18 Years and up
Accepting Healthy Volunteers?
- Male or female patients, aged ≥18 years
- Signed and dated written informed consent for 1368.17, in accordance with GCP and
local legislation prior to admission into the trial
- Women of childbearing potential (WOCBP) must be ready to use highly effective methods
of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per
year when used consistently and correctly. A list of contraception methods meeting
these criteria is provided in the patient information. Note: A woman is considered of
childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming
postmenopausal unless permanently sterile. Permanent sterilisation methods include
hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tuba ligation is NOT
a method of permanent sterilisation. A postmenopausal state is defined as no menses
for 12 months without an alternative medical cause.
- Have completed treatment and the EOT visit in the previous trial and are willing and
able to continue treatment in 1368.17.
- Have experienced study treatment-limiting adverse events during induction treatment
with study drug
- Have developed any of the exclusion criteria from the original induction study