This study has been transitioned to CTIS with ID 2023-508956-20-00 check the CTIS register for the current data. The purpose of this clinical research extension study is to evaluate whether prolonged treatment with secukinumab for up to another 4…
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Time to loss of response up to Week 104 (Randomized Withdrawal period) in
subjects who were HiSCR responders at Week 52 in the core studies. HiSCR is
defined as at least a 50% decrease in Abscess and Inflammatory Nodule (AN)
count with no increase in the number of abscesses or in the number of draining
fistulae.
Secondary outcome
To assess the long-term safety and tolerability of secukinumab in subjects with
moderate to severe HS using adverse events, laboratory values, vital signs.
Background summary
Secukinumab is a monoclonal antibody that can bind to interleukin-17A (IL-17A)
and thereby reduce the efficacy of IL-17A. IL-17A plays a role in inflammation
and we assume that it is partly responsible for the symptoms of HS. Therefore,
we expect that secukinumab and similar agents can reduce the symptoms of HS by
inhibiting the activity of IL-17A.
Study objective
This study has been transitioned to CTIS with ID 2023-508956-20-00 check the CTIS register for the current data.
The purpose of this clinical research extension study is to evaluate whether
prolonged treatment with secukinumab for up to another 4 years (Week 52 to Week
260) will bring benefits and be safe to patients with moderate to severe HS.
The main objectives of this study are:
* * To see if continuous use of secukinumab can help maintain improvement of HS.
* * To see if it is safe for patients with HS to continue to receive
secukinumab.
* * To compare the effects of continuing secukinumab treatment with an
interruption of the secukinumab treatment (using placebo instead).
Study design
This is a four year multicenter, randomized, double-blind, placebo-controlled,
parallel group study with two secukinum dose regimens in approximately 745
patients with moderate to severe HS. The research consists of:
• Randomized retention / treatment period of 52 weeks.
• Open label period up to a maximum of 3 years.
For patients who have not achieved the defined improvement of the disease in
the core study at week 52, the study will only consist of an open label section
for up to 4 years.
• Patients who stop the study early or who complete the study will start a
follow-up period after treatment (8 weeks).
Intervention
* Secukinumab 300 mg solution for s.c. injection in a 2 ml PFS
* Placebo solution for s.c. injection in a 2 ml PFS
Study burden and risks
Participants have a chance of possible side effects:
• Among the very common side effects (in more than 1 in 10 subjects) are upper
respiratory tract infections with symptoms such as a stuffy nose, runny nose,
itchy nose, sore throat (inflamed nose and / or throat) and a stuffy nose with
pain in the face (sinus inflammation).
• Common side effects (affects 1 in 10 to 100 subjects) include diarrhea and
itchy skin rash.
• Unusual side effects (affects 1 in 100 to 1,000 subjects) include a fungal
infection of the mouth and a low white blood cell count.
• Secukinumab can reduce the body's defense against infections. As a result,
you may be more susceptible to infections and possibly have an increased chance
of developing cancer. The infections reported during investigations were
usually not serious. Up to now no problems regarding cancer have been reported.
• In patients with Crohn's disease, a (severe) worsening of this bowel disease
was observed in some cases during treatment with secukinumab, but also with
placebo.
• There have also been subjects who received a new inflammation of the
intestine during a study with secukinumab.
• During treatment with secukinumab in daily practice, fungal infections (with
candida) of the mucous membranes and skin havebeen reported. In most cases,
this infection was not serious and the doctor did not have to interrupt the
treatment.
• Also report to the researcher if you are allergic to latex.
• A hypersensitivity reaction to the study medication can occur, immediately
after or many days after an injection. A severe hypersensitivity reaction can
be life-threatening. Symptoms of an allergic reaction include skin rash,
itching, difficulty or wheezing, lowering of blood pressure, swelling of the
throat, eyes or around the mouth, rapid heartbeat, fever, sweating or
shivering. Contact the researcher directly or call for other medical assistance
immediately if this affects you.
• It is unknown whether secukinumab has harmful effects for women who are
pregnant and babies. No problems have been reported in this area so far.
• You must not be vaccinated with live vaccines during treatment with
secukinumab.
• Secukinumab is still under investigation. This means that side effects can
occur that are still unknown.
The following test tests may entail the risks mentioned.
- Blood sampling: blood samples can hurt or cause a bruise. Sometimes somebody
faints. Rarely, a blood clot or an infection develops on the puncture site
Haaksbergweg 16
Amsterdam 1101 BX
NL
Haaksbergweg 16
Amsterdam 1101 BX
NL
Listed location countries
Age
Inclusion criteria
1. Written informed consent must be obtained before any assessment is performed.
2. Subjects who complete the whole study treatment period (52 weeks) in the
core studies
(CAIN457M2301 or CAIN457M2302) and have received secukinumab treatment during
the Treatment Period 2 of the core studies.
Exclusion criteria
1. A protocol deviation in the core study which, according to the investigator
will prevent the meaningful analysis of the extension study for the individual
subject.
2. Ongoing or planned use of prohibited HS or non-HS treatments. Time of use of
prohibited treatments in the core study must continue to be adhered to (see
Table 6-2)
3. Subjects not expected to benefit from participation in the extension study,
as assessed by the subject and investigator.
4. Subjects whose participation in the extension study could expose them to an
undue safety risk.
5. Current severe progressive or uncontrolled disease which in the judgment of
the investigator renders the subject unsuitable for the study.
6. Plans for administration of live vaccines during the study.
7. Women of childbearing potential, defined as all women physiologically
capable of
becoming pregnant, unless they are using methods of contraception.
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 |
|---|---|
| EU-CTR | CTIS2023-508956-20-00 |
| EudraCT | EUCTR2019-003230-17-NL |
| CCMO | NL73043.100.20 |