EUCTR2017-001003-74-CZActive, not recruitingPhase 1
A Multicenter, Open-Label, Follow-Up Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects with Psoriatic Arthritis
CB Biopharma SPR0 sites200 target enrollmentStarted: August 30, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- In the opinion of the Investigator, the subject is expected to benefit from participation in an Open Label Extension (OLE) study
- •- Subject completed PA0008 without meeting any withdrawal criteria
- •- Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception - Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active
- •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 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
Exclusion Criteria
- •- Female subjects who plan to become pregnant during the study or within 20 weeks following the last dose of IMP. Male subjects who are planning a partner pregnancy during the study or within 20 weeks following the last dose
- •- Subjects with any current sign or symptom that may indicate a medically significant active infection (except for the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of study entry. The medical monitor must be consulted prior to subject's
- •entry into PA0009 in such cases.
- •- Subjects who meet any withdrawal criteria in PA0008. For any subject with an ongoing Serious Adverse Event, or a history of serious infections (including hospitalizations) in the lead-in study, the Medical Monitor must be consulted prior to the subject’s entry into PA0009
Investigators
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