adult subjects with moderate-to-severe plaque psoriasis MedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Kyntheum 210 mg solution for injection in pre-filled syringe
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: BRODALUMAB
CAS Number: 1174395-19-7
Curr
Sponsors
LEO Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subject is =18 years of age at the time of screening. - Subject 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. - Subject has inadequately controlled plaque psoriasis currently treated with ustekinumab, and fulfil ALL of the following criteria: - Ustekinumab administered at least 3 times at or higher than the approved dose or frequency for at least 24 weeks. - IGA =2 at screening and baseline. - Absolute PASI >3 at screening and baseline. - The last administration of ustekinumab was =12 weeks before randomisation. - Subject has no active tuberculosis at screening (negative QuantiFERON® or purified protein derivative [PPD] test). Subjects with adequately treated latent tuberculosis are eligible. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 260 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 260
Exclusion criteria
Exclusion criteria: - Subject 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. - Subject has clinically important active infections or infestations, chronic, recurrent, or latent infections or infestations, or is immunocompromised (e.g. human immunodeficiency virus). - Subject 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. - Subject has a known history of Crohn’s disease. - Subject has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma. - Subject 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. - Subject has a known history of active tuberculosis. - Subject 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 (CSSRS) questionnaire at screening or baseline. - Subject 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. - Subject has a Patient Health Questionnaire-8 (PHQ-8) score of =10, corresponding to moderate-to-severe depression at screening or baseline. - Subject has previously received more than 1 tumour necrosis factor-a (TNF-a) inhibitor. - Subject has previously been treated with any anti-interleukin (IL)-17A, anti-IL-17 receptor subunit A, or anti-IL-23 besides ustekinumab. - Subject has known or suspected hypersensitivity to any component(s) of the IMPs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of brodalumab with guselkumab in adult subjects with moderate-to-severe plaque psoriasis and prior inadequate response to ustekinumab.;Secondary Objective: To evaluate the efficacy of brodalumab compared with guselkumab while ontreatment for up to 28 weeks in adult subjects with moderate-to-severe plaque psoriasis and prior inadequate response to ustekinumab. To evaluate the efficacy of brodalumab compared with guselkumab through Week 28 in adult subjects with moderate-to-severe plaque psoriasis and prior inadequate response to ustekinumab. To evaluate the safety of brodalumab compared with guselkumab throughout the trial (28 weeks) in adult subjects with moderate-to-severe plaque psoriasis and prior inadequate response to ustekinumab.;Primary end point(s): Primary endpoint: Having PASI 100 response at Week 16. ;Timepoint(s) of evaluation of this end point: At week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary endpoint: Time to PASI 100 response Secondary endpoints: Time to PASI 90 response Having PASI 100 response, assessed separately at Weeks 4, 8, and 28. Having PASI 90 response, assessed separately at Weeks 4, 8, 16, and 28. Having IGA of 0, assessed separately at Week 16 and Week 28. Having IGA of 0 or 1, assessed separately at Week 16 and Week 28. Having DLQI total score of 0 or 1, assessed separately at Weeks 4, 8, 12, 16, 20, 24, and 28. Change in SF-36v24 score from baseline, assessed separately at Weeks 4, 8, 16, and 28. Occurrence of TEAEs from baseline to Week 28.;Timepoint(s) of evaluation of this end point: Between week 0 and 28, as specified for each endpoint. | — |
Countries
Australia, Austria, Belgium, Czechia, Czech Republic, Denmark, France, Germany, Greece, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom
Contacts
Public ContactGlobal Regulatory Affairs
LEO Pharma A/S
Outcome results
None listed