EUCTR2021-005055-36-ES进行中（未招募）1 期
A randomised, double-blind, parallel group Phase III study to assess the efficacy and safety of 100 mg SC depemokimab in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) – ANCHOR-2 (depemokimAb iN CHrOnic Rhinosinusitis)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 250
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. 18 years of age and older inclusive, at the time of signing the informed consent.
- •CRSwNP / ECRS DIAGNOSIS
- •2. Endoscopic bilateral NP score of at least 5 out of a maximum score of 8 (with a minimum score of 2 in each nasal cavity) assessed by the investigator (see Appendix 10)
- •3.Participants who have had at least one of the following at Visit 1:
- •previous nasal surgery for the removal of NP;
- •have used at least three consecutive days of systemic corticosteroids in the previous 2 years for the treatment of NP;
- •medically unsuitable or intolerant to systemic corticosteroid.
- •4.Participants with severe NP symptoms defined as symptoms of nasal congestion/blockade/obstruction with moderate or severe severity (VRS score of 2 or 3) and loss of smell or rhinorrhoea (runny nose)
- •5.Presence of symptoms of chronic rhinosinusitis as described by at least 2 different symptoms for at least 12 weeks prior to Visit 1, one of which should be either nasal blockage/obstruction/congestion or nasal discharge (anterior/posterior nasal drip), plus
- •facial pain/pressure
- •reduction or loss of smell
- •6.Male or eligible female participants:
- •Female Participants:
- •A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
- •- Is a woman of non-childbearing potential (WONCBP) as defined in Appendix 4
- •- Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of <1%, as described in Appendix 4, from at least 14 days prior to the first dose of study intervention until at least 30 weeks after the last administered dose of study intervention.
- •A WOCBP must have a negative highly sensitive serum pregnancy test at Screening Visit 1 and a negative highly sensitive urine pregnancy test within 24 hours before the first dose of study intervention. Additional requirements for pregnancy testing are located in the SoA (Section 1.3).
- •Contraceptive use by WOCBP should be consistent with local regulations regarding the methods of contraception for those
- •participating in clinical studies.
- •The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated in relationship to the first dose of study intervention).
- •The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy
- •INFORMED CONSENT
- •7. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this study protocol.
- •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 250
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •CONCURRENT CONDITIONS/MEDICAL HISTORY
- •1.As a result of medical interview, physical examination, or screening investigation the physician responsible considers the participant unfit for the study
- •2.Cystic fibrosis
- •3.Antrochoanal polyps
- •4.Severe nasal septal deviation occluding one nostril preventing full assessment of nasal polyps in both nostrils
- •5.Participants who had a sino-nasal or sinus surgery changing the lateral wall structure of the nose making impossible the evaluation of nasalpolyp score
- •6.Acute sinusitis or upper respiratory tract infection (URTI) at screening or in 2 weeks prior to screening
- •7.Ongoing rhinitis medicamentosa (rebound or chemical induced rhinitis)
- •8.Participants who have had an asthma exacerbation requiring admission to hospital within 4 weeks of Screening
- •9.Participants who have undergone any intranasal and/or sinus surgery (for example polypectomy, balloon dilatation or nasal stent insertion) within 6 months prior to Visit 1; nasal biopsy prior to Visit 0 for diagnostic purposes only is excepted.
- •10.Participants where NP surgery is contraindicated in the opinion of the Investigator
- •11.Eosinophilic Diseases: Participants with other conditions that could lead to elevated eosinophils such as hyper-eosinophilic syndromes
- •including (but not limited to) EGPA (formerly known as Churg-Strauss Syndrome) or Eosinophilic Esophagitis
- •12.Parasitic infection: Participants with a known, pre-existing parasitic infestation within 6 months prior to Visit 1
- •13.Immunodeficiency: A known immunodeficiency (e.g. human immunodeficiency virus – HIV), other than that explained by the use of
- •corticosteroids (CSs) taken as therapy for asthma
- •14.Malignancy: A current malignancy or previous history of cancer in remission for less than 12 months prior to screening(NOTE:Participants that had localised carcinoma of the skin which was resected for cure will not be excluded).
- •15.Liver Disease:
- •Alanine aminotransferase (ALT) >2x ULN
- •Total bilirubin >1.5x ULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
- •Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy,
- •coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, persistent jaundice.
- •NOTE: Stable non-cirrhotic chronic liver disease (including Gilbert's syndrome, asymptomatic gallstones, and chronic stable hepatitis B or C) are acceptable if participant otherwise meets entry criteria.
- •16.Other Concurrent Medical Conditions: Participants who have known,pre-existing, clinically significant cardiac, endocrine, autoimmune,metabolic, neurological, renal, gastrointestinal, hepatic, haematological or any other system abnormalities that are uncontrolled with standard treatment.
- •17.Vasculitis: Participants with current diagnosis of vasculitis. Participants with high clinical suspicion of vasculitis at screening will be evaluated and current vasculitis must be excluded prior to enrolment.
- •18.Hypersensitivity: Participants with allergy/intolerance to the excipients of depemokimab in Section 6.1, a monoclonal antibody, or
- •19.COVID-19: Participants that, according to the investigator's medical judgment, are likely to have active COVID-19 infection must be
- •excluded. Participants with known COVID-19 positive contacts within the past 14 days must be excluded for at least 14 days following the
- •exposure during which the participant should remain symptom-free. R
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