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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
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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