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Efficacy and Safety of Brodalumab Compared With Guselkumab in the Treatment of Plaque Psoriasis After Inadequate Response to Ustekinumab

NCT ID: NCT04533737

Last Updated: 2025-03-14

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-17

Study Completion Date

2022-12-07

Brief Summary

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The trial investigates the efficacy and safety of brodalumab against guselkumab in treatment for patients with moderate-to-severe plaque psoriasis who still have some remaining symptoms after ustekinumab treatment.

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Detailed Description

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Brodalumab is an anti-interleukin 17 receptor A antibody (IL-17RA) and blocks the inflammatory effects of different IL-17 cytokines (IL-17A, IL-17C, IL-17F, IL-17A/F heterodimer, and IL-17E) in the skin. With increasing availability of novel biologics with new targets, the complexity of choosing the appropriate biologic treatment is ever more challenging for physicians. Therefore, the primary objective of this trial is to compare the efficacy of brodalumab versus guselkumab in adult participants with moderate to severe plaque psoriasis and inadequate response to ustekinumab, thereby providing new scientific information that could support decision making in the clinical setting. The study will run approximately 32 weeks for each participant (including a 2- to 4-weeks screening period and a 28-week treatment period), with the primary endpoint measurement at Week 16. Participants receive subcutaneous injections of brodalumab or guselkumab. Dummy injections are also given, so participants and assessors are unaware of which treatment is given.

Conditions

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Plaque Psoriasis Psoriasis Vulgaris Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Brodalumab (1.5 mL) and guselkumab (1.0 mL) are in pre-filled syringes and packaged open-label. Dummy injections are used for blinding.

Study Groups

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Arm 1 (brodalumab + dummy 1)

Participants receive:

* Brodalumab 210 mg (1.5 ml) at Weeks 0, 1, 2, and then every 2 weeks.
* Dummy 1 (placebo 1.0 ml) at Weeks 0, 4, and then every 8 weeks.

Group Type EXPERIMENTAL

Brodalumab

Intervention Type BIOLOGICAL

Pre-filled syringe with 210 mg brodalumab in 1.5 ml solution for subcutaneous injection

Placebo

Intervention Type OTHER

The placebo solution is similar to the active guselkumab (Dummy 1) or brodalumab (Dummy 2) solution except that it does not contain any active substance

Arm 2 (guselkumab + dummy 2)

Participants receive:

* Guselkumab 100 mg (1.0 ml) at Weeks 0, 4, and then every 8 weeks.
* Dummy 2 (placebo 1.5 ml) at Weeks 0, 1, 2, and then every 2 weeks.

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type OTHER

The placebo solution is similar to the active guselkumab (Dummy 1) or brodalumab (Dummy 2) solution except that it does not contain any active substance

Guselkumab

Intervention Type BIOLOGICAL

Pre-filled syringe with 100 mg guselkumab in 1 ml solution for subcutaneous injection

Interventions

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Brodalumab

Pre-filled syringe with 210 mg brodalumab in 1.5 ml solution for subcutaneous injection

Intervention Type BIOLOGICAL

Placebo

The placebo solution is similar to the active guselkumab (Dummy 1) or brodalumab (Dummy 2) solution except that it does not contain any active substance

Intervention Type OTHER

Guselkumab

Pre-filled syringe with 100 mg guselkumab in 1 ml solution for subcutaneous injection

Intervention Type BIOLOGICAL

Other Intervention Names

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Kyntheum® Dummy 1/Dummy 2 Tremfya®

Eligibility Criteria

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Inclusion Criteria

* Participant has a diagnosis of plaque psoriasis for at least 6 months before the first administration of investigational medicinal product (IMP) as determined by the investigator.
* Participant has inadequately controlled plaque psoriasis currently treated with ustekinumab, and fulfils ALL of the following criteria:

1. Ustekinumab administered at least 3 times at or higher than the approved dose or frequency before randomisation.
2. IGA ≥2 at screening and baseline.
3. Absolute PASI \>3 at screening and baseline.
* Participant has no evidence of active tuberculosis according to local standard of care for patients requiring initiation of a biologic treatment. Participants with adequately treated latent tuberculosis, according to local guidelines, are eligible.

Exclusion Criteria

* Participant was diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions (e.g. eczema) that would interfere with evaluations of the effect of IMP on plaque psoriasis.
* Participant has clinically important active infections or infestations, chronic, recurrent, or latent infections or infestations, or is immunocompromised (e.g. human immunodeficiency virus).
* Participant has any systemic disease (e.g. renal failure, heart failure, hypertension, liver disease, diabetes, anaemia) considered by the investigator to be clinically significant and uncontrolled.
* Participant has a known history of Crohn's disease.
* Participant has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma.
* Participant has a history of malignancy within 5 years, except for treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, or in situ breast ductal carcinoma.
* Participant has a known history of active tuberculosis.
* Participant has a history of suicidal behaviour (i.e. 'actual suicide attempt', 'interrupted attempt', 'aborted attempt', or 'preparatory acts or behaviour') based on the Columbia-Suicide Severity Rating Scale (C-SSRS) questionnaire at screening or baseline.
* Participant has any suicidal ideation of severity 4 or 5 ('some intent to act, no plan' or 'specific plan and intent') based on the C-SSRS questionnaire at screening or baseline.
* Participant has a Patient Health Questionnaire-8 (PHQ-8) score of ≥10, corresponding to moderate to severe depression at screening or baseline.
* Participant has previously been treated with any anti-interleukin (IL)-17A, anti-IL 17 receptor subunit A, or anti-IL-23 besides ustekinumab.
* Participant has known or suspected hypersensitivity to any component(s) of the IMPs.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LEO Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Expert

