Studie zur Beurteilung der kurz- und langfristigen Wirksamkeit, Sicherheit und Verträglichkeit von Secukinumab bei Patienten mit mittelschwerer bis schwerer Hidradenitis suppurativa.

Trade Name: Cosentyx
Product Name: Secukinumab
Product Code: AIN457
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Secukinumab
CAS Number: 1229022-83-6
Current Sponsor code: AIN457
Other descriptive name: SECUKINUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Gender:
Female: yes
Male: yes

Inclusion criteria:
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 512
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 29

Exclusion criteria:
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 such as inflammatory bowel disease) 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. Subjects positive for latent TB per work-up may be randomized to the trial if sufficient treatment has been initiated according to local routine clinical practice and was completed at least four weeks before randomization.
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. Wom