A Study to Evaluate Efficacy and Safety of GSK3858279 in Diabetic Peripheral Neuropathic Pain

Pain Clinical Trial

— NEPTUNE-17  

Official title:

A Multicenter Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Target Engagement of GSK3858279 in Adult Participants With Chronic Diabetic Peripheral Neuropathic Pain (DPNP) /NEPTUNE-17

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05838755
• Other study ID #: 214221
• Secondary ID: 2022-502313-28-0
• Status: Recruiting
• Phase: Phase 2
• Start date: September 20, 2023
• Est. completion date: June 24, 2025

Study information

• Verified date: December 2023
• Source: GlaxoSmithKline
• Contact: US GSK Clinical Trials Call Center
• Phone: 877-379-3718
• Email: GSKClinicalSupportHD[@]gsk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicenter randomized, double-blind, placebo-controlled phase 2 study to evaluate efficacy, safety, tolerability, pharmacokinetics, and target engagement of GSK3858279 in adult participants with chronic Diabetic Peripheral Neuropathic Pain (DPNP). The primary objective of the study is to assess the efficacy of GSK3858279 in participants with DPNP who have been unable to sufficiently manage their pain.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: June 24, 2025
• Est. primary completion date: March 11, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Participant must be 18-75 years of age inclusive, at the time of signing the informed consent.
• Type I or Type II diabetes with painful, distal, symmetrical, sensory motor neuropathy attributed to diabetes, of at least 6 months duration.
• A pain score =4 and less than or equal to (=) 9 by the 11-point NRS (0-10) for average daily pain intensity over the past 24 hours at the screening visit.
• Body mass index (BMI) within the range 18-40 kilogram per meter square (kg/m^2) (inclusive)
• Capable of giving signed informed consent.

Exclusion Criteria:

• History or presence of cardiovascular, renal, gastrointestinal, lymphatic disorders which in the opinion of the investigator would interfere with the study procedures and/or assessments.
• Participant has current painful peripheral neuropathy due to a cause other than diabetes (e.g. pernicious anemia, hypothyroidism, post-herpetic neuralgia).
• History of significant allergies to monoclonal antibodies.
• Current enrolment or past participation in a clinical study of an investigational medicinal product intervention within the last 30 days or 5 half-lives (whichever is longer) of signing consent.
• Participants who are unlikely to comply with the protocol (e.g. uncooperative attitude, inability to return for subsequent visits, inability to complete the eDiary daily etc.) and/or otherwise considered by the Investigator to be unlikely to complete the study.

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Neuralgia
• Pain

Intervention

Drug:
• GSK3858279
GSK3858279 will be administered
• Placebo
Placebo will be administered

Locations

Country	Name	City	State
Canada	GSK Investigational Site	Brampton	Ontario
Canada	GSK Investigational Site	New Westminster	British Columbia
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Vancouver	British Columbia
Canada	GSK Investigational Site	Winnepeg	Manitoba
China	GSK Investigational Site	Beijing
China	GSK Investigational Site	Guangzhou
China	GSK Investigational Site	Harbin
China	GSK Investigational Site	Luoyang
China	GSK Investigational Site	Shanghai
China	GSK Investigational Site	Wuhan	Hubei
China	GSK Investigational Site	Yueyang	Hunan
France	GSK Investigational Site	Angers cedex 9
France	GSK Investigational Site	Corbeil-Essonnes
France	GSK Investigational Site	Maubeuge
France	GSK Investigational Site	Mulhouse
Germany	GSK Investigational Site	Bad Homburg	Hessen
Germany	GSK Investigational Site	Mainz	Rheinland-Pfalz
Germany	GSK Investigational Site	Mainz	Rheinland-Pfalz
Germany	GSK Investigational Site	Muenster	Nordrhein-Westfalen
Germany	GSK Investigational Site	Wallerfing	Bayern
Japan	GSK Investigational Site	Chiba
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Ibaraki
Japan	GSK Investigational Site	Osaka
Japan	GSK Investigational Site	Tochigi
Japan	GSK Investigational Site	Tochigi
Japan	GSK Investigational Site	Tochigi
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Korea, Republic of	GSK Investigational Site	Daejeon
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Poland	GSK Investigational Site	Katowice
Poland	GSK Investigational Site	Katowice
Poland	GSK Investigational Site	Katowice
Poland	GSK Investigational Site	Sochaczew
Poland	GSK Investigational Site	Warszawa
South Africa	GSK Investigational Site	Bellville
South Africa	GSK Investigational Site	Lenasia	Gauteng
South Africa	GSK Investigational Site	Pretoria	Gauteng
South Africa	GSK Investigational Site	Somerset West
South Africa	GSK Investigational Site	Stanger
South Africa	GSK Investigational Site	Umkomaas
Spain	GSK Investigational Site	Alzira/Valencia
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	La Coruña
Spain	GSK Investigational Site	Málaga
Spain	GSK Investigational Site	Palma de Mallorca
Spain	GSK Investigational Site	Pozuelo De Alarcón. Madrid.
Spain	GSK Investigational Site	San Sebastian de los Reyes
Spain	GSK Investigational Site	Torrevieja
Turkey	GSK Investigational Site	Ankara	Altindag
Turkey	GSK Investigational Site	Antalya	Konyaalti
Turkey	GSK Investigational Site	Bursa	Nilüfer
Turkey	GSK Investigational Site	Denizli	Pamukkale
Turkey	GSK Investigational Site	Istanbul	Atasehir
Turkey	GSK Investigational Site	Izmir	Balcova
United Kingdom	GSK Investigational Site	Cannock	Staffordshire
United Kingdom	GSK Investigational Site	Leeds
United Kingdom	GSK Investigational Site	Liverpool
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	Teesside
United Kingdom	GSK Investigational Site	Wrexham
United States	GSK Investigational Site	Anniston	Alabama
United States	GSK Investigational Site	Bellevue	Washington
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Huntersville	North Carolina
United States	GSK Investigational Site	Lomita	California
United States	GSK Investigational Site	McAllen	Texas
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Red Oak	Texas
United States	GSK Investigational Site	Renton	Washington
United States	GSK Investigational Site	Surprise	Arizona
United States	GSK Investigational Site	Tustin	California
United States	GSK Investigational Site	Waltham	Massachusetts
United States	GSK Investigational Site	West Palm Beach	Florida
United States	GSK Investigational Site	Williamsville	New York

