Acne, psoriasis, atopic dermatitis

  • STATUS
    Recruiting
  • sponsor
    Novartis
Updated on 25 March 2021

Summary

Acne, psoriasis, atopic dermatitis

Description

A 52-week, multicenter, randomized, double-blind study of secukinumab (300mg) to demonstrate efficacy as assessed by psoriasis area and severity index and investigator's global assessment after 12 weeks of treatment, compared to ustekinumab, and to assess long-term safety, tolerability, and efficacy in subjects with moderate to severe plaque psoriasis.

You do not have to pay for the study drug, study visits or test that are part of the study.

Details
Clinical Study IdentifierTX145538
SponsorNovartis
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects must be able to understand and comply with the requirements of the study and communicate with the investigator, and must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulation
Men or women must be at least 18 years of age at the time of screening
Chronic plaque-type psoriasis present for at least 6 months and diagnosed before randomization
Moderate to severe plaque psoriasis as defined at randomization by
PASI score of ≥12 and
Body Surface Area (BSA) affted by plaque-type psoriasis ≥10% and
IGA mod 011 ≥3 (based on a scale of 0-4)
Candidate for systemic therapy, defined as having psoriasis inadequately controlled by
Topical treatment (including topical corticoseroids) and/or
Phototherapy and/or
Previous systemic therapy

Exclusion Criteria

Forms of psoriasis other than plaque psoriasis (e.g., pustular psoriasis, erythrodermic and guttate psoriasis)
Drug-induced psoriasis (e.g., new onset or current exacerbation from beta-blocker, calcium channel inhibitors or lithium)
Ongoing use of prohibited treatments. Washout periods detailed in the protocol must be adhered to. Subjects not willing to limit UV light exposure (e.g., sunbathing and/or the use of tanning devices) during the course of the study will be considered not eligible for this study. NOTE: administration of live vaccines within 6 weeks prior to Randomization or during the study period is also prohibited. Further BCG vaccine should not be given for one year prior to randomization or during treatment or for one year following discontinuation of treatment
Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or IL-17RA, or ustekinumab
Use of any other investigational drugs within 5 half-lives of the investigational treatment before study drug initiation or until the pharmacodynamics effect has returned to baseline, whichever is loner
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g. 20 weeks in EU). Effective contraception methods include
Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). 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 hysterectom), total hysterectomy or tubal ligation at least 6 weeks before taking study treatment. 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). For female subjects on the study, the vasectomized male partner should be the sole partner of that subject
Barrier methods of contraception: condom or occlusive cap
Use of oral, injected or implanted hormonal methods of contraception or other forms or hormonal contraception that have comparable efficacy (failure<1%), e.g., 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 study treatment. NOTE: Women
are consider post-menopausal and not of childbearing potential if they have
had
months of natural (spontaneous) amenorrhea with an appropriate clinical profile (eg., age appropriate, history of vasomotor symptoms), or
Surgical bilateral oophorectomy (with or without Hysterectomy), total hysterectomy or tubal ligation at least 6 weeks before taking study treatment In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by the follow up hormone level assessment is she considered not of childbearing potential
Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the of the benefit of secukinumab therapy. Also, 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 subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy. In addition, current severe progressive or uncontrolled diseases which render the subject unsuitable for the trial or puts the subject at increased risk, including any medica or psychiatric condition which, in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the stuy per protocol
Investigator discretion should be used for subjects with pre-existing or recent-onset central or peripheral nervous system demyelinating disorders
Presence of
Significant medical problems, including but not limited to the following: uncontrolled hypertension (systolic ≥160 mmHg and/or diastolic ≥95 mmHg), congestive heart failure (New York Heart Association status of class III or IV)
Serum creatinine level exceeding 2.0 mg/dL
Total white blood cell (WBC) count <2,500, platelets <100,000, neutrophils <1500 or hemoglobin <8.5 at screening
Active systemic infections during the 2 weeks prior to randomization (exception: common cold) or any infection that reoccurs on the regular basis, investigator discretion should be used regarding subjects who have traveled or resided in the ares of edemic cycoses, such as histoplasmosis, coccidoiodomycosis or blastomycosis and for subject with underlying conditions that may predispose them to infection, such as advanced or inadequately controlled diabetes
History of ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis infection as defined by a positive or indeterminate QuantiFERON TB-Gold test (QFT) at screening. Subjects with a positive OFT test may participant in te study if a full tuberculosis work up (according to local practice/guidelines) completed within 12 weeks prior to randomization establishes conclusively that the subject has no evidence of active tuberculosis. If the presence of latent tuberculosis is established, then treatment must have been initiated and maintained according o local country guidelines for at least 4 weeks prior to randomization
Past medical history record of, or current infection with, human immunodeficiency virus (HIV), hepatitis B or hepatitis C prior to randomization
History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (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)
Inability or unwillingness to undergo repeated venipuncture (e.g. because of poor tolerability or lack of access to veins)
History or evidence of ongoing alcohol or drug abuse, within the last 6 months prior to randomization
History of hypersensitivity to any of study drug constituent
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