Protocol section 2.1:* Demonstration of the long term safety of BI655130 in patients with moderate to severe active colitis Ulcerosa who have already been treated in previous studies.* Demonstration of the long term efficacy of BI655130 in patients…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Protocol section 2.1.2:
The primary endpoint is the number of patients adjusted by the exposure who
report a treatment-emergent adverse reaction (TEAE) up to week 336 of the
maintenance treatment.
Secondary outcome
Protocol section 2.1.3:
The number of patients with clinical remission at week 336 of maintenance
treatment.
Background summary
Protocol section 1.2 and 1.3:
Approximately one third of patients with moderate to severe colitis ulcerosa
are primary or secondary non-responders on biologicals. Furthermore, the
treatment can also be limited due to side effects. So despite the progress
made, there is still a need for new therapies with an improved safety profile
and mechanism of action.
Study objective
Protocol section 2.1:
* Demonstration of the long term safety of BI655130 in patients with moderate
to severe active colitis Ulcerosa who have already been treated in previous
studies.
* Demonstration of the long term efficacy of BI655130 in patients with moderate
to severe active colitis Ulcerosa who have already been treated in previous
studies.
Study design
Protocol section 3.1 and 3.2:
In this open label extension study, the safety and efficacy of BI655130 in the
longer term will be investigated in patients previously treated in previous
BI655130 induction studies 1368.5 (part 1) and 1368.4. Patients must have had
12 weeks of treatment (up to the end of treatment visit) in this previous
study. Patients will then be treated according to their previous treatment
outcome, namely:
* Patients who had a clinical response during week 12 in the previous studies
will receive subcutaneous BI655130 as maintenance treatment (300mg q12w SC)
until week 336 of this extension study.
* Patients who have had no clinical response during week 12 in the previous
studies will receive intravenous BI655130 as re-induction treatment (1200mg q4w
IV for 12 weeks). Patients who subsequently have a clinical response (compared
to baseline or the induction study) at week 12 of the re-induction period will
flow into the treatment schedule for subcutaneous maintenance treatment up to
week 336. In patients who do not respond to re-induction the treatment will be
stopped and an early End of Treatment and safety follow-up will take place.
Intervention
Protocol section 4.1 - 4.1.4:
A dose of 300 mg BI655130 will be administered subcutaneously every 12 weeks
for patients who responded to treatment in the previous study, or who responded
to treatment following an intravenous re-induction period.
Patients undergoing intravenous re-induction will receive 1200 mg of BI655130
i.v. administered. When there is treatment for a disease flare, a single dose
of 1200 mg BI655130 i.v. will be given.
Study burden and risks
Protocol section 1.4:
This is a newly developed drug that is still in the early stage of research and
therefore benefits for the patient can not be guaranteed. However,
participation in the study is of great importance to investigate the safety,
tolerability and dosage of BI655130.
Patients are exposed to the risks of the screening procedures and the risks
associated with the exposure to the study medication.
The total duration of the study for a patient is a maximum of 352 weeks.
Patients have a risk of (unknown) side effects, an allergic reaction to the
study medication, pain due to blood sampling or irritated skin due to the
electrodes used in making the ECGs.
Comeniusstraat 6
Alkmaar 1817MS
NL
Comeniusstraat 6
Alkmaar 1817MS
NL
Listed location countries
Age
Inclusion criteria
1. Male or female patients, aged >=18 years;
2. Signed and dated written informed consent for 1368.17, in accordance with GCP and local legislation prior to admission into the trial;
3. Women of childbearing potential (WOCBP) and men able to father a child 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;
4. Have completed treatment and the EOT visit in the previous trial and are willing and able to continue treatment in 1368.17.
Exclusion criteria
1. Have experienced study treatment-limiting adverse events during induction treatment with study drug;
2. Have developed any of the exclusion criteria from the original induction study
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2018-000334-35-NL |
| CCMO | NL65911.100.18 |