Chronic Plaque PsoriasisPhase 3NCT03766685

A Study to Evaluate the Safe and Effective Use of the Prefilled Safety Syringe or the Auto-injector for the Subcutaneous Self-injection of Bimekizumab Solution by Subjects With Moderate to Severe Chronic Plaque Psoriasis (PSO)

A Phase 3 study testing Bimekizumab in people with Chronic Plaque Psoriasis and Moderate to Severe Chronic Plaque Psoriasis, run by UCB Biopharma SRL at 39 sites in 2 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

The purpose of the study is to evaluate the ability of subjects with moderate to severe chronic plaque psoriasis (PSO) to safely and effectively self-inject bimekizumab at study start and 8 weeks after training in self-injection technique using a prefilled safety syringe or an auto-injector. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Plaque Psoriasis, Moderate to Severe Chronic Plaque Psoriasis
What is being tested?: Bimekizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 172 participants
Where: 39 sitesin 2 countries
Study dates: 20 Dec 2018to 8 Sep 2020
Phase: Phase 3
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 fulfills all inclusion criteria for the PS0014 [NCT03598790] study
Subject is considered reliable and capable of adhering to the DV0002 protocol (eg, able to understand and complete questionnaires, willing to self-inject, able to use investigational device according to the instructions for use (IFU), and able to adhere to the visit schedule) according to the judgment of the Investigator

Who cannot join

Subjects are not permitted to enroll in DV0002 if any of the PS0014 [NCT03598790] study exclusion criteria are met

Trial locations and contacts

39 sites in 2 countries.

Country

City, postcode or hospital

39 sites in 2 countries

United States27 sites

Dv0002 941
Alpharetta, Georgia, 30022
Dv0002 910
Bakersfield, California, 93309
Dv0002 922
Baton Rouge, Louisiana, 70809
Dv0002 906
Boca Raton, Florida, 33486
Dv0002 925
Brighton, Massachusetts, 02135
Dv0002 908
East Windsor, New Jersey, 08520
Dv0002 951
Houston, Texas, 77598
Dv0002 937
Johnston, Rhode Island, 02919
Dv0002 907
Miami, Florida, 33144
Dv0002 913
New York, New York, 10029
Dv0002 903
Ocala, Florida, 34471
Dv0002 905
Overland Park, Kansas, 66215
Dv0002 962
Owensboro, Kentucky, 42301
Dv0002 946
Phoenix, Arizona, 85032
Dv0002 920
Portland, Oregon, 97210
Dv0002 929
Portland, Oregon, 97223
Dv0002 901
Portsmouth, New Hampshire, 03801
Dv0002 963
Rochester, New York, 14623
Dv0002 914
San Antonio, Texas, 78213
Dv0002 955
San Diego, California, 92123
Dv0002 943
San Luis Obispo, California, 93405
Dv0002 967
Santa Monica, California, 90404
Dv0002 954
Skokie, Illinois, 60077
Dv0002 915
St Louis, Missouri, 63117
Dv0002 936
Tampa, Florida, 33624
Dv0002 917
Troy, Michigan, 48084
Dv0002 900
West Des Moines, Iowa, 50265

Other trials in United States

Canada12 sites

Dv0002 672
Edmonton
Dv0002 673
Halifax
Dv0002 671
Hamilton
Dv0002 675
Markham
Dv0002 663
Mississauga
Dv0002 660
Montreal
Dv0002 665
Québec
Dv0002 651
Richmond Hill
Dv0002 653
Toronto
Dv0002 662
Toronto
Dv0002 657
Waterloo
Dv0002 670
Windsor

Other trials in Canada

About this study

Official title: A Multicenter, Randomized, Open-Label Study to Evaluate the Safe and Effective Use of the Prefilled Safety Syringe or the Auto-Injector for the Subcutaneous Self-Injection of Bimekizumab Solution by Subjects With Moderate to Severe Chronic Plaque Psoriasis

Conditions: Chronic Plaque Psoriasis, Moderate to Severe Chronic Plaque Psoriasis
Being tested: Bimekizumab
Keywords: Bimekizumab, PSO, Psoriasis, Auto-Injector
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, BKZ
Subjects will receive bimekizumab at pre-specified time-points.

