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

Phase 2

Terminated

• Conditions: Pain
• Interventions: Drug: Placebo; Drug: GSK3858279

• Registration Number: NCT05838755
• Lead Sponsor: GlaxoSmithKline

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-20
• Study First Submitted QC: 2023-04-20
• Study First Posted: 2023-05-03
• Study Start: 2023-09-20
• Primary Completion: 2024-10-14
• Study Completion: 2025-02-17
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 147

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will receive placebo.
GSK3858279 Dose 1	GSK3858279	Participants will receive GSK3858279 dose 1.
GSK3858279 Dose 2	GSK3858279	Participants will receive GSK3858279 dose 2.

Primary Outcome Measures

Name	Time	Method
Change from baseline in the weekly average of average daily pain intensity at Week 12, assessed on the Numeric Rating Scale (NRS)	Baseline and Week 12	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.

Secondary Outcome Measures

Name	Time	Method
Occurrences of adverse events (AEs), serious AE (SAEs), and AEs of special interest (AESI)	Up to 27 weeks	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), serious hypersensitivity reactions and Injection site reactions.
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)	Up to 27 weeks	Hematological/clinical chemistry abnormalities summarized according to NCI CTCAE grade
Maximum concentration (Cmax) of GSK3858279	At Week 12	Cmax predicted from the D-E-R model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.
The time required for GSK3858279 to reach Cmax (tmax) in the plasma	At Week 12	Tmax predicted from the D-E-R model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.
Pre-dose (trough) concentration at the end of the dosing interval (Ctau) of GSK3858279	At Week 12	Ctau predicted from the D-E-R model fitted to GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.
Average concentration over a dosing interval (Cavg) of GSK3858279	At Week 12	GSK3859279 serum concentration time data collected at the indicated time points for PK analysis.
Area under the time-concentration curve (AUC) over the dosing interval (0-tau) (AUC[0-tau]) of GSK3858279	At Week 12	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.
Change from baseline in the Short-Form McGill Pain Questionnaire total score over time	Baseline and up to Week 27	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
Change from baseline in the weekly average of average daily pain intensity over time, assessed on the NRS	Baseline and up to Week 27	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.
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	At Week 12	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.
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	At Week 12	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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 West Yorkshire, United Kingdom