Severe asthma with an eosinophilic phenotype MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
GlaxoSmithKline Research & Development Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants: Participants who completed the double-blind study intervention treatment during Study 206713 or Study 213744. 2. 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 permits enrolment of adults only, participants recruited will be =18 years of age]. 3. Male or eligible female • Female Participants: • 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 OR o For all woman of childbearing potential (WOCBP) continuation of highly effective contraceptive method ( with a failure rate of =65 years) yes F.1.3.1 Number of subjects for this age range 76
Exclusion criteria
Exclusion criteria: 1. Health Status: Clinically significant change in health status during Study 206713 or Study 213744 which in the opinion of the investigator would make the participant unsuitable for participation in this study. 2. Malignancy: A current malignancy or a malignancy that developed during Study 206713 or Study 213744 (participants who had localised carcinoma of the skin that was resected for cure will not be excluded). 3. Participants who have other clinically significant medical conditions uncontrolled with SoC therapy not associated with Asthma, e.g., uncontrolled cardiovascular disease or ongoing active infectious disease which in the opinion of the investigator makes them unsuitable for the study. 4. Participants with known parasitic (helminth) infections within 6 months prior to Visit 1 will be excluded from the study or required to be adequately treated for helminth infections before initiation of GSK3511294. 5. Liver chemistry test: Participants who meet the following based results of week 48 assessment from Study 206713 or Study 213744 or from a later result: a) Alanine aminotransferase (ALT) >2x upper limit of normal (ULN) b) Total bilirubin >1.5x ULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) c) 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 eligibility criteria. 6. 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. 7. ECG Assessment: QTcF =450 msec or QTcF =480 msec for participants with Bundle Branch Block at Visit 1. 8. Smoking status: Current smokers 9. Hypersensitivity: Participants with allergy/intolerance to the excipients of GSK3511294 in Section 6.1 of the protocol, a monoclonal antibody, or biologic. 10. Pregnancy: Participants who are pregnant or breastfeeding. Participants should not be enrolled if they plan to become pregnant during the time of study participation. Requirements for pregnancy testing are located in Section 8.2.5. of the protocol 11. Permanent Discontinuation of study intervention in Previous Study: Participants who for any reason permanently discontinued study treatment in the previous study 206713/213744 will be excluded from this study. 12. Other investigational product/clinical study: • Participants who have received treatment with an investigational agent (biologic or non-biologic) within the past 30 days or 5 drug half-lives whichever is longer, prior to the first dose, other than Study 206713/213744 study treatment. The term “investigational” applies to any drug not approved for sale for the disease/indication to treat in the country in which it is being used or investigational formulations of marketed products • Participants who are currently participating in any other interventional clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe the long-term safety profile of GSK3511294 100 mg (SC) every 26 weeks in participants with severe asthma with an eosinophilic phenotype on top of existing asthma therapy over a 12 month open label extension phase;Secondary Objective: To evaluate the effects of long-term dosing of GSK3511294 100 mg (SC) every 26 weeks on a range of clinical markers of asthma control and additional efficacy assessments on top of existing asthma therapy over a 12 month open label extension phase;Primary end point(s): 1.Incidence of AEs/SAEs over 52 weeks 2.Incidence of immunogenicity as measured by the presence of ADA/NAb to GSK3511294 over 52 weeks;Timepoint(s) of evaluation of this end point: 1.Week 0 through Week 52 2.Week 0 through Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Annualized rate of Clinically significant exacerbations over 52 weeks 2.Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) score at discrete timepoints during the 52 week period 3.Change from Baseline in St. George's Respiratory Questionnaire (SGRQ) total score at Week 26 and Week 52 4.Change from Baseline in prebronchodilator FEV1 at Week 26 and Week 52 ;Timepoint(s) of evaluation of this end point: 1.Week 0 through Week 52 2.Baseline ( Week 0) and through Week 52 3.Baseline ( Week 0), Week 26 and Week 52 4.Baseline ( Week 0), Week 26 and Week 52 | — |
Countries
Australia, Canada, China, Czechia, Czech Republic, France, Germany, Hungary, Ireland, Italy, Japan, Poland, Portugal, Puerto Rico, Russian Federation, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactGSK Clinical Support Help Desk
GlaxoSmithKline Research & Development Limited
Outcome results
None listed