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Canada,  China,  France,  Germany,  Japan,  Korea, Republic of,  Poland,  South Africa,  Spain,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the weekly average of average daily pain intensity at Week 12, assessed on the Numeric Rating Scale (NRS)	Brief Pain Inventory item 5 is a single item designed to capture information on the self-reported average pain intensity over the past 24 hours. Participants will be asked to mark their average pain intensity daily, using the NRS, on an 11-point scale (0-10), with 0 = no pain, and 10 = pain as bad as you can imagine. Daily scores for each participant will be averaged over 7 days to obtain a weekly score.	Baseline and Week 12
Secondary	Occurrences of adverse events (AEs), serious AE (SAEs), and AEs of special interest (AESI)	AEs, SAEs, and AESIs will be collected. Any untoward medical occurrence in participant, temporally associated with use of study intervention, whether or not considered related to medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, medically important were categorized as SAE. AESIs of the study drug includes serious and opportunistic infections, tuberculosis (TB) and TB reactivation, serious hypersensitivity reactions and Injection site reactions.	Up to 27 weeks
Secondary	Change from Baseline in Haematology Parameters: neutrophils, lymphocytes, monocytes, eosinophils, basophils, white blood cell (WBC), and platelet count (Giga cells per liter)		Baseline and up to Week 27
Secondary	Change from Baseline in Haematology Parameters: Red blood cell (RBC) count, (Trillion cells per liter)		Baseline and up to Week 27
Secondary	Change from baseline in haematology parameter: Haemoglobin (Hb) (Grams per liter)		Baseline and up to Week 27
Secondary	Change from baseline in haematology parameter: Haematocrit (Proportion of red blood cells in blood)		Baseline and up to Week 27
Secondary	Change from baseline in clinical chemistry parameters: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), Gamma-glutamyl transferase (GGT), and Alkaline Phosphatase (AP) (International units per liter)		Baseline and up to Week 27
Secondary	Change from baseline in clinical chemistry parameter: Total bilirubin (Micromoles per liter)		Baseline and up to Week 27
Secondary	Number of participants with greater than or equal to (=) grade 3 hematological/clinical chemistry abnormalities according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE)	Hematological/clinical chemistry abnormalities summarized according to NCI CTCAE grade	Up to 27 weeks
Secondary	Maximum concentration (Cmax) of GSK3858279	Cmax predicted from the D-E-R model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.	At Week 12
Secondary	The time required for GSK3858279 to reach Cmax (tmax) in the plasma	Tmax predicted from the D-E-R model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.	At Week 12
Secondary	Pre-dose (trough) concentration at the end of the dosing interval (Ctau) of GSK3858279	Ctau predicted from the D-E-R model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.	At Week 12
Secondary	Average concentration over a dosing interval (Cavg) of GSK3858279	GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.	At Week 12
Secondary	Area under the time-concentration curve (AUC) over the dosing interval (0-tau) (AUC[0-tau]) of GSK3858279	AUC(0-tau) predicted from the D-E-R model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.	At Week 12
Secondary	Change from baseline in the Short-Form McGill Pain Questionnaire total score over time	The McGill pain questionnaire Short Form 2 is a 22-item questionnaire total score, which evaluates multi-dimensional pain over time. The questionnaire consists of 22 descriptors that are rated on an intensity scale from 0 = none to 10 = worse possible	Baseline and up to Week 12
Secondary	Change from baseline in the weekly average of. average daily pain intensity over time, assessed on the NRS	Brief Pain Inventory item 5 is a single item designed to capture information on the self-reported average pain intensity over the past 24 hours. Participants will be asked to mark. their pain intensity on a daily basis, using the NRS, on an 11-point scale (0-10), with 0 = no pain, and 10 = pain as bad as you can imagine. Daily scores for each participant will be averaged over 7 days to obtain a weekly score.	Baseline and up to Week 12
Secondary	Number of participants with greater than or equal to (=) 30 percentage (%) reduction from baseline in the weekly average of average daily pain intensity at Week 12, assessed on the NRS	To capture information on the self-reported weekly average daily pain intensity. Participants will be asked to mark their pain-intensity daily, using the NRS, on an 11-point scale (0-10), with 0 = no pain, and 10 = pain as bad as you can imagine. Daily scores for each participant will be averaged over 7 days to obtain a weekly score.	At Week 12
Secondary	Number of participants with greater than or equal to = 50 % reduction from baseline in the weekly average of average daily pain intensity at Week 12, assessed on the NRS	To capture information on the self-reported weekly average daily pain intensity. Participants will be asked to mark their pain-intensity daily, using the NRS, on an 11-point scale (0-10), with 0 = no pain, and 10 = pain as bad as you can imagine. Daily scores for each participant will be averaged over 7 days to obtain a weekly score.	At Week 12