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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Key

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 fulfil ALL of the following criteria: 1.
Ustekinumab administered at least 3 times at or higher than the approved dose or frequency for at least 24 weeks. 2. IGA ≥2 at screening and baseline. 3. Absolute PASI >3 at screening and baseline. 4. The last administration of ustekinumab was ≥12 weeks before randomisation.
  • - Participant has no active tuberculosis at screening (negative QuantiFERON® or purified protein derivative [PPD] test).
Participants with adequately treated latent tuberculosis are eligible. Key

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 received more than 1 tumour necrosis factor α (TNF α) inhibitor.
  • - 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04533737
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

LEO Pharma
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Medical Expert
Principal Investigator Affiliation LEO Pharma
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Austria, Belgium, Czechia, Denmark, France, Germany, Greece, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Plaque Psoriasis, Psoriasis Vulgaris, Psoriasis
Additional Details

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, assessors, and investigators are unaware of which treatment is given.

Arms & Interventions

Arms

Experimental: 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.

Active Comparator: 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.

Interventions

Biological: - Brodalumab

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

Other: - Placebo

The placebo solution is similar to the active brodalumab solution except that it does not contain any active substance

Biological: - Guselkumab

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

LEO Pharma investigational site, Woolloongabba, Queensland, Australia

Status

Recruiting

Address

LEO Pharma investigational site

Woolloongabba, Queensland, 4102

LEO Pharma investigational site, Carlton, Victoria, Australia

Status

Recruiting

Address

LEO Pharma investigational site

Carlton, Victoria, 3053

LEO Pharma investigational site, East Melbourne, Victoria, Australia

Status

Recruiting

Address

LEO Pharma investigational site

East Melbourne, Victoria, 3002

LEO Pharma investigational site, Fremantle, Western Australia, Australia

Status

Recruiting

Address

LEO Pharma investigational site

Fremantle, Western Australia, 6160

LEO Pharma Investigational Site, Graz, Steiermark, Austria

Status

Recruiting

Address

LEO Pharma Investigational Site

Graz, Steiermark, 8036

LEO Pharma Investigational Site, Wien, Austria

Status

Recruiting

Address

LEO Pharma Investigational Site

Wien, , 1090

LEO Pharma Investigational Site, Brussels, Belgium

Status

Recruiting

Address

LEO Pharma Investigational Site

Brussels, , 1200

LEO Pharma Investigational Site, Herstal, Belgium

Status

Recruiting

Address

LEO Pharma Investigational Site

Herstal, , B-4040

LEO Pharma Investigational Site, Namur, Belgium

Status

Recruiting

Address

LEO Pharma Investigational Site

Namur, , 5000

Pharma Investigational Site, Praha, Czech Republic, Czechia

Status

Recruiting

Address

Pharma Investigational Site

Praha, Czech Republic, 110 00

Pharma Investigational Site, Praha, Czech Republic, Czechia

Status

Recruiting

Address

Pharma Investigational Site

Praha, Czech Republic, 180 81

LEO Pharma Investigational Site, Copenhagen, Denmark

Status

Recruiting

Address

LEO Pharma Investigational Site

Copenhagen, , 2400

LEO Pharma Investigational Site, Hellerup, Denmark

Status

Recruiting

Address

LEO Pharma Investigational Site

Hellerup, , 2900

LEO Pharma Investigational Site, Roskilde, Denmark

Status

Recruiting

Address

LEO Pharma Investigational Site

Roskilde, , 4000

LEO Pharma Investigational Site, Marseille, Bouches-du-Rhône, France

Status

Recruiting

Address

LEO Pharma Investigational Site

Marseille, Bouches-du-Rhône, 13285

LEO Pharma Investigational Site, Martigues, Bouches-du-Rhône, France

Status

Recruiting

Address

LEO Pharma Investigational Site

Martigues, Bouches-du-Rhône, 13500

LEO Pharma Investigational Site, Montpellier, Hérault, France

Status

Not yet recruiting

Address

LEO Pharma Investigational Site

Montpellier, Hérault, 34000

LEO Pharma Investigational Site, Saint-Étienne, Loiré, France

Status

Recruiting

Address

LEO Pharma Investigational Site

Saint-Étienne, Loiré, 42055

LEO Pharma Investigational Site, Rouen, Seine-Maritime 10, France

Status

Recruiting

Address

LEO Pharma Investigational Site

Rouen, Seine-Maritime 10, 76031

LEO Pharma Investigational Site, Saint-Mandé, Val-de-Marne, France

Status

Recruiting

Address

LEO Pharma Investigational Site

Saint-Mandé, Val-de-Marne, 94160

LEO Pharma Investigational Site, Antony, France

Status

Withdrawn

Address

LEO Pharma Investigational Site

Antony, , 92160

LEO Pharma Investigational Site, Nice, France

Status

Recruiting

Address

LEO Pharma Investigational Site

Nice, , 06000

LEO Pharma Investigational Site, Toulouse, France

Status

Recruiting

Address

LEO Pharma Investigational Site

Toulouse, , 31000

LEO Pharma Investigational Site, Freiburg im Breisgau, Baden-Wuerttemberg, Germany

