in the PASI scores is 90% or greater and 0 if the percentage improvement from Baseline is less than 90%. This Outcome Measure presents results relative to PS0010 Baseline starting at PS0011 Baseline by PS0010 Week 12 response status.
Measured: From Baseline during the Treatment Period (up to Week 48)
Percentage of Participants With Investigator´s Global Assessment Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) Over Time
The Investigator's Global Assessment (IGA) measures the overall severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response is defined as clear (0) or almost clear (1) with at least a two category improvement from Baseline. This Outcome Measure presents results relative to PS0010 Baseline starting at PS0011 Baseline by PS0010 Week 12 response status.
Measured: From Baseline during the Treatment Period (up to Week 48)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Dec 201625 Sep 2018

First posted5 Jan 2017 (estimated)
Study start14 Dec 2016
Primary completion25 Sep 2018
Study completion25 Sep 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Chronic Plaque PsoriasisStudies of the same condition, open and under way.
More trials run by UCB Biopharma SRLThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 217 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03010527
Sponsor's protocol ID: PS0011
Other IDs: 2016-001892-57, 2016
Acronym: BE ABLE 2
Status last verified: Sep 2022
First submitted: 3 Jan 2017
Last updated: 18 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Blauvelt A, Papp KA, Merola JF, Gottlieb AB, Cross N, Madden C, Wang M, Cioffi C, Griffiths CEM. Bimekizumab for patients with moderate to severe plaque psoriasis: 60-week results from BE ABLE 2, a randomized, double-blinded, placebo-controlled, phase 2b extension study. J Am Acad Dermatol. 2020 Nov;83(5):1367-1374. doi: 10.1016/j.jaad.2020.05.105. Epub 2020 May 29.
PubMed 32473974
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.
PubMed 35544084

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Plaque Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, 48-Week, Double-Blind, Placebo-Controlled, Parallel-Group Extension Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
ClinicalTrials.gov ID: NCT03010527
Acronym / sponsor ID: BE ABLE 2 / PS0011
Conditions: Chronic Plaque Psoriasis
Keywords: Chronic plaque psoriasis, Psoriasis, Bimekizumab
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 217 participants (actual)
Lead sponsor: UCB Biopharma SRLIndustry (pharma, biotech, devices)
Study start: 14 Dec 2016 (actual)
Primary completion: 25 Sep 2018 (actual)
Study completion: 25 Sep 2018 (actual)
First posted: 5 Jan 2017 (estimated)
Results: Posted 25 Oct 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a multicenter extension study to assess the long-term safety, tolerability and efficacy of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Other: PlaceboSubjects with a PASI90 response at Week 12 and receiving Placebo in PS0010 entering PS0011 will receive Placebo.
Bimekizumab dosing regimen 1	Experimental	Drug: BimekizumabSubjects with a PASI90 response at Week 12 receiving dosing regimen 1 in PS0010 entering PS0011 will receive the same dosing regimen. Subjects who do not achieve PASI90 response at Week 12 receiving dosing regimen 1 in PS0010 will be assigned to a higher dosing regimen.
Bimekizumab dosing regimen 2	Experimental	Drug: BimekizumabSubjects with a PASI90 response at Week 12 receiving dosing regimen 2 in PS0010 entering PS0011 will receive the same dosing regimen. Subjects who do not achieve PASI90 response at Week 12 receiving dosing regimen 2 in PS0010 will be assigned to a higher dosing regimen.
Bimekizumab dosing regimen 3	Experimental	Drug: BimekizumabSubjects that were initially randomized to bimekizumab dosage regimen 3, 4 and 5 in PS0010 will receive bimekizumab dosing regimen 3.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Subject has provided informed consent
Subject completes all dosing requirements in feeder study and completes PS0010 study without meeting any withdrawal criteria
Female subjects of childbearing potential and male subjects with a partner of childbearing potential must continue to use an acceptable method of contraception (as detailed in PS0010) for up to 20 weeks after the last dose of study treatment in PS0011

Key exclusion criteria (4 listed)

