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GSK1070806 · 4 trials · 3 indications
To evaluate the efficacy of two repeat intravenous dose administrations of GSK1070806 in subjects with T2DM
EASI scoring system is standardized clinical tool for assessment of extent (area) and severity of atopic dermatitis (AD). Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk and lower limbs on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % body surface area with AD in body region: 0 (0%), 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100% The final EASI score was obtained by weight-averaging these 4 scores and scores ranged from 0 to 72, with higher scores= more severe or extensive condition. Posterior Median presented from Bayesian analysis under the hypothetical strategy. The percent change from baseline in the EASI score at week 12 in group 1 is reported here. Data reported as 'Median' refers to 'Posterior Median' and '95% Confidence Interval' refers to '95% Credible Interval'.
| Arm | Type | Description |
|---|---|---|
| GSK1070806 0.25mg/kg | ACTIVE_COMPARATOR | TwoIV administrations of 0.25mg/kg GSK1070806 4weeks apart |
| GSK1070806 5mg/kg | ACTIVE_COMPARATOR | Two IV administrations of 5mg/kg of GSK1070806 4 weeks apart |
| Placebo (Saline) | PLACEBO_COMPARATOR | Two IV administrations of saline 4 weeks apart |
| Part A: GSK1070806 | EXPERIMENTAL | Participants in Part A will receive single dose of GSK1070806 intravenous (IV) infusion |
| Part B: GSK1070806 | EXPERIMENTAL | Participants in Part B will receive single dose of GSK1070806 IV bolus |
| Part A: Placebo | PLACEBO_COMPARATOR | Participants in Part A will receive single dose of placebo |
| Group 1: GSK1070806 | EXPERIMENTAL | Participants received a single dose of 2 mg/kg GSK1070806 as intravenous infusion on Day 1. |
| Group 1: Placebo | PLACEBO_COMPARATOR | Participants received Placebo as intravenous infusion on Day 1. |
| Group 2: Dupilumab-IR with GSK1070806 | EXPERIMENTAL | Participants received a single dose of 2 mg/kg GSK1070806 as intravenous infusion on Day 1. |
| Group 2: Dupilumab IR with Placebo | PLACEBO_COMPARATOR | Participants received Placebo as intravenous infusion on Day 1. |
| GSK1070806 or placebo | EXPERIMENTAL | This is a single dose escalating study. On enrolment into the study, each subject will be assigned to a group. These groups will be aligned to specific dose levels of GSK1070806. All subjects will be randomised to receive either a single intravenously administered dose of GSK1070806 or matching placebo (saline). The randomisation is generated by GSK prior to study start. |
| Name | Type | Description |
|---|---|---|
| GSK1070806 | BIOLOGICAL | To investigate the efficacy and biomarker changes of GSK1070806 after 0.25mg/kg IV administration |
| Placebo (saline) | OTHER | To compare the efficacy and biomarker changes between placebo and active groups |
| Placebo | DRUG | Participants will receive placebo |
Inclusion Criteria: 1. A diagnosis of T2DM as determined by a responsible physician based on a medical evaluation including medical history, physical examination, and laboratory tests, with onset at least 6 months prior to Screening. 2. Male or female between 18 and 70 years of age inclusive, at th...
GSK1070806 is an investigational small molecule being studied for atopic dermatitis, diabetes mellitus, and inflammatory bowel diseases. It is in clinical development by GSK plc and is not approved for any indication.
GSK1070806 is an antibody that targets interleukin-18, as indicated by its first-in-human study title. It is being investigated for its role in inflammatory conditions, though specific molecular details are not provided.
GSK1070806 is developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and efficacy.
GSK1070806 is in Phase 1 clinical development, with completed trials in atopic dermatitis and inflammatory bowel diseases. It is investigational and not yet approved by regulatory authorities.
GSK1070806 has completed four clinical trials, including NCT01035645 in inflammatory bowel diseases, NCT01648153 in type 2 diabetes, NCT04975438 in atopic dermatitis, and NCT05590338 in healthy volunteers. All trials are completed.
GSK1070806 is not known to have alternative names. It is referred to by its development code in clinical trials and published research.