Status

Recruiting

Address

LEO Pharma Investigational Site

Freiburg im Breisgau, Baden-Wuerttemberg, 79104

LEO Pharma Investigational Site, Aachen, Germany

Status

Recruiting

Address

LEO Pharma Investigational Site

Aachen, , 52057

LEO Pharma Investigational Site, Augsburg, Germany

Status

Recruiting

Address

LEO Pharma Investigational Site

Augsburg, , 86163

LEO Pharma Investigational Site, Bad Bentheim, Germany

Status

Recruiting

Address

LEO Pharma Investigational Site

Bad Bentheim, , 48455

LEO Pharma Investigational Site, Bonn, Germany

Status

Recruiting

Address

LEO Pharma Investigational Site

Bonn, , 53127

LEO Pharma Investigational Site, Bramsche, Germany

Status

Recruiting

Address

LEO Pharma Investigational Site

Bramsche, , 49565

LEO Pharma Investigational Site, Buxtehude, Germany

Status

Recruiting

Address

LEO Pharma Investigational Site

Buxtehude, , 21614

LEO Pharma Investigational Site, Erlangen, Germany

Status

Recruiting

Address

LEO Pharma Investigational Site

Erlangen, , 91054

LEO Pharma Investigational Site, Frankfurt am Main, Germany

Status

Recruiting

Address

LEO Pharma Investigational Site

Frankfurt am Main, , 60590

LEO Pharma Investigational Site, Hamburg, Germany

Status

Not yet recruiting

Address

LEO Pharma Investigational Site

Hamburg, , 20246

LEO Pharma Investigational Site, Hamburg, Germany

Status

Recruiting

Address

LEO Pharma Investigational Site

Hamburg, , 20537

LEO Pharma Investigational Site, Kiel, Germany

Status

Recruiting

Address

LEO Pharma Investigational Site

Kiel, , 24105

LEO Pharma Investigational Site, Köln, Germany

Status

Not yet recruiting

Address

LEO Pharma Investigational Site

Köln, , 50937

LEO Pharma Investigational Site, Mainz, Germany

Status

Recruiting

Address

LEO Pharma Investigational Site

Mainz, , 55128

LEO Pharma Investigational Site, Mainz, Germany

Status

Not yet recruiting

Address

LEO Pharma Investigational Site

Mainz, , 55131

LEO Pharma Investigational Site, Memmingen, Germany

Status

Recruiting

Address

LEO Pharma Investigational Site

Memmingen, , 87700

LEO Pharma Investigational Site, Munich, Germany

Status

Not yet recruiting

Address

LEO Pharma Investigational Site

Munich, , 80802

LEO Pharma Investigational Site, Münster, Germany

Status

Recruiting

Address

LEO Pharma Investigational Site

Münster, , 48149

LEO Pharma Investigational Site, Selters, Germany

Status

Recruiting

Address

LEO Pharma Investigational Site

Selters, , 56242

LEO Pharma Investigational Site 1, Athens, Greece

Status

Not yet recruiting

Address

LEO Pharma Investigational Site 1

Athens, , 16121

LEO Pharma Investigational Site 2, Athens, Greece

Status

Recruiting

Address

LEO Pharma Investigational Site 2

Athens, , 16121

LEO Pharma Investigational Site, Nea Efkarpia, Greece

Status

Recruiting

Address

LEO Pharma Investigational Site

Nea Efkarpia, , 56403

LEO Pharma Investigational Site 1, Thessaloníki, Greece

Status

Recruiting

Address

LEO Pharma Investigational Site 1

Thessaloníki, , 54643

LEO Pharma Investigational Site 2, Thessaloníki, Greece

Status

Recruiting

Address

LEO Pharma Investigational Site 2

Thessaloníki, , 54643

LEO Pharma Investigational Site, Napoli, Italy

Status

Not yet recruiting

Address

LEO Pharma Investigational Site

Napoli, , 80121

LEO Pharma Investigational Site, Pisa, Italy

Status

Recruiting

Address

LEO Pharma Investigational Site

Pisa, , 56126

