Last updated: 11/10/2025 16:50:26
A Study to Evaluate Efficacy and Safety of GSK3858279 in Diabetic Peripheral Neuropathic PainNEPTUNE-17
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Change from Baseline in the Weekly Average of Average Daily Pain Score at Week 12, Assessed on the Numeric Rating Scale (NRS)
Timeframe: Baseline (Day -7 to Day -1) and Week 12
Secondary outcomes:
Number of Participants with Adverse Events (AEs), Serious AE (SAEs) and AEs of Special interest (AESI)
Timeframe: Up to 27 weeks
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 (NCI-CTCAE)
Timeframe: Up to 27 weeks
Maximum Concentration (Cmax) of GSK3858279
Timeframe: Pre-dose, Week 1, Week 4, Week 7, Week 8, Week 11, Week 12, Week 16, Week 20 and Week 27 post dose
Time to Maximum Concentration (Tmax) of GSK3858279
Timeframe: Pre-dose, Week 1, Week 4, Week 7, Week 8, Week 11, Week 12, Week 16, Week 20 and Week 27 post dose
Trough Concentration at the End of the Dosing interval (Ctau) of GSK3858279
Timeframe: Pre-dose, Week 1, Week 4, Week 7, Week 8, Week 11, Week 12, Week 16, Week 20 and Week 27 post dose
Average Concentration over a Dosing Interval (Cavg) of GSK3858279
Timeframe: Pre-dose, Week 1, Week 4, Week 7, Week 8, Week 11, Week 12, Week 16, Week 20 and Week 27 post dose
Area Under the Time-Concentration Curve (AUC) over the Dosing Interval (AUC[0-Tau]) of GSK3858279
Timeframe: Pre-dose, Week 1, Week 4, Week 7, Week 8, Week 11, Week 12, Week 16, Week 20 and Week 27 post dose
Change from Baseline in the Short-Form Mcgill Pain Questionnaire Total Score Over Time
Timeframe: Baseline (Day1), Week 2, Week 4, Week 8 and Week 12
Change from Baseline in the Weekly Average of Average Daily Pain Score Over Time, Assessed on the NRS
Timeframe: Baseline (Day -7 to Day -1), Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12
Proportion 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
Timeframe: At Week 12
Proportion of Participants with Greater Than or Equal To >= 50 % Reduction from Baseline in the Weekly Average of Average Daily Pain Score at Week 12, Assessed on the NRS
Timeframe: At Week 12
Interventions:
Enrollment:
147
Primary completion date:
2024-14-10
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Pain
Product
GSK3858279
Collaborators
Not applicable
Study date(s)
September 2023 to February 2025
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 75 Years
Accepts healthy volunteers
No
- 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.
- 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).
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Participant must be 18-75 years of age inclusive, at the time of signing the informed consent.
Exclusion criteria:
- 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.
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.
Trial location(s)
Location
GSK Investigational Site
Huntersville, NC, United States, 28078
Status
Study Complete
Location
GSK Investigational Site
West Yorkshire, United Kingdom, LS10 1DU
Status
Study Complete
Location
GSK Investigational Site
San SebastiAn de los Rey, Spain, 28702
Status
Study Complete
Location
GSK Investigational Site
West Palm Beach, FL, United States, 33401
Status
Study Complete
Location
GSK Investigational Site
Williamsville, NY, United States, 14221
Status
Study Complete
Location
GSK Investigational Site
Wrexham, United Kingdom, LL13 7YP
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Pozuelo de AlarcOn Madr, Spain, 28223
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Renton, WA, United States, 98057
Status
Terminated/Withdrawn
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Other
Actual primary completion date
2024-14-10
Actual study completion date
2025-17-02
Plain language summaries
Summary of results in plain language
Available language(s): English, French, German, Japanese, Korean, Polish, Chinese (Simplified), Spanish
To view plain language summaries on trialsummaries.com click here.
Additional information about the trial
Additional information
Not applicable
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