EUCTR2020-003612-28-AT进行中（未招募）1 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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,700
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. 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, OR
- •=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 Week 26.
- •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 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.
- •Note: If the childbearing potential changes after start of the study
- •(e.g., a preme
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, bronchopulmonary 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 asthma.
- •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 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.
- •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) or 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 guidance.
- •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 =480 msec for participants with Bundle Branch Block in the central over-read 12-lead ECG at screening Visit 1.
- •14. Smoking history: Current smokers or former smokers with a smoking history of =20 pack years (number of pack years = (numbe
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