LEO Pharma Investigational Site, Roma, Italy

Status

Not yet recruiting

Address

LEO Pharma Investigational Site

Roma, , 00133

LEO Pharma Investigational Site, Rozzano, Italy

Status

Recruiting

Address

LEO Pharma Investigational Site

Rozzano, , 20089

LEO Pharma Investigational Site, Bergen Op Zoom, Bergen, Netherlands

Status

Withdrawn

Address

LEO Pharma Investigational Site

Bergen Op Zoom, Bergen, 4614 VT

LEO Pharma Investigational Site, Almere, RL Almere, Netherlands

Status

Recruiting

Address

LEO Pharma Investigational Site

Almere, RL Almere, 1311

LEO Pharma Investigational Site, Amsterdam, Netherlands

Status

Recruiting

Address

LEO Pharma Investigational Site

Amsterdam, , 1105 AZ

LEO Pharma Investigational Site, Mieres, Asturias, Spain

Status

Recruiting

Address

LEO Pharma Investigational Site

Mieres, Asturias, 33611

LEO Pharma Investigational Site, Bilbao, Vizcaya, Spain

Status

Recruiting

Address

LEO Pharma Investigational Site

Bilbao, Vizcaya, 48013

LEO Pharma Investigational Site, Alicante, Spain

Status

Recruiting

Address

LEO Pharma Investigational Site

Alicante, , 03010

LEO Pharma Investigational Site, Barcelona, Spain

Status

Recruiting

Address

LEO Pharma Investigational Site

Barcelona, , 08026

LEO Pharma Investigational Site, Barcelona, Spain

Status

Recruiting

Address

LEO Pharma Investigational Site

Barcelona, , 08036

LEO Pharma Investigational Site, Granada, Spain

Status

Recruiting

Address

LEO Pharma Investigational Site

Granada, , 18016

LEO Pharma Investigational Site, Madrid, Spain

Status

Recruiting

Address

LEO Pharma Investigational Site

Madrid, , 28031

LEO Pharma Investigational Site, Madrid, Spain

Status

Recruiting

Address

LEO Pharma Investigational Site

Madrid, , 28041

LEO Pharma Investigational Site, Pontevedra, Spain

Status

Recruiting

Address

LEO Pharma Investigational Site

Pontevedra, , 36003

LEO Pharma Investigational Site, Valencia, Spain

Status

Recruiting

Address

LEO Pharma Investigational Site

Valencia, , 46026

Pharma Investigational Site, Solna, Stockholm, Sweden

Status

Not yet recruiting

Address

Pharma Investigational Site

Solna, Stockholm, 171 76

LEO Pharma Investigational Site, Basel, Switzerland

Status

Withdrawn

Address

LEO Pharma Investigational Site

Basel, , 4031

LEO Pharma Investigational Site, Saint Gallen, Switzerland

Status

Not yet recruiting

Address

LEO Pharma Investigational Site

Saint Gallen, , 9007

LEO Pharma Investigational Site, Zürich, Switzerland

Status

Not yet recruiting

Address

LEO Pharma Investigational Site

Zürich, , 8091

LEO Pharma Investigational Site, Bath, Avon, United Kingdom

Status

Recruiting

Address

LEO Pharma Investigational Site

Bath, Avon, BA1 3NG

LEO Pharma Investigational Site, Dudley, West Midlands, United Kingdom

Status

Not yet recruiting

Address

LEO Pharma Investigational Site

Dudley, West Midlands, DY1 2HQ

LEO Pharma investigational site, Leeds, West Yorkshire, United Kingdom

Status

Recruiting

Address

LEO Pharma investigational site

Leeds, West Yorkshire, LS7 4SA

LEO Pharma investigational site, Wakefield, West Yorkshire, United Kingdom

Status

Withdrawn

Address

LEO Pharma investigational site

Wakefield, West Yorkshire, WF1 4DG

LEO Pharma Investigational Site, London, United Kingdom

Status

Recruiting

Address

LEO Pharma Investigational Site

London, , SW17 0QT

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