Study groups in NCT03766685
Study group	Role	What they receive
Bimekizumab-SS	Experimental	Subjects will receive assigned bimekizumab dose regimen using a prefilled safety syringe (SS). Receives: Drug: Bimekizumab
Bimekizumab-AI	Experimental	Subjects will receive assigned bimekizumab dose regimen using an auto-injector (AI). Receives: Drug: Bimekizumab

What is being measured

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

Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-safety Syringe (SS)-1mL or the Bimekizumab-auto-injector (AI)-1mL at Week 8, After Training in Self-injection Technique
Safe and effective self-injection was evaluated by the study personnel and was defined as: - Complete dose delivery: Participant self-injected the complete dose of bimekizumab as confirmed by a visual inspection of the bimekizumab-safety syringe (SS) or the bimekizumab-auto-injector (AI) which shows that the investigational medicinal product (IMP) was delivered completely (ie, container is empty), and - No Adverse Device Effects (ADEs) that would preclude continued use of the device for self-injection (ie, no serious ADEs (SADEs) and/or ADEs leading to withdrawal).
Measured: Week 8
Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-SS-2mL or the Bimekizumab-AI-2mL at Week 8, After Training in Self-injection Technique
Safe and effective self-injection was evaluated by the study personnel and was defined as: - Complete dose delivery: Participant self-injected the complete dose of bimekizumab as confirmed by a visual inspection of the bimekizumab-SS or the bimekizumab-AI which shows that the IMP is delivered completely (ie, container is empty), and - No ADEs that would preclude continued use of the device for self-injection (ie, no serious ADEs (SADEs) and/or ADEs leading to withdrawal).
Measured: Week 8

Secondary outcomes (2)

Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-SS-1mL or the Bimekizumab-AI-1mL at Baseline, After Training in Self-injection Technique
Safe and effective self-injection was evaluated by the study personnel and was defined as: - Complete dose delivery: Participant self-injected the complete dose of bimekizumab as confirmed by a visual inspection of the bimekizumab-SS or the bimekizumab-AI which showed that the IMP was delivered completely (ie, container is empty), and - No ADEs that would preclude continued use of the device for self-injection (ie, no SADEs and/or ADEs leading to withdrawal).
Measured: Baseline (the first self-injection visit)
Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-SS-2mL or the Bimekizumab-AI-2mL at Baseline, After Training in Self-injection Technique
Safe and effective self-injection was evaluated by the study personnel and was defined as: - Complete dose delivery: Participant self-injected the complete dose of bimekizumab as confirmed by a visual inspection of the bimekizumab-SS or the bimekizumab-AI which shows that the IMP is delivered completely (ie, container is empty), and - No ADEs that would preclude continued use of the device for self-injection (ie, no SADEs and/or ADEs leading to withdrawal).
Measured: Baseline (the first self-injection visit)

Timeline

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

20 Dec 20188 Sep 2020

First posted6 Dec 2018
Study start20 Dec 2018
Primary completion14 Jul 2020
Study completion8 Sep 2020

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 172 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03766685
Sponsor's protocol ID: DV0002
Status last verified: Jul 2025
First submitted: 5 Dec 2018
Last updated: 14 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Sebastian M, Bagel J, Hoepken B, Knapp B, Bicer C, MacPherson M, Langley RG. Single-Injection Options for Administering a 320 mg Dose of Bimekizumab: 2 mL Safety Syringe and Auto-injector. Dermatol Ther (Heidelb). 2025 May;15(5):1113-1134. doi: 10.1007/s13555-025-01366-6. Epub 2025 Mar 29.
PubMed 40156698
Bagel J, Tatla D, Hellot S, Knapp B, Murphy C, Peterson L, Sebastian M. Bimekizumab Self-Injection Devices: Two Multicenter, Randomized, Open-Label Studies on Self-Administration by Patients With Psoriasis. J Drugs Dermatol. 2022 Feb 1;21(2):162-171. doi: 10.36849/jdd.6274.
PubMed 35133113

