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Also known as Aletekitug (GSK1070806), GSK1070806
Aletekitug · 6 trials · 4 indications
To evaluate the efficacy of two repeat intravenous dose administrations of GSK1070806 in subjects with T2DM
Adverse events will be collected.
Serious AEs will be collected.
Participants who discontinue study intervention due to AEs will be reported.
Hematology, clinical chemistry, and urinalysis will be collected.
Blood pressure, temperature and pulse rate readings will be collected.
ECG readings will be collected.
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 |
| Aletekitug | EXPERIMENTAL | Participants will receive Aletekitug. |
| Aletekitug (GSK1070806) | EXPERIMENTAL | Participants will receive Aletekitug. |
| 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 |
| Aletekitug (GSK1070806) | BIOLOGICAL | Aletekitug will be administered. |
| Aletekitug | BIOLOGICAL | Aletekitug will be administered. |
| 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...
Aletekitug is an investigational monoclonal antibody being developed for the treatment of ulcerative colitis, specifically moderate to severe cases. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
Aletekitug is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The drug is in early-stage clinical trials for ulcerative colitis.
Aletekitug is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved for any use. Two Phase 1 trials are planned but have not yet started recruiting participants.
Aletekitug is involved in two Phase 1 trials: NCT07747467, a study of multiple interventions in moderate to severe ulcerative colitis, and NCT07747480, a substudy focusing on Aletekitug alone. Both trials are not yet recruiting and each plans to enroll 16 participants.
Yes, Aletekitug is also known as GSK1070806. Both names refer to the same investigational monoclonal antibody being studied for ulcerative colitis.