EUCTR2015-002653-35-BE进行中（未招募）1 期
A phase 3 study investigating the efficacy, safety, and tolerability of Dupilumab administered to adult patients with severe atopic dermatitis who are not adequately controlled with or are intolerant to oral cyclosporine A, or when this treatment is not medically advisable
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 330
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female, 18 years or older
- •2. Severe, Chronic AD, (according to American Academy of Dermatology Consensus Criteria [Eichenfield 2014])
- •3. EASI score =20 at the screening and baseline visits
- •4. IGA score =3 (on the 0 to 4 IGA scale) at the screening and baseline visits
- •5. =10% body surface area (BSA) of AD involvement at the screening and baseline visits
- •6. Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with TCS
- •7. Have applied a stable dose of topical emollient (moisturizer) twice daily for at least the 7 consecutive days immediately before the baseline visit
- •8. Documented history by a physician of either:
- •A. No prior CSA exposure and not currently a candidate for CSA treatment due to:
- •medical contraindications (eg, uncontrolled hypertension on medication), or
- •use of prohibited concomitant medications (eg, statins, digoxin, macrolide
- •antibiotics, barbiturates, anti-seizure, nonsteroidal anti-inflammatory drugs,
- •diuretics, angiotensin-converting-enzyme inhibitors, St John’s Wort, etc), or
- •increased susceptibility to CSA-induced renal damage (elevated creatinine) and
- •liver damage (elevated function tests), or
- •increased risk of serious infections
- •B. Previously exposed to CSA, and CSA treatment should not be continued or restarted due to:
- •intolerance and/or unacceptable toxicity (eg, elevated creatinine, elevated liver function tests, uncontrolled hypertension, paraesthesia, headache, nausea, hypertrichosis, etc), or
- •inadequate response to CSA (defined as flare of AD on CSA tapering after a maximum of 6 weeks of high dose [5 mg/kg/day] to maintenance dose [2 to 3 mg/kg/day] or a flare after a minimum of 3 months on maintenance dose). Flare is defined as increase in signs and/or symptoms leading to escalation of therapy, which can be an increase in dose, a switch to a higher-potency class of TCS, or the start of another systemic non-steroidal immunosuppressive drug. Or
- •requirement for CSA at doses >5 mg/kg/day, or duration beyond those specified in the prescribing information (>1 year), or
- •hypersensitivity to CSA active substance or excipients.
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 130
排除标准
- •1. Participation in a prior dupilumab clinical study
- •2. Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, prior to baseline
- •3. Hypersensitivity and/or intolerance to corticosteroids or to any other ingredients contained in the TCS product used in the study
- •4. Systemic CSA, systemic corticosteroids, immunosuppressive/immunomodulating (eg, azathioprine [AZA], methotrexate [MTX], mycophenolate mofetil [MMF], or Janus kinase [JAK] inhibitors or phototherapy within 4 weeks prior to baseline
- •5. Treatment with TCI within 1 week prior to baseline visit
- •6. Treatment with biologics as follows:
- •Any cell-depleting agents including but not limited to rituximab: within 6 months before the baseline visit, or until lymphocyte count returns to normal, whichever is longer
- •Other biologics: within 5 half-lives (if known) or 16 weeks prior to the baseline visit, whichever is longer
- •7. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the baseline visit
- •8. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
- •9. Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit or superficial skin infections within 1 week before the baseline visit. NOTE: patients may be rescreened no sooner than 2 weeks after infection resolves.
- •10. Known or suspected history of immunosuppression, including history of invasive opportunistic infections (eg, tuberculosis [TB], histoplasmosis, Listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution; or unusually frequent, recurrent, or prolonged infections, per investigator judgment
- •11. Presence of any 1 of the following TB criteria:
- •a. A positive tuberculin skin test at the screening visit
- •b. A positive blood QuantiFERON®-TB or T-Spot test at the screening visit
- •c. Chest x-ray (posterior-anterior and lateral views) at screening or within 3 months before the screening visit (radiology report must be available) with results consistent with prior TB infection (including but not limited to apical scarring, apical fibrosis, or multiple calcified granuloma). This does not include non-caseating granulomata.
- •NOTE: Any of these 3 TB tests will be performed on a country-by-country basis according to local guidelines only if required by regulatory authorities or ethics boards.
- •12. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening
- •13. Positive hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBc Ab), or hepatitis C antibody (HCV Ab) at the screening visit. Patients with isolated positive HBcAb may undergo additional tests and may enter the study if active hepatitis B infection or carrier status has been definitively ruled out, subject to medical monitor's written approval.
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