NL-OMON54219尚未招募3 期
A 52-week, randomised, double-blind, double-dummy, parallel group,multi-centre, non-inferiority study assessing exacerbation rate, additional measures of asthma control and safety in adult and adolescent severe asthmatic participants with an eosinophilic phenotype treated with GSK3511294 (depemokimab) compared with mepolizumab or benralizumab - 206785 (NIMBLE)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 34
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 12 至 99（—）
入选标准
- •1. Age: Adults and adolescents >=12 years of age, at the time of signing the
- •informed consent/assent.[For countries where local regulations or the
- •regulatory status of study medication permit enrolment of adults only,
- •participants recruited will be >=18 years of age] Note for Germany, UK and
- •Norway Participants: In Germany, UK and Norway, only adult participants (>=18
- •years) are to be included in this clinical trial. Note for Austrian
- •Participants: In Austria, participants who are >=16 years are to be included in
- •this clinical trial.
- •2. Asthma: Participants who have a documented physician diagnosis of asthma for
- •>=2 years that meets the National Heart, Lung, and Blood Institute guidelines
- •[NHLBI, 2007] or GINA guidelines [GINA, 2020].
- •3. Anti-IL-5/5R Therapy: Receiving either mepolizumab 100 mg SC or benralizumab
- •30 mg SC for >=12 months prior to Screening and have a documented benefit to
- •therapy assessed by either:
- •>=50% reduction in exacerbation frequency since initiating treatment,
- •ORhttps://www.toetsingonline.nl/to/ccmo_monitor.nsf/europe.gif?OpenImageResource
- •>=50% reduction in maintenance OCS use since initiating treatment, OR
- •no exacerbations in the past 6 months whilst receiving anti-IL-5/5R therapy
- •and an ACQ-5 score of <=1.5 at Screening.
- •4. Inhaled Corticosteroid: A well-documented requirement for regular treatment
- •with medium to high dose ICS in the 12 months prior to Visit 1 with or without
- •maintenance OCS. The maintenance ICS dose must be >=440 mcg fluticasone
- •propionate [FP] hydrofluoroalkane product [HFA] daily, or clinically comparable
- •[GINA, 2020; see Appendix 10 of the protocol]. Participants who are treated
- •with medium dose ICS will also need to be treated with a Long-acting
- •beta-agonist (LABA) to qualify for inclusion.
- •5. Additional Controller Medication: Current treatment with at least one
- •additional controller medication, besides ICS [e.g., LABA, LAMA, leukotriene
- •receptor antagonist (LTRA), or theophylline].
- •6. Male or eligible female.
- •A female participant is eligible to participate if she is not pregnant or
- •breastfeeding, and 1 of the following conditions applies:
- •o Is a woman of non-childbearing potential (WONCBP) as defined in
- •Section 10.4.1 of the protocol
- •o 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 Section
- •10.4.2 of the protocol from at least 14 days prior to the first dose of study
- •intervention until at least 30 weeks after either: the first dose (if study
- •intervention was permanently discontinued prior to Week 26), or the dose at
- •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 during and after study intervention are located in
- •Section 8.3.5 of the protocol.
- •Contraceptive use by women should be consistent with local regulations
- •regarding the methods of contraception for those participating in clinical
- •The investigator should evaluate the potential for contraceptive method
- •failure (e.g., noncompliance, recently initiated in relationship to the first
- •dose of study intervention).
排除标准
- •1. Concurrent Respiratory Disease: Presence of a known pre-existing, clinically
- •important lung condition other than asthma. This includes (but is not limited
- •to) current infection, bronchiectasis, pulmonary fibrosis, XML File Identifier:
- •8gn94WbuVgZQJdjuTL83BkI1PnI=Page 24/38bronchopulmonary aspergillosis, or
- •diagnoses of emphysema or chronic bronchitis (chronic obstructive pulmonary
- •disease other than asthma) or a history of lung cancer.
- •2. Eosinophilic Diseases: Participants with other conditions that could lead to
- •elevated eosinophils such as hyper-eosinophilic syndromes including (but not
- •limited to) Eosinophilic Granulomatosis with Polyangiitis (EGPA, formerly known
- •as Churg-Strauss Syndrome) or Eosinophilic Esophagitis.
- •3. Parasitic Infection: Participants with a known, pre-existing parasitic
- •infestation within 6 months prior to Visit 1 are to be excluded.
- •4. Immunodeficiency: A known immunodeficiency (e.g. human immunodeficiency
- •virus - HIV), other than that explained by the use of CSs taken as therapy for
- •5. Malignancy: A current malignancy or previous history of cancer in remission
- •for less than 12 months prior to screening (Participants that had localised
- •carcinoma of the skin which was resected for cure will not be excluded).
- •6. Liver Disease: 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
- •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.
- •7. Other Concurrent Medical Conditions: Participants who have known,
- •preexisting, clinically significant cardiac, endocrine, autoimmune, metabolic,
- •neurological, renal, gastrointestinal, hepatic, haematological or any other
- •system abnormalities that are uncontrolled with standard treatment.
- •8. Vasculitis: Participants with current diagnosis of vasculitis. Participants
- •with high clinical suspicion of vasculitis at screening will be evaluated and
- •current vasculitis excluded prior to enrolment.
- •9. COVID-19: Participants that, according to the investigator's medical
- •judgment, are likely to have active COVID-19 infection should be excluded.
- •Participants with known COVID-19 positive contacts within the past 14 days
- •should be excluded for at least 14 days following the exposure during which the
- •participant should remain symptom-free.
- •10. Other mAbs used in the treatment of asthma: Participants who have received
- •omalizumab (Xolair), dupilumab (Dupixent), reslizumab (Cinqair/Cinqaero) or
- •Tezepelumab (Tezspire) within 130 days prior to Visit 1.
- •11. Other mAbs not used for the treatment of asthma: Participants who have
- •received any mAb within 5 half-lives of Visit 1. Authorised treatments for
- •COVID-19 are permitted and should be used in line with local regulatory
- •12. Investigational Medications: Participants who have received treatment with
- •an investigational drug within the past 30 days or five terminal phase
- •half-lives of the drug whichever is longer, prior to visit 1 (this also
- •includes investigational formulations of marketed products).
- •13. ECG Assessment: QTcF >=450msec or QTcF >=
研究者
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