A Clinical study with brodalumab for patients suffering from psoriasis and not benefitting the TNF-alpha treatment.

Phase 1

• Conditions: 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: EUCTR2018-001021-10-SE
• Lead Sponsor: Sahlgrenska University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-17
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1) Signed and dated informed consent has been obtained
2) Men or women =18 years of age at the time of screening
3) Subjects with moderate to severe plaque psoriasis diagnosed =6 months before
randomisation
4) Subjects on TNF-alpha inhibitors, either Adalimumab or Etanercept, for at least 24 weeks (Etanercept) or 16 weeks (Adalimumab), with at time of inclusion an absolute PASI score >7 or PASI 3-7 + DLQI >5 + BSA >3.
5) Subject has no known history of active tuberculosis
6) A female subject of childbearing potential* is eligible to participate if she is not pregnant.
*Female subjects are considered of childbearing potential unless they have undergone
hysterectomy, bilateral salpingectomy or bilateral oophorectomy, or have been post-menopausal for at least one year prior to first visit.
7) Using effective contraceptive measures:
Women of childbearing potential should use an effective method of contraception during
treatment and for at least 12 weeks after treatment.
Male subject with a female partner of childbearing potential who is willing to use effective contraceptive methods*. Male subjects should not donate sperm for at least 12 weeks following last dose of investigational product.
*Effective contraceptive methods as required by local regulation or practice for at least 12 weeks following last dose of investigational product.
8) Subject and/or subject’s designee is/are capable of administering subcutaneous
injections
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 75
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

1) Subject has an active infection as follows: any active infection for which systemic anti-infectives were used within 28 days prior to first dose of IMP, a serious infection defined
as requiring hospitalisation or intravenous anti-infectives within 8 weeks prior to the first
dose of IMP, recurrent or chronic infections or other active infection that, in the opinion of the investigator, might cause this study to be detrimental to the subject.
2) 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.
3) Subjects with active or known history of inflammatory bowel disease (IBD) including Crohn’s disease.
4) Previous treatment with IL-17 inhibitors (Secukinumab and/or Ixekizumab)
5) Planned surgery, which in the opinion of the investigator would influence planned
treatment with IMP.
6) Subjects with a history of suicidal behaviour.
7) Known or suspected hypersensitivity to any components of the IMP.
8) Current participation in any other interventional clinical study, ending another
interventional clinical study less than 4 weeks prior to screening visit, or receiving other
investigational agents (based on interview of the subject).
9) Subjects who have received treatment with any non-marketed drug substance (i.e. an
agent which has not yet been made available for clinical use following registration) within
the last 4 weeks prior to screening visit.
10) Previously enrolled in this clinical study.
11) In the opinion of the (sub)investigator, the subject is unlikely to comply with the clinical study protocol (e.g. due to alcoholism, drug addiction or psychotic state).
12) Subjects in close affiliation with the study personnel (e.g. immediate family member or subordinate), subjects who are a member of the clinical study personnel, or an employee of the sponsor or a CRO involved in the study.
13) Subjects under guardianship, hospitalised in a public or private institution, for a reason other than research, or subjects deprived of freedom.
14) Female subjects who are pregnant or breastfeeding.
15) Subject has any concurrent medical condition that, in the opinion of the investigator,
could cause this study to be detrimental to the subject.

Study & Design

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