Adjusted brodalumab dose compared with standard brodalumab dose in subjects with moderate-to-severe plaque psoriasis and =120 kg body weight

Phase 1

• Conditions: moderate-to-severe plaque psoriasis and a body weight =120 kg.; MedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2017-004998-13-HU
• Lead Sponsor: EO Pharma A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-20
• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 384

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.
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

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 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