| Eligibility |
Inclusion Criteria:
Patients eligible for inclusion in this Treatment Plan have to meet all of the following
criteria:
1. Adult male and female patients (= 18 years) who are able and willing to provide
written informed consent prior to enrolling in the cohort.
2. HS diagnosis for = 6 months (defined as onset of HS with supporting documentation)
3. 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
4. Not eligible or able to enroll in a clinical trial or no relevant clinical trials
available
Exclusion Criteria:
1. Total fistulae count = 20 at baseline.
2. Active ongoing inflammatory diseases other than HS that require treatment with
prohibited medications (section 3.3.2).
3. Underlying conditions (including, but not limited to metabolic, hematologic, renal,
hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal
disorders, including history of inflammatory bowel disease) which in the opinion of
the treating physician significantly immunocompromises the patient and/or places the
patient at unacceptable risk for receiving an anti-IL-17A immunomodulatory therapy.
4. Current severe progressive or uncontrolled diseases which renders the patient
unsuitable for the managed access program or puts the patient at increased risk,
including any medical or psychiatric condition which, in the treating physician's
opinion, would preclude the participant from adhering to the treatment plan.
5. Use or planned use of prohibited treatment (section 3.3.2).
6. History of hypersensitivity to any of the secukinumab constituents.
7. History of chronic or recurrent systemic infections or active systemic infections
during the last two weeks (exception: common cold) prior to the access request.
8. Evidence of tuberculosis infection as defined by a positive QuantiFERON® TB-Gold test
(QFT) at the time of requesting access. Patients with a positive or indeterminate QFT
test may get access 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 tuberculosis. Patients who
test positive for latent TB per work-up may get access if sufficient treatment has
been initiated according to local routine clinical practice/guidelines and was
completed at least four weeks prior to the access request.
9. Medical history of infection with human immunodeficiency virus (HIV), hepatitis B or C
prior to access request, except for hepatitis C successfully treated and cured.
10. 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).
11. History or evidence of ongoing alcohol or drug abuse, which in the opinion of the
physician will prevent the patient from adhering to the treatment plan.
12. Pregnant or lactating women.
13. Women of childbearing potential, defined as all women physiologically capable of
becoming pregnant, unless they are using methods of contraception during the entire
duration of the treatment or longer if required by locally approved prescribing
information (e.g., in European Union (EU) 20 weeks).
Contraception methods include:
- Total abstinence when this is in line with the preferred and usual lifestyle of the
patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation
methods) and withdrawal are not acceptable methods of contraception.
- Female sterilization (have had surgical bilateral oophorectomy with or without
hysterectomy), total hysterectomy, or bilateral tubal ligation at least six weeks
prior to the access request. In case of oophorectomy alone, only when the reproductive
status of the woman has been confirmed by follow-up hormone level assessment.
- Male sterilization (at least 6 months prior to screening). The vasectomized male
partner should be the sole partner for that patient.
- Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault
caps). For United Kingdom: with spermicidal foam/gel/film/cream/vaginal suppository.
- Use of oral (estrogen and progesterone), injected or implanted hormonal methods of
contraception or other forms of hormonal contraception that have comparable efficacy
(failure rate <1%), for example hormone vaginal ring or transdermal hormone
contraception or placement of an intrauterine device (IUD) or intrauterine system
(IUS).
In case of use of oral contraception, women should have been stable on the same pill for a
minimum of 3 months before taking secukinumab.
In case local regulations deviate from the contraception methods listed above, local
regulations apply and will be described in the informed consent template.
Note: Women are considered post-menopausal and not of childbearing potential if they have
had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile
(e.g., age appropriate, history of vasomotor symptoms) or have had surgical bilateral
oophorectomy (with or without hysterectomy), total hysterectomy or bilateral tubal ligation
at least six weeks prior to enrollment. In the case of oophorectomy alone, only when the
reproductive status of the woman has been confirmed by follow-up hormone level assessment
is she considered not of childbearing potential.
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