A Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects With Psoriatic Arthritis
Status: | Active, not recruiting |
---|---|
Conditions: | Arthritis, Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery, Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/20/2019 |
Start Date: | November 22, 2017 |
End Date: | November 2020 |
A Multicenter, Open-Label, Follow-Up Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects With Psoriatic Arthritis
This is a study to assess the long-term safety and tolerability of bimekizumab in subjects
with psoriatic arthritis
with psoriatic arthritis
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
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
- 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
We found this trial at
12
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials