Efficacy and safety of brodalumab compared with guselkumab in the treatment of plaque psoriasis after inadequate response to ustekinumab.

Phase 1

• Conditions: adult subjects with moderate-to-severe plaque psoriasis; MedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2019-004099-20-AT
• Lead Sponsor: EO Pharma A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-28
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 240

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 before randomisation.
- IGA =2 at screening and baseline.
- Absolute PASI >3 at screening and baseline.

- Subject has no evidence of active tuberculosis according to local standard of care for patients requiring initiation of a biologic treatment at screening.
Subjects with adequately treated latent tuberculosis according to local guidelines, are eligible.
a. A tuberculosis test can be performed at the central laboratory.
b. If a local laboratory test is performed to confirm this criterium, the local laboratory should be assessed before the local testing is performed.

- Subjects who is a woman of childbearing potential* must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline.
* A woman is defined as being of childbearing potential if she is not postmenopausal (at least 12 months with no menses without an alternative medical cause prior to screening) and not surgically sterile (hysterectomy, bilateral salpingectomy or bilateral oophorectomy).

- Subject who is a woman of childbearing potential* must use a highly effective** form of birth control throughout the trial and at least for 12 weeks after last administration of IMP.
** A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year) such as bilateral tubal occlusion, intrauterine device, intrauterine hormone-releasing system, combined (oestrogen and progesteron containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progesteron-only hormonal contraception associated with inhibition of ovulation ( oral, injectable, implantable), sexual abstinence (when this is in line with the preferred and usual life style of the subject), or vasectomised partner (given that the subject is monogamous).

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 240
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 240

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. NOTE: This exclusion criterion is not applicable in this version of the protocol. It is kept to avoid re-numbering of the exclusion criteria.
- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified