EUCTR2020-003612-28-ITActive, not recruitingPhase 1
A 52-week, randomised, double-blind, double-dummy, parallel group,multicentre, 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 compared with mepolizumab or benralizumab - NA
GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT0 sites1,700 target enrollmentStarted: June 7, 2021Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 1,700
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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]
- •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,
- •=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
- •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 one 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
- +7 more not shown
Exclusion Criteria
- •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
- •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) 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.
- •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 at screening Visit 1.
- +5 more not shown
Investigators
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