1. To evaluate the long-term safety of spesolimab in patients with fistulising Crohn*s disease who have completed treatment in previous trials.2. To evaluate the long-term efficacy of spesolimab in patients with fistulising Crohn*s disease who have…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Exposure adjusted rate of patients reporting a treatment emergent adverse event
(TEAE) up to week 336 of maintenance treatment.
Secondary outcome
- Proportion of patients with perianal fistula remission at weeks 48, 96, 144,
192, 240, 288 and 336
- Proportion of patients with perianal fistula response at weeks 48, 96, 144,
192, 240, 288 and 336
- Proportion of patients with clinical remission at weeks 48, 96, 144, 192,
240, 288 and 336
- Proportion of patients with endoscopic remission at weeks 48, 96, 144, 192,
240, 288 and 336
Background summary
Fistulas represent one of the most important complications in patients with CD.
The number of patients with severe and recurrent problems arising from CD
fistulas is considerably high. Surgery, though often required, does not always
provide a definitive cure. Current treatments with medications show limited
efficacy. Thus, there remains a significant unmet Medical need for better
treatments of this CD complication See also protocol section 1.1.
Study objective
1. To evaluate the long-term safety of spesolimab in patients with fistulising
Crohn*s disease who have completed treatment in previous trials.
2. To evaluate the long-term efficacy of spesolimab in patients with
fistulising Crohn*s disease who have completed treatment in previous trials.
Study design
This is an open label, single group, long-term extension study of approximately
7 year duration.
It is expected that a maximum of 20 patients will roll-over from study
1368-0008.
See protocol section 3.1.
Intervention
Patients will receive spesolimab maintenance treatments 300mg subcutaneously
every 4 weeks for 336 weeks (approximately 7 years).
In case of a confirmed flare disease or fistula relapse a single dose of 1200mg
intravenous infusion of spesolimab will be given to the patient, followed by an
intensified subcutaneous maintenance treatment (600mg spesolimab subcutaneous
injection every 4 weeks).
See protocol section 4.1.
Study burden and risks
Patients entering this trial will already have received a benefit from
treatment with spesolimab in a preceeding trial. This, in adition to the
medical need for effective and well tolerated drug specifically and directly
treating the structural aspects of CD makes it conceivable to anticipate that
the benefits of receiving further treatment will outweigh the risks in these
patients.
Moreover, since there are no mechanism- or compound-related safety alarm
signals from all available data from spesolimab, it is highly likely that
eligible patients for the study, CD patients with perianal fistulising disease,
will not be exposed to undue risks and adverse events.
The total duration of the study for a patient is a maximum of 336 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, discomfort and (small) risk for
complications during the rectoscopy/proctoscopy and biopsies.
See protocol section 1.4.
Basisweg 10
Amsterdam 1043 AP
NL
Basisweg 10
Amsterdam 1043 AP
NL
Listed location countries
Age
Inclusion criteria
- Patient older than 18 years
- Has completed all treatments (placebo or active treatment) and the EOT visit
in the parent induction trial in fistulising CD and is willing and able to
continue treatment in 1368-0007
- Has obtained an individual health benefit, per investigator judgement (such
as fistula response or remission or other clinical improvement), from treatment
in the parent trial
- Signed and dated written informed consent for 1368-0007
- Women of childbearing potential (WOCBP) must be ready to use highly effective
methods of birth control
Exclusion criteria
- Have experienced treatment-limiting adverse events during induction treatment
with study drug
- Have developed any condition which meets the exclusion criteria from the
original induction study
- Any condition which in the opinion of the investigator affects the safety or
ability to participate in this trial
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 | EUCTR2019-001673-93-NL |
| ClinicalTrials.gov | NCTnummernognietbekend |
| CCMO | NL72654.056.20 |