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

RecruitingPhase 4
An Open Label Trial to Evaluate Efficacy and Safety of Roflumilast 0.3% Cream for Chronic Plaque and Nail Psoriasis
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RecruitingPhase 2
Early Intervention in Plaque Psoriasis: is Bimekizumab Able to Delay Chronic Inflammation?
Psoriasis
RecruitingObservational study
Serum Substance P, Neuropathic Pain, and Central Sensitization Across Treatment Groups in Chronic Plaque Psoriasis
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Active, not recruitingPhase 3
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants
Psoriasis
Not yet recruitingPhase 2
Comparative Study on Unani Formulation Vs Active Control in Plaque Psoriasis
Chronic Plaque Psoriasis, Plaque Psoriasis

All Chronic Plaque Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Open-Label Study to Evaluate the Safe and Effective Use of the Prefilled Safety Syringe or the Auto-Injector for the Subcutaneous Self-Injection of Bimekizumab Solution by Subjects With Moderate to Severe Chronic Plaque Psoriasis
ClinicalTrials.gov ID: NCT03766685
Acronym / sponsor ID: DV0002
Conditions: Chronic Plaque Psoriasis, Moderate to Severe Chronic Plaque Psoriasis
Keywords: Bimekizumab, PSO, Psoriasis, Auto-Injector
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 172 participants (actual)
Lead sponsor: UCB Biopharma SRLIndustry (pharma, biotech, devices)
Study start: 20 Dec 2018 (actual)
Primary completion: 14 Jul 2020 (actual)
Study completion: 8 Sep 2020 (actual)
First posted: 6 Dec 2018 (actual)
Results: Posted 8 Aug 2023

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Bimekizumab-SS	Experimental	Drug: BimekizumabSubjects will receive assigned bimekizumab dose regimen using a prefilled safety syringe (SS).
Bimekizumab-AI	Experimental	Drug: BimekizumabSubjects will receive assigned bimekizumab dose regimen using an auto-injector (AI).

Who may qualify

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

Key inclusion criteria (2 listed)

Subject fulfills all inclusion criteria for the PS0014 [NCT03598790] study
Subject is considered reliable and capable of adhering to the DV0002 protocol (eg, able to understand and complete questionnaires, willing to self-inject, able to use investigational device according to the instructions for use (IFU), and able to adhere to the visit schedule) according to the judgment of the Investigator

Key exclusion criteria (1 listed)

Subjects are not permitted to enroll in DV0002 if any of the PS0014 [NCT03598790] study exclusion criteria are met

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: UCB4940, BKZSubjects will receive bimekizumab at pre-specified time-points.	Drug	Bimekizumab-AI, Bimekizumab-SS

Primary outcome

Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-safety Syringe (SS)-1mL or the Bimekizumab-auto-injector (AI)-1mL at Week 8, After Training in Self-injection Technique
Time frame: Week 8
Safe and effective self-injection was evaluated by the study personnel and was defined as: - Complete dose delivery: Participant self-injected the complete dose of bimekizumab as confirmed by a visual inspection of the bimekizumab-safety syringe (SS) or the bimekizumab-auto-injector (AI) which shows that the investigational medicinal product (IMP) was delivered completely (ie, container is empty), and - No Adverse Device Effects (ADEs) that would preclude continued use of the device for self-injection (ie, no serious ADEs (SADEs) and/or ADEs leading to withdrawal).
Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-SS-2mL or the Bimekizumab-AI-2mL at Week 8, After Training in Self-injection Technique
Time frame: Week 8
Safe and effective self-injection was evaluated by the study personnel and was defined as: - Complete dose delivery: Participant self-injected the complete dose of bimekizumab as confirmed by a visual inspection of the bimekizumab-SS or the bimekizumab-AI which shows that the IMP is delivered completely (ie, container is empty), and - No ADEs that would preclude continued use of the device for self-injection (ie, no serious ADEs (SADEs) and/or ADEs leading to withdrawal).

2 secondary outcomes

Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-SS-1mL or the Bimekizumab-AI-1mL at Baseline, After Training in Self-injection Technique
Time frame: Baseline (the first self-injection visit)
Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-SS-2mL or the Bimekizumab-AI-2mL at Baseline, After Training in Self-injection Technique
Time frame: Baseline (the first self-injection visit)

Results and safety

Results posted to the registry on 8 Aug 2023, 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-SS-1mL 320 mg	66	65
Bimekizumab-AI-1mL 320 mg	68	61
Bimekizumab-SS-2mL 320 mg	19	19
Bimekizumab-AI-2mL 320 mg	19	18

