A Study to Evaluate Efficacy and Safety of GSK3858279 in Diabetic Peripheral Neuropathic Pain (NEPTUNE-17)

GlaxoSmithKline (GSK)

Status and phase: Terminated; Phase 2

Conditions: Pain

Treatments: Drug: Placebo; Drug: GSK3858279

Study type: Interventional

Funder types: Industry

Identifiers

NCT05838755

214221

2022-502313-28-00 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 147 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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147 participants in 3 patient groups, including a placebo group

GSK3858279 Dose 1

Experimental group

Description:

Participants will receive GSK3858279 dose 1.

Treatment:

Drug: GSK3858279

GSK3858279 Dose 2

Experimental group

Description:

Participants will receive GSK3858279 dose 2.

Treatment:

Drug: GSK3858279

Placebo

Placebo Comparator group

Description:

Participants will receive placebo.

Treatment:

Drug: Placebo