Last updated: 11/10/2025 16:50:26

A Study to Evaluate Efficacy and Safety of GSK3858279 in Diabetic Peripheral Neuropathic PainNEPTUNE-17

GSK study ID
214221
See study documents
Clinicaltrials.gov ID
NCT05838755
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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:
  • Drug: GSK3858279
  • Drug: Placebo
    • 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:

      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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Angers cedex 9, France, 49933
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Anniston, AL, United States, 36207
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bad Homburg, Germany, 61348
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Barcelona, Spain, 08023
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Beijing, China, 100032
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bellevue, WA, United States, 98007
    Status
    Study Complete
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    Study documents

    Protocol
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    Available language(s): English
    Download document(s)

    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
    Download document(s)

    To view plain language summaries on trialsummaries.com click here.

    Additional information about the trial

    Additional information
    Not applicable
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