Main Objective:To demonstrate the efficacy of secukinumab compared to placebo withrespect to HiSCR after 16 weeks of treatment.Secondary objective:To demonstrate the efficacy of secukinumab compared to placebo after 16 weeks of treatment with…
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Achievement of HiSCR at Week 16. 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
* Percentage change from baseline in AN count at Week 16
* Flaring up to Week 16. Flare is defined as at least a 25%
increase in AN counts with a minimum increase of 2 AN
relative to baseline.
* Achievement of NRS30 at Week 16, among subjects with
baseline NRS >= 3. NRS30 is defined as at least a 30%
reduction and at least 2 unit reduction from baseline in Patient's Global
Assessment of
Skin Pain - at worst
Background summary
The purpose of this study is to demonstrate superiority of secukinumab at Week
16, based on HiSCR rates versus placebo, along with the maintenance of efficacy
of secukinumab at Week 52 in subjects with moderate to severe HS. Moreover,
this study will also assess the safety and tolerability of secukinumab. See
paragraph 1.1 of the protocol for full details on the background of the study.
Study objective
Main Objective:
To demonstrate the efficacy of secukinumab compared to placebo with
respect to HiSCR after 16 weeks of treatment.
Secondary objective:
To demonstrate the efficacy of secukinumab compared to placebo after 16 weeks
of treatment with respect to AN count.
To demonstrate the efficacy of secukinumab compared to placebo after 16 weeks
of treatment with respect to:
* proportion of patients with HS flares
* proportion of patients with clinical response in HS related skin pain.
Study design
This is a multicenter, randomized, double-blind, placebo controlled, parallel
group study with two secukinumab dose regimens in approximately 541 patients
with moderate to severe HS. The study consists of: Screening (up to 4 weeks),
Treatment Period 1 (16 weeks) and Treatment Period 2 (36 weeks). Subjects who
prematurely discontinue the study, or who complete the study and cannot or do
not wish to continue in a planned optional extension study, will enter a
post-treatment Follow-Up period (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 have been 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
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NL
Listed location countries
Age
Inclusion criteria
1. Written informed consent must be obtained before any assessment is performed.
2. Male and female patients >= 18 years of age.
3. Diagnosis of HS >= 1 year prior to baseline.
4. Patients with moderate to severe HS defined as:
* A total of at least 5 inflammatory lesions, i.e. abscesses and/or
inflammatory nodules
AND
* Inflammatory lesions should affect at least 2 distinct anatomic areas
5. Patients agree to daily use of topical over-the-counter antiseptics on the
areas affected by HS lesions while on study treatment.
Exclusion criteria
1. Total fistulae count >= 20 at baseline.
2. Any other active skin disease or condition that may interfere with
assessment of HS.
3. Active ongoing inflammatory diseases other than HS that require treatment
with prohibited medications (see Table 6 2).
4. Use or planned use of prohibited treatment. Washout periods detailed in the
protocol have to be adhered to (see Table 6 2).
5. History of hypersensitivity to any of the study drug constituents.
6. History of lymphoproliferative disease or any known malignancy or history of
malignancy of any organ system treated or untreated within the past 5 years,
regardless of whether there is evidence of local recurrence or metastases
(except for skin Bowen*s disease, or basal cell carcinoma or actinic keratoses
that have been treated with no evidence of recurrence in the past 12 weeks;
carcinoma in situ of the cervix or non-invasive malignant colon polyps that
have been removed).
7. Pregnant or lactating women.
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 | EUCTR2018-002062-39-NL |
| ClinicalTrials.gov | NCT03713632 |
| CCMO | NL67727.100.18 |