Primary outcome: Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-safety Syringe (SS)-1mL or the Bimekizumab-auto-injector (AI)-1mL at Week 8, After Training in Self-injection Technique

Time frame: Week 8. Number (90% Confidence Interval). Unit: percentage of participants

Measure	Bimekizumab-SS-1mL 320 mg (FAS-s-1mL) n = 63	Bimekizumab -AI-1mL 320 mg (FAS-a-1mL) n = 62
Value	100 (95.4 to 100)	100 (95.3 to 100)

Population analysed: The Full Analysis Set for device presentation bimekizumab-SS-1mL (FAS-s-1mL) and bimekizumab-AI-1mL (FAS-a-1mL) consisted of all study participants in the SS-s-1mL and SS-a-1mL who self-injected at least 1 dose of bimekizumab using the given device presentation and who had an assessment of self-injection. Here, number of participants were included who were evaluable for the assessment.

Primary outcome: Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-SS-2mL or the Bimekizumab-AI-2mL at Week 8, After Training in Self-injection Technique

Time frame: Week 8. Number (90% Confidence Interval). Unit: percentage of participants

Measure	Bimekizumab-SS-2mL 320 mg (FAS-s-2mL) n = 19	Bimekizumab-AI-2mL 320 mg (FAS-a-2mL) n = 19
Value	100 (85.4 to 100)	94.7 (77.4 to 99.7)

Population analysed: The Full Analysis Set for device presentation bimekizumab-SS-2mL (FAS-s-2mL) and bimekizumab-AI-2mL (FAS-a-2mL) consisted of all study participants in the SS-s-2mL and SS-a-2mL who self-injected at least 1 dose of bimekizumab using the given device presentation and who had an assessment of self-injection.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Baseline up to Week 16. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bimekizumab-SS-1mL 320 mg (SS-s-1mL)	0 of 65 (0%)	0 of 65 (0%)	0 of 65
Bimekizumab AI-1mL 320 mg (SS-a-1mL)	0 of 68 (0%)	0 of 68 (0%)	0 of 68
Bimekizumab-SS-2mL 320 mg (SS-s-2mL)	0 of 19 (0%)	1 of 19 (5.3%)	0 of 19
Bimekizumab-AI-2mL 320 mg (SS-a-2mL)	0 of 19 (0%)	1 of 19 (5.3%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 40156698Sebastian M, Bagel J, Hoepken B, Knapp B, Bicer C, MacPherson M, Langley RG. Single-Injection Options for Administering a 320 mg Dose of Bimekizumab: 2 mL Safety Syringe and Auto-injector. Dermatol Ther (Heidelb). 2025 May;15(5):1113-1134. doi: 10.1007/s13555-025-01366-6. Epub 2025 Mar 29.
Derived from this study: PubMed 35133113Bagel J, Tatla D, Hellot S, Knapp B, Murphy C, Peterson L, Sebastian M. Bimekizumab Self-Injection Devices: Two Multicenter, Randomized, Open-Label Studies on Self-Administration by Patients With Psoriasis. J Drugs Dermatol. 2022 Feb 1;21(2):162-171. doi: 10.36849/jdd.6274.
Product InformationLink provided by the sponsor.
FDA Safety Alerts and RecallsLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Chronic Plaque Psoriasis

RecruitingPhase 4
An Open Label Trial to Evaluate Efficacy and Safety of Roflumilast 0.3% Cream for Chronic Plaque and Nail Psoriasis
Chronic Plaque Psoriasis, Nail Psoriasis
RecruitingPhase 2
Early Intervention in Plaque Psoriasis: is Bimekizumab Able to Delay Chronic Inflammation?
Psoriasis
RecruitingObservational study
Serum Substance P, Neuropathic Pain, and Central Sensitization Across Treatment Groups in 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

39 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bimekizumab in people with Chronic Plaque Psoriasis and Moderate to Severe Chronic Plaque Psoriasis, run by UCB Biopharma SRL at 39 sites in 2 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 2 inclusion and 1 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 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States, Canada. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 8 Aug 2023). 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?

Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-safety Syringe (SS)-1mL or the Bimekizumab-auto-injector (AI)-1mL at Week 8, After Training in Self-injection Technique (time frame: Week 8). The study lists 2 primary outcomes in all. 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 NCT03766685, 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 14 Jul 2025.