A clinical trial to evaluate treatment with a drug called secukinumab inadult patients who are diagnosed with moderate to severe hidradenitissuppurativa (long term skin disease characterized by the occurrence ofinflamed and swollen lumps)
- Conditions
- hidradenitis suppurativaMedDRA version: 20.0Level: LLTClassification code 10020041Term: Hidradenitis suppurativaSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2018-002063-26-IT
- Lead Sponsor
- OVARTIS PHARMA AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 471
Patients eligible for inclusion in this study must meet all of the following 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 447
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24
Patients meeting any of the following criteria are not eligible for inclusion in this study.
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.
4. Underlying conditions (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the opinion of the investigator significantly immunocompromises the patient and/or places the patient at unacceptable risk for receiving an immunomodulatory therapy.
5. Current severe progressive or uncontrolled diseases which renders the patient unsuitable for the trial or puts the patient at increased risk, including any medical or psychiatric condition which, in the Investigator’s opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.
6. Use or planned use of prohibited treatment. Washout periods detailed in the protocol have to be adhered to.
7. For patients enrolling in the non-antibiotic strata: use of systemic antibiotics for the treatment of HS within 28 days before baseline.
For patients enrolling in the antibiotic strata: patients enter the study under concomitant treatment with systemic antibiotics (as per protocol) on a stable dose (defined as a dose or dose regimen that has not changed in the previous 28 days before baseline and is considered unlikely to change at least for the first 16 weeks during the study).
8. History of hypersensitivity to any of the study drug constituents.
9. Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17 A/F or the IL-17 receptor.
10. History of chronic or recurrent systemic infections or active systemic infections during the last two weeks (exception: common cold) prior to randomization.
11. Evidence of tuberculosis infection as defined by a positive QuantiFERON® TB-Gold test (QFT) at screening. Patients with a positive or indeterminate QFT test may participate in the study if a full tuberculosis work-up (according to local practice/guidelines) completed within 12 weeks prior to randomization, establishes conclusively that the patient has no evidence of active or latent tuberculosis.
12. Medical history record of infection with human immunodeficiency virus (HIV), hepatitis B or C prior to randomization, except for hepatitis C successfully treated and cured.
13. 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).
14. History or evidence of ongoing alcohol or drug abuse, which in the opinion of the investigator will prevent the patient from adhering to the protocol and completing the study.
15. Pregnant or lactating women.
16. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g. in European Union
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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:<br>¿ proportion of patients with HS flares<br>¿ proportion of patients with clinical response in HS related skin pain.;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: Week 16
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Flaring up to Week 16. Flare is defined as at least a 25%<br>increase in AN counts with a minimum increase of 2 AN<br>relative to baseline.<br>¿ Achievement of NRS30 at Week 16, among subjects with<br>baseline NRS = 3. NRS30 is defined as at least a 30%<br>reduction from baseline in Patient's Global Assessment of<br>Skin Pain - at worst;Timepoint(s) of evaluation of this end point: at/ up to Week 16