Adjustable brodalumab dosage regimen compared with standard brodalumab treatment for 52 weeks in subjects with moderate-to-severe plaque psoriasis and >=120 kg body weight; ADJUST

Phase 4

• Conditions: chronic skin condition; plaque psoriasis; 10014982

• Registration Number: NL-OMON56463
• Lead Sponsor: eo Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

* Signed and dated informed consent has been obtained prior to any
protocol-related procedures.
* Age >=18 to <75 years at the time of screening.
* Diagnosed with chronic plaque psoriasis at least 6 months before
randomisation as determined by the investigator.
* Body weight >=120 kg at the time of screening.
* Moderate-to-severe plaque psoriasis as defined by: BSA >=10% and
PASI >=12 at screening and baseline.
* No evidence of active or latent tuberculosis according to local standard of
care for patients requiring initiation of a biologic treatment

Exclusion Criteria

* 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 theinvestigational
medicinal product (IMP) on subjects with plaque psoriasis.
* Clinically important active infections or infestations, chronic, recurrent or
latent infections or infestations, or is immunocompromised (e.g., human
immunodeficiency virus, hepatitis B, and hepatitis C).
* Any systemic disease considered by the investigator to be uncontrolled
and either immunocompromising the subject and/or placing the subject at
undue risk of intercurrent diseases (including, but not limited to, renal
failure, heart failure, liver disease, diabetes, and anaemia).
* 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 squamous or basal cell carcinoma, in situ cervical cancer,
or in situ breast ductal carcinoma.
* 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 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint:<br /><br>• Having at least 90% lower Psoriasis Area and Severity Index (PASI) score<br /><br>relative to baseline (PASI 90 response) at Week 40.</p><br>