Role: STUDY_DIRECTOR

LEO Pharma

Locations

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LEO Pharma Investigational Site

Graz, Styria, Austria

Site Status

LEO Pharma Investigational Site

Vienna, , Austria

Site Status

LEO Pharma Investigational Site

Brussels, , Belgium

Site Status

LEO Pharma Investigational Site

Herstal, , Belgium

Site Status

LEO Pharma Investigational Site

Namur, , Belgium

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LEO Pharma Investigational Site

Copenhagen, , Denmark

Site Status

LEO Pharma Investigational Site

Hellerup, , Denmark

Site Status

LEO Pharma Investigational Site

Roskilde, , Denmark

Site Status

LEO Pharma Investigational Site

Marseille, Bouches-du-Rhône, France

Site Status

LEO Pharma Investigational Site

Martigues, Bouches-du-Rhône, France

Site Status

LEO Pharma Investigational Site

Rouen, Seine-Maritime 10, France

Site Status

LEO Pharma Investigational Site

Saint-Mandé, Val-de-Marne, France

Site Status

LEO Pharma Investigational Site

Antony, , France

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LEO Pharma Investigational Site

Nice, , France

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LEO Pharma Investigational Site

Saint-Priest-en-Jarez, , France

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LEO Pharma Investigational Site

Toulouse, , France

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LEO Pharma Investigational Site

Freiburg im Breisgau, Baden-Wurttemberg, Germany

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LEO Pharma Investigational Site

Aachen, , Germany

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LEO Pharma Investigational Site

Augsburg, , Germany

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LEO Pharma Investigational Site

Bad Bentheim, , Germany

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LEO Pharma Investigational Site

Bonn, , Germany

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LEO Pharma Investigational Site

Bramsche, , Germany

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LEO Pharma Investigational Site

Buxtehude, , Germany

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LEO Pharma Investigational Site

Cologne, , Germany

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LEO Pharma Investigational Site

Darmstadt, , Germany

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LEO Pharma Investigational Site

Erlangen, , Germany

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LEO Pharma Investigational Site

Frankfurt am Main, , Germany

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LEO Pharma Investigational Site

Hamburg, , Germany

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LEO Pharma Investigational Site

Hamburg, , Germany

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LEO Pharma Investigational Site

Kiel, , Germany

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LEO Pharma Investigational Site

Mainz, , Germany

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LEO Pharma Investigational Site

Mainz, , Germany

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LEO Pharma Investigational Site

Memmingen, , Germany

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LEO Pharma Investigational Site

Munich, , Germany

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LEO Pharma Investigational Site

Münster, , Germany

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LEO Pharma Investigational Site

Selters, , Germany

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LEO Pharma Investigational Site 1

Athens, , Greece

Site Status

LEO Pharma Investigational Site 2

Athens, , Greece

Site Status

LEO Pharma Investigational Site 1

Thessaloniki, , Greece

Site Status

LEO Pharma Investigational Site 2

Thessaloniki, , Greece

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LEO Pharma Investigational Site

Thessaloniki, , Greece

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LEO Pharma Investigational Site

Napoli, , Italy

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LEO Pharma Investigational Site

Pisa, , Italy

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LEO Pharma Investigational Site

Roma, , Italy

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LEO Pharma Investigational Site

Rozzano, , Italy

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LEO Pharma Investigational Site

Bergen op Zoom, Bergen, Netherlands

Site Status

LEO Pharma Investigational Site

Almere Stad, RL Almere, Netherlands

Site Status

LEO Pharma Investigational Site

Amsterdam, , Netherlands

Site Status

LEO Pharma Investigational Site

Mieres, Principality of Asturias, Spain

Site Status

LEO Pharma Investigational Site

Bilbao, Vizcaya, Spain

Site Status

LEO Pharma Investigational Site

Alicante, , Spain

Site Status

LEO Pharma Investigational Site

Barcelona, , Spain

Site Status

LEO Pharma Investigational Site

Barcelona, , Spain

Site Status

LEO Pharma Investigational Site

Granada, , Spain

Site Status

LEO Pharma Investigational Site

Madrid, , Spain

Site Status

LEO Pharma Investigational Site

Madrid, , Spain

Site Status

LEO Pharma Investigational Site

Pontevedra, , Spain

Site Status

LEO Pharma Investigational Site

Valencia, , Spain

Site Status

LEO Pharma Investigational Site

Solna, Stockholm County, Sweden

Site Status

LEO Pharma Investigational Site

Sankt Gallen, , Switzerland

Site Status

LEO Pharma Investigational Site

Zurich, , Switzerland

Site Status

LEO Pharma Investigational Site

Bath, Avon, United Kingdom

Site Status

LEO Pharma Investigational Site

Dudley, West Midlands, United Kingdom

Site Status

LEO Pharma investigational site

Leeds, West Yorkshire, United Kingdom

Site Status

LEO Pharma Investigational Site

London, , United Kingdom

Site Status

Countries

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Austria Belgium Denmark France Germany Greece Italy Netherlands Spain Sweden Switzerland United Kingdom

References

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Reich K, Bianchi L, Khemis A, Maul JT, Tsianakas A, Schempp CM, Petersen K, Noergaard MM, Puig L. Brodalumab Versus Guselkumab in Patients with Moderate-to-Severe Psoriasis with an Inadequate Response to Ustekinumab: A Randomized, Multicenter, Double-Blind Phase 4 Trial (COBRA). Dermatol Ther (Heidelb). 2024 Feb;14(2):453-468. doi: 10.1007/s13555-023-01092-x. Epub 2024 Feb 1.

Reference Type RESULT
PMID: 38300408 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2019-004099-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1283-7584

Identifier Type: OTHER

Identifier Source: secondary_id

LP0160-1510

Identifier Type: -

Identifier Source: org_study_id

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