Adjusted brodalumab dose compared with standard brodalumab dose in subjects with moderate-to-severe plaque psoriasis and =120 kg body weight
- Conditions
- moderate-to-severe plaque psoriasis and a body weight =120 kg.MedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2017-004998-13-CZ
- Lead Sponsor
- EO Pharma A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 384
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.
- 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 current active tuberculosis.
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 350
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 34
- 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 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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the effect on psoriasis symptoms of an adjustable brodalumab dosage regimen to standard brodalumab treatment in subjects with moderate-to-severe psoriasis and a body weight =120 kg.;Secondary Objective: To evaluate the safety of an adjustable brodalumab dosage regimen in subjects with moderate-to-severe psoriasis and a body weight =120 kg.<br><br>To evaluate pharmacokinetics (PK) of brodalumab in subjects with moderate to-severe psoriasis and a body weight =120 kg.<br><br>To explore the effect of brodalumab on systemic inflammation in subjects with moderate-to-severe psoriasis and a body weight =120 kg.;Primary end point(s): Primary endpoint:<br>Having at least 90% lower Psoriasis Area and Severity Index (PASI) score relative to baseline (PASI 90 response) at Week 40.;Timepoint(s) of evaluation of this end point: Week 40
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Key secondary endpoint:<br>- Having static Physician’s Global Assessment<br>(sPGA) score of 0 or 1 at Week 40.<br>Secondary endpoints:<br>- Having PASI 90 response at Week 52.<br>- Having sPGA score of 0 or 1 at Week 52.<br>- Having sPGA of genitalia (sPGA-G) of 0 or 1 at<br>both Weeks 40 and 52.<br>- Having sPGA-G score of 0 or 1 at Week 40.<br>- Having sPGA-G score of 0 or 1 at Week 52.<br>- Having PASI 100 response at Week 40.<br>- Having PASI 100 response at Week 52.<br>- Change from baseline at Weeks 40 and 52 in<br>PASI score.<br>- Change from baseline at Weeks 40 and 52 in<br>affected body surface area (BSA).<br>- Having Dermatology Life Quality Index (DLQI)<br>total score of 0 or 1 at Week 40.<br>- Having DLQI total score of 0 or 1 at Week 52.<br>- Change from baseline at Weeks 40 and 52 in<br>DLQI total score.;Timepoint(s) of evaluation of this end point: Week 40/Week 52