Efficacy and safety comparison of brodalumab versus guselkumab in adult subjects with moderate-to-severe plaque psoriasis and inadequate response to ustekinumab; COBRA
- Conditions
- chronic skin conditionplaque psoriasis10014982
- Registration Number
- NL-OMON52789
- Lead Sponsor
- eo Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 5
- Signed and dated informed consent has been obtained prior to any
protocol-related procedures.
- Age >=18 years of age at the time of screening.
- Diagnosed with plaque psoriasis for at least 6 months before the first
administration of IMP as
determined by the investigator.
- inadequately controlled plaque psoriasis currently treated with ustekinumab,
and fulfils ALL of
the following criteria:
- Ustekinumab administered at least 3 times at or higher than the
approved dose or frequency
before randomisation.
- Investigator's Global Assessment (IGA) >=2 at screening and baseline.
- Absolute PASI >3 at screening and baseline.
- No current evidence of active tuberculosis test).according to local standard
of care for patients requiring initiation of a biologic treatment..
• 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 the investigational
medicinal product (IMP) on plaque psoriasis.
• Clinically important active infections or infestations, chronic, recurrent or
latent infections or infestations, or is immunocompromised (e.g., human
immunodeficiency virus) or known history of eg hepatitis B, C, HIV
• Any systemic disease (including, but not limited to, renal failure, heart
failure, liver disease, diabetes, and anemia) considered by the investigator to
be clinical significant and uncontrolled and/or placing the subject at undue
risk of intercurrent diseases
• Known history of Crohn*s disease.
• Myocardial infarction or stroke, or unstable angina pectoris within the past
12 months.
• Any active malignancy.
• History of malignancy within 5 years, except for treated and considered cured
cutaneous quamous or basal cell carcinoma, in situ cervical cancer, or in situ
breast ductal carcinoma.
• History of suicidal behavior (i.e., *actual suicide attempt*, *interrupted
attempt*, *aborted attempt*, or *preparatory acts or behavior*) based on the
Columbia-Suicide Severity Rating Scale (C-SSRS) questionnaire at screening or
at baseline.
• Any suicidal ideation of category 4 or 5 (*active suicidal ideation with some
intent to act, without specific plan* or * active suicidal ideation with
specific plan and intent*) based on the C-SSRS questionnaire at screening or at
baseline.
• A Patient Health Questionnaire (PHQ)-8 score of >=10 corresponding to
moderate-to-severe depression at screening or at baseline.
History of depressive disorder with severe episode(s) within the last 2 years
Known or suspected hypersensitivity to any component(s) of the IMPs.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Having PASI (psoriasis area severity index) 100 response at Week 16.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Key secondary endpoint:<br /><br>• Time to PASI 100 response.<br /><br><br /><br>Additional Secondary endpoints:<br /><br>Time to PASI 90 response.<br /><br>• Having PASI 100 response, assessed separately at Weeks 4, 8, and 28<br /><br>Having PASI 90 response, assessed separately at Weeks 4, 8, 16, and 28.<br /><br>• Having IGA (Investigator Global Assessment) of 0, assessed separately at Week<br /><br>16 and Week 28.<br /><br>• Having IGA of 0 or 1, assessed separately at Week 16 and Week 28.<br /><br>• Having Dermatology Life Quality Index (DLQI) total score of 0 or 1, assessed<br /><br>separately at Weeks 4, 8, 12, 16, 20, 24, and 28.<br /><br>• Change in Short Form Health Survey version 2 (SF-36v2) score from baseline,<br /><br>assessed separately at Weeks 4, 8, 16, and 28.<br /><br>Occurrence of treatment-emergent adverse event(TEAEs)from baseline to Week 28.<br /><br></p><br>