EUCTR2018-001021-10-SEActive, not recruitingPhase 1
Brodalumab in a randomised, open, phase IV study evaluating clinical efficacy in psoriasis patients switching from TNF-alpha inhibitor treatment
Sahlgrenska University Hospital0 sites90 target enrollmentStarted: May 17, 2018Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 90
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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.
Investigators
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