Subject has previously participated in this study.
Female subjects who plan to become pregnant during the study or within 20 weeks following last dose of study medication. Male subjects who are planning a partner pregnancy during the study or within 20 weeks following the last dose
Subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study.
Subject must have a negative interferon gamma release assay (IGRA) as measured at Week 8 of PS0010

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BimekizumabAlso: UCB4940Subjects will receive bimekizumab injections every four weeks (Q4W)	Drug	Bimekizumab dosing regimen 1, Bimekizumab dosing regimen 2, Bimekizumab dosing regimen 3
PlaceboSubjects will receive Placebo injections every four weeks (Q4W)	Other	Placebo

Primary outcome

Incidence of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Treatment
Time frame: From Baseline until Safety Follow-Up Visit (up to Week 64)
Treatment-emergent Adverse Events (TEAEs) were defined as those events which started on or after the date of first dose of PS0011 investigational medicinal product (IMP), or events in which severity worsened on or after the date of first dose of PS0011 study medication. The exposure adjusted incidence rate (EAIR) is defined as the number of subjects (n) with a specific AE adjusted for the exposure and was scaled to 100 subject-years: where the numerator is the total number of subjects experiencing the AE and the denominator is the total time at risk scaled to 100 subject-years; that is, the total summation of individual subject-years at risk up to the first occurrence of the AE for subjects with that AE, and the total subject-years at risk for those subjects not experiencing that AE, divided by 100.

2 secondary outcomes

Percentage of Participants With Psoriasis Area Severity Index (PASI90) Response Over Time
Time frame: From Baseline during the Treatment Period (up to Week 48)
Percentage of Participants With Investigator´s Global Assessment Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) Over Time
Time frame: From Baseline during the Treatment Period (up to Week 48)

Results and safety

Results posted to the registry on 25 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bimekizumab 64 mg Q4W	15	15
Bimekizumab 160 mg Q4W	111	92
Bimekizumab 320 mg Q4W	91	75

Primary outcome: Incidence of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Treatment

Time frame: From Baseline until Safety Follow-Up Visit (up to Week 64). Number (95% Confidence Interval). Unit: no. of new events per 100 subject-years

Measure	Bimekizumab 64 mg Q4W (SS) n = 15	Bimekizumab 160 mg Q4W (SS) n = 111	Bimekizumab 320 mg Q4W (SS) n = 91
Value	110.68 (53.08 to 203.55)	225.26 (182.88 to 274.53)	206.82 (162.95 to 258.86)

Population analysed: The Safety Set (SS) consisted of all participants who received at least 1 dose of the study medication in PS0011.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bimekizumab 64 mg Q4W (SS)	1 of 15 (6.7%)	10 of 15 (66.7%)	0 of 15
Bimekizumab 160 mg Q4W (SS)	7 of 111 (6.3%)	56 of 111 (50.5%)	0 of 111
Bimekizumab 320 mg Q4W (SS)	7 of 91 (7.7%)	51 of 91 (56%)	2 of 91

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 32473974Blauvelt A, Papp KA, Merola JF, Gottlieb AB, Cross N, Madden C, Wang M, Cioffi C, Griffiths CEM. Bimekizumab for patients with moderate to severe plaque psoriasis: 60-week results from BE ABLE 2, a randomized, double-blinded, placebo-controlled, phase 2b extension study. J Am Acad Dermatol. 2020 Nov;83(5):1367-1374. doi: 10.1016/j.jaad.2020.05.105. Epub 2020 May 29.
Results publication: PubMed 35544084Gordon 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.
Product InformationLink provided by the sponsor.
FDA Safety Alerts and RecallsLink provided by the sponsor.

Related trials for Chronic Plaque Psoriasis

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

UCB Cares study director

001 844 599 2273 (UCB)

36 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bimekizumab in people with Chronic Plaque Psoriasis, run by UCB Biopharma SRL at 36 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in Poland, United States, Canada, Czechia, Japan and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Treatment (time frame: From Baseline until Safety Follow-Up Visit (up to Week 64)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03010527, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2022; AzTrials last refreshed its copy on 2 Nov 2026.